This Month

r r iI his month, FDA Consumer presents its final arti-

JL cle about the regulation of household productsand toys. Beginning in March, this function will be assumed by the newly created Product Safety Commission. FDA's Bureau of Product Safety, whose protection activities have been prominently featured in pastissues, will form the nucleus of this new regulatoryagency. The history of the legislation that created theProduct Safety Commission and the new law's highlights are summarized in "A New Era in ConsumerSafety."

Our color story this month is about the laser—a beamof light that can work wonders. The laser holds greatpotential benefits, but if not used correctly can be veryharmful to the eyes. We describe some things the lasercan do for you, and precautions you should take.

Another story that emanates from the Bureau ofRadiological Health this month is on the use of x raysto screen people for tuberculosis and other diseases.Last year, FDA in conjunction with professional groupsadvised against the use of x rays for mass screening programs. We describe the five reasons for this recommendation in "Mass Chest X Rays Are on the WayO u t . "

"Don't Let It Bug You" aptly describes our storyabout flu vaccines. If you've been in bed with the fluthis year or in previous years, you ought to read thisstory. It won't help you get better any quicker, but itwill tell you things you may not know about influenza,and what scientists are doing to try to bring it underc o n t r o l .

If you're a dog owner, you'll be interested in ourstory on dog foods—"Dishing Up the Dog Food."You'll learn what to look for on the labels of dog foods,and what FDA does to assure that dog foods are nutrit ious and safe.

FDA Consumer / February 1973 j 1

Quotes

4 4 n nI he era of insularity is over for the FDA. WeJL are not and we should not be shielded from

the scrutiny of the consuming public, the regulated industries, the scientific community, or any other interestthat has a right to pass judgment on our performance.The FDA is, I am proud to say, in the forefront of asincere and vitally important effort to bring Government closer to the people it serves. We are seeking innovative ways of making the regulatory processmore democratic, more open, and more creative. I amconvinced that that is the only way we can carry outour mandate fairly and responsibly."

Charles C. Edwards, M.D., Commissioner of Food and Drugs,before the Food and Drug Law Institute, Washington, D.C.,December 13, 1972.

C C T PI he fact that Congress simply has not consid-X ered or spoken on a particular issue cer

tainly is no bar to Ae Food and Drug Administrationexerting initiative and leadership in the public interest.Except where expressly prohibited, I believe FDA isobligated to develop whatever innovative and creativeregulatory programs are reasonable and are most appropriate to achieve the fundamental objectives laid downby Congress. And in spite of the diversity of theAgency's new programs, I am not at all certain thatFDA has yet begun to explore the full reaches of existing statutory authority."

Peter Barton Hutt, Assistant General Counsel for Food, Drugs,and Product Safety, Department of Health, Education, andWelfare, before the Food and Drug Law Institute, Washington,D.C., December 12,1972.

Consumer Forum

In future issues the space on this page will be reserved for a new feature of FDA Consumer, apage we are calling CONSUMER FORUM. It givesyou, the consumer, the opportunity to have your viewspublished in FDA Consumer.

Letters of any length are acceptable, depending oncontent and interest, but letters of 150 words or lesshave a better chance of being published. Letters mustbe signed, but we will withhold the name upon requestand for valid reason. We will, however, use initios ifwe don't use the name. We reserve the right to condenseletters to a suitable length for publication.

Letters to CONSUMER FORUM can be on anytopic of concern to FDA—foods, drugs, cosmetics,household, chemicals, toys, vaccines, radiation, medicaldevices. But remember—if you have a complaint abouta specific product, or you feel a product is hazardous,you should channel your comments to the FDA District office nearest you. You will get the quickest actionon a consumer complaint by going directly to the Dist r i c t .

Send letters to CONSUMER FORUM, FDA Consumer, PA-25, Food and Drug Administration, 5600Fishers Lane, Rockville, Maryland 20852.

2 /February 1973 jFDA Consumer

E l l i o t L . R i c h a r d s o nSecretary, U.S. Department ofHealth, Education, and Welfare

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

C h a r l e s H . D i c kA s s t . C o m m i s s i o n e rf o r P u b l i c A f f a i r s

Wayne L. Pines/Editor

Harold C. Hopkins/Editorial Director

Jesse R. Nichols/Art Director

Joan M. Galloway/Managing Editor

Frederick L. Townshend/Production Mgr.

Tom Healy/Photographer

FDA CONSUMER, the official magazine of theFood and Drug Administration, is publishedmonthly, except for combined July-August andDecember-January issues. Subscriptions may beordered from the Superintendent of Documents,Government Printing Office, Washington, D.C.20402, at $6.50 a year ($1.75 additional for foreignmailing).

Address for editorial matters: FDA CONSUMER,PA-20, Food and Drug Administration, 5600Fishers Lane, Rockville, Md. 20852.

Articles published in FDA CONSUMER are inthe public domain and text may be republishedwithout permission. Use of funds for printingthis publication approved by the Office ofManagement and Budget November 1, 1972.

FDA CONSUMER was previously known asF D A P A P E R S .

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 whichhave been rendered under this Act, includingthe nature of charge and the disposition thereof.

(b) The Secretary may also cause to bedisseminated information regarding food, drugs,devices, or cosmetics in situations involving, inthe opinion of the Secretary, imminent dangerto health, or gross deception of the consumer.Nothing in this section shall be construed toprohibit the Secretary from collecting, reporting,and illustrating the results of the investigationsof the Department.

C o n s u m e rVOL. 7, NO. 1/February 1973

Don't Let It Bug You

A New Era in Consumer Safety

Mass Chest X Rays Are on the Way Out

Laser: The Powerful Little Light

Dishing Up the Dog Food

News Highlights

Regional Reports

S t a t e A c t i o n s

S e i z u r e s a n d P o s t a l S e r v i c e C a s e s

Notices of Judgment

FDA Consumer / February 1973 j 3

f f m M m

Don't Let It Bug^mby Jim Buchan

The layman's flu is not alwaysthe same as the physician'sflu. This and othermisunderstandings aboutinfluenza, and the difficultyof controlling the virus ofsome types with vaccinesbecause of periodic geneticchanges in the virus, are someof the problems the Bureauof Biologies faces in researchon and regulation of fluvaccines for consumerprotection.

Your stomach's upset. Yourhead aches. A case ofdiarrhea keeps you in the generalproximity of modern plumbing.

You have the "flu." Right?Wrong! You probably have

one of a number of intestinaldisorders, or one of a varietyof common colds or respiratorydiseases that are similar to fluand clinically often impossibleto d i f fe ren t ia te .

You've just read in thenewspaper that the "flu" virus hasbeen seen and photographed forthe first time and that a newcure-all vaccine is about to emergeon the national and world scenes.We've conquered "flu," your e a s o n .

Wrong again.What these reports are

describing is something calledacute infectious gastroenteritis.But the news reports call it "flu"because it's a catch-all term thatseems to fit any and all disordersof the stomach and respiratorysystem.

