REACHING IPli UNREACHABLES...the understandable biases of industry, government, or the various...

F D AS E P T E M B E R 1 9 7 1

P A P E R S

R E A C H I N G I P l iU N R E A C H A B L E S

P U B U C 'ADVISORY GROUPS

K /i

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"We ore corefully to preserve tbot life which the Author ofnoture has given us, for it wos no idle gift."

Harvey W. Wiley, 1844-1930Father of the Federal Food and Drugs Act of 1906

F r o m h i s c o m m e n c e m e n t a d d r e s s"Life and the Coming Time"

Hanover Coliege, 1867

For two decades we have known about the considerable health problem the Japanese have had withVibrio parahaemolyticus, a micro-organism found in improperly cooked seafoods which causes acute gastroenteritis. During the past five of those years we havealso learned that this micro-organism inhabits all thecoastal and estuarine waters of the United States, andprobably marine waters everywhere.

During the five years microbiologists of FDA andother Federal and State agencies have realized that themicro-organism was a potential threat to health hereand have been learning more about it—where it's found,conditions under which it thrives, how to detect it infood and water or sediment samples, the foods usually involved, the pathogenic and nonpathogenic typesof the organism, and something about the illness itcauses. These studies have been proceeding apace,even though no confirmed illnesses were reported inthis country.

But the picture has now changed. In August twooutbreaks of foodborne illness in Maryland involving340 people have been confirmed as being caused byV. parahaemolyticus (see page 16). Much is stillunknown about this micro-organism, and its relativeimportance as a foodborne disease threat here is yet tobe assessed. But the knowledge that a threat once potential is now real should give additional impetus tot h e w o r k .

FDA Papers / September 1971 / 1

4 ( r IT0 the Federal regulatory agency of any nation—yours or mine—science is an essential tool

to be fashioned to fit very specific priorities. Theneed exists for directed scientific competence—applied research if you will—research aimed atcreating knowledge and data which can standagainst the pressures of legal challenge as well asthe understandable biases of industry, government,or the various special interest groups with whomthe agency is involved.

"This is not to say that we in FDA or any otherGovernment regulatory agency can hang backw i t h t h e a t t i t u d e o f ' l e t s c i e n c e d o i t a l l . ' T h e r eare t imes tha t we w ish we cou ld . Bu t we a l l knowthat limitations exist; that new knowledge is notautomatically generated just because we need it.Just as emotionalism and good intent can neversubstitute for good science, neither can scienceexcuse the need for judgment."

Charles C. Edwards, M.D., Commissioner of Food andDrugs, at the Opening Session of the 31st Congress ofthe Pharmaceutical Sciences (FIP), Washington, D.C.,September 7, 1971.

" A the sophistication of marketing practicesand product technology increases, I would

expect increased Government regulation to insurethis increased sophistication is used for the benefitof the consumer. Food addi t ives increased the shel flife and palatability of many foods, but because thepractice of adding additives could be easily abused,it was brought under Government regulation. Asnew foods and types of foods are developed usingtextured protein and other forms of 'Food Engineering,' I would expect new measures would betaken to insure the safety, nutritional quality, andeconomic value of these products."

James D. Grant, deputy commissioner of food and drugs,at the Grocery Manufacturers of America Public Planning Policy Seminar, Washington, D.C., September 17,1 9 7 1 .

E l l i o t L . R i c h a r d s o nSecretary. U.S. Department ofH e a l t h , E d u c a t i o n , a n d W e l f a r e

Roger O. Egeberg, M.D.Asst. Secretary for Healtha n d S c i e n t i fi c A f f a i r s

Charles C. Edwards, M.D.Commissioner of Food and Drugs

J o h n T . W a l d e nDeputy Asst. Commissionerf o r P u b l i c A f f a i r s

Harold C. Hopkins/Editor ial Director

J e s s e R . N i c h o l s / A r t D i r e c t o r

Dan O'Too le /Photographer

Joan M. Galloway/Managing Editor

Frederick L. Townshend/Product ion Mgr.

PHOTOGRAPHY: Dr. Rita Colwell—Georgetown University, Washington, D.C., inside front cover, bottom right20; Fred Ward—Black Star 7-11; FDA.

FDA PAPERS, the official magazine of the Foodand Drug Administration, is published monthly,except for combined July-August and December-January issues. Subscriptions may be orderedfrom the Superintendent of Documents,Government Printing Office, Washington, D.C, 20402,at $3.50 a year ($1.00 additional for foreign mailing).

Address for editorial matters: FDA PAPERS,CE-20. Food and Drug Administration,5600 Fishers Lane, Rockviile, Md. 20852.

Articles published In FDA PAPERS are in thepublic domain and text may be republishedwithout permission. Use of funds for printing thispublication approved by Director of the Bureauof the Budget August 15, 1966.

Section 705 [375] of the Food, Drug, andC o s m e t i c A c t .

(a) The Secretary shall cause to be publishedfrom time to time reports summarizing alljudgments, decrees, and court orders which havebeen rendered under this Act, Including the natureof the charge and the disposition thereof.

(b) The Secretary may also cause to be disseminatedinformation regarding food, drugs, devices, orcosmetics in situations involving, in the opinionof the Secretary, imminent danger to health, orgross deception of the consumer. Nothing in thissection shall be construed to prohibit the Secretaryfrom collecting, reporting, and Il lustrating theresults of the investigations of the Department.

A d v i s o r s t o t h e E d i t o r *

H. Nelson Fitton, Department of Agriculture;George Creel, Department of Housing andUrban Development; William J. Cotter, PostOffice Department; Henry Scharer, Departmentof Commerce; Dr. Milner B. Schaefer,Department of the interior; Dr. Sam Kalm,Veterans Administration; Dr. Peter V. Siegel,Federal Aviation Agency; Dr. Spofford G.English, United States Atomic EnergyCommission; Dr. Harve J. Carlson, NationalScience Foundation; Howard J. Lewis,National Academy of Sciences; Arthur Settel,B u r e a u o f C u s t o m s .

*The Food and Drug Administration is solelyr e s p o n s i b l e f o r t h e c o n t e n t s o f F D A PA P E R S . T h eA d v i s o r s t o t h e E d i t o r a r e c o n s u l t a n t s o n m a t t e r srelating to the functions of the Federal Departmentsa n d A g e n c i e s l i s t e d .

2 / September 1971 / FDA Papers

P A P E R SVOL 5, NO. 7 / SEPTEMBER 1971

Reaching the Unreachahle Food Plant Employee 4Getting basic principles of sanitation across to food plant workers

whio speak only Spanishi or who have low education levels.

Puhlic Advisory Committees: Their Role in FDA Decisions iHow outside experts and specialists help solve major Agency problems.

How Fares the Consumer Under FPLA? 12A progress report on implementation of the Fair Packaging and Labeling Act.

Vihrio Parahaemolyticus: A^e^QtiMal Foodhorne Disease Problem 16Disease outbreaks in this country give new impetus

to study of this micro-organism.

Field Reports 23

News Highlights 27

Sta te Ac t i ons 29

Seizures and Postal Service Cases si

Notices of Judgment 34

4 7 1 2


Reaching the Unteachable Food Plant Employee

by Dale Hunter

The lower Rio Grande Valley of Texas is a land ofstartling contrasts. Within this valley there exist seredesert expanses and areas of lush subtropical vegetation. Handcrafted merchandise is important in commerce along with the products of sophisticated, highlymechanized, and technologically advanced industries.The region has a year-round gentle climate, unexcelledrecreational facilities, and a stimulating Mexican-American culture. Tourists and residents alike enjoygolf, swimming, and other summer sports in January.

Although the warm weather and mixed cultural environment provide fun and excitement for the tourists,they present some distinct problems to the extensiveand varied food industry of the area. The climate isresponsible for the rich yields of fruits and vegetablesbut it also accounts for the ever present and overlyabundant numbers of insects and other pests, the problem of maintaining a satisfactory time-temperature relationship in the processing of foods, and an environmentthat is ideal for the growth of microbes.

A less obvious but serious problem arises from thecultural background of the available work force of thearea. A large part of the unskilled and semiskilled laborpool consists of people who speak Spanish and little orno English, whose behavioral patterns are the producto f a n o t h e r s o c i o e c o n o m i c w o r l d . C u l t u r a l d i f f e r e n c e sand the language barrier challenge the most progressivein-house or outside employee training programs.

Selecting information most beneficial to these employees, determining how to present it, and preparingit in both English and Spanish adds to the difficulty.

In 1968, at the request of several members of theshrimp breading industry, FDA's Dallas District agreedto prepare in Spanish a training session of three to fourhours on basic sanitation principles for one of our workshops to be presented to workers in breaded shrimpplants in the Valley. This session was to aim at firstline supervisors and floor women who understood littleEnglish.

We had recognized the cultural-language barrier forsome time but this was our first real attempt to overcome it. We enlisted the help of Nicholas T. Serafy, aconsultant microbiologist to the food industry locatedin Brownsville, Texas. Mr. Serafy advised our staffmembers on the t rans la t i on o f t echn i ca l ma te r i a l ,proofed and corrected translated materials, and personally translated the most difficult papers. Severalmembers of the shrimp industry in Brownsville alsoassisted in planning the scope and depth of the variouspresentations, but the bulk of this work fell upon twoDallas District analysts. Humberto Guerrero and JuanTijerina accepted, without hesitation, the challenge oftranslating the materials needed into Spanish.

Dr. Kearby Fugate and James Hyndman, Districtmicrobiologists, helped prepare one talk giving a basicdescription of bacteria and another on the relationshipof personal hygiene and bacteria to food. These two lectures, tjie sound track for the movie "An Outbreak ofStaph Intoxication," and the sound track for the film

strip "Basic Biology of Bacteria" were translated intoSpanish.

On November 9, 1968, we used these two speechesand film sound tracks in the opening session of a shrimpworkshop at Brownsville, Texas. We felt that the Spanish language presentation was well received by theemployees and also was acceptable to industry management. Since then, we have had two further occasions touse the film sound tracks and parts of the speeches.

In July 1970, we were invited to participate in anin-plant training workshop by a shrimp processing firmin Dallas. This company had entered into a contract tohire and provide on-the-job training for the hard-coreunemployed under the U.S. Department of Labor"JOBS" Program. The company had also hired a commercial training organization to interview, hire, test,counsel, train, and advise all new employees under thisprogram. The in-plant program would be presented tothe firm's new employees hired under the program alongwith a number of its floor women and supervisors.

The firm's screening covers several topics or aspectsof employment, among them "class training" and"health rules." The "class training" topic informs theprospective employee that he will take a series of testsand will receive 80 to 320 course hours of training depending on his individual need as reflected by the testbattery. This classroom course work is in addition toon-the-job guidance to be given as he learns about foodhandling in a shrimp plant.

The "health rules" topic involves a general discussionof uniforms, hair nets, jewelry, fingernails, health cards,etc. These rules are explained to the employees duringtheir interview and they are further emphasized by thesupervisors on the job. Management has recognized forsome time the benefits to be derived from discussions byFederal, State, or local government health officials withcompany employees of these "health rules," of the employee practices looked for during inspections, andpersonal hygiene.

The July 1970 class consisted of about a hundrednew employees, divided into four equal groups of about25 each. The average educational level reported by thisclass was eighth grade and the educational level measured by the tests was about fourth grade. Three groupswere predominantly black and one Mexican-American.For four days we presented a two-hour workshop withone of these groups attending each day.

John Bittenbender, Dallas District's resident inspector in Brownsville spoke to the three English-speakinggroups. He used a series of slides showing both desirableand objectionable sanitary practices and conditions. Heexplained the basics of bacteria and the relationship ofbacteria to personal hygiene and to food. He used themovie "Simple Plants: Bacteria," a secondary schooloriented film presenting basic knowledge about bacteria,to add substance to his remarks on bacteria. The movie"An Outbreak of Staph Intoxication," a description ofthe events occurring during a case of food poisoning,was used to show the effects of poor sanitation practices


and the resu l ts o f bacter ia l contaminat ion o f foods.Juan Tijerina accompanied Mr. Bittenbender to

translate the slide presentation for the Spanish-American class. He drew from the basic speeches previouslypreparing for the 1968 shrimp breading industry workshop for translating and to answer questions about bacteria. His previous experience as a school teacher washelpful in relating to the group. The Spanish soundtracks for "An Outbreak of Staph Intoxication" and"Basic Biology of Bacteria" were also used with thisg r o u p .

In February 1971, we were again invited to presentan in-plant workshop for another class of new employees hired by the same firm under the "JOBS" Program. The new class was similar in size to the first, buttwo of the subgroups were Spanish-speaking. The educational attainment level was somewhat higher thanfor the previous class, but their knowledge of sanitationpractices in food plants was still scant.

The same program presented to the previous classwas used. Charles Roderick, a Dallas microbiologist,made the slide presentation to the two English-speakinggroups, and Juan Tijerina handled the project for theSpanish-speaking groups. Mr. Roderick has had considerable experience in the inspection of food plantsas part of an inspector-bacteriologist team.

The Spanish language recordings of the film soundtracks helped us to present tailored, well-received programs in both instances. Their success brings our effort-effect ratio into better balance. We believe the speechesand taped sound tracks are distinct contributions to theindustry educational effort of Dallas District.

It is difficult to measure the effect of a given in-planttraining session or series of in-plant or industry-wideworkshops. Company management does feel that theFDA sessions were beneficial. The following examplesof improvements were cited;

(1) At the first workshop, slides showed an employeebrushing off the bag end seam and stripping theouter layer of the multilayer paper bags beforedumping their contents into the breading tank.The procedure prevents contaminated debris fromthe bag's exterior from entering the tank. An employee who had been in charge of the firm's breading machine for several years was impressed bythe slides and the reason given by the inspectorfor following these procedures. He asked his superv i s o r i f h e c o u l d d o l i k e w i s e i n t h e f u t u r e . P e rmission was granted. The firm feels that this wasa definite improvement in its operation.

(2) A slide showing wooden-handled shovels beingused in an ice-room was cited as an objectionablepractice. The wood, a porous material, collectsbacteria which can contaminate employees' hands.Aluminum-handled implements were also shownand an explanation was made of why the smoothmetal is better than the wood. This employee also

suggested to his supervisor that all their wooden-handled implements be replaced with aluminum,and this was immediately done.

(3) During the most recent workshop the significance of rodents to foodborne diseases was explained to one of the groups of employees alongwith the essential role everyone should play in afirm's pest control program. Group members atonce reported having seen signs of rodent activityin their locker room. The company managementinvestigated, called in an exterminator, and thusended a potentially disastrous problem before ithad spread to other areas of the plant.

Many slides and verbal descriptions of both undesirable and desirable employee and sanitation practiceswere presented to the groups. Explanations were madeof why flies, roaches, rodents, birds, and bacteria areobjectionable. Naturally a firm cannot give us examplesof employees who decided, after attending the workshop, not to scratch their foreheads, handle other un-sanitized surfaces, pick spilled shrimp off the floor andreplace them on the line, come to work with a cold andfail to report it to their supervisor, or allow flies orother pests to remain in their homes or work areas. Butthey do feel that observations of employees at workand conversations with them indicate that they are generally more aware of good sanitation practices and arebringing this awareness to their jobs.

We have invested a small amount of Governmentfunds and Government employees' time in assisting withthe education of these newly employed workers who willhold jobs in a segment of the food industry where highsanitation control is critical. The time and money, webelieve, has to be a sound investment. Not only will ithelp these people produce cleaner, safer food at work,but it will encourage them to introduce similar practices in their homes.

D a l e H u n t e r , p r o g r a manalyst , Dal las Dis t r ic t ,j o i n e d F D A I n 1 9 6 0 a tS t . L o u i s a n d t r a n s f e r r e dto Da l l as D is t r i c t i n 1961 .


P U B L I C A E ^ / I S O R Y C O M M mT h e i r R o l e i n F D A D e c i s i o n s b y R i c h a r d l S c h m i d t

The policy of enlisting the servicesof public advisory committees ona continuing basis to assist the Commissioner of Food and Drugs in discharging his responsibilities underthe Federal Food, Drug, and Cosmetic Act was adopted by the Foodand Drug Administration in 1964.During the intervening years, FDAhas developed an active program inthe use of advisory committees whichhas proved its value by bringing toFDA the advice and opinions of theleaders of the medical and scientificcommunities on a variety of important and timely issues.

Public advisory committees areused widely today in the FederalGovernment and in FDA as a meansof complementing the knowledgeand expertise available from Agencystaff members. They bring to beara b r o a d b a s e o f a c a d e m i c a c h i e v ement and practical experience in adiversity of scientific and biomedicalclinical settings that proves invaluab le to FDA in i t s es tab l i shment o f ascientific basis of judgment in determining the safety and efficacy offoods and drugs and in developingguidelines for industry compliancewith the law. Public advisory com

mittees are most useful in focusingattention and expert opinions on topical issues and in providing for objective evaluation and recommendations. The committee process alsohelps create confidence in the regulatory role of FDA since it providesfor thorough examination of available scientific data before final decisions are made at the regulatoryleve l .

A b r i e f d i s c u s s i o n o f t h e b a c k

ground and duties of some of ourcommittees may be helpful in relating their roles to that of the Foodand Drug Administration.

One of the more important committees in FDA at present is thePoison Prevention Packaging Technical Advisory Committee created bythe Poison Prevention PackagingAct of 1970 (Public Law 91-601)which was signed into law by President Nixon on December 30, 1970.The Act provides for the establishment of a technical advisory committee to advise the Secretary in thedevelopment of standards for special packaging intended to protectchildren from personal injury or illness resulting from handling, using,or ingesting household substances.

Donald E. Hayhurst, Ph.D.(standing), Auburn University,Auburn, Alabama, chairman ofthe Po ison Prevent ion

Packaging Technical AdvisoryCommittee, makes a reportduring the committee's meetingSeptember 76 in Washington.The committee was establ ished inApril of this year with a membershipcomposed of consumers, industry,and Government, as required by theAct. The committee met for the firsttime on May 13 and 14.

The use o f methadone ma in tenance as a means of controlling certain types of narcotic addiction hasgrown increasingly popular in recentm o n t h s . F D A h a s d e t e r m i n e d t h a t

methadone, when used for this purpose, is an Investigational NewDrug. The Methadone MaintenanceAdvisory Committee was thereforeestablished on November 6, 1970,to provide advice on the approval ofthese Investigational New Drug Applications and to advise FDA on theconduct o f such s tud ies to insure thesafety of the patient and the accumulation of significant data.

The rapid growth of the medicaldevice industry and the increasingcomplexity and sophistication ofmed ica l dev i ces l ed to t he es tab l i shm e n t o f t h e M e d i c a l ' D e v i c e A d v i s

ory Committee on April 2, 1971, toassist FDA in dealing with new problems and questions concerning dev i c e s . T h i s c o m m i t t e e a d v i s e s t h e

Agency on proposed plans, pro-


At left: John J. Thieike (left),Economic Laboratory, Inc.,New York City, and RichardSlade (right). NorthwesternNational Bank of Minneapolis,M i n n e s o t a .

Below: Ned W. Smull, M.D.(left). Children's MercyHospital, Kansas City; MaryjaneMorgan (center), Decatur,Georgia; and Robert H. A.Haslam, M.D. (right), johnsHopkins Hospital, Baltimore.


grams, and activities in the areas ofmedical device inventory and classification, standards setting, and regulation from the standpoint of practical, technical, and medical ramifications, and provides expert medical,industrial, and scientific guidance,background, and opinion on thesafety, hazards, and efficacy of various medical devices.

The Obstetrics and GynecologyAdvisory Committee was establishedon August 31, 1965, to advise theFood and Drug Administration onthe safety and efficacy of drugs usedin the practice of obstetrics and gynecology. This committee has beenlargely concerned in recent yearswith the questions of safety and efficacy of the oral and intrauterinecontraceptives, and has publishedtwo widely circulated reports onthese subjects in 1966 and 1968.