What, then, is influenza, or "flu?"The dictionary says it's "an

acute highly contagious infectiousvirus disease that is characterizedby sudden onset, fever, prostration,severe aches and pains, andprogressive inflammation of therespiratory mucous membrane,and is frequently complicated bysecondary infections such aspneumonia."

"Flu" occurs in epidemic orpandemic forms. An "epidemic"is a local outbreak that infects ahigh percentage of the populationin a particular region of a countryor local area, while a "pandemic"is worldwide. Hence, theworldwide outbreaks of flu in1957 and 1968, known to thepublic by "Asian" and "HongKong," were pandemics, whilethe outbreaks in isolated sectionsof the United States that occurevery two or three years, areepidemics.

The Food and DrugAdministration's Bureau ofBiologies, where about 260 peopleare responsible for establishingand maintaining standards ofquality and safety of all biologicalproducts including vaccines, hasdone extensive research into andregulation of flu vaccines.

It has been found that

influenza, one of the world'sgreatest respiratory diseaseproblems, is still poorly controlledthrough vaccines.

Does that mean that fluvaccines are useless?

Not at all. But the flu viruschanges so rapidly that vaccinesare often one step behind.

This seems to be an anomalyin a day when polio has been

conquered and when diseases suchas measles, rubella, and mumpscan be controlled by highlyeffective vaccines. The publicexpects a vaccine to produceimmediate and lasting immunity.

The flu virus, unfortunately,keeps changing. Thus, the vaccinein use today against the knownstrains of flu may not be effectivenext year against a worldwidepandemic that might erupt whenthe influenza virus undergoes"antigenic mutations" or a major"antigenic shift." Once such a shiftoccurs, the new virus rapidlyreplaces the earlier viruses thathave been circulating.

The uncertainty andunpredictable behavior of fluviruses places a limitation on theeffective use of vaccines as abroad public health measureagainst the disease.

The influenza v i rus was no t

positively identified until the1930's, but influenza has beenrecognized for centuries. Theactual discovery of the virusin 1933 was the cu lm ina t i onof more than a decade ofresearch following the pandemico f 1 9 1 8 - 1 9 .

There are three types of fluvirus. A, B, and C. Type A isthe type associated with theworldwide pandemics, while typeB is generally limited to epidemicswithin a country or region. TypeC is associated with localo u t b r e a k s .

The current vaccine in use isformulated to protect against themost commonly known virus typesA and B, since these are thetwo most likely to show geneticchange. The type A virus present

FDA Consumer / February 1973 j 5

this year shows slight changesfrom the Hong Kong strain of1968. If the changes appear tobe significant, the vaccine nowin use will be changed toincorporate the newly emergingvirus. Changes in the vaccineare considered every year, withactual changes being made whennew viruses appear which showboth antigenic change and signsof spreading to produce epidemics.

The Cente r fo r D isease Cont ro lin Atlanta and the World HealthOrganization are constantly onthe alert for the emergence ofnew flu strains in the world.Their findings are invaluable indetermining the extent of diseasebeing produced by the new flustrain and judging the effectiveness

of new vaccines.There is a real need for early

warning of major virus changesin the world to allow time forspecific vaccine production. Thereis sometimes a 6- to 8-month timelag to produce sufficient vaccinefor general use and the selectionof the strain that will be moste f fec t i ve .

Developing the VaccineThe flu vaccine is produced infertilized hens' eggs (chickembryo inside) inoculated withflu virus. The egg is inoculatedand the embryo becomes infectedalong with the membranesurrounding it. The virus is thenreleased in the fluids surrounding theembryo. The egg is then opened

and the flu id removed. Th is in fec tedfluid becomes the starting materialfor the vaccine. The virus is thenk i l l e d .

It should be reemphasized thatthe virus in the vaccine is dead,and thus cannot produce flu.Adead v i rus cannot induce thedisease.

Some people may develop feverand body aches after havingreceived vaccine. These adversereact ions to influenza vacc inesare generally believed to resultfrom nonvirus proteins, mostlychick embryo products. It's oneof the reasons people allergic toeggs, egg products, chickens, orch icken fea thers shou ld no ttake the vaccine.

We now have a more highly

An important function in researchin to vacc ines and o ther work

concerning flu virus is the"manufacture" of supplies of thevarious types and strains of virus.The virus is usually reproduced infertile eggs. At top left, eight-day-old eggs are candled for visualinspection through the shell todetermine if the embryo is alive.

A vial of live virus is removed froma pool in cold storage, thawed, and(top right) is being pipetted into aflask of pH buffered solution byRon Mayner, microbiologist.

A hole is made in the top of theegg and a quantity of the virus insolution is inoculated (bottom left)into the allantoic fluid surroundingthe embryo. The hole is then sealedand the egg allowed to incubate for48 hou rs .

After incubation, the egg is reopened(bottom right), the allantoic fluidcontaining the live virus iswithdrawn, and after centrifugationto remove most of the particulatematter, is placed in ampules andstored at - 70°C. The ampules inthis batch constitute a pool for usew h e n n e e d e d .

purified vaccine than a few yearsago. The nonvirus proteins havebeen removed from the fluids byultracentrifugation or otherpurifleation processes. The majoradvantage is that you now cangive a higher dose of the antigen(which causes the protectiveantibodies) while reducing thepossibility of reactions.

Who Should Get a Flu Shot?One of the greatest misconceptionscirculating about flu shotsconcerns who should get them.With mass inoculation programsthe general rule for mostcommunicable diseases, it's anatural public reaction to addflu to the list when visitingthe family doctor.

The Public Health Service saysthat only people who arechronically ill or who are in theolder segment of the populationshould use the vaccine. These arethe target people. Generali m m u n i z a t i o n o f c h i l d r e n i sconsidered unnecessary, except forthose chronically ill.

There are situations, however,when some key segments of thecommunity might be inoculated,but only when a truly majorepidemic or pandemic is predicted.These might include essentialservice groups such as personsengaged in care of the sick,law enforcement, fire protection,transportation, and communication,or institutionalized people whoare aged or debilitated.

The main reason the

chronically ill and older citizensshould get flu shots is the dangerfrom pneumonia, which in thesegroups often evolves from asevere case of influenza.

T h e r e c o m m e n d a t i o n s o n w h oshould or should not receive fluvaccine are based on statisticallyproven risk, not on a shortage ofvaccine, as believed by some.Actually, each year unused vaccineis re tu rned to the manufac turers .

A good vaccine offers about80 percent protection. The degreeof protection depends on the typeof virus in the vaccine as comparedto the flu strain that is currentlycirculating among the population.

The cyclic nature of the fluvirus is a subject of much debate

Live flu virus is used by the Bureau of BiologiesDivision of Virology for several purposes. Virus is sentto manufacturers when needed in production ofvaccines. Less frequently, strains of virus are sent tovarious research laboratories for experimental use. TheDivision regularly performs two kinds of tests with liveviruses; The hemagglutination test is used to determinethe titer, or potency, of specific virus pools. Thehemagglutination inhibition test is used to check serataken from individuals to determine if they have beeninfected with a particular virus strain, to identifyunknown strains of virus, and to screen antisera for

infectious antibodies in epidemiological work.In the hemagglutination test, various dilutions of

virus are made and tested and the thinnest dilution atwhich the virus is still present is called the "titer," whichbecomes the measurement unit or standard for use ofthat virus. This is done by adding .5 cubic centimeter ofthe various dilutions to an equal amount of red bloodcells from a chicken in wells of a tray. Agglutinationforms a uniform haziness at the botom of the well,indicating virus is present (left in photo). If no virusis present, the blood does not agglutinate and remainsas a dot in the well (right in photo).

among scientists. Although majorantigenic shifts tend to follow acyclical pattern, it is not knownwhether flu viruses undergoinggenetic changes will ever exactly"repeat" themselves. If such arecurring cycle could bedetermined, it might be possibleto predict what viruses mightappear next. This would allowvaccines to be prepared whichmight be available in advance ofmajor antigenic changes. Sucha prospect appears to be far inthe future, however. To date,changes cannot be accuratelypredicted, and the struggle toupdate vaccines continues.

W h o M a k e s Va c c i n e s ?The Bureau of Biologies, as a

regulatory body, keeps a tightrein on the production of suchbiologies as vaccines. Only about250 plants are licensed to makebiologies of any kind, with onlysix producing influenza virusv a c c i n e s .

Both the product and themanufacturer are licensed. Thus,a manufacturer with a l icensemust get separate licenses foreach product he makes.

Manufacturers' testing recordsare kept on each batch of vaccines,and total production records mustbe submitted to BoB along withsamples taken at random. Themanufacturer does the testing, butthe Bureau of Biologies conductsrandom tests of its own. It

provides extremely tight control

over the production of biologies.Over half of the staff at BoB

is comprised of laboratorypeople. Its director. Dr. HarryM. Meyer, Jr., is a biologiesresearcher in his own right. Sois his deputy. Dr. RuthK i r s c h s t e i n .

Among the group areinternationally recognized experts.Dr. Meyer points out that byhaving key research people onhis staff, the Bureau is in constantcontact with the rest of thesc ien t i fi c fie ld .

W h e r e t o N o w ?For the future, the Bureau hasgeared its activities to improvingpresent procedures, and preparingfor the day when major

In the preparation of antiserumfor use in the hemagglutinationtest, live virus is injected into thewing vein of a chicken (at left) byBob Blackburn (left) and WilliamBarthlow, biological laboratorytechnicians. After two weeks theblood is removed from thechicken and centrifuged. Theserum is obtained, tested forsterility, frozen, and held for use.

breakthroughs may occur inour understanding and abilityto control the devilish bug.

Dr. Meyer insists that existingregulations are enlightened andin keeping with the latest inbiologies, but candidly admitsthat the present potency test isfar from perfect and must beimproved. He is delighted thatthe vaccine for flu has been greatlypurified and improved in potency,but sees even greater progress inthat direct ion in the future.

On a long-term basis. Dr. Meyeris keeping an eye on the promisingresearch being conducted on newlive vaecines for influenza.

Although BoB is not in thebusiness of actually developingnew vaccines. Dr. Meyer wants

the Bureau to be ready to keeppace with major researchbreakthroughs in this area.While it may be years beforesuch breakthroughs will yieldvaccines for routine use, BoBis preparing to implement its roleas an arm of FDA so that the

licensing and regulatory functioncan be carried out without delayfor the safety and effectivenessof future products.

In the meantime, the Bureauof Biologies hopes the publicbecomes aware of the factsand fa l lac ies associated wi tht h e t e r m " fl u . " Yo u d o N O T

get flu every year. You cannotcatch flu from taking a flu shot.You need not take a shot unlessyou are chronically ill or are

in the older age group whererespiratory ailments often produeecomplications such as pneumonia.Yes, the flu vaccines are safe.No, there's no general, lastingvaccine for flu. And by all means,please quit calling thats t o m a c h a c h e " t h e fl u . "

In other words, don't letit "bug" vou.

J . W. B u c h a n i s a f r e e - l a n c e w r i t e r .

11 n i i t - t > i s t t s s » r e c e ' s i c V i j r i n i i

n n ii n ■ ■ ■ ■ Bcr'af e V rfff ifffitififif'fiirfffiriPS'n r - i J i r r B B M B M P F t s r i f f t n u n fi r aI ■ ■ ■ ■ ■ B'af e V rfff ifffitifHif'fi

S l i iSaSS iSg i l l lSI ■ ■ ■ n5PiR*««.i!r-

Samples of manufacturers' fluvaccine are subjected to extensivecontrol tests in Bureau laboratories.In the general safety test, guineapigs and mice are injected withmassive doses of vaccine andobserved for seven days. If noadverse reactions occur, the productmeets the requirements for generalsafety. During the observationperiod, the animals are weighedand examined to determineif they are maintaining normalweight and in good health.

This electron micrograph (left)shows clumps of Type Aflu viruses. Hong Kong strain,at a magnification of about62,000 times.

This spring will mark the launching of a new Federal agency, the Consumer Product SafetyCommission. The current functions of FDA's Bureau of Product Safety will be transferredto this new, independent agency. It will regulate an enormous range of products used byconsumers each day. This is the story of what the new Commission is, and how it cameabout .

A N e w E r a l nConsumer Safety

by Malcolm W. Jensen and Thomas M.Folkes

The Consumer Product Safety Act, signed into lawby President Nixon October 27, 1972, was thesingle most important consumer protection measurepassed by the 92nd Congress. It represents a dramaticstep forward in the Federal Government's efforts toprotect the American public from unreasonable injuriesassociated with consumer products.

The Act established a Consumer Product SafetyCommission which will operate independently. The newCommission will be responsible for regulating a widevariety of consumer products, including toys and thousands of household products not covered under previouslaws. However, the term "consumer product" does notinclude motor vehicles, pesticides, aircraft, firearms,boats, or tobacco products. Regulation of these items isleft to other agencies. The regulation of foods, humanand veterinary medicines, cosmetics, medical devices,biologicals, and radiation remains with FDA.

The new law allows the public a wide degree ofparticipation in assuring that products pose no unreasonable hazards. This article describes the history ofproduct safety within the Federal Government andsketches some of the important provisions of the newl a w .

The History

Modern regulation by the Federal Government of consumer products is really still in its infancy. The FDA'sbasic, but limited, law which has protected the American public from hazardous household substances in therecent past has been the Federal Hazardous SubstancesAct of 1960. It requires all household containers of potentially dangerous substances to be labeled conspicuously, to warn consumers and to provide needed safetyinformat ion.

An amendment to that law, the Child Protection Actof 1966, authorized the Government to ban householdsubstances so hazardous that even warning labels arenot adequate safeguards. The Child Protection and Toy

Safety Act of 1969 further expanded that law to coverelectrical, thermal, and mechanical hazards in toys andother articles intended for use by children.