The Psychotomimetic Agents Advisory Committee was establishedjointly by FDA and the National Institute of Mental Health on March 9,1967, to recommend action to betaken by the Commissioner of Foodand Drugs on notices of claimedinvestigational exemption for new

drugs involving psychotomimeticagents. It also recommends tothe director. National Institute ofMental Health, action to be takenon requests received by NIMH forsupplies of psychotomimetic agentsfor scientific study purposes.

In addition to the foregoing publicadvisory committees, a group oftechnica l commit tees has been established by FDA beginning in 1967 toprovide expert advice where thereis a continuing need. To assist inevaluating new drugs, committeesh a v e b e e n e s t a b l i s h e d o n s u c h s u b

jects as anti-infective agents, cardiovascular and renal drugs, dermatology, endocrinology and metabolism,neuropharmacology,' radioactivepharmaceuticals, and respiratory andanesthetic drugs. These committeesare composed entirely of specialistsin the pertinent field of the bio-med-i c a l s c i e n c e s a n d r e l a t e d s c i e n t i fi cfields, and have proved to be usefulin providing an exchange of inform a t i o n a n d v i e w s b e t w e e n F D A a n dt h e m e d i c a l a n d s c i e n t i fi c c o m m u n ities. In regularly scheduled meetings,FDA's professional staff is given theopportunity to present issues of na-

Cerald L. Roy (left), Kerr ClassManufacturing Corp.,Lancaster, Pennsylvania, andHenry Verhulst (right), director.D i v i s i o n o f H a z a r d o u sSubstances and Poison Control,Bureau of Product Safety, FDA.

tional public health significance involving specific drug problems thatare before the Agency for decision.Recently, our technical committeeshave assisted in devising generalguidelines for the clinical investigation of various drug classes. The aimof these guidelines will be to definethe type of research necessary toprove that drugs being tested areboth safe and effect ive.

On February 26, 1962, PresidentKennedy issued Executive Order11007 which prescribed regulationsfor the formation and use of advisorycommittees. This order requires thatno public advisory committee shallb e e s t a b l i s h e d u n l e s s t h e h e a d o f a

department or agency (the Secretaryof Health, Education, and Welfare)has formally determined that its formation is in the public interest inconnection with the duties imposedon that department or agency by law.The order also imposed uniformstandards to be observed in the conduct of meetings.

Under this order, all public advisory committees other than those specifically provided for by law terminate two years from the date of establishment unless the Secretary formally determines that their continuance is in the public interest. Thisprovision is a built-in safeguardagainst continuance of committeesthat may have ceased to fulfill theirintended purposes and functions.Thus, every two years FDA mustevaluate the accomplishments andperformances of each of its nonstatutory committees and decide whether to request the Secretary to cont inue the commi t tee o r to recommendthat it be terminated. The Secretary


At left: Charles Hagen (left), Seymour of Sycamore,Inc., Sycamore, Illinois; Alfred MuUiken (center).Chemical Specialties Manufacturing Association,New York City; and John D. Northrup (right),Owens-Illinois, Inc., Toledo, Ohio.

Below: Sam Hart (left), deputy director. Bureau ofProduct Safety, FDA, and Robert C. Scherz, M.D.(right), Madigan General Hospital, Tacoma,Washington.

has delegated to the Assistant Secretary for Health and Scientific Affairsthe authority to establish, continue,and terminate certain types of commi t tees .

In add i t ion to Execut ive Order11007, the Department has published its own committee management regulations for the guidance ofthe constituent agencies.

There are three types of committees presently used in FDA and inthe Department.

Class A committees are the toplevel policy advisory groups andare always advisory to the agencyhead, who sits as chairman. Unlesscreated by statute, these committeesare always established by the Secretary and members are selected bythe Secretary from nominationsmade by the agency. These committees consist partly of representativesfrom the appropriate scientific community, such as food technology andscience or medicine, and partly ofrepresentatives of consumer interests. Their function is to provide ad-viqe and guidance to the agency intheir particular area of expertise on

policy matters of national significance as well as to review and makerecommendations on applicationsfor research project grants and research training projects relevant tothe mission of FDA as required bylaw. These committees also serve asforums for the exchange of viewsa n d r e c o m m e n d a t i o n s o f a w i d e v a

riety of interested groups. Class Agroups carry the uniform title of"National Advisory Committees" asopposed to those created by statute,which are called "National AdvisoryC o u n c i l s . "

Class B committees are those defined as having "limited policy implications." These committees are established by the Assistant Secretaryf o r H e a l t h a n d S c i e n t i fi c A f f a i r s a n dmembers are selected by the Assistant Secretary from nominationsmade by the agency. Class B committees in FDA include, for example, the Methadone MaintenanceAdvisory Committee and the Obstetrics and Gynecology AdvisoryC o m m i t t e e .

C l a s s C c o m m i t t e e s a r e t e c h n i c a lin nature. These are established by

the Assistant Secretary for Healthand Scientific Affairs and membersare selected by the Commissioner ofFood and Drugs.

The Department-wide committeemanagement program is administ e r e d f r o m t h e i m m e d i a t e O f fi c e o fthe Secretary. The Department Committee Management Officer is responsible for coordinating all requests from the agencies that requireaction by the Secretary or the Assistant Secretary for Health and Scientific Affairs, and for interpretingrules and regulations for the agenc ies .

The FDA Committee Managem e n t O f fi c e i s l o c a t e d i n t h e O f fi c eo f t h e A s s o c i a t e C o m m i s s i o n e r f o rScience and is responsible for coordinating all FDA committee management activities within establishedrequirements, policies, and procedures; providing a focal point forguiding the establishment, staffing,and management of public advisorycommittees; developing informationand reports on FDA committees: anddeveloping and disseminating FDApolicy and procedures on establish-


At left: Peter P. Cach (center). Sunbeam PlasticsCorp., Evansville, Indiana; and Walter M. Booker,Ph.D. (right), Howard University Medical School,Washington.

Below: Malcolm W. jensen (left), director. Bureau ofProduct Safety, FDA, and Myron S. Weinberg, Ph.D.(right), Foster D. Snell, Inc., Florham Park, Newjersey.

ing, staffing, and utilizing committ e e s .

The National Advisory Food andDrug Council which had been establ ished in 1964 was abol ished in Jan

uary 1970 when, after a review ofthe previous year's experience, itw a s c o n c l u d e d t h a t t h e s t r u c t u r e o fits membership was not appropriateto deal effectively with current programs and responsibilities. Sincethat time, FDA has not had a committee to advise on top level policymatters. However, the Secretary hasexpressed a desire that the functionsof public advisory committees berelated more closely to the development and implementation of Department policy and that they provide forbroad public representation in thedecision-making processes. FDA istherefore now in the process of establishing top level National Advisory Committees in the areas of foods,drugs, veterinary medicine, andproduct safety. Consumer interestswill be adequately represented oneach of these committees. In July1968, certain Public Health Serviceprograms that involved the adminis

t r a t i o n o f r e s e a r c h a n d r e s e a r c h

training grants were transferred toFDA. Applications for these grantsh a d r e c e i v e d a n i n i t i a l s c i e n t i fi cmerit review through an appropriateStudy Section at the National Institutes of Health, and the final reviewprocess was accomplished by theNational Advisory EnvironmentalControl Council, which has recentlybeen dissolved due to reorganizationand realignment of agency responsibilities. Each of these grant programsin the food and product safety areaswill now be handled by the appropriate FDA National Advisory Comm i t t e e .

Public advisory committees havecome to play a vital role in decisionmaking processes at all levels in theFood and Drug Administration. Ourcommittee members are well qualified scientists and public spirited individuals who provide diversity ofjudgment, outlook, and backgroundso essential to our programs. FDAis indeed grateful for the time andeffort expended by these outstandingcitizens in working with us to furtherthe health programs of the Nation.

Richard L. Schmidt, committee managem e n t o f fi c e r , O f fi c e o f t h e A s s o c i a t eCommissioner for Science since January1970, joined FDA In 1960.

F D A P a p e r s / S e p t e m b e r 1 9 7 1 / I I

How Fares the Consumer Under FPL A?by John Gomilla

Few pieces of consumer legislation have matchedthe stormy evolution, ambitious scope, and potential for benefit to the consumer's pocketbook as theFair Packaging and Labeling Act of 1966. Argumentsagainst the need for the legislation, though not persuasive enough to prevent enactment, in retrospectnow provide a yardstick against which both the progressa n d t h e b e n e fi t s c a n b e e v a l u a t e d .

Has the FPLA proved to be a "no law" law as someconsumerists maintained would be the case? Did thelaw stifle the creativity of the package and label designeras that industry had contended it would? Finally andmost important, is the consumer deriving any tangiblebenefits from the FPLA in the marketplace today? Letus explore the current status of this law and the mannerin which it is being implemented and possibly gain aninsight into what the future holds under its provisionsfor both the consumer and the affected industry.

In the five years since the Fair Packaging and Labeling Act became law on November 3, 1966, much hasbeen done and is being done by the Food and DrugAdministration, State authorities, and industry to provide consumers with the statute's intended benefits,especially in the labeling and packaging of foods. Members of the food industry have revised thousands oflabels, and plates have been made from which billionsof new labels have been printed to comply with thisAct and the regulations.

Not all manufacturers have complied, however; FDAis still finding it necessary to detain imports and initiatemany seizures involving foods whose labels do notcomply.

Along with these enforcement activities FDA isdeveloping regulations to implement those provisionsof the FPLA that (1) deal with the use of label representations which imply that a consumer commodity isbeing offered for retail sale at a lower than ordinaryor customary price, (2) provide for standards to control label statements characterizing package size, and(3) prohibit nonfunctional slack fill of packages. Toobtain information needed by the FDA to promulgatethese regulations. State authorities are conducting retailsurveys under cost reimbursement contracts in anunusual State-Federal cooperative undertaking that hasbeen both thoroughgoing and revealing.

Promptly after passage of the FPLA five years ago,FDA began work to implement the provisions of theAct for which this Agency was made responsible: thoseapplying to foods, over-the-counter drugs, devices, aiidcosmetics as defined in the Federal Food, Drug, andCosmetic Act, with certain important exceptions. Excluded from the provisions of the FPLA were foods;meat and meat products, poultry and poultry products;and alcoholic beverages subject to the Federal AlcoholA d m i n i s t r a t i o n A c t .

Before labels could be revised to comply with thegeneral provisions of the Act, detailed regulations were

needed. The FDA published in the Federal Registerof March 17, 1967, a proposal that included new regulations to implement the FPLA provisions concerningfood labels and made much needed revisions of generalregulations that had been issued under the FDC Acta quarter of a century earlier. Revised regulations werepublished on July 21, 1967, and after comments andobjections had been considered the FDA published afinal order September 20, 1967.

Since July 1, 1969, the FPLA and new labelingregulations have applied to all foods imported orshipped in interstate commerce except those specificallyexcluded by the Act or subject to exempting regulationspromulgated as provided for in the Act. By this datemost food manufacturers and distributors had obtainedand were using labels revised to comply with the orderpublished in September 1967.

But there were some who were not complying. In1970 the FDA detained hundreds of lots of importedfoods and initiated seizure actions against about ICQlots of foods in interstate commerce, charging violationof the FPLA and the regulations implementing thatAct. These seizure actions involved 163 samples offoods whose labels failed to comply with one or moreprovisions of the Act or regulations; most samples werefound violative in two or more respects. Nineteensamples were also found misbranded under varioussec t i ons o f t he FDC Ac t .

About three-fourths of the violative samples (125 of163) did not have the required declaration of quantityof contents printed in the minimum type size prescribedby regulation. About half (82) failed to meet the requirement that packages weighing one pound or more,but less than four pounds, must declare the net weight,both in ounces and in pounds and ounces or poundsand fractions (or the equivalent declaration in volumetric terms required on packages of a pint or more butless than a gallon).

On almost half (80) of the samples, the quantity ofcontents declaration was not printed in the lower 30percent of the principal display panel area as requiredby regulations. On about one-fourth (43) of the samples, the quantity of contents statement lacked con-spicuousness because it was not separated from otherprinted matter by the prescribed distance. On the labelsof 21 samples the quantity of contents declaration eitherdid not appear on the principal display panel or wasnot repeated on alternate principal display panels.There is no legal requirement that food labels tell howmany individual servings a package contains, but if sucha statement is printed on the label, the size of eachserving must be specified. Ten of the samples borelabels stating the number but not the size of servings.

The FDA is continuing its program of action to detainimports and to initiate seizures of interstate food shipments that do not comply with the FPLA and theregulations. It must be emphasized, however, that


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seizures are not always determined to be the preferredcourse of action when noncomplying consumer commodities are encountered. Hundreds of warning lettershave been issued to industry by our field District officesand have proved quite effective in obtaining correctionswithout the need for formal seizure. In addition, thisAgency has been as active as its resources will permitin educating industry in all phases of compliance withthe FPLA. We hope that these educational efforts willpromote voluntary compliance and minimize the needfor formal regulatory action.

In its administration of the FPLA, FDA has soughtand received the active cooperation of State authoritiesin accord with provisions in section 9 of the Act. Closecooperation with the States in the promulgation ofregulations has been especially important because FPLAsupersedes any and all State laws that ''provide for thelabeling of the net quantity of contents of the packageof any consumer commodity covered by this Act whichare less stringent than or require information differentfrom the requirements of section 4 of this Act or regulations promulgated pursuant thereto."

To assist State authorities and promote uniformityin enforcement, the FDA prepared a manual for Stateofficials which includes FDA requirements and important interpretations. Later a revision of this manualwas made avai lable to interested trade associat ionsand members of industry to facilitate compliance andpromote uniformity in the labeling of foods, drugs,devices, and cosmetics.

Under section 5 of the FPLA, regulations may bepromulgated, when needed to prevent deception orfacilitate value comparisons, to: (1) establish standardsfor the manner in which sizes are described, such as"king size," "family size," or similar descriptive terms;(2) control use of label statements which imply that acommodity is offered for retail sale at a price lowerthan that ordinarily and customarily charged; (3) require that other consumer commodities be labeled, likefoods, with the common or usual name and list ofingredients; and (4) prohibit nonfunctional slack fillof packages. The FDA is authorized to promulgatesuch regulations covering foods, drugs, devices, andcosmetics. The Federal Trade Commission is responsible for regulations concerning other consumerc o m m o d i t i e s .

In May 1970, both the FDA and the FTC publishedproposed regulations intended to protect consumersagainst misleading or confusing claims or implicationsthat a commodity is being offered for retail sale ata price lower than ordinarily and customarily charged.Both proposals dealt with "cents off" representations;the FDA proposal also covered "economy size" claims.The FTC proposal concerning "economy size" claimswas published November 24, 1970. Both agencies havetried to reconcile differences in their respective proposals so that final regulations may be as uniform aspossible and thus provide common terms and generalrequirements that both industry and the consumer canunderstand as applying to all kinds of products, regardless of which agency has jurisdiction. Differences in

regulatory authority, established procedures, and enforcement capabilities may result in final regulationswhich are not exact duplicates. However, there will beuniformity in their major provisions.

In a recent action to finalize the previously proposed"cents off" and "economy size package" regulations,the Food and Drug Administration published an orderin the Federal Register of June 30, 1971. As is provided for in such rulemaking, interested parties usedthe opportunity to respond to the regulation. Theseresponses, consisting of opinions, requests for clarification, and objections to- certain provisions, are beingevaluated and a decision will issue shortly. An effectivedate of December 31, 1971, was set for these regulations, but this date is not inflexible and is subject tomodification by the Commissioner of Food and Drugss h o u l d c i r c u m s t a n c e s w a r r a n t .

Over the years the FDA has consistently receivedcomplaints from irate consumers about the slack fillingof packages. Despite Section 403(d) of the Food, Drug,and Cosmetic Act which deems a food to be misbrandedif its container is so made, formed, or filled as to bemisleading, the FDA was notably unsuccessful in copingwith this problem. In each contested case of allegedslack filling brought under this FDC Act section, theF e d e r a l c o u r t s e x h i b i t e d a r e l u c t a n c e t o c o n s i d e r a

package to be nonfunctionally slack filled if its labelcarried an accurate declaration of the quantity ofc o n t e n t s .

In view of FDA's inability to deal with the continuingallegations of slack filling received from consumers, theenactment of the Fair Packaging and Labeling Act,specifically authorizing this Agency in Section 5(c)(4)to issue regulations to prohibit nonfunctional slack fill,was hailed as a golden opportunity for a fresh approachto a problem that began with the first packages.

The previous decisions of the Federal courts emphasize the need for clearly demonstrating the extent towhich the space not occupied by the consumer commodity in the package is functional, that is, necessaryto protect the integrity of the product; or nonfunctionalto the extent that the consumer may possibly be deceived.Simply stated, where in the packaging of a product isthe line to be drawn that distinguishes functional fromnonfunctional? How full must a package be? How muchsettling of the product is unavoidable, even in the mostcarefully controlled manufacturing and filling operations?

To answer such questions the Food and Drug Administration launched an extensive survey to find outmore about the magnitude and extent of the problemwhere it was most apparent to the consumer—theretail marketplace. Six broad categories of packagedfoods were selected for the retail survey. These wereproducts which have a significant place in the Americandiet or which are the basis of recurring complaintsabout slack filling. They were macaroni and noodleproducts; dry cereal and grain products; candy; loose-filled crackers, cookies, etc.; dry cake mixes; and dryd e s s e r t s . To a s s i s t u s i n t h i s e x t e n s i v e i n f o r m a t i o n -

gathering operation, we enlisted the services of manyState regulatory agencies through cost-reimbursable


contracts. This project ushered in a new and innovativeera of State-Federal cooperation for the Food and DrugA d m i n i s t r a t i o n .

For the 1971 fiscal year, contracts were negotiatedwith 11 States: Alabama, Idaho, Florida, Maryland,Minnesota, Missouri, Oklahoma, Pennsylvania, Texas,Washington, and Wisconsin. These contracts providedfor State authorities, in accord with detailed FDAinstructions, to collect and examine consumer packagesof selected foods to obtain data concerning (a) slackfill and (b) package size characterization as relatedto net contents. The findings were to be reported eachm o n t h t o F D A .

Under these contracts. State authorities collectedand examined more than 10,000 samples. The datafrom this survey has been assembled but has not yetbeen organized and analyzed. Therefore, broad conclusions concerning interpretation of results are notpossible at this time.

But even a casual scanning of the raw data concerning percentage of package fill brings to light somestriking contrasts and raises some interesting questions.In many of the samples of breakfast cereals made fromwheat, rice, and oats, packages were full or almost full,but in other samples the packages were far from full.Some packages of rice breakfast foods were only abouttwo-thirds full; some packages of wheat breakfast foodswere less than half full and one was only slightly morethan one-fourth full. In one sample of oatmeal thepackages were only a little over half full. During thesurvey it was noted that one breakfast food manufacturer had voluntarily reduced the size of a container byalmost six cubic inches without any change in thequantity of contents.

Even greater variations were found in the fill ofmacaroni and spaghetti products. In many samples thepackages were filled or almost filled; in other samplespackages were only half filled, and in a few instancesthe food occupied as little as one-fifth or less of theavailable space. In many of the samples of cookiemixes, pudding mixes, and other prepared mixes, thepackages were found to contain only one-half to two-thirds as much as they could hold. Some packagesof candy, including hard candies and licorice as wellas more fragile chocolates, were found only about half-filled. Whether the slack fill in these packages isfunctional or nonfunctional will call for thoroughinvestigation.

The State authorities also check the net weights ofthe samples examined. They found that in about 7percent of the samples the net weight was 1 percentor more below the declared weight. Each of these hasbeen reported to the FDA District in whose territorythe manufacturer is located for appropriate correctiveaction by the District or State officials.