These laws—plus several other related ones that affect product safety, such as the Poison Prevention Packaging Act of 1970—have been enforced by FDA'sBureau of Product Safety, and will be enforced by thenew Commission.

The beginnings of the Bureau of Product Safety canbe traced to the reorganization of the Public HealthService in 1968. Responsibilities for regulating thesafety of household products and for investigatingdeaths and injuries associated with flammable fabricswere assigned to FDA.

After several internal reorganizations—which foundproduct safety functions assigned in turn to the Bureauof Medicine, the Office of the Commissioner, and theBureau of Foods—the Bureau of Product Safety wascreated in October 1970. Since then, the Bureau hasgrown to the point where it will form the nucleus forthe new Consumer Product Safety Commission.

The New Law

The need for a new law to protect consumers from unsafe products stemmed from a determination by theCongress that an unreasonable number of injuries wasoccurring among American consumers. The FederalHazardous Substances Act and other laws were deemedinadequate.

A new law was recommended by the congressionallyappointed National Commission on Product Safety in1970. The Commission's report provided the stimulusand model for the legislation that eventually was to bepassed by Congress.

Hearings were held in both the House and theSenate in 1971 and 1972. The most publicized controversy was over the placement of the broader responsibilities for product safety protection. There were threeproposals: to place them within a larger FDA, to take

10 / February 1973 / FDA Consumer

FDA's functions and place them in an independent consumer safety agency, or to establish an independentConsumer Product Safety Commission while leavingthe regulation of products such as foods and medicineswithin FDA. In October the Congress decided on thethird course. The President signed the Act on October27, 1972.

Congress was very specific in setting forth the purposes of the Act:• To protect the public against injuries associatedwith consumer products.• To assist consumers in evaluating the comparativesafety of products.• To develop uniform standards for consumer produ c t s .• To minimize conflicting State and local regulations.• To promote research and investigations into thecauses and the prevention of product-related deaths,illnesses, and injuries.

To accomplish these goals, the Act provides for theestablishment of an independent Consumer ProductSafety Commission empowered to develop and enforceuniform safety standards and to ban hazardous produ c t s .

The Consumer Product Safety Commission

The Commission will have five Commissioners, appointed by the President, one of whom will be designated chairman. The terms of the first appointees will bestaggered—each nominee will serve a term of three,four, five, six, or seven years. Subsequent appointeeswill serve seven years; none can be removed except forneglect of duty or malfeasance in office. No more thanthree of the members of the Commission may be of thesame political party.

The Chairman will exercise all the executive and administrative functions of the Commission. He will appoint and supervise personnel, except those reportingdirectly to the other Commissioners, and will governthe use and expenditure of funds.

The Commissioners will be advised by a ProductSafety Advisory Council. The Commissioners will namethe 15 members. This group, selected for expertise invarious areas of product safety, will be drawn from threesources: five members from Federal, State, and localgovernmental agencies; five members from industry, including at least one representative of small business; andfive members who are community leaders or who represent consumer organizations.

This group will meet when called by the Commission,but must meet at least four times a year. All its proceedings will be public.

Other advisory groups will be the existing NationalAdvisory Committee for the Flammable Fabrics Actand the Technical Advisory Committee for the PoisonPrevention Packaging Act.

The Act authorizes the following operational fundsfor the first three years of the Commission:

Fiscal year 1973 (beginning July 1, 1973) ..$55 millionF i s c a l y e a r 1 9 7 4 $ 5 9 m i l l i o nF i s c a l y e a r 1 9 7 5 $ 6 4 m i l l i o n

These sums are the maximum basic amounts that maybe made available; there is no provision stating that thefull amount must be appropriated. Additional fundsmay be appropriated for planning and construction ofresearch, development, and testing facilities.

Functions and Authority

The primary function of the Consumer Product SafetyCommission is, of course, to protect the public from injuries associated with consumer products.

T h e b a s i c s o u r c e o f i n f o r m a t i o n f o r C o m m i s s i o n a ction will be an Injury Information Clearinghouse whichwill collect, investigate, analyze, and disseminate product-related injury data and information. This information will be used for continuing studies into deaths, injuries, diseases, other health impairments, and economic losses resulting from such accidents.

Other projects of the Commission include researchand investigations into the safety and possible improvement of consumer products; developing product safetytest methods and devices; and offering training in theproduct safety field, particularly in assisting other public and private organizations in the development ofsafety standards and test methods.

The Commission may require industry to maintainspecific records, make reports, and provide needed inf o r m a t i o n .

The Commission can conduct hearings and inquiries,and can require the attendance and testimony of witnesses and the provision of relevant evidence.

The Commission may make available to the publicany of the results of any of its investigations, though itmay not disclose trade secrets or other confidential information. It cannot be compelled to release information not normally available to the public under the Freed o m o f I n f o r m a t i o n A c t .

Those public disclosures which would readily identify a company, must be preceded by a notice to enable the company to comment before the release of theinformation. Notice is not required, however, when thedisclosure involves an imminently hazardous product ora product not conforming to product safety standards.

The Commissioner is empowered to develop standards for products to eliminate or reduce the risk of injuries to consumers. If the Commission decides that nostandard could significantly reduce a hazard, it can bana product entirely.

The impetus for development of a safety standardmay come from within the Commission, from a proposalby the Product Safety Advisory Council, from a privatepetition, or on the order of a district court.

When it has been determined that a standard is necessary, the Commission may either solicit offers from outside groups or may decide that a Federal or non-Federalstandard already in existence will suffice. (continued)

FDA Consumer / February 1973 / II

If it is found that no standard already exists, theCommission must accept one or more of the qualifiedoffers submitted. If after 30 days of requesting offers,no qualified one is received, or if the only offer is fromthe manufacturer, distributor, or retailer of the product,the Commission itself may proceed independently toset up such a standard.

Once the Commission has initiated development of astandard (the development period will normally be 150days), it then has 210 days in which to publish a proposed standard or withdraw the notice. This period maybe extended if necessary.

The publication of proposed standards and their effective dates will include a description of the hazardsrelated to the products in question and give the following information:• The degree and nature of the risk that the standardshould eliminate or reduce.• The type or number of consumer products subject tothe s tandard .• The need of the public for the products involved.• The standard's probable effect on product utility,cost, and availability.• Means of minimizing adverse effects on competitionand manufacturing practices while protecting publichealth and safety.• Data indicating that the standard is necessary to eliminate risk of injury; or, if the product is to be banned, thatno feasible standard could adequately protect consumers from unreasonable risk of injury.

The completed standard has to be suitable for promulgation under the Act; be supported by test data; andprovide suitable test methods for assuring that a product complies with the standard.

Once a rule, whether a standard or ban, is proposed,the Commission can hold hearings on it. Within 60days, it must either publish or withdraw the proposal.

If published in final form, the rule will normally takeeffect 30 to 180 days later. Rules will ordinarily affectonly products manufactured after the effective date.

Significant amendments to any previous rules can bemade under these same procedures. A rule can be revoked by the Commission if it is found unnecessary.

Federal safety standards will supersede State and local standards and regulations unless the requirementsare identical.