Over 800 food product labels were found to bearvarious descriptions of size. Some carried one sizedesignation for such a wide range of package sizes ofthe same food that it would make value comparisonsdifficult, and would certainly be confusing. For instance,one food was sold in 5, 7, 8, 9, 10, 11, 12, 13, 15, 16,

18, 20, and 42-ounce packages, all described as "largesize." Other size designations were more imaginativethan informative. Among these were "Jug Size,""Ketchup-Lovers Size," "Coffee-Lovers Size," "TribeSize," "Pass-around Size," "Patio Size" and "FunS i z e . "

The new venture in State-Federal relations provedb e n e fi c i a l t o a l l c o n c e r n e d . F D A o b t a i n e d t h e i n f o r m ation it needed; the State agencies were able to employand train more people, and to enter new areas of regulatory activity. Both Federal and State agencies willbenefit from the better communications and workingrelations that evolved as they joined in this commone n d e a v o r .

The operation was so successful that it is beingcontinued in fiscal year 1972. Contracts have beennegotiated with 10 States to conduct another retailsurvey, this time to: (1) ascertain the impact of theFPLA in the marketplace, to determine the level orextent of compliance, and, when violations are found,to initiate corrective actions through State agenciesor the FDA; and (2) to determine what representationsare being made on labels concerning cost savings, tofind whether the promised savings are actually passedon to consumers, and, if not passed on, to estimate theloss to consumers. This survey includes cosmetics aswell as foods. It is too early to predict the results, butalready the State agencies are finding many cosmeticpackages and some food packages that do not complywith the FPLA. Appropriate regulatory action will betaken against violative lots by State or FDA officials.

Food labels now provide consumers informationabout what food is in the package, who makes ordistributes it, and how much the package contains.Regulations are being developed that will provideconsumers further protection against confusing characterizations of package size, false and misleading promises of savings through the use of "cents off" or"economy size" claims, and packages that deceive. Inthe process, FDA has pioneered the use of cost-reimbursement contracts that have benefited State agencies and developed information needed by this Agency.

The work that is being done to implement the FairPackaging and Labeling Act gives promise that thewill of the people in seeking this important legislationand the intent of the Congress in enacting it will befulfilled in a way that is both advantageous to consumersand fair to industry.

J o h n G o m i l l a , c h i e f o fthe Fai r Packaging andLabe i ing Branch o f theD i v i s i o n o f R e g u i a t o r yG u i d a n c e i n t h e B u r e a uo f F o o d s O f fi c e o f G o m -p i i a n c e , j o i n e d F D A ' sN e w O r l e a n s D i s t r i c t a san inspector in 1956.


VIBRO PARAIHAEMOLYTICUS:

F o o d b o r n e D i s e a s e P r o b l e m

Last August 14 a picnic was held in Maryland at which550 guests attended. It was a feast of ChesapeakeBay steamed crabs, a regional delicacy that has been esteemed by Marylanders since colonial days. Some 16hours later, 320 of the picnickers became ill withsymptoms such as diarrhea, severe abdominal cramps,nausea, vomiting, fever, headache, and chills. A number of the affected people were hospitalized.

Two days later, at a much smaller picnic, 20 out of 30guests developed a similar illness from eating steamedcrabs. The symptoms of the smaller outbreak wereidentical with those of the first. No death occurred ine i t h e r o u t b r e a k .

Maryland State Health Department officials foundthat c rabs f rom the same ba tch were d is t r ibu ted to bo th

picnics. Maryland Department of Health and FDAl a b o r a t o r i e s e x a m i n e d c r a b s o b t a i n e d f r o m o n e o f t h e

picnics and also stools from several ill persons. Theusual expected enteric pathogens such as Salmonellaor Shigella were not found in the stools or the crabs.Instead an organism known as Vibrio parahaemolyticuswas found. This organism is known to be an important cause of foodborne disease in Japan, but it hasn e v e r b e e n i d e n t i fi e d w i t h o u t b r e a k s i n t h e U n i t e dStates.

The analyses and investigations by the State ofMaryland and FDA were sufficient to establish for thefirst time on record that V. parahaemolyticus was responsible for outbreaks of disease in this country.Equally as important to public health in the UnitedStates, the findings supported and gave immediate relevancy to the concern of FDA and other public healthagencies over the past several years that the microorganism posed a potential threat to public health inthis country.

Vibrio parahaemolyticus has been recovered from allparts of the marine environment, including seafoodproducts, both in waters that are polluted and watersnot known to be polluted. It has been found in samplestaken from practically all major bodies of marine watersurrounding the United States. It thrives better inw a r m w e a t h e r t h a n i n c o l d a n d t h e i l l n e s s e s i t c a u s e sare usually associated with warm weather. It is killedby thorough cooking.

Until the outbreaks in Maryland in August, the onlyinstances of illness to be reported as due to Vibrioparahaemolyticus had been in Japan. The first outbreak of disease for which Vibrio parahaemolyticus isknown to have been responsible occurred in Osaka,Japan, on October 21-22, 1950. Of the 272 victims

who developed an acute gastroenteritis after eating"shirasu" (boiled, semidried sardine larvae), 22 died.Autopsy specimens yielded an organism that Dr.Tsunesaburo Fujino, in describing the outbreak thenext year, named Pasteurella parahaemolyticus. Subsequently, numerous similar outbreaks occurred andthe organism underwent several redesignations. Finally,in 1963, Dr. Riichi Sakazaki of the Japanese NationalInstitute of Health and others suggested the nameVibrio parahaemolyticus after a definitive study ofmany cultures. The name has been widely acceptedthroughout the world.

Vibrio parahaemolyticus is an enteropathogenic,gram-negative, curved, rod-shaped, facultative microbe,and the most favorable condition for its growth is ina medium containing 2-4 percent salt. It particularlyfavors alkaline conditions and multiplies rapidly at37° centigrade. It appears to be able to live in marinewaters without an animal host. It has been found inc o a s t a l a n d e s t u a r i n e w a t e r s a n d s e d i m e n t s a n d o nmarine fish, crustaceans, and shellfish in many areas ofthe world, including all coastal waters of the UnitedStates. It is believed to be universally distributed in them a r i n e e n v i r o n m e n t .

Outbreaks of food poisoning caused by this organismin Japan have usually followed the eating of raw seafoods and other contaminated products. Outbreaksoccur commonly in Japanese coastal areas, and the highincidence there is undoubtedly due to the nationalcustom of eating raw fishery products. The symptomsof the disease usually occur within 15-17 hours aftereating and include violent epigastric pains, nausea, vomiting, and diarrhea. Fever, headache, and chills may occur, along with mucus and blood in the victim's stools.Symptoms usually subside in one or two days. The number of recorded cases in Japan is high—ranging from10,000 to 14,000 a year—and accounts for 40 to 70 percent of all reported illnesses in that country from bacterial causes. American travelers returning from the Orienth a v e c o n t r a c t e d t h e d i s e a s e a n d a n u m b e r o f c a s e shave involved American military personnel serving inthe Orient. Vibrio parahaemolyticus was suspected intwo outbreaks of gastroenteritis in Seabeck, Washington, reported in "Foodborne Outbreaks—Annual Summary, 1969," published by the Center for Disease Cont r o l .

When public health officials in this country beganto evaluate reports of the many outbreaks of foodbornedisease in Japan associated with Vibrio parahaemolyticus, there appeared to be no cause for great concern


Vibrio parahaemolyticus in foodproducts'is associated almostexclusively with seafood, and

has been found in practically allseafood products—fish,

shellfish, crustaceans, andothers. At top, samples of red

snapper, croaker, and bluecrabs to be analyzed for thatorganism are shown with anelectric blender and a saline

solution used for blending anddiluting the sample. After

blending of the sample,portions from one gram to one

ten-thousandth gram areinoculated into two di fferent

e n r i c h m e n t m e d i a a n dincubated. The two one-gram

portions are shown (middlephoto) in the larger tubes and

the dilutions, rangingdownward left to right, in the

smaller tubes. Two different

liquid enrichment media areused in the Division of

Microbiology analysis to insurerecovery of the organism. The

varying dilutions provide aquantitative picture of the

number of organisms present.Microbiologist Barry Wentz

(bottom photo) streaks anisolation plate with a culture

of the incubated food sample.The plate will be incubated to

obtain isolated colonies ofVibrio parahaemolyticus.

After incubation, the plate (top left) shows coloniesof Vibrio parahaemolyticus (blue-green) and othermicro-organisms (yellow). The colonies of Vibrioparahaemolyticus are picked off the plate with atransfer needle by Dr. Morris Fishbein (top right).The colonies removed from the plate are inoculatedinto a prepared tube of agar screening medium.At bottom left, Dr. Ira Mehlman examines tubes afterincubation. A red color at the top of the tube andyellow at the bottom, as shown here, is apresumptive indication of the presence of Vibrioparahaemolyticus. A pure culture of Vibrioparahaemolyticus is shown (bottom right) at about1,000 magnification. The organisms are characterizedby their curved rod shapes.

In a liquid salt tolerance test toconfirm the organism, culturesare inoculated in flasks ofgrowth media containing saltconcentrations of 0, 6, 8, and 10percent, and are incubated andagitated overnight. Thecloudiness of the second andthird flasks in the first row showsthat Vibrio parahaemolyticuswill grow at 6 and 8 percentrespectively, but will not growin the first flask (0 percent) andfourth (10 percent). The secondand third rows contain other

organisms and thus do notexhibit this growth pattern.

Dr. Riichi Sakazaki (left), renowned Japanese authorityon Vibrio parahaemolyticus, examines a Czybalski saltgradient plate at the FDA's Division of Microbiologylaboratories while serving as a consultant to the Division.The Czybalski technique employs a salt tolerance test toconfirm presence of the organism. In this Czybalskigradient plate (above) prepared by Dr. Sakazaki, culturesof known Vibrio parahaemolyticus were streaked at leftand right and unknown cultures streaked second and thirdf r o m l e f t . T h e s e c o n d c u l t u r e r e a c h e d t h e s a m e s a l t

concentration level on the scale as the known organismsand is confirmed as Vibrio parahaemolyticus. The thirdculture did not grow at the higher level and is negative.

Some Japanese scientists believe that theWagatsuma agar plate, containing human redblood cells, can determine the virulence of astrain of Vibrio parahaemolyticus. Thishemolytic test, referred to as the Kanagawaphenomenon, is based on the ability of anorganism to digest blood cells within 24 hours.The Wagatsuma plate (top left photo) illustratesthis. Cleared zones around the two colonies attop show digested blood cells, indicatingpathogenicity, and the colony at bottom,without a cleared zone, indicatesnonpathogenicity. In a serological test (bottom

left photo) to confirm a particular strain ofVibrio parahaemolyticus, a saline solutioncontaining the organism is mixed with antiserumspecific for it. The test is postive if agglutinationtakes place, as shown at right, and negative ifno agglutination takes place, as shown at left.At top right is shown a pure culture of Vibrioparahaemolyticus streaked for colony isolationon a selective agar plate. This electronphotomicrograph (bottom right) of Vibrioparahaemolyticus, made by Dr. Rita Colwell,Georgetown University, shows the organism ata magnification of around 108,000.

by Morris Fishbein, Ph.D., and Joseph C. Olson, Jr., Ph.D.

about similar outbreaks in the United States. On the fied substance, however, was lethally toxic when inocu-face of it, the problem appeared to be confined to lated into the peritoneal cavity of test mice. In FDA'sJapan. But by 1968, Drs. John Liston and John Baross Division of Microbiology laboratories, different frac-of the University of Washington reported the isolation tions of crude Kanagawa hemolysin have proved lethalof Vibrio parahaemolyticus from fish, shellfish, and to mice when inoculated intraperitoneally. A purecrustaceans—and from the waters and sediments—of enterotoxin substance, if one indeed exists, has yet tothe Puget Sound area of the Pacific Coast. Thus the be isolated, purified, and used to produce the specifichazardous potential had assumed more serious propor- disease syndromes in either man or animals.

As part of a program to intensify and expand aware-The Division of Microbiology bacteriologists and the ness and knowledge among public health officials in

other scientists of the Food and Drug Administration this country about Vibrio parahaemolyticus as a path-provide the scientific support that makes it possible for ogen with the same potential for causing disease herethis Agency to assure the safety of the food supply under as in Japan, the Division of Microbiology arrangedthe Food, Drug, and Cosmetic Act. It is the Division's for a month's visit by Dr. Sakazaki (see photos) to thetask to be alert to new potential hazards such as toxic United States in July-August 1971, under the sponsor-substances produced by micro-organisms or to infectious ship of the World Health Organization, for a series ofbacteria capable of causing foodborne disease, and to seminars to bring Federal, State, and university micro-initiate studies to determine their possible significance, biologists up to date on the newest findings in JapanThe recovery of Vibrio parahaemolyticus from the Puget concerning this organism.Sound area introduced a new health problem, with sev- Acting as a temporary consultant to the Division,e r a l u n k n o w n s . D r . S a k a z a k i p r e s e n t e d s e m i n a r s o n J a p a n e s e r e s e a r c h

Many questions arose simultaneously. Was the orga- to audiences in Washington, Cincinnati, Seattle, andnism confined to the Puget Sound area or could it be College Station, Texas. Ironically, Dr. Sakazaki's visitfound on the rest of the Pacific Coast? Was it present on to this country ended just a few days before the Mary-the Gulf Coast and the Atlantic Seaboard? What ma- land outbreak became the first confirmed instance ofrine forms may be involved as hosts? What were the illness caused by Vibrio parahaemolyticus in thequantitative relationships between this micro-organism United States.and the disease it caused? Had there been outbreaks of In the United States, one unusual pathogenic aspectillness from eating seafood in the past that had been of Vibrio parahaemolyticus has been observed that hadattributed to other causes? What about the patho- not been reported in the scientific literature before,genicity of the Puget Sound isolates? Japanese research For some time now. Dr. R. E. Weaver of the Centerhad shown that there were both virulent and avirulent for Disease Control at Atlanta has been collecting aforms of this organism. It would be necessary for FDA number of cultures of the micro-organism that haveto get the answers to many of these questions as soon been isolated from infections of the hands and feet,as possible, and Division microbiologists set about the eyes and ears, and also from the bloodstreams of per-t a s k . s o n s w h o h a v e b e e n i n c o n t a c t w i t h m a r i n e s h o r e a r e a s

Japanese scientists found that the virulent forms were of different parts of the United States. These infectionsrecovered invariably from patients ill with the disease have usually started from scratches or cuts caused byand the avirulent forms mainly from marine animals, the sharp edges of clams or oyster shells embedded inwater, and sediment samples instead of human victims. the sand.They also observed a positive correlation between The serology of Vibrio parahaemolyticus has beenenteropathogenicity and the Kanagawa phenomenon, well worked out by Japanese scientists. The micro-The Kanagawa reaction is based on the capability of organism possesses three antigenic components theVibrio parahaemolyticus to produce a specific type of O, K, and H antigens. The O antigens are consideredhemolysin (beta type) when incubated 24 hours on a to be body or somatic in origin and are stable in thespecially prepared blood agar plate. At the present time presence of heat. The K antigens are derived from theno one can explain satisfactorily whether the avirulent capsular or envelope portion of the bacterium and aretypes of Vibrio parahaemolyticus found in seafood may primarily polysaccharide in nature. The H or flagellarbe converted into the infectious types capable of pro- antigens are of little value in serological identificationducing disease outbreaks in man and, if such a conver- since these are nonspecific in the bacteria genus Vibrio.sion takes place, what would cause it. By the most recent count, there are 11 O group

A considerable amount of work remains to be done antigens and 53 K antigens associated with this micro-by scientists to delineate the pathogenic role of this organism. This results in the current recognition of 54organism. Dr. Sakazaki has reported that a highly puri- individual serotypes of Vibrio parahaemolyticus—basedfied Kanagawa hemolysin (produced by Dr. Y. Obara) on the combination of O and K antigens found to occurfailed to elicit a pathogenic response in the ligated ileal naturally in this bacterium. When the Japanese in-loop portion of the intestine of test rabbits. This puri- vestigators first devised this antigenic scheme, the


micro-organisms used were obtained from patientsonly. But since there are still many undescribed serotypes of Vibrio parahaemolyticus in seafoods that evidently continue to infect humans, the number of newlyfound serotypes continues to increase. In our own experience at the Division of Microbiology laboratorieswith hundreds of seafood isolates, we have been ableto serotype only 40 percent, the other 60 percent beinguntypable at the present stage of technical capability.

Scientists in the United States, since the findingsby Drs. Liston and Baross reported in 1968, have beenactive in isolating and identifying the micro-organismfrom the marine environment and studying its properties. In FDA's Seattle District, Dr. Gary Houghtby isstudying the response or growth of the micro-organismat different temperatures. In the San Francisco District, Warren Landry has been isolating the bacteriumfrom the coasta l she l lfish o f Texas and Lou is iana for the

past two years. Mr. Landry also has demonstrated thatit may be recovered from frozen shellfish products forup to three months after freezing. Drs. Carl Vanderzantand R. Nickelson of the Texas A & M University haverecovered the bacterium from commercial shrimp pondculture operations and also are making methodologyand serology studies.

On the eastern seaboard, Dr. Morris Fishbein andBarry Wentz, both in FDA s Division of Microbiology,have developed the methodology of isolation and recovered hundreds of strains of the micro-organism frommany varieties of marine fish, shellfish, and crustaeeansin Chesapeake Bay and all the coastal areas of theUnited States, and are now working on the Kanagawahemolysin. In the Division's laboratories at Cincinnati,

D r. R o b e r t Tw e d t a n d h i s a s s o c i a t e s h a v e s t u d i e d t h erabbit ileal loop response to this organism. More re-eently they have devised a culture medium for use inreeovery of Vibrio parahaemolyticus.

Another pioneer in this country is Dr. Rita Colwellof Georgetown University in Washington. She and hermicrobiology students have conducted an extensivestudy of the nearby Chesapeake Bay area and have recovered many Vibrio parahaemolyticus strains. Herpapers on the taxonomy of the micro-organism are av a l u e d c o n t r i b u t i o n i n t h e fi e l d . I n F D A ' s B o s t o n D i s

trict, Barbara McEachern has recovered the bacteriumfrom a variety of seafoods taken from the New Englandshore area. Likewise, Dr. W. K. Thomson of the Canadian Food and Drug Directorate has made a number ofisolations from seafood and currently is making pathogenicity studies.

Because of the still limited knowledge about theprevalence of Vibrio parahaemolyticus foodbome infection in the United States, there is a need to collectenough information to assess its relative importanceas a foodborne disease here. FDA's Divisions of Microbiology and Shellfish Sanitation and other scientists inthe Federal and State agencies and universities in thiscountry, Japan, and Canada are working in close conjunction to keep abreast of the continuing developmentsconcerning Vibrio parahaemolyticus and the disease itcauses. In this regard, all State and municipal healthdepartment laboratories should inelude among theirvarious tests of food suspected of causing an outbreakan examination for the presence of V. parahaemolyticus.Appropriate procedures for this purpose are availablefrom FDA's Division of Microbiology.