A State and local jurisdiction may apply for an exemption if a State standard js more stringent, is requiredby local needs, and does not unnecessarily burden int e r s t a t e c o m m e r c e .

Industry and the New ActEach manufacturer of a product regulated under thelaw will have to issue a certificate to the distributor andretailer, guaranteeing its conformity to safety standards.This certificate will give the name of the manufactureror private labeler, and the date and place of manufac

ture. The Commission may prescribe the tests the product must undergo.

The Commission may also require that labels contain the place and date the product was made, thename of the manufacturer, a certification that theproduct meets standards, and what those standards are.In addition, when the actual manufacturer's name doesnot appear on the label, the Commission can requirethat the label be coded so that the seller can identifythe actual manufacturer to the purchaser.

The manufacturer of any consumer product that involves a design, material, or form of energy exchangewhich has not previously been used substantially in consumer products and about which little is known in termsof safety must notify the Commission of its proposedintroduction and furnish it with a description. This is not,however, a requirement for premarketing clearance.

Every manufacturer, private labeler, or distributor ofa consumer product must keep records as prescribed bythe Commission. These records are open to inspectionby the Commission. In addition, the Commission caninspect any site where consumer products are beingmanufactured, stored, or transported.

Every manufacturer, distributor, and retailer of aconsumer product must immediately inform the Commission of any information that indicates the productmay pose a substantial hazard. If, after hearings, theCommission determines that the product does indeedpose a hazard, it may require the manufacturer to release a notice to that effect to the public and to thoseknown to have received the product.

The Commission may order the manufacturer, distributor, or retailer to bring a product into conformitywith existing rule or to repair the defect. A second optionfor the company is to replace the product with an equivalent. A third option is to refund the purchase price tothe purchaser, less a reasonable allowance for use.

The Commission may file an action in a U.S. districtcourt against an imminently hazardous product oragainst anyone who manufactures, distributes, or sells it.The court in which the action is filed can declare theproduct imminently hazardous and order action to alleviate the risk.

An imported product may be denied entry into theUnited States if it fails to meet standards, is an imminent hazard, or is manufactured by a company failing to meet inspection and recordkeeping requirements.

If an imported product cannot be modified, or if itsmodification is not proceeding satisfactorily, it must beexported or, in certain cases, destroyed. Destruction isalso permissible if the product is not exported within areasonab le t ime .

The Act does not apply to any consumer productmanufactured solely for export from the United Statesunless it is to be sold at any U.S. installation outsidethe country.

The following acts are specifically prohibited undert h e l a w :

12 I February 1973 / FDA Consumer

• Manufacturing or offering for sale any consumerproduct not in conformity with an applicable standard,or any product which has been banned.• The importation into the United States of any suchproduct.• Failure or refusal to disclose records, make reports,or provide information as required.• Failure to notify the Commission of a substantialproduct hazard; failure to comply with a subsequentCommission directive to give notice of this hazard; orfailure to comply with a Commission order to repair,replace, or refund the purchase price of such a product.• Failure or refusal to furnish a certificate guaranteeing the compliance of a product regulated under the Act.• Knowing issuance of a false certificate.• Failure or refusal to comply with any rule related tolabeling or stockpiling.

Any person who knowingly commits a prohibited actis subject to a civil penalty of up to $2,000 for eachviolation. The maximum penalty cannot exceed$500,000 for any related series of violations.

Any civil penalty may be modified by the Commission after taking into consideration the size of the business, the person charged, and the gravity of the viola-t i o n .

Any person who knowingly and willingly commits aprohibited act after receiving notice of noncompliancefrom the Commission can be fined up to $50,000 or beimprisoned for up to a year, or both. Any representativeof a corporation can be subject to the same penalty.

Violation of prohibited acts may be restrained byorder sought by the Commission and issued by the district courts. The courts may also restrain any personfrom distributing any product that does not comply witha consumer product safety rule. If any consumer productfails to conform to a rule (or other actions prohibitedby the Act), it may be seized and condemned in anaction in a U.S. district court.

Participation of the Public

Any interested person or organization can petition theCommission to issue, amend, or revoke a consumerproduct safety rule. The petition, to be filed in theprincipal office of the Commission, must show whyaction is needed and describe the rule or amendmentwhich the petitioner wants issued.

A decision on the petition must be made within 120days. If it is granted, the Commission will immediatelyinitiate a rulemaking procedure. If the petition is denied,the Commission must publish the reasons.

An additional remedy will be available for the publicthree years from the effective date of the Act (October27, 1975). It would allow a petitioner whose plea hasbeen denied or whose petition has not been acted onwithin the 120-day period to begin a civil action in aU.S. district court to compel the Commission to initiate a proceeding.

Any interested person may also bring an action inany district court to enforce a Commission order requiring public notice of a product hazard or requiringremedial action. Additionally, also, any person or organization adversely affected may seek judicial review ofconsumer product safety standards, orders removingor materially amending such rules, and banning orders.

Any person injured by a product in violation of aCommission rule or order may sue in any district court.Compliance with product safety rules does not relieveany person from liability. The failure of the Commission to take any action or begin a rulemaking proceeding on a consumer product will not be admissible asevidence in a product liability suit.

C o n c l u s i o n s

Several conclusions emerge from the legislative historyand the language of the new law:• A vigorous approach to the reduction of product-related injuries and deaths is to be taken.• Unreasonable risk is to be determined on the basisof va l id da ta .• The economic impact of a consumer product safetystandard being considered must be taken into account.• The public is to be given full opportunity to play amajor role in the development of standards.• All segments to be affected by a standard are to berepresented in the process of developing the standard.

Undoubtedly, the Consumer Product Safety Commission will continue activities already established bythe Bureau of Product Safety and build further uponthem. The basis for all Commission activities will behard and valid data on product-related injuries anddeaths. From these data will come analyses, and aneffort to encourage action by the industrial and business community. If they fail to act or if their actionsare not adequate or universally adhered to, the regulatory authority of the Commission will be brought intoplay-

Consumer education will supplement regulatory ef-f o r t s .

The Commission will make every effort to establisha partnership with States to encourage them to establish State programs and to assume the responsibilityfor administration and enforcement of their related lawor laws, consistent with the Federal program.

The Product Safety Commission faces an exciting andchallenging future with a very real opportunity to provide maximum protection to the public with minimumdisruption of the free market system.

Malcolm W. Jensen is director of FDA's Bureau ofProduct Safety.

Thomas M. Folkes is executive assistant to the director ofthe Bureau of Product Safety.

FDA Consumer / February 1973 /13

MassChestX RwAre OnnK'WiiyOut

Mobile chest x-ray unitswere used widely during the1940's and 1950's to detecttuberculosis. Today, there aremore effective ways. FDA isnow urging elimination of massx-ray screening of the generalpopulation. Here are the fivereasons why FDA reached thisd e c i s i o n .

community chest fund drivesused to allocate money for masschest x-ray screening programs todetect tuberculosis?

Remember the warning to haveyour annual, free TB x-ray check?