Morris Fishbein, Ph.D. (ieft), researchmicrobioiogist in the Division ofMicrobioiogy, Bureau of Foods, joinedFDA in Washington in 1948. Joseph C.Oison, Jr., Ph.D. (right), director.Division of Microbioiogy, Bureau ofFoods, joined FDA in 1967.

i0


field reportsATUNTA DISTRICT Professor James Harvey Young, CINCINNATI DISTRICT A seizure was made ofDepartment of History, Emory University, Atlanta, 310,000 units of fireworks, valued at $35,000, by U.S.author of the books The Toadstool Millionaires and marshals and agents of the Internal Revenue ServiceThe Medical Messiahs, and Professor Chikataro on June 25 at Miller Fireworks and Novelty Co., Inc.,Kawasaki, once associated with the University of Holland, Ohio. The firm was the source of a majorityOsaka School of Pharmaceutical Sciences and now in of fireworks found at 55 retail outlets which had beenthe process of establishing a school of pharmaceutical charged with selling illegal fireworks. The firm's owner,sciences at Kobe Gakuin University, visited Atlanta John F. Miller, was arrested by Internal RevenueDistrict on June 23. They discussed the operation of Service agents and charged with illegal purchase ofFDA with Acting Regional Food and Drug Director black powder and illegal manufacture of explosives.Joseph J. Milunas and Laboratory Director Sol Cohen Cincinnati District assisted in the action,and toured the office and laboratory facilities. Cincinnati Consumer Specialist Catherine Knarr, as aData processing was one of the major topics discussed member of the Greater Cincinnati Nutrition Committee,at the Association of Food and Drug Officials of is helping in a survey of various health departmentsSouthern States meeting in Lexington, Kentucky, on and other agencies with nutritional responsibilities. TheApril 18. Atlanta District personnel explained FDA's survey's purpose is to assess current services availablecurrent system of data retrieval and the proposed system i* ih® greater Cincinnati area and the nutritional prob-to become effective in July 1972. State food and drug lems and needs of the area so that resources, activities,officials seemed to agree that standard industrial classi- and services of the various agencies can be coordinated.fication would appear to be the most compatible identi- Cincinnati District is continuing a series of meetingsfication system. General meetings as well as formal and employment opportunities for District per-informal conferences with State personnel indicated songj Speakers have included Voyce Whitley, FDA,that FDA officials are making progress in their attempt ggQ director; Dewey Fuller, assistant director, Cincin-to work more closely with their State counterparts. uati Urban League; and Dr. Edith Parkey, past

president. Federally Employed Women, and formerBOSTON DISTRICT A training session in State shell- consultant to the Post Office Department as architecturalfish program evaluation was held June 8-11 at FDA's engineer.Northeast Technical Services Unit (NTSU) in Davis-ville, Rhode Island. All regional shellfish consultants, KANSAS CITY DISTRICT Accidental spilling of para-special program branch chiefs, and various headquar- thion, an extremely toxic pesticide chemical, inside aters personnel attended the training program, conducted commercial truck at Omaha, Nebraska, on June 29by the Division of Shellfish Sanitation, Office of Food resulted in the destruction by burial of approximatelySanitation, Bureau of Foods, in cooperation with FDA $10,000 worth of candy, paper goods, school supplies.Training Institute and NTSU. and bedding contaminated by the chemical. The truck.

The course is designed specifically for regional shell- enroute to Omaha, picked up a cargo of some 70 casesfish consultants and other FDA personnel responsible of candy at a St. Joseph, Missouri, candy manufacturer,for the review and evaluation of State shellfish control The trucker then added to the load various chemieals,programs. Its purposes are to provide detailed instruc- including parathion, from a St. Joseph chemical com-tions in policy and procedures for uniform evaluation pany. When the truck was opened at Omaha, it wasof programs, to evaluate problems associated with found that a 30-gallon drum of parathion had rupturedspecific geographical localities, and to present the and contaminated the cargo. Four employees wererelationships of the shellfish division with other Federal exposed to the parathion and were placed underagencies. Boston District was visited on June 30 by observation. The trucking firm assumed full responsi-eight members of a Japanese delegation interested in bility for the incident and offered its cooperation inthe analysis of canned tunafish. Analyst Tony LaTerza the investigation.demonstrated the procedure for examining canned tuna Involved in the investigation and supervision offor decomposition and its preparation for mercury destruction of the contaminated items were FDA'sanalysis. The procedure for identifying mercury in Omaha resident inspector; U.S. Department of Trans-fish was also demonstrated. Frank Allhands, Office portation personnel; the Nebraska Department of Agri-of Product Technology, Bureau of Foods, Washington, culture. Dairy and Food Division; and an industry-and several top District personnel also participated in formed Pesticide Safety Team headed by the Stauffert h e s i x - h o u r m e e t i n g . C h e m i c a l C o . , O m a h a .


The industry unit is one of a group of more than40 such safety teams operating throughout the UnitedStates. The National Agricultural Chemicals Association formed the network of teams to minimize the riskof injury arising from the accidental spillage or leakageof poison pesticides. It operates a telephone network;the central phone, 531-961-4300 in Cincinnati, Ohio,is monitored on a 24-hour basis.

Glenn Kreuscher, director, Nebraska State Departmentof Agriculture, was commissioned by the Food andDrug Administration to join the group of State officialsengaged in FDA's animal feed inspection program. Mr.Kreuscher's appointment means that all States in RegionVII are now involved in the cooperative feed inspectionp r o g r a m .

During the commissioning ceremony in Lincoln,Nebraska, on May 24, Regional Food and Drugs Director C. A. Armstrong noted that the already excellentworking relationship between the State and FDA andMr. Kreuscher's new key role in that relationshipincreased consumer protection in Nebraska.

Lack of New Animal Drug Applications resulted inthe seizure of veterinary products of three manufacturers in June. "Nataniycin," an oxytetracycline injectable veterinary drug, valued at $192 and shipped bySioux Nation, Sioux Falls, South Dakota, was seizedin Sioux City, Iowa. Raw powder transported personallyby the owner of Wartig Veterinary Clinic, Wisner,Nebraska, was seized in Fresno, California, where itwas being made into oxytetracycline HCl injectable.The lot was valued at $866. A veterinary over-the-counter preparation manufactured and shipped byCadco, Inc., Des Moines, Iowa, and valued at $32,000,was seized in Omaha, Nebraska. This seizure was alsobased on false and misleading claims.

LOS ANGELES DISTRICT Dis t r ic t o ffic ia ls obta inedthe cooperation of drug manufacturers and distributorsin Los Angeles District to relabel their stocks ofvitamin C tablets to conspicuously declare the presenceand amount of sodium ascorbate they contain. Nationwide investigation, initiated by the Food and DrugAdministration in Washington, D.C., several monthsago, found that sodium ascorbate was found in manyvitamin C tablets in amounts as large as 50 percent.Ingestion by some vitamin users who are unaware ofthe sodii^m content is a possible hazard if large dosesare taken. Los Angeles District contacted 105 firms;all those whose labels did not clearly show presenceo f sod ium asco rba te re l abe led t he i r s t ocks and reca l l edthem if appreciable amounts were on the market.Elaine Roentgen, District consumer specialist, held twoworkshops in June for public school teachers at Riverside, California, on flammable fabrics and packagingand labeling; spoke at the San Diego Heart AssociationConference at San Diego on the impact of consumereducation in selection of diets; appeared on a LosAngeles television program to discuss flammable

fabrics; and was a member of a panel on food additivesat the nutri t ionists section of the Conference of theWestern Branch of American Publ ic Health Association, Beverly Hills, California.

MINNEAPOLIS DISTRICT Dr. F. E. Sterner, Districtveterinarian, attended a two-day series of meetingswith personnel from three Wisconsin State agencies.At a meeting with the Toxicology Department of theVeterinary Diagnostic Laboratory, Dr. Sterner emphasized the public health significance of reporting herdsof swine pastured in areas where heavy metal orpesticide poisoning has been diagnosed to prevent theirslaughter as a salvage procedure. With Wisconsin FeedControl personnel, Dr. Sterner discussed the District'smedicated feed cooperative program. His discussionswi th the Wisconsin Extension Veter inar ians affirmedthe policy of continuing exchange of pertinent information. The Extension will mail 700 veterinary adversereaction cards to veterinary practitioners in the Statefor them to complete with descriptions of any adversereactions they encounter and then return the cardst o F D A .

H. P. Roberts, deputy regional food and drug director,and Fermer Adair, District food and drug officer,attended a meeting with oflScials of the WisconsinDepartment of Agriculture Food Division and 14members of the Italian cheese manufacturing industryof Wisconsin in Madison on June 16. The meetingconcerned the production by some manufacturers oia provolone-type cheese which, the District alleges,purports to be provolone but does not conform to thestandard of identity for such cheese. The industry wasnotified by FDA and the State agency that afterapproximately 60 days, action may be taken againstthe cheese unless it is made to conform to the standard.Industry representatives indicated that a meeting ofthe Wisconsin Italian Cheese Manufacturers Association was to be held in two weeks. At that time, theassociation was to attempt to propose a standard ofidentity for a high-moisture, low-fat provolone cheeseand would submit the proposed standard' to FDA forc o n s i d e r a t i o n .

Approximately $1 million worth of cocoa beans fromGhana, totaling 28,000 bags, was detained by Minneapolis District in Milwaukee on May 11 because ofrat adulteration of the product aboard ship. The lotwas being reconditioned. On July 1, another shipmentof 24,000 bags of cocoa beans from Ghana arrivedin Milwaukee. No contamination of any kind wasfound in the second shipment and detainment wasu n n e c e s s a r y.

NEW ORLEANS DISTRICT District analyses showedthat three samples of fresh water fish caught in theRed River, in northern Louisiana, contained residuesof mirex (a pesticide for the control of fire ants) inthe amounts of .05, .06, and .20 parts per million,respectively. The June 3 analyses were made on an


investigatory basis, and since no guidelines exist asto what constitutes an excessive amount of the chemical,no action was taken. The District is conducting anothersurvey of fish in the area to determine the extent ofthe chemical's presence.

NEW YORK DISTRICT A notification of cancellation,effective June 7, of an FDA Investigational New DrugExemption for his experimental methadone treatmentfor narcotics addicts was delivered to Dr. Rafiq Jan,operator of the West Side Medical Center, New York.The notification letter, signed by Henry E. Simmons,M.D., director of the FDA Bureau of Drugs, was handdelivered to Dr. Jan on June 3 by Robert Martin,deputy regional food and drug director, FDA RegionII; George Gerstenberg, director, Domestic InspectionBranch, New York District; and Dan Sitko, supervisoryinspector of the District. The exemption for the experimental methadone treatment program had been issuedunder a joint program administered by FDA and theDepartment of Justice's Bureau of Narcotics andDangerous Drugs. Two agencies ordered the exemptioncanceled because the Center, they charged, was dispensing methadone "indiscriminately."

Since the termination of the exemption, the NewYork City Hospital Corporation has set up a referralunit to handle any of Dr. Jan's patients wishing totransfer to other methadone programs. District officialsestimate that about half of the approximately 3,000patients affected by the IND cancellation will use thereferral unit to enroll in other programs. The Bureauof Narcotics and Dangerous Drugs was investigating thepossibility that some patients were not actual addicts,but were selling the methadone to other persons.

Approved shellfish harvesting areas in New York andNew Jersey were threatened with possible contamination by the discharge of approximately 1.3 billion gallons of raw sewage into waters off New York City whenplant workers in 11 out of the 13 city sewage treatmentplants struck June 8 and 9. New York District immediately alerted New York State and New Jersey shellfishauthorities to the potential danger.

The New Jersey Department of Environmental Protection immediately closed the areas of Sandy HookBay and the Neversink River previously approved forshellfish harvesting. Bacteriological sampling of thearea was ini t iated and was to continue unti l i t canbe shown beyond doubt that the areas are safe. Sincethe areas are approximately 10 to 12 miles from NewYork City, it is possible that the pollution will notr e a c h t h e m .

The New York State Department of EnvironmentalConservation closed aii area in the Atlantic Ocean tothe harvesting of sea clams. The area, near the mouthof New York harbor, could have been affected and wasto remain closed until water and shellfish samples showthat shellfish in the area are of acceptable quality. Thedepartment and the Nassau County Bureau of WaterPollution are also sampling the water of Oyster Bay in

Long Island Sound. The area is about 15 miles fromNew York City, and hydrographic calculations Indicatea possibility, though extremely small, that the pollutionmay reach the bay, so officials are keeping it underguard.New York District Consumer Specialist Mary Gillbegan a publicity effort in early June on the proposal,originated by a group of Washington, D.C., law students, to require ingredient listings on the labels ofstandardized foods. A release was delivered to newspapers, consumer organizations, professional organizations, and radio and television consumer-oriented programs. Home economics departments of colleges inNew York City and New Jersey were contacted, and anannouncement of the proposed requirement was madeat the dinner meeting of the Southeastern District NewYork S ta te Home Economics Assoc ia t ion . M iss G i l lsuggests that the proposal will answer many consumerd e m a n d s .

I n 1 9 6 9 , N e w Yo r k D i s t r i c t o f fi c i a l s m e t w i t h t h eassistant economic minister from the Embassy ofArgentina to discuss at length pesticide residues inArgentine cheeses. Since then, several pieces of legislation have been enacted in Argentina to control the useof DDT, BHC, and other chlorinated organic compounds, and on May 13 a local representative of thelargest cheese shipper in Argentina submitted testreports to the District which showed levels of pesticidesin current importations to be practically negligible. Hestated that the Government controls and banning of theusage of the pesticides are showing good results.

The U.S. Board of Tea Appeals met twice in May toconsider an FDA examiner's rejection, for inferiorquality, of two lots of tea entered at Baltimore, ande x a m i n e d a t N e w Yo r k D i s t r i c t . B o t h l o t s w e r e b l e n d e din Europe of bulk teas from several countries. One, consisting of 325 chests totaling 33,102 pounds, wasshipped from Hamburg; the other, 200 chests totaling25,600 pounds, was from Rotterdam. Both appealswere denied and the examiner's rejection upheld.

PHILADELPHIA DISTRICT Richardson-Merrill, NewYork, doing business as Vick Chemical Co. Division,New York, and Vick Manufacturing Division, Hatboro,Pennsylvania, pleaded guilty on June 18 to three countsof violation of the Food, Drug, and Cosmetic Act andwas fined $1,000 on each by District Court Judge JohnB. Hannum in Philadelphia. The firm had distributedgreaseless Vapo-Rub, a decongestant, without an FDANew Drug Approval. Numerous reports of eye injurieshave been made because the new form of the productcontained ingredients that caused severe eye irritationt o u s e r s .

Keystone Rendering Co., Inc., Philadelphia, enteredinto consent decree June 29 for permanent injunction,w h i c h r e s t r a i n s t h e fi r m a n d i t s o f fi c e r s f r o m m a n u f a c

turing and distributing in interstate commerce any feed


product containing Salmonella or manufacturing undermethods and operations that could lead to Salmonellacontamination of feed products. The action resultedfrom an April inspection by the District, which foundthe firm to be operating under insanitary conditionshighly conducive to bacteriological contamination.Analyses of in-line and finished product samples werepositive for Salmonella. A shipment of bulk meat scrapmeal was seized when extensive Salmonella was foundin a sample of it. The firm agreed to institute severalstructural changes and revisions in control procedureto improve its sanitation safeguards.

SEATTLE DISTRICT A total of 1,496 30-pound casesof frozen processed potatoes was seized at Kansas City,Kansas. Seattle District inspection of the manufacturer.Chef Reddy Foods, Inc., Othello, Washington, revealedthat the product had been prepared and packed underinsanitary conditions. The lot was to be disposed of bydonation to the Kansas State Penitentiary for use as hogfeed, but was buried when the hogs refused to eat theproduct.Franklin D. Clark, Region X food and drug director,presented a paper on multiuse plastic milk containersa t t h e 3 5 t h A n n u a l E d u c a t i o n a l C o n f e r e n c e o f t h e N ational Environmental Health Association, held at Portland, Oregon, June 26 through July 2. Mr. Clark'spaper concerned a study conducted by Region X milkand food personnel regarding quality control problemsassociated with the use of such containers. James L.Shoemake, regional milk and food consultant, served aschairman for the Milk Quality Section of the meeting,which was attended by approximately 80 milk regula-

a ■■ ■ ■

tory and industry officials. They expressed considerableinterest in the topics presented by nationally recognizedleaders in the mi lk fie ld .

The Maxi-Food, Mini-Money Consumer EducationWorkshop on nutrition and food buying was presentedin Mount Vernon and Everett, Washington, on June 15and 16. A total of 87 case workers, migrant workers,public health nurses, and other community workersattended. Jointly sponsored by the Washington StateDivision of Health and the Seattle District, the consumer education program has been presented in sixareas of the State already. Joan Bergy, District consumer specialist, and Carol Ives, State Division ofHealth nutritionist, developed the program, which advises consumers on how to receive the most food andnutrition for the least money.

r

F D A D I S T R I C T O F F I C E S

ATLANTA 60 Eighth St., N.E.A t l a n t a , G a . 3 0 3 0 9

B A LT I M O R E 9 0 0 M a d i s o n A v e .B a l t i m o r e , M d . 2 1 2 0 1

BOSTON 585 Commerc ia l S t .B o s t o n , M a s s . 0 2 1 0 9

B U F FA L O 5 9 9 D e l a w a r e Av e .B u f f a l o , N . Y. 1 4 2 0 2

CHICAGO Main Post Office BIdg.R m . 1 2 2 2 4 3 3 W. Va n B u r e n S t .Chicago, III. 60607CINCINNATI 1141 Central Pkwy.C i n c i n n a t i , O h i o 4 5 2 0 2

DALLAS 3032 Bryan St.D a l l a s , Te x . 7 5 2 0 4

DENVER New Customhouse BIdg.R m . 5 6 0 4 / 2 0 t h & C a l i f o r n i a S t s .D e n v e r , C o l o . 8 0 2 0 2

DETROIT 1560 E. Jefferson Ave.D e t r o i t , M i c h . 4 8 2 0 7

KANSAS CITY 1009 Cherry St.Kansas City, Mo. 64106

LOS ANGELES 1521 W. Pico Blvd.Los Angeles, Calif. 90015

MINNEAPOLIS 240 Hennepin Ave.Minneapolis, Minn. 55401N E W O R L E A N S U . S . C u s t o m h o u s eR m . 2 2 2 / 4 2 3 C a n a l S t .N e w O r l e a n s , L a . 7 0 1 3 0

NEW YORK 850 3rd Ave. (at 30th St.)Rm. 700/Brooklyn, N.Y. 11232

P H I L A D E L P H I A U . S . C u s t o m h o u s eR m . 1 2 0 4 / 2 n d & C h e s t n u t S t s .Philadelphia, Pa. 19106SAN FRANCISCO Federal Office BIdg.R m . 5 1 8 / 5 0 F u l t o n S t .S a n F r a n c i s c o , C a l i f . 9 4 1 0 2

SEATTLE Federal Office BIdg.R m . 5 0 0 3 / 9 0 9 F i r s t A v e .

S e a t t l e , Wa s h . 9 8 1 0 4

H E W R E G I O N A L O F F I C E S l - X

BOSTON J. F. Kennedy Federal BIdg.Boston, Mass. 02203NEW YORK 26 Federa l P lazaN e w Yo r k , N . Y. 1 0 0 0 7

P H I L A D E L P H I A 4 0 1 N o r t h B r o a d S t .Philadelphia, Pa. 19108ATLANTA 50 7th St., N.E.R m . 4 0 4 / A t i a n t a , C a . 3 0 3 2 3

CHICAGO New Post Office BIdg.433 W. Van Buren St./Chicago, Ml. 60607KANSAS CITY 601 E. 12th St .Kansas City, Mo. 64106D A L L A S 111 4 C o m m e r c e S t .Rm. 911/Dallas, Tex. 75202DENVER Federal Office BIdg.1 9 t h & S t o u t S t s . / D e n v e r, C o l o . 8 0 2 0 2

SAN FRANCISCO Federal Office BIdg.R m . 4 1 6 / 5 0 F u l t o n S t .S a n F r a n c i s c o , C a l i f . 9 4 1 0 2

SEATTLE Arcade Plaza BIdg.1 3 2 1 2 n d Av e . , S e a t t l e , Wa s h . 9 8 1 0 1


FDA Requires Stronger WarningsOn 39 Household Detergent Labels

The Food and Drug Administration announced June28 it will require a number of manufacturers to improvelabeling on household laundry and dishwashing detergents to warn against eye and skin irritations andinjury from ingestion. The manufacturers have agreedto take the necessary relabeling actions.

Commissioner of Food and Drugs Charles C. Edwards, M.D., said, "I commend detergent manufacturersfor prompt and cooperative response to the FDA findings. I am confident the result will be increased safelyfor the American consumer."

The need for additional warnings was confirmed byFDA on the basis of tests performed by Agency scientists on 39 detergent products.

Sixteen products failed one or more of these tests.Packages also failed to include adequate cautionarylabeling as required by the Federal Hazardous Substances Act. All 16 manufacturers have submitted plansfor relabeling their products in stores and warehousesand for properly labeling the products in production.When the plans are implemented, FDA will considerthe products in compliance. No further regulatory action is contemplated at this time.

Nine other detergent manufacturers were told tobegin including adequate cautionary labeling on allfuture production.

These products already carry some cautionary labeling, but the warning was judged inadequate. The FDAtests indicated these nine products did not present aproblem serious enough to require relabeling of packages now in stores and warehouses. Beginning withthe next label printing, all future shipments, however,must carry cautionary labeling consistent with thedegree of irritation or toxicity of the product.

Fourteen products among the 39 tested by FDAwere found to be either safe for use without cautionarylabeling or already properly labeled.

The tests included nonphosphate and low-phosphate,as well as the regular phosphate-based detergents. Surveillance testing by FDA's Bureau of Product Safetywill continue on other detergent products.

The 16 products to be relabeled, including all existingstock and future production, are Acme No-PhosphateLaundry Detergent, Bestline Phosphate-Free DetergentB-70, Pure Water, Fab Lemon Freshened with Borax,Giant, Klean, Concern, Un-Polluter, Logic PhosphateFree, Cold Water All, Controll Phosphate Free LaundryDetergent, Miracle White Non-Polluting Detergent,Ecolo-G, Balance, Basic-L Laundry Concentrate, and

King Kullen Phosphate Free Laundry Detergent.The nine products for which revision of labeling has

been asked on future production are Burst, Sears Non-Polluting Laundry Detergent, PFD, Phosphate FreeDetergent, Trend, Safeway Detergent PAR, Montgomery Ward Lo-Suds, Bio-D, and T-Rif.

Decals on Dinnerware Pose Lead,Cadmium Problems, FDA Reports

The Food and Drug Administration reported in Julythat decals used to decorate ceramic dinnerware canbe a source of leachable lead and cadmium which maybe absorbed by foods and beverages. The decal presentsa special, newly-recognized problem, affecting all typesof dinnerware on which i t is used.

The Agency emphasized that under normal conditions of use such dinnerware presents no health hazard,but it advised consumers, as a reasonable precaution,not to store acidic foods or beverages in dinnerware.

Dinnerware comprises a broad category of productsincluding inexpensive pottery, intermediate-priced earthenware, and expensive fine and bone china.

FDA has been working with manufacturers for twoyears to eliminate leaching of heavy metals resultingfrom the glazing process. The Agency says this problemis being corrected. The decal problem was uncoveredin an FDA-industry study of glazing.

FDA said products such as fruit juice, carbonatedbeverages, wines, cider, all foods containing vinegar,sauerkraut, cooked fruits, and fruit products are justsome examples of acidic foods which should not bes t o r e d i n d i n n e r w a r e .

Although only one injury attributed to decal-deco-rated dinnerware has been reported, several alleged injuries involving other types of ceramic pottery haveo c c u r r e d .

These findings and the recent positive identificationof the decal as the source of leaching led to the statement by the Agency July 13.

Factors affecting leaching from the decal-markeddinnerware are frequency of use, the length of time foodsor beverages remain in the piece, and the location ofthe decal on the surface. For example, decorative border decals on the edges of a flat plate pose much lessof a problem than decals on the inside bottom of as a l a d b o w l .

Manufacturers have been advised by FDA of the decalproblem and are cooperating with the Agency to assurethat future stocks will meet acceptable standards forl e a d a n d c a d m i u m .


FDA is undertaking a production-line inspection program to assure the safety of decal application on domestic dinnerware production. The Agency is encouragingmanufacturers to label future production that is foundwithin Government guidelines for leachable heavy meta l s .

A testing program covering imported dinnerware isalso underway. The purpose of these tests is to preventproducts manufactured abroad containing high levels oflead and cadmium from entering the country. Since1970, more than 500 import shipments of the dinner-ware have been detained by FDA.

Regulations on Promotional CampaignsEstablished to Safeguard Consumer

The Food and Drug Administration has announced finalaction to place strict regulations on "cents off" promotions, introductory offers, and economy size designationsfor foods, drugs, cosmetics, and other products.

"The new regulations will establish clear rules forlength and frequency of 'cents off' campaigns anda m o u n t s o f m e r c h a n d i s e i n v o l v e d a n d d e fi n e t h e t e r m

'regular price'," according to Charles C. Edwards,M.D., Commissioner of Food and Drugs.

He added that under the rules the housewife or otherbuyer will be able to determine from the label that anactual saving is being offered and how much thissaving is over regular price of the product. The buyerwill also be able to make meaningful value comparisonsb e t w e e n b r a n d s .

"We believe this policy will clarify the situation forindustry and will greatly assist the consumer who istoday too often confused instead of benefited by suchpromotions," said Commissioner Edwards.

"It will end such practices as perpetual promotionsbased on artificial 'regular price' designations," hea d d e d .

The new FDA regulations, published June 30 in theFederal Register, are virtually identical to regulationsbeing published simultaneously by the Federal TradeC o m m i s s i o n .

The regulations, to become effective December 31,1971, cover four specific points:

• "cents off" promotions• introductory offers• coupon promotions• economy size packagingThe "cents off" rules specify the amount of mer

chandise which may be offered and the number andspacing of such promotions per year.

"Cents off" claims must be clearly represented onproduct labels under a standard format giving regularprice, cents off price, and actual money saved.

The regulations further provide for new productintroductions but maintain safeguards for the consumerby establishing clearly defined limits on the length of

time an introductory offer can run before a regularprice must be established.

For coupon promotions, the regulations permit redemption in money or goods either unconditionally orconditioned upon subsequent purchases. All conditions,however, must be clearly and conspicuously stated onthe labe l .

Finally, the new rules require that if a sponsor offersan "economy size" or similarly designated package,that package must assure the consumer of a saving ofat least 5 percent over the next best price per unitoffered by the sponsor.

"This program has been worked out through closecooperation between FDA and FTC. It is an excellentexample of Government agencies cooperating to thebenefit of the American public," concluded Commissioner Edwards.

SAE Studying Radiation InterferenceTo Electronic Heart Pacemakers

A cominittee of the Society of Automotive Engineershas begun laboratory studies of the sensitivity of heartpacemakers to electromagnetic radiation interference,Commissioner of Food and Drugs Charles C. Edwards,M.D., has announced.

Studies of the electronic devices, which sustain near-normd heart beats and often life in an estimated 50,000Americans, are being conducted as a public service bymembers of the SAE Electromagnetic CompatibilityCommittee, Dr. Edwards said July 7.

The Committee is working under an informal agreement with the FDA Bureau of Radiological Health andhas arranged for the use of industrial laboratories without cost to the Government. Manufacturers have furnished the Bureau with pacemakers for the research.

Interference sensitivities of pacemakers will be examined in terms of performance characteristics over a widerange of radiation frequencies. Information obtainedwill be used by the investigators in developing low-costtest procedures which manufacturers may employ in designing interference-proof pacemakers.

Electromagnetic radiation interference has been associated with one of two types of pacemakers—the widely-used demand or synchronous type that acts only in instances of heart malfunction. Interference with this typeof pacemaker has been caused by radiation from a variety of equipment, including medical diathermy and electrocautery units, radio transmitters, radar scanners, gasoline engine ignition systems, electric shavers and foodmixers, television receivers, and microwave ovens.

Information about pacemakers and action taken onthe interference problem is contained in a new Bureauof Radiological Health Report, "Electromagnetic Radiation Interference with Cardiac Pacemakers." The publication may be purchased for 45 cents a copy from theSuperintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.


Named to Board Kenneth Carl,administrator of the Dairy andConsumer A f fa i rs D iv is ion o f theOregon Department of Agriculture,w a s n a m e d t o t h e e x e c u t i v e b o a r dof the Association of Food and DrugOfficials of the United States for thenext two years. The honor was confer red a t the 75 th annua l conven t ionof the association recently at Columbus, Ohio, which Mr. Carl attendedas the representative for his departm e n t a n d f o r F D A ' s F o o d S t a n d a r d sC o m m i t t e e f r o m t h e W e s t e r n A s s ociation of Food and Drug Officials,a s a m e m b e r o f A F D O U S M e m b e r

ship and Federal-State Relationscommittees, and as the alternatedelegate for the Western States onthe AFDOUS advisory council tothe FPA.

Mr. Carl said the highlight of theconvention was the offer by Commiss ioner o f Food and DrugsCha r l es C . Edwards , M .D . , o f afull partnership program involvingStates and the FDA. Dr. Edwards,a speaker at the convention, pictured the program as a total work-sharing enterprise in all aspects,including surveillance, compliancewith laws and regulations, research,and planning. Its advantages, hesaid, would include effective elimination of duplication, more completecoverage, increasing uniformity,c ross - fe r t i l i za t ion o f i deas , flex ibility in setting up cooperative programs, and retention of expertise ina given program area for bothagencies.

Mr. Carl said the program presented by Dr. Edwards is similar tothat already in effect between hisdepartment and FDA's Region X.Under the existing program, theState does most of the inspectionwork, and FDA utilizes the results.Mr. Carl noted that this arrangement is a recognition of the capabilities of State food inspectors.

Delegates to the convention

adopted the report of the FDAadvisory council calling for theestablishment of organic food standards and recommending the development of a model food salvage actfor adoption by the States.

Weight-Labeling Checks In making weight checks of packaged itemsin the delicatessen sections of grocery stores, weights and measuresinspectors from the Oregon Department of Agriculture have found thatat least one packer has discontinuedweight labeling. The responsibilityfor weight labeling then falls to thestore since Oregon law requires aweight statement on all packageditems except those customarily soldin some other manner, such asb e r r i e s a n d s m a l l f r u i t . R a t h e r t h a nmake an incorrect guess on the tareweight of the container or packagingmater ial , the store must then unwrap, weigh, and repackage theproduct, and some stores havechosen to discontinue carrying thei t e m r a t h e r t h a n i n c u r t h e e x t r a

handling costs. K. J. Simila, assistant administrator for weights andmeasures with the Dairy and Cons u m e r S e r v i c e s D i v i s i o n o f t h edepartment, estimated that onlyabout 10 percent of the smokedand cured meat items are beingpackaged in the retail markets.About 30 percent of the remaindercome from plants in Oregon, hes a i d .

Inspectors have found cottagecheese and prepared salads packedshortweight in plastic cup containers. They found that the products are packed in standard-sizecontainers with a standard weightprinted on the cap. Since the produ c t s d o n o t a l l h a v e t h e s a m e d e n

sity, however, underfilling can occur,said Mr. Simila. Under the law, theretailer is responsible for accurateweights on all packaged productsoffered for sale. Those not packaged

in air-tight containers pose additional quantity labeling problemsresulting from weight loss as theydry out.'

Embargo M issour i D iv i s ion o fHealth Inspector Richard Brownembargoed the contents of a storagewarehouse after fire destroyed thenearby Clinical Laboratories Co.,Kansas City, Missouri, on June 8.Drugs, clinical reagents, and biologi-c a l s s t o r e d i n t h e w a r e h o u s e w e r e

exposed to extreme heat, smoke, andwater damage. Mr. Brown and FDAKansas Ci ty Dis t r ic t InspectorMary-Margaret Richardson superv i sed t he bu r i a l o f an es t ima ted$15,000 worth of the materials ata local sanitary landfill.

Commissioned Fourteen inspectors and two supervisors of the IowaDepartment of Agriculture, FeedDivision, were presented FDA commissions at the department's meeting June 10-11 in Des Moines,Iowa. The feed inspectors were tobegin making FDA-type inspectionsof the State's 1,200 medicated feedprocessors about July 1. Their commissions were made possible throughbasic instruction and on-the-job fieldtraining by FDA's Kansas CityDistrict personnel. Dr. William C.Burnett, District veterinarian, andGeorge L. Vinz, assistant to thedirector for Federal-State relations,presented the commissions as representatives of the District.

Inspectors receiving commissionswere Darl E. Baumgarner, C. W.Danie lson, Evan E. El l io t t , Danie lW. Fish, Esse W. Freed, Charlie M.Johnson, George L. Kullberg, GlennO. Mourer, Edward G. Singer,Roland A. Coil, Solomon Krass,Max G. Nordyke, Claude A. Pollard, and Wayne E. White. StateSecretary of Argiculture L. B. Liddyreceived his commission in January(see FDA Papers, Apri l 1971).


Duane H. Leive, director, FeedDivision, and Julius D. Hook, Statelaboratory administrator, also received commisions and wi l l d i rectthe inspection program for the depar tment .

Fire Damage The Wisconsin StateDepartment of Agriculture embargoed the entire premises of ColeChemical Division of Hopkins Agricultural Chemical Co., Madison,Wisconsin, because of a fire whichrazed the veterinary supplies firm onApril 6. When it was discoveredthat some fire-damaged veterinarydrugs may have been sold for salvage, the State imposed the embargo. FDA's Minneapolis Districtcollected official samples and onJ u n e 8 s e i z e d s i x l o t s o f h e a t -

damaged drugs. The owner destroyed almost all other drug produ c t s i n t h e e s t a b l i s h m e n t . T h e

products were valued at about$150,000.

New Regulation Puerto Rico hasadopted a regulation requiring allaluminum cooking pots manufact u r e d o r s o l d i n P u e r t o R i c o t o b emade of virgin aluminum. The regulation resulted from the finding ofexcess amounts of lead in pots madeby local manufacturers using scrapa l u m i n u m . F D A ' s S a n J u a n o f fi c efound no lead problem with aluminum pots imported into Puerto Ricoo r m a n u f a c t u r e d o n t h e m a i n l a n d .

Bi l ly G. Mi les, FDA laboratorysupervisor, San Juan Section, Region II, attended a press conferencewith Puerto Rico Health SecretaryE r n e s t o C o l o n Y o r d a n a n d o t h e r

top government officials to announcethe regulation.

Foods Destroyed The WisconsinDepartment of Agriculture reportedthat on June 11, at the request ofTillie-Lewis Foods, Inc., Stockton,California, and under a disposalagreement, approximately SVi tonsof various foods containing cycla-mates was destroyed. The productsincluded canned fruits, jams, andjellies. The cans were crushed andb u r i e d .

The State also destroyed 43V2

cases of low-calorie canned peachesat a Railroad Salvage store in Milwaukee. The peaches were artificially sweetened with cyclamates.

New Regulation The Tennessee Department of Agriculture, Food andDrug Division, issued a regulationbanning the household use of conc e n t r a t e d s u l f u r i c a c i d a s a d r a i ncleaner, effective June 21. Cleanerst h e D i v i s i o n t e s t e d c o n t a i n e d b etween 93 and '95 percent sulfuricacid. An injury from one of theproducts led to the ban.

New Director Dr. John D. Cashmanwill take office as the new directorof the Ohio State Department ofHealth in early November. He ispresently assistant United States surgeon general.

Quarantine Permitted The NewYork State Department of Agriculture and Markets can now quarantine food-producing animals suspected of having accumulations ofbiological or chemical residues intheir t issues that would make thefood product unsafe to eat. The authority was granted when GovernorNelson Rockefeller signed into lawa bill to amend the Agriculture andMarkets Law on April 6. The Statehad recently found milk contaminated with DDT and eggs contaminated with a chicken feed additive,but unti l now could quarantinen e i t h e r t h e h e r d o f c a t t l e n o r t h echickens responsible, although themilk and eggs could be seized.

State-FDA Agreement An agreem e n t h a s b e e n m a d e b e t w e e n t h eRhode Island Department of Health,D i v i s i o n o f F o o d P r o t e c t i o n a n d

Sanitation, and FDA's Boston District marking the first instance whereState-FDA food program activitieswill be totally integrated. The newagreement calls for total work-sharing in all food programs and for periodic planning sessions at which responsibility for coverage of certainfirms will be divided. Reports of allenforcement activities will be shared,including results of sample analyses,establishment inspections, and legal

actions involving Rhode Island-based firms and products. Workscheduling procedures have been initiated using the Region's data processing equipment and automaticmonthly print-out controls on unaccomplished scheduled work by bothF D A a n d S t a t e .

On June 3, to inaugurate theagreement, a workshop was held int h e R h o d e I s l a n d S t a t e O f fi c e B u i l d

ing for about 55 State inspectors todiscuss inspection techniques, follow-up procedures for consumer complaints, and food poisoning investigation and reporting. State and FDAtop staff and supervisors in attendance discussed procedures to implement the agreement.

Under the agreement, neitherState nor FDA agencies will assumetotal responsibility for a given program or industry.

County Issues Order The Rockland County Office of ConsumerProtection, New York, issued a"stop removal order" to Toy & SportWarehouse, Spring Valley, NewYork, who was selling lawn dartswhich lacked proper warning labeling as required by the Toy SafetyAct. The toy was distributed byTown & Country Games, Ltd., College Point, New York, who thenissued corrective labeling to customers as part of its attempted corr e c t i v e a c t i o n r e c a l l .

The authority for the order wasbased on the county's Local Law#5 of 1970, which was utilizedfor the first time in this case. Thelaw established the county's Officeof Consumer Protection and gaveit the authority to cooperate withlocal. State, and Federal agenciesin matters of consumer protection.FDA's resident inspector at PortChester, New York, accompaniedthe county official when he presen ted t he o rde r t o t he fi rm .

Enr iched F lour Use The Sta te o fWashington has amended its BakeryProduct Enrichment Act to requirethe use of enriched flour in all bakery products, including specialtybread and rolls, and in all macaroniand macaroni products.


seizures & postal service casesSEIZURE ACTIONS charging violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous Sub

stances Act are published when they are reported by the FDA District Office.

A total of 72 actions to remove from the consumer market concerning economic and labeling violations. Other seizuresproducts charged to be violative were reported in June/July. included 4 of food additives, 1 of vitamins and dietary foodThese included 31 seizures of foods: 4 involved charges con- 22 of drugs (including 14 of veterinary and medicated feed),cerning poisonous and deleterious substances, 15 involved 1 of medical devices, 2 of prophylactics, and 11 of hazardouscharges concerning contamination, and 12 involved charges substances.

PRODUCT, PLAGE & DATE SEIZED MANUFACTURER (M) , PACKER (P) ,SHIPPER (S) , DEALER (D)

Cottonseed, whole/Santa Fe Springs, Calif.2 /18/71

lams Plus dog food/Ctiicago, III. 5/19/71Swordfish/Gloucester, Mass. 3/16/71Williams Pear Brandy/Union, N.J. 5/13/70

FOOD I Poisonous and Deleterious Substances

Parker Valley Gin Co./Parker, Ariz. (M,S) Contains aflatoxin, a highly toxic contaminant forwhich there is no tolerance,

lam's Food Co./Dayton, Ohio (M,S) Contains Salmonella micro-organisms.Danland Seafood Corp./New York, N.Y. (P) Contains excessive mercury.H.C. Konig/Steinhagen, Germany (S); Sut- Contaminated with methanol,

terer & Cie/West Germany (M)

Contamination, Spoilage, Insanitary HandlingCocoa beans/Philadelphia, Pa. 5/14/71

Eggs, whole, frozen/Roxbury, Mass. 6/9/71Field peas w/snaps/Nashville, Tenn. 6/3/71

Filberts, shelled, peanuts, shelled, chocolate-covered peanuts/Cambridge, Mass.5/26/71

Flour, beans/Bedford Heights, Ohio 6/17/71

Peanuts/Brooklyn, N.Y. 6/25/71Peas, black-eyed, flour, peanuts/Shreve-

port, La. 6/21/71Pecan(s), shelled/Boston, Mass. 5/26/71

pieces, shelled/South Bend, Ind. 5/17/71

Pistachio nuts/Terra Bella, Calif. 7/13/71

Potato flakes/Houston, Tex. 4/16/71

Potatoes, prepared, frozen/Kansas City,Kans. 3/30/71

Salmon, pink, whole, frozen/Seattle, Wash.5/24/71

Turbinado sugar, Kleenraw sugar/Tulsa,Okla. 5/25/71

Wheat, bulk/Morristown, S. Dak. 6/30/71

Tacony Industrial Storage Co./Philadelphia, Moldy, insect-damaged, and decomposed cocoa beans.Pa. (D)

Easy Egg Co./Whitesboro, N.Y. (P,S) Decomposed.Miss America Foods, Inc./Cullman, Ala. Off flavor, similar to kerosene.Easy Egg Co./Whitesboro, N.Y. (P,S) Decomposed.Miss America Foods, Inc./Cullman, Ala. Off flavor, simila

(P,S)New England Confectionery Co./Cambridge, Rodent infested.