Well, those days are gone forever.At least that's FDA's aim.

Modern diagnostic techniques,plus a decline in the incidence oftuberculosis, have made mass chestx-ray screening unnecessary amongthe general population.

In fact, the continued use of x raysfor general tuberculosis screening ishighly undesirable, because largenumbers of people are being needlessly exposed to x rays.

TB de tec t i on i s be t t e r accomplished today by the tuberculin skintest. This is a test in which a smallamount of tuberculin is placed underthe skin. If the skin becomes inflamed, then the person may nowhave TB or in the past have beeninfected and may require further exa m i n a t i o n .

The tuberculin test is safer thanthe chest x ray because it does notexpose people to unnecessary radiation. Recognizing the increasedsafety of the tuberculin test, FDA'sBureau of Radiological Health, theAmerican College of Radiology, and

by Valorie Britain

the American College of Chest Physicians prepared a joint statement inearly 1972 recommending that masschest x-ray surveys of the generalpopulation for TB and other cardiopulmonary disease be discontinued.

The Bureau of Radiological Healthis now involved in an educationaleffort to inform the American publicabout the policy. The ultimate aimof the educational program is to reduce significantly the use of the chestX ray among the general populationas a screening mechanism.

The policy statement makes clear,however, that screening programsmay be indicated in areas of high TBincidence and in special populationgroups especially susceptible to lungdisease. Even under such conditions,the tubercul in skin test should beconsidered for init ial screeningwhenever possible.

The statement also urges that TBtreatment facilities be available as anessential part of the community public health program.

The call for elimination of massx-ray screening came about a quarter of a century after it had enjoyedits peak of popularity. During the1940's, tuberculosis was much moreprevalent than it is today. The valueof early detection through x rays wasunquestioned. It was believed thatthe benefits clearly outweighed ther i sks .

According to the National Tuberculosis and Respiratory Disease Association, the mass chest x-ray survey was an "American phenomenon.It swept the country." By means ofa single chest x ray, it was believed,most active and presymptomatic TBcases could be discovered beforesevere lung damage occurred.

Today, however, there are fivereasons for discontinuing massscreening. It was these five reasons

that led FDA's Bureau of Radiological Health to join in the nationaldrive to reduce mass chest x-rayscreening.

T h e fi r s t r e a s o n i s t h a t m a s s

screening is not really an effectivemeans of detecting TB. More than95 percent of the people who develop active TB today are identifiedby means other than communityx-ray screening programs. Most TBis discovered because a person hassymptoms which lead him to seekm e d i c a l a d v i c e .

This is true even for inner cityareas and selected population subgroups where the incidence of TB ishigher than in suburban and rurala r e a s .

Mass screening, programs detectact ive TB in fewer than l /20th of1 percent of persons x-rayed and,ironically, are least effective in thevery areas they are particularly intended to serve—high TB incidencelocations. This is because most people in such areas do not avail themselves of the chest x-ray service.

Surveys in various parts of thecountry have confirmed that massx-ray screening is generally unproductive in detecting tuberculosis. A1969 survey in Cleveland uncoveredonly 18 new active TB cases out of109,000 x-ray examinations. A survey in Kentucky found only 45new cases out of 93,159 personsscreened. And a Denver mass screening program between 1965 and 1970found only 54 active cases among276,598 chest x rays.

Some people have called for thecontinuation of chest x-ray screening on the basis of its value as anannual check for cardiopulmonarydiseases other than TB, notably lungcancer and emphysema. This reasoning is not valid, however, since thex-ray examination has not been

FDA Consumer / February 1973/15

What should consuiiiers do ahout mass screening?

If you are healthy, do not decide on your own to have a chest x ray asa precautionary measure. Have an x-ray examination only when recommended by a physician.

If you feel ill or are suspicious of some chest disorder, seek profess iona l med ica l a t ten t ion .

If you are directed by your employer, a health agency, or someoneelse to have a chest x-ray examination for TB, ask instead about thetuberculin skin test. Students, high TB incidence groups such as patients in mental hospitals and nursing homes, inmates of prisons andjails, and persons employed as food handlers, teachers, barbers, andhairdressers all may be asked to be tested for TB. In all these cases,consideration should be given to the skin test as an initial check. X-rayexaminations should be restricted to positive reactors.

found rewarding in identifying thesec o n d i t i o n s .

A second reason for discontinuingmass screening is that TB is on thedecline. The dynamics of tuberculosis have changed greatly in theUnited States in the last dozen years.The number of newly reported active cases of TB nationwide droppedfrom 57,535 in 1959 to approximately 35,217 in 1971.

In many sections of the country,the disease is virtually nonexistenttoday. Active TB cases are foundmostly in individuals infected in thepast, the disease having remaineddormant over the years, rather thanin persons who have newly acquiredthe disease, as well as in older ageg r o u p s .

As a result of the decline in TB,the mass chest x-ray detection program produces a low yield of active,undiagnosed cases of TB. Such ayield no longer justifies the fexposureof a large segment of the healthypopulation to radiation. Only thoseprograms that result in significantcasefinding can be defended, such asan emergency survey program fora high incidence area or populationg r o u p .

The third reason is that the tuberculin skin test provides a more ac

curate indication of the presence ofTB than the x-ray film. If the tuberculin test indicates the presence ofTB, then an x ray can be used todetermine whether the TB is active.

A fourth reason for discontinuingmass x-ray screening is the deliveryof an unnecessary amount of radiation to a large segment of the population. The decreased incidence ofTB has coincided with an increasedconcern about needlessly exposingpersons to radiation. Since so fewcases of active TB were foundthrough the chest x-ray program andbecause the tuberculin test is moreeffective in detecting tuberculosis,and results in zero-radiation exposure, this was a situation where radiation exposure could be significantlyreduced without jeopardizing medical care.

Why the increased concern aboutradiation exposure? While diagnostic x-ray procedures, including thechest X ray, are among the mostvaluable tools of modern medicine,scientists today are concerned aboutthe possible long-term effects on thebody as a result of low-level doses.Their concern is about the cumulative effect of the numerous x raystaken during a lifetime.

Since safe levels of radiation dose

have not been established, prudencedictates that exposure to man-maderadiation should be avoided exceptw h e n i t c a n b e s h o w n t h a t t h e r i s kis justified by the expected benefit.Although the health risk from thesmall amounts of radiation receivedduring a chest x-ray examination isexceedingly low, there is no reasonto impose this minor hazard on thepopulation without good cause.

The fifth reason is that the x-rayunits often used for chest x-rayscreening produce higher levels ofx-ray exposure than other equipment. For the most part, photo-fluorographic machines, which use2Vi- by 2Vi-inch films to recordan x-ray image on a fluorescentscreen, have been used in the x-rayvans, as we l l as in some hea l thc l i n i c s .

Although more economical, theseunits may expose persons to up to 10times more radiation than does theconventional or fixed x-ray unit, using a 14- by 17-inch film. In addition,the photofluorographic unit producesan x-ray film of inferior diagnosticquality when compared to the 14- by1 7 - i n c h fi l m .

Because of these five reasons, thex-ray examination should not beused as a technique for screening thegeneral population for TB and othercardiopulmonary diseases. Instead,TB x-ray screening programs shouldbe aimed at specific groups with ahigh risk of contracting the disease,and even in these cases, the tuberculin skin test is the preferred technique for initial screening.

This is not to say that an individualshould avoid having an x-ray examination when it is indicated. But thex-ray examination is a diagnostic toolthat should be prescribed by a physician who has knowledge of the individual's case.

Valorie Britain is an informationspecialist in FDA's Bureau ofRadiological Health.

16 I February 19731 FDA Consumer

LASERThe Powerful L/ittle Light That Performs Like Magic

Because it is so powerful, the laser is potentiallydangerous, and must be used with extreme care. This iswhat the laser is, what its potential is, and whatcautions the public must take to protect itself frompossible injury.

by Margaret Morrison

rhe year is 1983. You're shopping in your supermarket and come up to the checkout stand witha cart full of foods. Faster than you can say "six-pack,"the label on every product in the cart is examined, recorded, the price rung up—and you're on your way in afraction of the time it used to take.

Or it's 1978. You want to see a favorite movie fromthe 30's. So you walk into a music store, purchase adisc no larger than the average LP record, take it homeand "play it back" on your TV screen—a full-lengthfeature on one small disc.

Or it's now, 1973. You're getting settled in your seaton a Boeing 747 and you look out over the huge wings,each longer than the distance the Wright brothers firstflew, and you know somebody—or something—^had toprecisely align those wings or you'd never get off theground.

All of these things will happen—are happening—through the use of the laser, the amazing light that"came to light" such a few short years ago.

If you are like most Americans, you first heard aboutthe laser beam sometime in the '60's. And you heard ofit in terms of some new kind of magic invention thatcould work unheard-of marvels, much like the thingsyou'd read in science fiction comics (Flash Gordon pullsout his ray gun and demolishes an entire planet withone pull of the trigger).

The laser is indeed a miracle maker. But in a muchmore practical, down-to-earth way than most peoplerealize. In the few years since its power has been recognized, application of the laser has resulted in revolutionary contributions in the fields of medicine, scienceand industry, communications and education, and evenin the home.

Remarkable as its uses are, the laser is actuallynothing more than a device which produces and amplifies light. The word "laser" stands for Light Amplifica-

FDA Consumer / February 1973 j 17

LASER

tion by Stimulated Emission of Radiation. The mechanism by which this process is accomplished was postulated by Einstein in 1917, but it was not until 1960that it was applied and put into operation.

Light is one of several forms of electromagneticradiation, along with x rays, radiowaves, and others.The difference between various radiations is energy,which is in proportion to the wave's frequency. Onekind of radiation is ordinary light, by which we see.

But the lasers are a different kind of light source altogether. They are unique in that they possess the following four properties: (1) small divergence, (2)monochromaticity, (3) coherence, and (4) high intensity. In nontechnological terms these mean:(1) Ordinary light spreads out from its source, to illuminate an area such as a room; but the laser light, instead of spreading or diverging, shines straight aheadin a concentrated beam, so essentially none of its energyis lost as the beam travels.(2) The laser light may be of only one color.(3) Coherence in the laser light means two or morelight waves traveling in lock-step fashion, such asmarching soldiers. While this is a much simplified explanation, you might get something of the idea byimagining two or more trains on side-by-side tracks,traveling over a slightly up-and-down terrain and arriving at every stop at the same time—simultaneouslydelivering a larger load than one train could.(4) The light from a laser is so intense it usually exceeds even the sun in radiance.

It is easy to see why a light with these properties canbe a powerful tool for mankind, yet a dangerous one ifnot used with extreme care. Because of its potential forinjury, the laser has come under the surveillance ofF D A .

FDA's Bureau of Radiological Health, which is responsible for implementing the Radiation Control forHealth and Safety Aet, is concerned with all productsthat produce radiation, including the laser.

In the near future the Bureau will publish proposedstandards for products embodying lasers, classifying andidentifying the hazard associated with the radiationfrom the device, and specifying radiation safety performance features, including warning signs.

Compliance with these standards will result in greatersafety for consumers, with types of lasers and theiruses clearly defined. To use a certain low-powered enclosed laser, for example, should be no more dangerousthan watching your television.

The need for radiation safety performance standards

for laser products came about because of the wide variety of functions they are now performing.

One of the first uses of the laser principle was inmedicine. The development of photocoagulators whichfocus a laser beam through the pupil of the eye onto theretina made it possible to "fasten" or "mend a tear" inthe retina, much more quickly and successfully thanhas been possible with conventional surgical tools.

In the operating room, the laser beam, focused into asmall spot, serves as a surgical knife. And since it is ofsuch hieh intensitv, it can also sterilize or cauterize tissue as it cuts. This is important in surgical procedureson organs such as the liver and kidney, where loss ofblood is a severe problem.

In the area of experimental research, lasers of varying intensities are being used to make precise lesions inportions of the brain or spinal cord without injury tosurrounding brain tissues.

While information about use of the laser in the treatment of malignant disease is ineomplete, experimentalstudies with animals have shown that the laser beamcan destroy tissue, such as a tumor, when the involvedtissue can be totally encompassed by a laser beam ofsufficient density. Unfortunately, in some cases the impact of the laser beam may cause spreading of someviable malignant cells into adjacent healthy tissue,ther promising medical applications of the laser areKy being investigated in the fields of dermatology,

dentistry, genetic scanning, and medical teaching aids!But much of this work in medicine is still in the experimental stage, with a great deal of study yet to be donebefore conclusive results can be fully realized.

In industry, progress in the application of the laserhas been much more rapid. With its intense energy, thelaser already is performing a number of highly developed functions—doing things faster, and with greaterprecision, than was ever possible before.

The laser can slice through ultrahard metals, such astungsten, in seconds. Heat-resistant metals can be manipulated with lasers, and this application is being usedin our space program. The laser is used to drill completely smooth and precise holes, as small as a few mil-lionths of an inch, in materials where the surroundingarea must not be harmed by heat or vibration. Certaintypes of welding are far easier with a laser because thequick flash of heat binds materials together instantly ina solid mass; or it can perform the most delicate andminute electronic welding.

Because of its coherent light, the laser has many applications in the geodetic field, especially in surveyina

J8 / February 1973 / FDA Consumer

The yellow beam trom a kryptonion laser, at tiie top, is projectedand split to travel to twocalorimeters, allowing the mostaccurate measurement of laserenergy yet achieved. A duplicateof this system is now in use inFDA labo ra to r i es .Photograph from the NationalBureau of Standards.

An optical physicist at FDA'sBureau of Radiological Health(top) monitors the performance ofa laser product in an effort todetermine the magnitude of anypossible hazards.

A t t h e S h r i n e B u r n s I n s t i t u t e o f

the Medical Center, University ofCincinnati, CO2 laser excisionof a burn in a patient is followedby immediate graft replacementbecause of bloodless surgery ofthe laser.