Mass. (D)

American Seaway Foods, Inc./Bedford Held under insanitary conditions; rodent contaminated.Heights, Ohio (D)

H a v m o r F o o d P r o d u c t s / B r o o k l y n , N . Y . ( D ) "Simonton Grain Co., Inc./Shreveport, La.

(D)Dasher Pecan Co./Valdosta, Ga. (S) E. coli in finished product." (P,S) Prepared and packed under insani tary condi t ions;

E. coli.Kerman Pistachio of California/Terra Bella, Held under insanitary conditions.

Calif. (D)H o u s t o n C e n t r a l W a r e h o u s e & C o l d S t o r a g e / "

Houston, Tex. (D)Chef Reddy Foods, Inc./Othello, Wash. Prepared and packed under insanitary conditions.

(M,S)B & B Fisheries/Kodiak, Alaska (P,S) Partly decomposed.

Akin Distributors, Inc./Tulsa, Okla. (D) Held under insanitary conditions; rodent contaminated.

M o r r i s t o w n G r a i n C o . / M o r r i s t o w n , S . D a k . " ; a n d i n s e c t c o n t a m i n a t e d .(D)

a n d i n s e c t c o n t a m i n a t e d .

Allied Patty Mix/Ada, Okla. 5/13/71

Avo avocado salad dip/Albuquerque, N. Mex.6/4/71

Big Sip 6 space pak fruit flavored drinks/Chicago, III. 6/9/71

Maple syrup "Rich-Top"/Milwaukee, Wis.6/8/71

Mushrooms, canned/Denver, Colo. 7/1/71

Nut candies/Cedar Grove, N.J. 5/24/71

Pecan pralines/New Orleans, La. 7/1/71

Shrimp, frozen/Buena Park, Calif. 6/9/71breaded Chunk-ees/Memphis, Tenn.

6/28/71

Economic and Labeling Violations

Globus Laboratories, Inc./Hackensack, N.J. Below labeled content in protein; label does not bear( M , S ) t h e p l a c e o f b u s i n e s s o f t h e m a n u f a c t u r e r , p a c k e r ,

or d is t r ibu to r.

Ashley's Restaurant/El Paso, Tex. (M,S) Not in conformity with the Fair Packaging andLabeling Act.

Big Sip, Inc./Manchester, Tenn. (M,S) Net contents statement fails placement and type sizerequirements.

Re-Mi Foods, Inc./Schiller Park, III. (M,S) A dark brown, slightly viscous liquid has been substituted for maple syrup.

Great Lakes Mushroom Coop/Warren, Mich. Not in compliance with the standard fill of container( D i s t r i b u t o r ) f o r c a n n e d m u s h r o o m s ; m a g g o t s .

Valerie Sweets, Inc./Cedar Grove, N.J. (D) Not in conformity with the Fair Packaging andLabeling Act.

L a m m e ' s C a n d i e s S i n c e 1 8 8 5 , I n c . / A u s t i n , "Tex. (M,S)

I n d u s t r i a l P e s q u e r a / G u a y a q u i l , E c u a d o r ( P, S ) "Sea Pak Div. of W. R. Grace & Co./St. Fail to conform with definition and standard of

S i m o n s I s l a n d , G a . ( P , S ) i d e n t i t y f o r b r e a d e d s h r i m p .

Great Lakes Mushroom Coop/Warren, Mich.(D is t r i bu to r )

Valerie Sweets, Inc./Cedar Grove, N.J. (D)

Simons Island, Ga. (P,S)


PRODUCT, PLACE & DATE SEIZEDMANUFACTURER (M) , PACKER (P) ,

SHIPPER (S), DEALER (D)

Livonia, Mich. 6/24/71

Strawberries/Buffalo, N.Y. 6/2/71

Syrup/Shreveport, La. 6/4/71

Economic and Labejing Violations (cont'd)Sea Pak Div. of W. R. Grace & Co./St. Not in conformity with the Fair Packaging and

S i f T i o n s I s l a n d , G a . ( P, S ) L a b e l i n g A c t .Humboldt Canning Co., Inc./Humboldt,

Tenn. (P)Blackburn Syrup Works/Jefferson, Tex.

(M,S)

Feta cheese/Methuen, Mass. 6/9/71

Worcester, Mass. 7/1/71

Spinach, chopped/Tampa, Fla. 7/7/71W.M.C. Baking Specialty/Colorado Springs,

Colo. 6/30/71

Food Additives

Imported from Greece. A. Fantis, Inc./ Contains benzene hexachloride, an unsafe foodN e w Y o r k , N . Y . ( S ) a d d i t i v e .

Aista Olive Co., Inc./New York, N.Y.(Import)

Seabrook Farms Co./Seabrook, N.J. (P,S) Contains diazinon, an unsafe food additive.Wheat Products Co., Inc./Colorado Springs, Contains nitrites and nitrates, unsafe food additives.

Colo. (M) (Return shipments from Ala.,Calif., and N.J.)

Vitamins—Dietary Food

L H C chocolate drink/Chicago, III. 6/15/71 Compact Industries, Inc./Lake Mills, Iowa Labeling lacks special dietary information; contains( M , S ) s u g a r a n d s a c c h a r i n e .

Analgesic antacid chaser for hangover/Brooklyn, N.Y. 6/1/71

Ascorbic acid/St. Paul, Minn. 5/18/71

Estrand-Gens ffb tablets/Valley Stream,N.Y. 5/25/71

Phenylbutazone/St. Louis, Mo. 5/28/71

Sta-Slim injectable/Phoenix, Ariz. 7/1/71

Vice spice/Detroit, Mich. 1/18/71 (notpreviously reported)

Whi te Quadr isect tab le ts /Peor ia , I I I .3/18/71

DRUGS / Human Use

Comay Laboratories/Lake Forest, III. (M,S) New drug not approved for safety and efficacy.

Altair Laboratories, Inc./Perth Amboy, N.J. Not in conformity with good manufacturing practice.(M,S)

Richlyn Laboratories/Philadelphia, Pa. (M,S) Subpotent in methyltestosterone.

Imported from Switzerland. Benzian AG New drug not approved for safety and efficacy.(M,S)

D - M P h a r m a c e u t i c a l s , I n c . / R o c k v i l l e , M d . "(M,S)

C r o w n I n d u s t r i e s & S u p p l y C o . / D e t r o i t , n o t i n c o n f o r m i t y w i t hM i c h , ( p ) t h e F a i r P a c k a g i n g a n d L a b e l i n g A c t .

George N. Bell Manufacturing Chemist/ Not in conformity with good manufacturing practice.Indianapolis, Ind. (M,S)

Cinch horse conditioner/Denver, Colo.6/14 and 6/15/71

Cough check syrup/Minneapolis, Minn.6/7/71

Furazolidone medicated premix/Moorpark,Calif. 5/19/71

Leamycin (oxytetracycline HCI) injectable/Newman Grove, Nebr. 6/21/71

Natamycin injectable solution/Sioux Falls,S. Dak. 5/18/71Belle Plaine, Minn. 5/27/71

Sioux City, Iowa 6/7/71Oxy-Tet brand of oxytetracycline HCI/

Fresno, Calif. 6/8/71Pine-O-Pine cleanser disinfectant/Oklahoma

City, Okla. 5/24/71

Redglo energy blood tonic/Hato Rey, P.R.5/18/71

Super Speed Anemiaban, Codesine gel, ironcacodylate, Pepto-Liv/Charles Town, W.Va. 6/22/71

Super Endurance (vitamin B Compound)/Winnfield, La. 6/17/71

Super Tone liquid supplement/Omaha, Nebr.5 /25/71

U-Tha-Sol, Cap-Chur-Gem, Cap-Chur-Barb/Douglasvilje, Ga. 6/24/71

Veter inary /Med ica ted Feed

Franklin Laboratories/Denver, Colo. (D) and New animal drug without effective approved NewR e p a c k e r A n i m a l D r u g A p p l i c a t i o n .

Eastern Laboratories, Inc./Vineland, N.J. Below labeled strength in declared amounts of( M , S ) d e x t r o m e t h o r p h a n h v d r o b r o m i d e a n d c h l o r o h e n i r a -

Davis-Edwards Pharmacal Corp./Danbury,Conn. (M,S)

W-W, Inc./Wisrier, Nebr. (M) from importedraw mater ia l .

Professional Veterinary Laboratories/Minneapolis, Minn. (M)

Wendt Laboratories, Inc./Belle Plaine,Minn. (D)

Wendt Laboratories/Minneapolis, Minn. (M)Livestock Health Products, Inc./Fresno,

Calif. (D)Pine-O-Pine Co./Houston, Tex. (M)

Thoroughbred Remedy Corp./Elmont, L.I.,N.Y. (M,S)

Anthony Products Co./El Monte, Calif.(M,S)

Cadco, Inc./Des Moines, Iowa (M,S) l ew animal drug without effective approved NewAnimal Drug Application.

Palmer Chemical & Equipment Co./Douglas- New animal drugs without effective approved Newv i l l e , G a . ( D ) A n i m a l D r u g A p p l i c a t i o n ; n o t i n c o n f o r m i t y w i t h

good manufacturing practice.

Animal Drug Application.Below labeled strength in declared amounts of

dextromethorphan hydrobromide and chlorpheniramine maleate; false and misleading claims.

New animal drug without effective approved NewAnimal Drug Application.

False and misleading claims to be effective for use in

dop to treat superficial burns, minor wounds, cuts,poison ivy, chigger bites; "pine oil" is partlysynthetic; no warning against use on cats.

New animal drug without effective approved NewAnimal Drug Application.

False and misleading claims to be effective in horsesfor treatment of vitamin B complex deficienciesand anemia due to iron deficiency; new animaldrugs without effective approved New Animal DrugApplication.


PRODUCT, PLACE & DATE SEIZED MANUFACTURER (M), PACKER (P),SHIPPER (S) , DEALER (D)

Slenderton reducing machine/GainesvilGa. 5/18/71

MEDICAL DEVICE

American Physiotherapy Corp./Dallas, Tex.(M)

False and misleading claims to be effective forincreasing caloric usage, and for firming waist,hips, abdomen, and thighs,- dangerous to healthwhen used by laymen with the frequency andduration recommended.

ProphylacticsDean's Peacock's, rubber/Milwaukee, Wis. Dean Rubber Co./North Kansas City, Mo. Defective quality

4 / 2 1 / 7 1 ( M , S )Hopkins, Minn. 4/23/71

Alcohol/Kansas City, Mo. 5/26/71

Castor beans/Fredonia, N.Y. 6/8/71

Cherry bombs/nr. Granada, Miss. 6/4/71

M-80 fireworks, Silver Salutes/Holland,Ohio 6/25/71

M-80's/Millersville, Tenn. 6/4/71Contact cement and contact cement

thinner/Chicago, III. 6/23/71Fireworks/Holly Springs, Miss. 6/4/71

Silver Salutes/Vaiden, -Miss. 6/4/71Goodlettsville, Tenn. 6/4/71Cherry bombs, M-80 ifireworks/Millers-

ville, Tenn. 6/4/71 (2 actions)

HAZARDOUS SUBSTANCES

Harker Paint & Varnish Co./Springfield,Mo. (Repacker, S)

Fredonia Seed Co./Fredonia, N.Y. (Repacker)

Jack's Place Pit Bar-B-Que/nr. Granada,Miss. (D)

Millers Fireworks & Novelty Co., Inc./Holland, Ohio (D)

Raymonds Gift Shop/Millersville, Tenn. (D)Craftsman Wood Service Co./Chicago, III.

(D)Colonial Inn Restaurant/Holly Springs, Miss.

(D)Stuckey's Pecan Shop/Vaiden, Miss. (D)George B. Evans/Goodlettsville, Tenn. (D)B & B Fireworks Co./Millersville, Tenn.

(D) and M & H Sales Co./Millersville,Tenn. (D)

Lacks consumer protection information required bythe Fed. Hazardous Substances Act.

Toxic seed packaging lacked required conspicuouslabeling statements.

Banned hazardous substances; lack consumer protection information required by the Fed. HazardousSubstances Act.

Lack consumer protection information required bythe Fed. Hazardous Substances Act.

Banned hazardous substances.

U.S. POSTAL SERVICE actions taken in medical cases under provisions of the Postal Fraud Statutes as reportedby the Assistant Postmaster General.

False Representation Orders Issued by Judicial Officer Under 39 U.S.C. 3005

June 21, 1971 (suspended July 17, 1971, pending court appeal): FalseRepresentation Order issued against Parker Publishing Co., Inc.,West Nyack, New York 10994. Advertising and sale by mail ofpublication "Nutrition for Health" represented as providing anutritional regime that constitutes an adequate, effective, orreliable preventioh, treatment, and/or cure, for numerous ailments, as well as endowing subscribers with knowledge thatwill enable them to obtain and maintain good health.

June 25, 1971: False Representation Order issued against The MailShop and Imperial Trading, P.O. Box 45153, Chicago, Illinois60645. Advertising and sale by mail of "Lovely Curves Bust De

veloping Cream" for underdeveloped busts. Additional productsmarketed in the same manner and represented as aphrodisiacs,or sexual stimulants, were "Vaginex Female Cream," "Perk-Up,""Vice Spice," and "Golden Youth Pills."

July 30, 1971: False Representation Order issued against EleanorMartin Co., Douglas, Michigan 49406. Advertising and sale bymail of miracle formula cream "Nutrivena B25" to eliminatewrinkles, lines, and general aging appearance.

Complaints Filed by the Law Department Under 39 U.S.C. 3005 (False Representation)

June 15, 1971: Tir-Ado Chemical Corp., 2147 East 4th Street, Brooklyn, New York 11223. Solicitations of orders and sales throughthe mails of "European Love Drops" represented as a miraclesexual rejuvenator.

June 28, 1971 (amended August 3, 1971): Krisnel, Inc., Dept. 897,P.O. Box 188, Osbornsville, New Jersey 08723, and Lyncrist, Inc.,P.O. Box 536, Breton Woods, New Jersey 08723 (same operator).Advertising and sale by mail of "Syntron Method" promising dramatic weight losses.

July 16, 1971: Special Choice Grapefruit Diet, Dept. 7383, 7471 Melrose Avenue, Los Angeles, California 90046. Advertising andsale by mail of the revolutionary grapefruit diet represented asenabling subscribers to lose ten pounds in ten days and regaintheir youthful figures.

July 22, 1971: Marvelex Co., Dept. 7440, 7471 Melrose Avenue, LosAngeles, California 90046. Advertising and sale by mail of "Marvelex Plan" promising dramatic weight losses in only eight weeks.

July 30, 1971: Skinpeel, 210 Barbara Circle, Ocean Springs, Mississippi 39561. Advertising and sale by mail of "Skinpeel Course"represented as enabling subscribers to look years younger withoutplastic surgery.


notices of judgmentOrleans, La., who processed the article from milk chocolate coatingshipped in interstate commerce, the article was in violation of the FairPackaging and Labeling Act, since the principal display panel of the labellacked a declaration of the net quantity of contents; 15 U.S.C. 1453(aX2).Consent decree authorized release to the processor for relabeling. (16)

NOTICES OF JUDGMENT on Seizure Act ions

FOOD / Poisonous and Deleterious SubstancesCottonseed meal, at Logan, Dist. Utah.

Charged 12-30-70: while held for sale, the article contained an addedpoisonous and deleterious substance, namely, aflatoxin; 402(a)fl). Defaultdecree authorized donation to public institution for use as fertilizer. (1)

Feeds, for animals, Hygrade, at Bucyrus, E. Dist. Mich.Charged on or about 1-2-70: when shipped by Hygrade Food ProductsCorp., Mishawaka, Ind., the articles contained the added poisonous anddeleterious substance, Salmonella bacteria; 402(a)(1). Default decreeordered destruction. (2)

Yeast, brewer's, Yeastal, at Glendale, C. Dist. Calif.Charged 11-27-70: when shipped by Yeast Products, Inc., Paterson, N.J.,the article contained the added poisonous and deleterious substance.Salmonella micro-organisms; 402(a)(1). Default decree ordered destruct ion. (3)

FOOD / Contamination, Spoilage, Insanitary Handling

Beans, green, cut, canned, at Seattle, W. Dist. Wash.charged 7-21-70: when shipped by Rogers Walla Walla, Inc., Milton-Freewater, Greg., the article, labeled in part "Old Ranger Brand TenderBlue Lake Cut Green Beans . . . Packed for J. C. Wright Sales Co., Seattle,Wa s h . " a n d " E l m d a l e G r e e n B e a n s C u t . . . D i s t r i b u t o r s P a c i fi c M e r c a ntile Co., San Francisco, Calif.," lacked conformity to the standard ofidentity, since it was not sealed in a container and so processed by heatas to prevent spoilage—403(g)(l)j and while held for sale, the articlewas held under insanitary condiiions in cans, a number of which wereswelling and leaking and had small holes therein—402(a)(4). Defaultdecree ordered destruction. (4)

Cashew nuts, at St. Paul, Dist. Minn.Charged 12-15-70; when shipped by Simab Corp., New York, N.Y., thearticle contained insect filth and moldy nuts; 402(a)(3). Consent decreeauthorized release to Fisher Nut Co., St. Paul, Minn., for export to original foreign supplier. (5)

Cornmeal, at Quincy, N. Dist. Fla.Charged 10-7-70: when shipped by Murphy Grain & Milling Co., Owens-boro, Ky., the article contained rodent and insect filth and was preparedand packed under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release to the shipper for conversion to animal feed. (8)

Flour, at Mobile, S. Dist. Ala.Charged 11-30-70: while held by City Sales Co. of Mobile, Inc., Mobile,Ala., the article contained rodent filth and insects and was held underinsanitary conditions; 402(a)(3), 402(a)(4). Consent decree ordered destruction. (7)

Onion rings, breaded, frozen, at Saginaw, E. Dist. Mich.Charged 11-10-69: when shipped by Moore's Seafood Products, Inc., FortAtkinson, Wis., the article contained E. coli and bacterial filth and hadbeen prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (8)

Peanuts, shelled, at Charlotte, W. Dist. N.C.Charged 12-1-70: when shipped by Burke Coun^ Peanut Co., Waynesboro,Ga., the article contained insect filth; 402(a)(3). Consent decree authorized release to Mitchum's, Inc., Charlotte, N.C., for reconditioning. (9)

Peanuts, shelled, salted, Snacktime, at Little Chute. E. Dist. Wis.Charged 1-14-71: when shipped by Johnson Nut Co., Div. of FairmontFoods Co., Hopkins, Minn., the article contained insect filth and had beenprepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (10)

Rice, at Minneapolis, Dist. Minn.Charged 12-3-70: while held by North Star Warehouse, Inc., Minneapolis,Minn., the article contained insect filth and was held under insanitaryconditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (11)

Shrimp pieces, frozen. Gulf City, at Shreveport, W. Dist. La.Charged 10-13-70: when shipped by Gulf Cities Fisheries, Inc., Pascagoula,Miss., the article contained decomposed shrimp, and the label statement"Shrimp in the Shell" was false and misleading, since the article consisted of peeled pieces of shrimp; 402(a)(3), 403(a). Default decreeordered destruction. (12)

Walnut meats, Snacktime, and mixed nuts, Crest-pac, at Boise, Dist. Idaho.Charged 11-30-70: when shipped by Johnson Nut Co., Div. of FairmontFoods Co., Hopkins, Minn., the articles contained insect filth and hadbeen prepared and packed under insanitary conditions; and the label ofthe mixed nuts was false and misleading in that they contained no filbert or pecan nuts; 402(a)(3), 402(a)(4) 403(a). Default decree ordereddestruction. (13)

Walnuts, unshelled, Blue Ribbon, at Flint, E. Dist. Mich.Charged 12-31-70: when shipped by Continental Nut Co., Chico, Calif., thearticle contained insect filth and was prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Consent decree authorized release tothe shipper for reprocessing. (14)

FOOD / Economic and Labeling ViolationsBeverage mix, Soyamel Banana, at Dallas, N. Dist. Tex.

Charged on or about 12-30-70: when shipped by Worthington Foods, Inc.,Worthington, Ohio, the label lacked required information concerning itspurported vitamin properties—403(j); and the article was in violation ofthe Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was not placed within the bottom 30 percent of the areaof the principal display panel, and was stated in a type size less than3/16 inch high—15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decreeordered destruction. (15)*

Chocolate rabbits, at New Orleans, E. Dist. La.Charged on or about 1-25-71: while held by Merlin's Candies, Inc., New

Coffee, drip, canned, Arco, at Superior, W. Dist. Wis.Charged 12-3-70: when shipped by Andersen-Ryan Coffee Co., Duluth,Minn., the article was in violation of the Fair Packaging and LabelingAct in that the declaration of net quantity of contents on the principaldisplay panel and alternate principal display panel was not separatedfrom other printed label information appearing below the declaration:the quantity of contents was expressed as "Net Wt. 1 Lb." instead or"Net Wt. 16 Oz. (1 lb.)"; and the quantity of contents was stated in atype size less than 3/16 inch high: 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i),

relabe/" n ^ (1 ") decree authorized release to the shipper forDip, avo, at Albuquerque, Dist. N. Mex.

Charged 1-22-71: when shipped by Ashley's Frozen Foods, El Paso, Tex.,the article was in violation of the Fair Packaging and Labeling Act, inthat declarations of net quantity of contents did not appear on both ofthe principal display panels, and the declaration of net quantity of contents was not separated by a space of not less than 1/8 inch fromother printed label information appearing above the declaration, and wasstated in a type size less than 1/8 inch high; 15 U.S.C. 1453(a)(2),1453(a)(3)(C)(i). Default decree ordered destruction. (18)

Flavoring, imitation vanilla, Belmo, at Fort Wayne, N. Dist. Ind.Charged 5-15-70: when shipped by Belmont Laboratories, Detroit, Mich.,the article contained artificial flavoring and failed to state that fact—403(k); and the article was in violation of the Fair Packaging and Labeling Act, in that the declaration of net quantity of contents was notplaced on principal display panel, the net quantity of contents was expressed as "Contents 1 Pint" instead of "Net 16 fl. oz. (1 pt.)," andwas stated in a type size less than 1/8 inch high—15 U.S.C. 1453(a)(2),chaNta fe ns ^ ^ Default decree authorized donation to a

Fruit, mixed, canned, at Fargo, Dist. N. Dak.Charged 8-5-70: when shipped by Allied Canners & Packers, Inc., SanFrancisco. Calif the article, labeled in part "Tasty Ripe Mixed Fruit. . . Contadina foods Division of Carnation Company Los Angeles Calif.,"was in violation of the Fair Packaging and Labeling Act, in that the netquantity of contents was exoressed as "Net Wt. 1 Lb. 13 Oz." Instead of"Net Wt. 29 Oz. (1 Lb. 13 ()z.)"; the net quantity of contents was statedm a type size less than 1/8 inch high; and the label stated "Servings(Approx.) 4-7 Portions" but lacked the net quantity of each such serving;15 U.S.C. 1453(a)(3)(A)(l), 1453(a)(3)(C)(i), 1454(a)(4). Consent decree authorized release to Contadina Foods, Inc., Los Angeles, Calif., for relabeling. (20)

Popcorn, unpopped. Big Fop, at Culloden, S. Dist. W. Va.Charged 12-30-70: when shipped by National Oats Co., Delaware, Ohio,the article was in violation of the Fair Packaging and Labeling Act inthat the net quantity of contents was expressed as "Net Weight 2Pounds" rather than "Net Wt. 32 Oz. (2 Lbs.)"; 15 U.S.C. 1453(a)(3XA)(i).Default decree authorized donation to charitable organizations. (21)

Sauce, barbecue, at North Little Rock, E. Dist. Ark.Charged 3-5-71: when shipped by Superior Foods, Inc., Dallas, Tex., thearticle, labeled in part "Hickory House Original Hickory Smoked BarbecueSauce . . . Packed and Distributed by Better Foods, Inc., Dallas, Tex.,"was in violation of the Fair Packaging and Labeling Act, in that the netquantity of contents declaration was not separated by a space equal to1/8 inch in height from other printed label information appearing aboveand below the declaration; and the net quantity of contents declarationwas expressed as "1 Lb. 2 Oz." rather than "Net Wt. 18 Oz. (1 Lb. 2Oz.)," and was stated In a type size of less than 1/8 inch high—15 U.S.C.1453(a)(2), 1453(a)(3)(A)(l), 1453(a)(3)(C)(l); and the label of the articlelacked the common or usual name of each ingredient—403(i)(2). Defaultdecree authorized donation to charitable or public institutions. (22)

Shrimp, breaded, frozen, at Chicago, N. Dist. III.Charged 2-9-71: when shipped by Golden Shore Seafoods, Inc., Brunswick, Ga., the article, labeled in part "Country's Delight Breadeo FantailShrimp . . . Dist. by Certified Grocers of Illinois, Inc., Chicago, Illinois,"was in violation of the Fair Packaging and Labeling Act, In tnat the declaration of net quantity of contents was expressed as "Net Wt. 20 Ozs."instead of "Net Wt. 20 Oz. (1 Lb. 4 Oz.)," and was stated In a typesize less than 3/16 Inch high; 15 U.S.C. 1453(a)(3)(A)(i) 1453(a)(3)(C)(i).Consent decree authorized reTease to the shipper for relabeling. (23)

VITAMINS/DIETARY FOODSVitamin A capsules, U.S.P., at Cincinnati, S. Dist. Ohio.

Charged 12-14-70: while held for sale, the article's strength differed fromU.S.P. standard, since the art ic le was understrength in vi tamin A(approx. 11.4 percent); 501(b). Default decree ordered destruction. (24)

FOOD ADDITIVE

Cranberry juice cocktail and canned plums, at St. Paul, Dist. Minn.Charged 12-9-70: while held for sale, the articles contained the nonconforming food additive calcium cyclamate; 402(a)(2)(C). Default decreeordered destruction. (25)

DRUGS / Human Use

Codeine phosphate injection, U.S.P., in syringes, at Jackson, E. Dist. Mich.Charged 6-9-69: when shipped by Intra Products, Dayton Ohio, the article's quality fell below the U.S.P. standard, since the faulty protectivesheaths of the syringe needles failed to assure the ster llty of the article, and the articles were not packaged as prescribed in the U.S. Pharmacopeia for single-dose containers; 501(b), 502(g). Default decreeordered destruction. (26)


Cosanyl extract compound, concentrated, at Detroit, E. DIst. Mich.^ 5 ' ' ® . ^ C o - ' D e t r o i t , M i c h . , t h earticle, which the dealer had manufactured in part from squill which hadbeen shipped in interstate commerce, had been prepared and held under

insanitary conditions, and the circumstances of the article's manufacture,processing, packing, and holding lacked conformity with current good

deTtSon '"f27r '"' 501(a)(2)(B). Consent decree orderedOextrchamphetamine sulfate capsules, at Mansfield, N. Dist. Ohio.

^■2:70: when shipped by Plymouth Laboratories, Inc.,Plymouth, Mich., the strength of the article, labeled in part "D-A-S-fTimekaps (D-Amphetamine Sulfate) Brand of Timed Disintegrating capsule. . . Distributed by The Caldwell & Bloor Co., Mansfield, Ohio," differedfrom its represented strength: the declared quantity of amphetamine wasfalse and misleading, since the article was subpotent (approx. 13 percent); and the circumstances of the article's manufacture, packing, and

conformity with current good manufacturing practice;501(a)(2)(B), 501(c), 502(a). Default decree ordered destruction. (28)

Dextrocell No 2 amphetamine and thyroid combination tablets, at Richmond,E. Dist. Va.Charged 11-4-70: when the article in 100-tablet and 1,000-tablet bottleswas shipped by Leeds-Dixon Labs., Moonachie, N.J., the article was a newdrug without an effective approved New Drug Application—505(a); andwhile the article in 100-tablet and 1,000-tablet bottles was held by thedealer, Jones & Vaughan, Inc., Richmond, Va., and while the article in5-tablet vials was held by such dealer after being repacked from bulk,the accompanying labeling of the article in such bottles and vials contained false and misleading claims that the article (because of its thyroid content) was adequate and effective in the treatment of a variety ofclinical conditions such as chronic colds, functional menstrual disorders,and certain types of anemias and obesity; the listing of thyroid in theformulation as an active ingredient of the article v^ich was indicatedfor use as an adjunct in the dietary treatment of obesity was false andmisleading, since the presence of thyroid in the article was of no valuefor such use; and the labeling of the article in the 5-tablet vials lackedadequate directions for use and was not exempt therefrom, since sucharticle was a new drug without either an effective approved New DrugApplication or a filed notice of claimed investigational exemption—502(a), 502(f)(1). Default decree ordered destruction. (29)

Digoxin tablets, U.S.P., at Brooklyn, E. Dist. N.Y.Charged 11-25-69: when shipped by Davis-Edwards Pharmacal Corp., Dan-bury, Conn., the article's quality fell below the U.S. Pharmacopeia standards, since the article failed the test for content uniformity; 501(b).Default decree ordered destruction. (30)

Kola nuts, squill, and cherry bark, at Detroit, E. Dist. Mich.Charged 6-3-69: while held for sale, the articles contained insects;501(a)(1). Consent decree ordered destruction. (31)

Meprobamate tablets, N.F., at Fenton, E. Dist. Mich.Charged 5-23-69: when shipped fay Rabin Winters, Div. of Brunswig DrugCo., El Segundo, Calif., the quality and purity of the article fell belowNational Formulary standards, since the article contained quinidine sulfate, and the circumstances of the article's manufacture, processing,packing, and holding lacked conformity with current good manufacturingpractice; 501(a)(2)(B). Default decree ordered destruction. (32)

Methamphetamine combination tablets, at Detroit, E. Dist. Mich.Charged 5-19-69: while held for sale, after manufacture by PlymouthLaboratories, Inc., Plymouth, Mich., from ingredients shipped in interstatecommerce, the article was deficient in methamphetamine HCI (approx.17 percent) and in amobarbital (approx. 12 percent), and the circumstances of the article's manufacture, processing, packing, and holdinglacked conformity with current good manufacturing practice; 501(a)(2)(B),501(c). Default decree ordered destruction. (33)

Ox-Vital oxygen supply with mask, at Shreveport, W. Dist. La.Charged 8-10-70: when shipped by Lother-Mischka, West Germany, thelabeling contained false and misleading claims that the article was adequate and effective as a source of first aid and lifesaving oxygen inangina pector is, heart infarctus, choking, accident shock, and al lrespiratory disorders; the label lacked the name and place of businessof the manufacturer, packer, or distributor and an accurate statement ofquantity of contents; the labeling lacked adequate directions for use andadequate directions for safe use could not be written since the articlecontained an insufficient quantity of oxygen; and the labeling lackedadequate warnings against use; 502(a), 502(b)(1), 502(b)(2), 502(f)(1),502(f)(2). Default decree ordered destruction. (34)

Prednisolone capsules, at Mansfield, N. Dist. Ohio.Charged on or about 1-2-70: when shipped by Plymouth Laboratories, Inc.,Plymouth, Mich., the strength of the article, labeled in part "PrednisoloneTimekaps . . . Distributed by Caldwell & Bloor Co.," differed from itsrepresented strength, and the declared quantity of prednisolone ingredient was false and misleading, since the article was subpotent and thecircumstances of the article's manufacture, processing, packing, and holding lacked conformi ty wi th cur rent good manufactur ing pract ice;501(a)(2)(B), 501(c), 502(a). Default decree ordered destruction. (35)

Proplex hormone combination suspension, at Ferndale. E. Dist. Mich.Charged 11-3-70: while held for sale after manufacture by Atlas Pharmaceutical Laboratories, Inc., Detroit, Mich., from ingredients shipped ininterstate commerce, the circumstances of the article's manufacture,processing, and packing lacked conformity with current good manufacturing practice and the label of the article lacked the required prescriptionlegend; 501(a)(2)(B), 503(b)(4). Default decree ordered destruction. (36)

Squill, at Detroit, E. Dist. Mich.Charged 5-14-69: while held for sale, the article contained insects;501(a)(1). Consent decree ordered destruction. (37)

DRUGS / VeterinaryMedic-Aid 2-50 penicillin-streptomycin combination powder, at San Antonio,

W. Dist. Tex.Charged 1-14-70 and amended 4-24-70: when shipped by Salsbury Labs.,Little Rock, Ark., the strength of the article differed from what it wasrepresented to possess and its labeling was false and misleading because of a deficiency in its streptomycin sulfate content, and its labeling was also misleading, since it represented that the article contained1 5 , 0 0 0 m g . s t r e p t o m y c i n s u l f a t e p e r 2 - o z . p a c k e t a n d t h e l a b e l i n g f a i l e dt o r e v e a l t h e m a t e r i a l f a c t o f t h e a c t u a l a m o u n t o f s t r e p t o m y c i n b a s e

content which was only 80 percent of the declared amount of streptomycin sulfate; 501(c), 502(a).South Texas Serum & Supply Co., San Antonio, Tex., claimant, filed ananswer, served a request for admissions which was answered, and wasserved with written interrogatories by the Government. The claimant an-swered the interrogatories and then filed a motion which was grantedto hold further proceedings in the case in abeyance pending certain administrative determinations. Thereafter the claim and answer of theclaimant was withdrawn and a decree was entered ordering destructionof the article. (38)

Wil-Grp-Matic thiabendazole cattle warmer, at Longmont, Dist. Colo.Charged 12-31-70: while held by Malo Feed Co., Longmont, Colo., aftermanufacture by that firm from thiabendazole which had been shipped ininterstate commerce, the article's strength in respect to thiabendazolewas less than represented and its label contained false and misleadingclaims as to its thiabendazole content; 501(c}, 502(a). Consent decreeauthorized release to Malo Feed Co. for relabeling. (39)

MEDICAL DEVICESPorta-Sauna folding steam-bath cabinet, at Bridgeport, Dist. Conn.

Charged 9-16-66 and amended 7-15-68: when shipped by Walter NugentEnterprises, Detroit, Mich., statements in the article's labeling falselyand misleadingly represented and suggested that the article was adequate and effective as a treatment for colds, sinus trouble, overweight,acne, tension, arthritis, bursitis; that use of the device promoted aslender stature, a clear, healthy look, and a bounce to the user's step,adding years of health and happiness to a person's life, stimulates circulation, opens and cleanses pores, and keeps the user fit and slender—502(a); and that the labeling lacked adequate warnings against its misuse, such as "Warning—Elderly persons or those suffering from heartdisease or high blood pressure should not use this device unless directedby a physician"; 502(f)(2).The articles were ciaimed by City Lumber Co. of Bridgeport, Inc.,Bridgeport, Conn., and by the shipper. Upon motion of City Lumber Co.of Bridgeport, Inc., the case was transferred to the Eastern District ofMichigan. Thereafter, City Lumber Co. of Bridgeport withdrew its claim.Written interrogatories were served by both the Government and theclaimant after a number of motions by the parties and the filing of answers to the interrogatories, the Government moved for summary Judgment . The D is t r i c t Cou r t sa id :

"This is an in rem action arising under the provisions of the FederalFood, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. The government'scomplaint, as amended, charges the devices, portable steam baths designated as 'Porta-Saunas,' to have been shipped in interstate commercewhile they were misbranded within the meaning of 21 U.S.C. § 352.Walter W. Nugent has intervened as a claimant in the case, and hasvigorously contested all action by the government in the matter.

"This Court has carefully considered all the filings in this action,including the interrogatories of the plaintiff and the responses to themmade by the claimant, and concludes that the plaintiff is entitled tohave its motion for summary judgment granted. It appears from theclaimant's responses to the government's interrogatories that the claimant manufactured the units seized, that claimant shipped the units fromits plant in Michigan to Bridgeport, Connecticut, and that the twobrochures attached to claimant's answers to plaintiff's interrogatoriesdesigned to describe the units and promote their sales, were alsoshipped in interstate commerce from Michigan to Connecticut. * * *

"The plaintiff's amended complaint charges that the accompanyinglabeling for the claimant's steam baths contains false and misleadingtherapeutic claims, and this charge is substantiated by the affidavitsappended to plaintiff's present motion. The opposing affidavit of JackFront, who is not a licensed physician, does not seriously controvert thestatements of the three doctors dispelling the claims of the steam bath.The government is only required to prove that any one of the representations is false or misleading under 21 U.S.C. § 352(a), United StatesV. An Article of Device . . . Diapulse, 389 F.2d 612 (2nd Cir. 1968);United States v. Hoxsey Cancer Clinic, 198 F.2d 273, 281 (5th Cir. 1952),and this Court is satisfied that the affidavits of the three doctors submitted along with the plaintiff's motion for judgment establish at leastone violation of subsection (a). It should be noted that the statementsin the accompanying labeling material represent that the art icle isadequate and effective as a treatment for colds, overweight, sinus trouble, acne, tension, arthritis, and bursitis, and that it can add years ofhealth and happiness to a person's life, also keeping the user fit andslender. The affidavits of the three doctors submitted in support of theplaintiff's motion controvert the claims of the device as to its capacityto alleviate acne, arthritis, bursitis, colds, or sinus conditions.

"In addition to the misleading and false labeling in violation of 21U.S.C. § 352(a), the labeling does not contain adequate warnings withinthe purview of 21 U.S.C. § 352(f)(2). In the middle of seven paragraphsappearing on a page entitled 'Tips on Steam Bathing,' marked Exhibit'R' by the claimant and attached to his answers to plaintiff's interrogatories, the language 'Anyone with a heart condition, high blood pressureor other physical impairment should only use a steam bath with adoctor's advice' is found. The affidavit of Robert J. Gosling, M.D. statesthat the intense heat generated by the Porta-Sauna units constitutes apotential danger to elderly persons and those suffering from heart conditions, high blood pressure, or other cardio-vascular problems, yet theclaimant's warning only cautions persons 'with a heart condition, highblood pressure or other physical impairments.' Thus elderly persons arenot warned by this language, and in addition, the warnings which aregiven are insufficient under Section 352(f)(2) faecause of the format inwhich they are presented. This informative page which the purchaser receives along with the unit, according to claimant's response to interrogatory number 20, does not demand the attention which Section352(f)(2) requires, nor does the embedded warning, written only in smallregular type, constitute 'prominence' within the meaning of Section352(c) of Title 21. The quality of a warning which is 'adequate' underSection 352(f)(2), or 'prominent' under Section 352(c) will necessarilyvary from case to case, but this Court is of the opinion that the warnings in the instant case, when the nature of the device is considered,a r e n o t s u f fi c i e n t c o m p l i a n c e w i t h t h o s e t w o s u b s e c t i o n s . T h e p u r p o s eof this statute is to protect the consumer, and it is therefore not tobe read restrictively, notwithstanding its provision for confiscation ofp r o d u c t s f o u n d t o b e i n v i o l a t i o n o f i t s m a n d a t e s . U n i t e d S t a t e s v .Sullivan, 332 U.S. 689 (1948); United States v. Dotterweich, 320 U.S. 277(1943).

"To be entitled to judgment, the government need only prove that thed e v i c e s u n d e r s e i z u r e w e r e i n t r o d u c e d i n t o i n t e r s t a t e c o m m e r c e w h i l e


misbranded under any one of the, provisions of the Food, Drug, andCosmetic Act. * * *

"In the instant litigation, this Court grounds its finding that theplaintiff is entitled to judgment upon (1) a finding that the devices aremisbranded within the meaning of 21 U.S.C. § 352(a), the brochure beingfalse and misleading in that it represents that the steam bath is aneffective treatment for colds, sinus conditions, acne, arthritis, andbursitis, when it in fact is not; and (2) upon the alternative ground thatthe Claimant's devices were not labeled with adequate and conspicuouswarnings of potential dangers of use within the meaning of 21 U.S.C.§ 352(c) and 352(f)(2). The plaintiff's motion for summary judgment istherefore well taken and will be allowed. An order will be entered acc o r d i n g l y . "

Thereafter the claimant appealed. Upon appeal, the Court of Appealsf o u n d a s f o l l o w s : ^

"No stay was requested by appellant pending appeal. The file containsa certificate by the United States Marshal that he complied with theCourt's order by destroying the res on December 19, 1968.

"The United States has filed a motion to dismiss the appeal on groundsof mootness. The case having been heard on oral arguments and briefson the docket of this Court, the Court concludes that the res havmgbeen destroyed in this in rem proceeding, the motion to dismiss form o o t n e s s i s w e l l t a k e n . . . u x x u

"It is ORDERED that the motion to dismiss is granted and that theappeal be and hereby is dismissed. Entered by order of the Court."

On 5-18-70, certiorari was denied, 398 U.S. 912. (40)

Respirator, at Madison Heights, E. Dist. Mich.Charged on or about 7-9-69: when shipped by Crown Products Co., Cleveland, Ohio, the article, labeled in part "Res-Q-Aire Emergency RespiratorReady to Use—Easy to Use—Portable Lightweight ... For Every Breathing Difficulty ... A product of Machsa Incorporated Distributed Exclusively by Crown Products Co. Cleveland, Ohio, a Division of the ChilcoteCompany," bore the name "Res-Q-Aire" and statements in the cartonlabel which were false and misleading as to the adequacy and effectiveness of the article as a means of resuscitation; the labeling lackedadequate directions for use and none can be written, since the articlewas neither safe nor effective for its intended purposes; the labelinglacked adequate warnings against use in conditions involving obstructions,aspirated objects, persons with dentures, and infants or children wherethe volume of air would be excessive; and the article was dangerous tohealth when used as directed; 502(f)(1), 502(f)(2), 502(j). Default decreeorde red des t ruc t i on . ( 41 )

Theramatic model A-6DT40 electronic instrument, at Houston, S. Dist. Tex.Charged 7-28-70: when shipped, the article's labeling lacked adequatedirections for use for the purposes intended, since such directions couldnot be written for use by laymen of the article for such purposes, andthe article was not exempt as an Rx device, since adequate informationfor its use could not be furnished under which practitioners could usethe article safely and for the purposes intended; 502(f)(1). Default decreeorde red des t ruc t i on . ( 42 )

Va c u - M a i d v a c u u m c l e a n e r, a t M u r f r e e s b o r o , M . D i s t . Te n n .Charged 12-15-70: when shipped by Vacu-Maid, Inc., Ponca City, Okla.,the labeling contained false and misleading claims that the article wasadequate and effective for sanitizing and removing invisible dust, pollen,and bacteria, especially in sickrooms, for relieving allergy victims, andpreventing family epidemics and respiratory disorders; 502(a). Consentdecree authorized release to the shipper for relabeling. (43)

COSMETICS / BEAUTY PRODUCTS

Ahead Hair Restorer cream, at Wilmington, Dist. Del.Charged 4-10-67: when shipped by unknown shipper, the article, labeledin part "Ahead Hair Restorer . . . Kelly Products, Inc. . . . Royal Oak,Michigan," was a new drug without an effective New Drug Application,its label failed to bear the established name of each active ingredient,and the article had been manufactured in an unregistered establishment;505(a), 502(e)(l)(A)(ii), 502(o).

Kelly Products, Inc., Royal Oak, Mich., appeared as claimant, filed ananswer, and served written interrogatories upon the Government. TheGovernment filed answers to certain interrogatories of the claimant andobjections to the remaining interrogatories, and also served written interrogatories upon the claimant to which the claimant filed objections.In an opinion handed down on October 18, 1967 (42 F.R.D. 181), thecourt sustained claimant's objection to one of the Government's interrogatories, denied claimant's objections to the other interrogatories, anddenied the Government's objections to claimant's interrogatories. TheGovernment thereafter filed a motion for summary judgment. On 10-28-68,the court handed down an opinion in favor of granting the Government'smotion for summary judgment wherein the court stated:

". . . The product marketed by this claimant is directed to peopletroubled by alopecia; the relief sought is literally that represented inthe packaging literature; a 'full head of hair,' nothing less.

"Thus, whether or not 'Ahead' causes hair to grow, or whether itaffects only the surface of the scalp and thus 'promotes hair growth,' Ihold that 'Ahead' is a 'drug' within the meaning of the statute.

"Having determined that 'Ahead' Is a drug as defined by the statute,I m u s t n o w c o n s i d e r w h e t h e r o r n o t i t w a s m i s b r a n d e d w h e n i t w a sintroduced into, or while it was in, interstate commerce. As noted above,in its answer to the complaint for forfeiture, Kelly Products, Inc., admitted that 'Ahead' was shipped from the state of Michigan. The seizureof the drugs in Delaware confirms that the product was, indeed, in interstate commerce. Title 21 U.S.C. § 352 makes a drug misbrandedwhen it is fabricated from two or more ingredients and those ingredientsare not detailed in the labeling. In answer to an interrogatory, KellyProducts, Inc., indicated that 'Ahead' is fabricated from two or moreingredients. A reading of the carton label, the labeling on the jar andthe packaging literature does not disclose the ingredients used in theproduct. Accordingly, I find that 'Ahead' was misbranded within them e a n i n g o f t h e s t a t u t e . [ S e e F o o t n o t e ]

" I t u r n n o w t o t h e g o v e r n m e n t ' s c o n t e n t i o n t h a t ' A h e a d ' i s a ' n e wdrug' as defined in 21 U.S.C. § 321(p) which may not be introduced intointerstate commerce unless an application filed pursuant to 21 U.S.C.§ 355(b) is effective with respect to the article and that no such applic a t i o n h a d b e e n m a d e b y K e l l y P r o d u c t s , I n c . B e c a u s e I h a v e a l r e a d ydetermined that 'Ahead' is a drug Which was misbranded when introduced into, or while in, interstate commerce and, thus, is subject tocondemnation, I believe that it is unnecessary to decide whether it isalso a 'new drug.'

"Accordingly, the government's motion for summary judgment will begranted on the grounds that 'Ahead' is a drug which was misbrandedwhen introduced into, or while in, interstate commerce."[Footnote: "The government has filed an affidavit of the Director, Bureauof Regulatory Compliance, United States Food and Drug Administration,indicating that Kelly Hair Products, Royal Oak, Michigan, has not registered under 21 U.S.C. § 360 as required by 21 U.S.C. § 352(o) as amanufacturer of a drug. Therefore, 'Ahead' was also misbranded withint h e m e a n i n g o f 2 1 U . S . C . § 3 5 2 ( o ) . " ] x . .

In accordance with the above opinion the court entered a decree ofcondemnation on the basis that the article was a misbranded drug asalleged, and ordered that the article be destroyed. (44)

E v e r t o n e s k i n c r e a m , a t M i a m i , S . D i s t . F l a . . ^Charged 12-22-69: while the article was held by Mamilab Products, Inc.,Miami, Fla., after being labeled by that firm following its manufacturefrom ingredients shipped in interstate commerce, the labeling containedfalse and misleading claims that the article would act on sagging andpendulous breasts by improving the circulation, contracting the interstitialmuscle fibers and rendering the breast substance firm and round; andthe labeling lacked adequate directions for use and was not exempttherefrom, since it was a new drug for which no approval of a NewDrug Application was effective and for which no notice of claimed investigational exemption was on file; 502(a), 502(f)(1). Mamilab Products,Inc., claimant, filed an answer and was served with written interrogatories which it answered. Thereafter, a consent decree was enteredordering the destruction of the article. (45)

Le Conte Hormones Growhair Treatment ointment, conditioner rinse, shampoo,and hair spray, at Atlanta, N. Dist. Ga.Charged 5-13-70: when shipped by Le Conte Cosmetics, Los Angeles,Calif., the article, consisting of the ointment, rinse, shampoo, and spraydescribed above, was a new drug without an effective approved NewDrug Application, and its label failed to bear the established name ofeach active ingredient; 505(a), 502(e)(l)(A)(ii). Elton C. Toland, t/a leConte Cosmetics, claimant, filed an answer and served interrogatoriesupon the Government which were answered. The Government then filedinterrogatories upon the claimant after which the claimant's claim andanswer were dismissed upon stipulation of the parties, and a decreeordering the destruction of the article was entered. (46)

HAZARDOUS SUBSTANCES

Cherry bombs, M-80 firecrackers, and 1 11/16"-firecrackers, at Charleston,E. Dist . Mo.Charged 7-2-70: while held by Cain's Novelty Shop, Charleston, Mo., thea r t i c l e s w e r e fi r e w o r k s d e v i c e s w h i c h w e r e b a n n e d h a z a r d o u s s u b s t a n c e sby regulations, since the articles were intended to produce audibleeffects by a charge of more than 2 gr. of pyrotechnic composition;2(q)(l)(B). Default decree ordered destruction. (47)

Ornaments, glass, liquid-filled, at San Juan, Dist. P.R.Charged 7-29-70: while held for sale, the article contained petroleumdistillates, was therefore combustible, and presented a special hazardbecause of its petroleum distillate content; and it lacked a number ofrequired conspicuous label statements; 2(p)(l)(A,B,E,F,G,j), 3(b). Defaultd e c r e e o r d e r e d d e s t r u c t i o n . ( 4 8 )

NOTICES OF JUDGMENT on Cr iminal Act ions

F O O D

Laurinburg Milling Co., a corporation, Laurinburg, M. Dist. N.C.Charged 8-6-70 by grand jury: salt and bicarbonate of soda were held ina building accessible to rodents and insects and were contaminated withrodent or insect filth; and when shipped, flour and hush-puppy mix contained insect filth and had been prepared and packed under insanitaryconditions; 402(a)(3), 402(a)(4). Guilty plea; fine. (49)

NOTICES OF JUDGMENT on Injunction ActionEagle Products, Inc., William G. Bevan, Jr., president, James R. Cocquyt, vice

president, and Maurice T. Cocquyt, treasurer, Mishawaka, N. Dist. Ind.Charged 10-28-70 in complaint for injunction: that the defendants wereengaged in manufacturing, processing, and packing blended animal feedsconsisting of tankage and meat and bone meal, in distributing such feedsin interstate commerce, and in holding them for sale after shipment ofone or more of their components in interstate commerce; and that whenshipped and while held for sale, such feeds contained an added poisonous and deleterious substance. Salmonella micro-organisms and had beenprepared, packed, and held at defendants' plant under insanitary conditions; 402(a)(1), 402(a)(4).

A consent decree of preliminary injunction was entered which enjoinedthe defendants against the violations complained of. The decree alsorequired that before making any further interstate shipments of theanimal feeds and before manufacturing, processing, packing, and distributing any of such feeds while held at the defendants' plant for saleafter sfiipment of one or more of its components in interstate commerce, the defendants should establish methods, facilities, and controlstha t wou ld assu re t ha t such f eeds we re no t con tam ina ted w i t h Sa lmone l l amicro-organisms, and that the feeds on hand should be destroyed or soreprocessed as to destroy any Salmonella micro-organisms in the feeds.

N o t i c e s o f J u d g m e n t a r e g i v e n p u r s u a n t t o s e c t i o n 7 0 5 o f t h eFederal Food, Drug, and Cosmetics Act and section 13 of the FederalH a z a r d o u s S u b s t a n c e s A c t . N o t i c e s o f J u d g m e n t r e p o r t c a s e s i nv o l v i n g s e i z u r e p r o c e e d i n g s , c r i m i n a l p r o c e e d i n g s , a n d i n j u n c t i o np r o c e e d i n g s . S e f z u r e p r o c e e d i n g s a r e c i v i l a c t i o n s t a k e n a g a i n s tgoods alleged to be in violation, and criminal and injunction proceedings are aga ins t fi rms or ind iv idua ls charged to be respons ib le fo rv io la t ions . The cases genera l l y invo lve foods , d rugs , dev ices , cosm e t i c s , o r h a z a r d o u s s u b s t a n c e s w h i c h w e r e a l l e g e d t o b e a d u l t e r a t e do r m i s b r a n d e d o r o t h e r w i s e v i o l a t i v e o f t h e l a w w h e n i n t r o d u c e di n t o a n d w h i l e i n i n t e r s t a t e c o m m e r c e , o r w h i l e h e l d f o r s a l e a f t e rs h i p m e n t i n i n t e r s t a t e c o m m e r c e .

No t i ces o f Judgmen t a re p repa red by Food , D rug , and Env i ronm e n t a l H e a l t h D i v i s i o n , O f fi c e o f t h e G e n e r a l C o u n s e l , D H E W .

P u b l i s h e d b y d i r e c t i o n o f t h e S e c r e t a r y o f H e a l t h , E d u c a t i o n , a n dW e l f a r e .

Charles C. Edwards, M.D., Commissioner of Food and DrugsWashington, D.C., September 1, 1971

36 / September 1971 / FDA Papers ☆U.S. GOVERNMENT PRINTING OFFICE: 1972-482-098/1

proper useofray diagnosis

X-ray diagnosis is among the most vaiuabie tools of modern medicine, butthere are risks in human exposure to ionizing radiation. A 28-page booklet,"X-Ray Examinations ... a Guide to Good Practice," describes the manyprecautions that should be taken in deciding whether to use X-ray and onthe care that should be taken, both by the physician and the X-ray technician. It also describes improvements being made on X-ray equipment toreduce human exposure to a minimum. The booklet was prepared by theAmerican Goiiege of Radiology Commission on Radiologic Units, Standards,and Protection, with the assistance of the FDA's Bureau of RadiologicalHealth and the cooperation of the American Medical Association. For saleby the Superintendent of Documents, Government Printing Office, Washington, D.G. 20402. Stock No. 5505-0003. 35 cents.

/y

UNITED StatesG o v e r n m e n t P r i n t i n g O f fi c e

D I V I S I O N O F P U B L I C D O C U M E N T S

WASHINGTON, D. C. 20402

OFFICIAL BUSINESS u .

P O S T A G E A N D F E E S P A I D

S . G O V E R N M E N T P R I N T I N G O F F I C E

F D L l - F D A C o n f e r e n c e T h e F i f t e e n t hA n n u a l J o i n t E d u c a t i o n a l C o n f e r e n c e o fthe Food and Drug Law Ins t i tu te andthe Food and Drug Adminis t rat ion wi l lb e h e l d D e c e m b e r 7 - 8 a t t h e S t a t l e r H i lton Hotel, Washington, D.C.

Several major changes in program format have been made for this year's conference, which will run two full days. Inaddition to a general session devoted tofoods, drugs, cosmetics, consumer interests, and an "FDA Bulletin Board," twoadditional general sessions will be held—

» on product adver t is ing and on food andover- the-counter drug adver t is ing. Thec o n f e r e n c e a l s o w i l l f e a t u r e fi v e w o r k

shops—food. , human drugs, veter inarydrugs, product safety, and cosmetics. Outstanding government and industry authorities in each of these fields, as well asconsumer representatives, will participateas speakers and discussants.

S l i d e S e r i e s " T h e A B C ' s o f S a l m o

nella," a slide series consisting of 42 colorsl ides and accompanying booklet narration, is now available. The presentationis appropriate for showing plant managersand employees what Salmonella is—whereit comes from—how it spreads—and howit can be kept out of food.

The set is composed of two parts—partone is directed to plant managers andpa r t two t o emp loyees—and i nc l udesguidel ines for preventing bacter ial contamination in food products. The present a t i o n a l l o w s t h e i n s e r t i o n o f a d d i t i o n a lslides which food processors may wish touse to emphasize correction of its sanitation problems.

Produced by the Food and Drug Administration in cooperation with the foodprocessing industry, the slide series hasproved useful as a training tool to manyfood firms and is applicable to bacterialcontamination problems facing the foodindust ry today. The complete set w i thbooklet may be ordered for $5.25 postpaid f rom Wor ld in Color Product ions,P.O. Box 392, Elmira, New York 14902.

A n n o u n c e m e n t s

ICLA GENERAL ASSEMBLY The International Committee on Laboratory Animals(ICLA) will have its next general assembly in Hannover, Federal Republic ofGermany, on September 22, 1972. A symposium on the theme, "The LaboratoryAnimal in Drug Testing," will precede the meeting and will cover three days—September 19-21. Each day will start with a leading paper given by an invitedspeaker and will cover comparative metabolism and the selection of experimentalanimals; organization for the acute, subacute, and long-term testing of drugs; andthe choice of animals for pharmacological research.

The program committee invites interested scientists to submit papers on subjectsrelated to these three main topics. Points of special interest would be geneticalaspects, mutagenesis, teratology, carcinogenesis, pharmacokinetics, environmentalfactors (microflora, climate, husbandry, transportation), the possibilities and limitationsof tissue and organ culture techniques, and primates and the larger domestic animals.The time allowed for each speaker will be 15 minutes, plus 10 minutes for discussion.A b s t r a c t s s h o u l d h a v e a m a x i m u m o f 2 0 0 w o r d s a n d s h o u l d b e s e n t t o t h e c h a i r m a nof the program committee: Professor Dr. Dr. A Spiegel, 3 Hannover-Linden, Lettow-Vorbeck-Allee 57—Federal Republic of Germany.

Abstracts should be sent to the chairman before April 1, 1972; any received afterthat date cannot be accepted. All papers will be given in English. Since the three-daysymposium will not leave time for more than 30 papers, the abstracts submitted willbe considered by the program committee and a selection will be made. The authorsof the accepted papers will be notified before the end of May 1972 and will beasked to submit full manuscripts of their papers at the time of the symposium.

Further details are available from the chairman of the program committee or fromthe chairman of the local organizing committee: Priv. Doz. Dr. W. Heine,Zentralinstitut fiir Versuchstierzucht, 3 Hannover-Linden, Lettow-Vorbeck-Allee 57—Federal Republic of Germany.

Additional information regarding details of the symposium will be announced ata la ter da te .

DIRECTORY AVAILABLE The June 1971 edition of FDA's National Drug CodeDirectory is now available. The directory contains information on pharmaceuticalproducts representing about 95 percent of the total dollar value of American prescription drug sales. National drug codes, which identify approximately 23,000prescription and over-the-counter products, currently are used by several Statemedicaid and private health insurance programs. They are being printed directly ondrug labels by more than 50 companies and on a growing number of solid dosageforms of drugs. Code-identified drug products can speed treatment of children andadults who have accidentally ingested marked drugs.

The directory may be ordered from the Superintendent of Documents, GovernmentPrinting Office, Washington, D.C. 20402, at $4.25 per copy. The order number isHE 20.4012:971, Basic directory data is also available on magnetic tape from theNational Technical Information Service, Operations Division, Springfield, 'Virginia22151, at $55 per 2,400-foot reel. The order number is PB-200-083.

( F D A ) 7 2 - 1 0 0 2

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