One of the first and most importantapplications of the laser was inthe treatment of eye disease. Here,Dr. H. Christian Zweng (lowerphoto), Stanford University andPalo Alto Medical Clinic, treatsthe eye of a patient using a laserphotocoagulator.Photograph courtesy of the PaloAlto Medical Clinic, Palo ^Ito,California.

Lasers hold great potential fortreatment of disease. At top,laser t reatment of melanomacancer of the leg.

At left, laser treatment of dentalcaries.

Photographs from the LaserLaboratory, Medical Center,University of Cincinnati. Director,Leon Goldman, M.D.

Lasers are being employed tomeasure long distances moreaccurately than ever before, asseen in a photograph (top) takenin the Southwest . A reflectedbeam from a mirror more than 5miles away can be seen as a smalldot on the horizon.

A common application of lasers today-a low powered helium-neon laser used inclassroom instruction (below left).

Laser light is a convenient tool for the instructor, since it shows how light rays arereflected and refracted. In photograph (below right), two laser beams passingthrough lenses are refracted and show the focal point of the lens system wherethey cross. Experiments such as this formerly required a great deal moreequipment and were much more time consuming and costly.

L \ S E R

and measuring. The laser's beam can be made to diverge as little as one-third of an inch per mile. Tunnelshave been dug with amazing precision using laser alignment, for example, an 18-foot tunnel through 4 miles ofrock, with an error of only 2 inches. The laying of cableor pipe over difficult terrain or under water can be facilitated beyond belief.

T h e r e a r e t w o a r e a s i n w h i c h t h e l a s e r h a s b e e n o f

special value to the military. Long distance measuringinstruments—developed by use of the laser principle—make it possible to measure any line of sight on theground, ground to air, or ship to shore, and this application is used by the military for missile tracking. Alsothe pilot of a bomber plane is able to designate a targetby laser beam, and the bomb is then guided by thebeam's reflection from the target.

The laser has brought exciting possibilities to thefield of photography, since a laser photograph termed ahologram gives a truly three-dimensional image. Thisno doubt will lead to innovative developments in thefield of entertainment—motion pictures and TV—aswell as educat ion.

In the laboratory of the future, it is possible the laserwill be used in spectroscopy (examining and determining the content and condition of substances by thecolors they produce or absorb); the analysis of growingplants to determine the kinds of nutrients farmersshould add in order to produce a better crop; the alignment and improvement of various scientific devices andresearch tools; and much more.

At present, one of the most common uses of the laseris that of a demonstration tool for teaching optics andwave mechanics. It is very effective in high school andcollege courses in physics and optics; and some studentsare experimenting with the construction of lasers in theirh o m e " l a b o r a t o r i e s . "

Wherever and however the laser is used, though, itcan be an intensely powerful instrument. And since itis so powerful, it has—along with its usefulness—anobvious potential for misuse. With the growing use oflasers in the classroom and home, where there are numbers of people who might not understand the hazards,it is important that instructors, students, and parents beaware of the dangers, and of the precautions that canbe taken to reduce the risks.

As might be expected, lasers used in classroom instruction are usually not as powerful as some in use inindustry and research. However, even a small class-room-type laser can emit enough power to be unsafefor direct viewing. This means you should be extremely

careful that the beam of light never strikes the eyeball—that you never look into the laser beam. Also, besure the beam is directed in such a way that it will notstrike a shiny surface, which can then reflect the beaminto the eye. This should be guarded against even thoughthe viewer may be seated in the rear of the classroomo r a u d i t o r i u m .

Lasers are basically simple devices which can andare being constructed by high school students and otherind iv idua ls in te res ted in sc ien t i fic dev ices . Some s tudentshave successfully constructed lasers in their basements.Working under these conditions, generally without supervision, can be safe only if fundamental safety precautions are followed strictly.

rhere are a number of simple steps and devices youshould use to prevent the occurrence of an accidental contact between the eye and the beam of an unenclosed laser.

One such device is the beam shutter, a cover fittedover the aperture of the laser, which allows the operatorto shut off the laser beam without turning off the laser.The shutter should be made of opaque, nonreflectivematerial and should completely stop passage of the laserbeam. As with all mechanical aids, however, the important thing is that the operator develop the habit of shuttering the beam at all times when it is not actuallyneeded .

Another safety measure is the use of a suitable targetfor the beam, since it will travel out from the laser untilit is absorbed or reflected. The target should be madeof nonreflective light-absorbing material, such as blackfoam rubber, or black ink on blotter paper.

Since accidents can happen during the setup andalignment of a laser experiment, precautions must betaken to protect any observers by placing a shield between them and the laser and its associated equipment.One way of doing this, when working with low-powerlasers, is to hang a black, dull-surfaced curtain or drapebetween the observers and the laser. Another easy wayof accomplishing this is to use a large cardboard boxwith holes cut in the sides for setting up the demonstration and in the end for exit of the laser beam. Flaps cancover the openings when viewing of the experiment isnot actually required.

Painting the experimental equipment with a flat, dull,black paint may be the single most important precaution you can take. Never use chrome or stainless steel,which can reflect the beam.

hen purchasing a laser for classroom use, youshould buy one with a key lock for the power

FDA Consumer / February 1973/23

L A S E R

supply, if possible, or have such a lock installed. Thiswill prevent its being used by someone not authorized todo so or not trained in safety precautions.

Also, when constructing or using homemade lasers,avoid possible electrical shock, and contain any possibleexplosions, by covering any exposed wiring or glass onthe laser with a shield.

There should be a dry run of all experiments beforethey are presented to observers or to a schoolroom class.This helps the operator spot the possible hazards andeliminate them before any damage can be done.

The best safety rule is to know that a hazard mayexist with any unenclosed laser and to combine thisknowledge with common sense. Whenever an unenclosed low-power laser is used in the classroom, home,or laboratory, you'll be wise to follow these 20 rules:

Work Area Con t ro l s

1. Do not use the laser in areas where a chance passerby not aware of danger might be attracted to its operat i o n .

2. Signs saying the laser is being operated and that itmay be dangerous should be placed in conspicuous locations both inside and outside the work area and ondoors giving access to the area.

3. Whenever possible, the doors should be locked tokeep out nonessential onlookers during use of the laser.4. The lighting in the area should be as bright as practicable, to constrict the pupils in the eyes of the observe r s .

5. Set up the experiment so the laser beam is not atnormal eye level—place it below 3 feet or above 6V2feet .

6. Set up a target for the beam, made out of a blackabsorbing material. Also set up shields to prevent thedirect beam, or strong reflections, from going beyondthe area needed for the demonstration or experiment.7. Double check to make-sure no tool or other reflective material is left in the path of the beam.

8. To prevent shock, all exposed wiring and glass onthe laser should be covered with a shield. All nonener-gized parts of the equipment should be grounded.9. The laser should be equipped with a key switch tolock the power supply.

10. An operable laser should never be left unattended.

Operating; Controls

1. A detailed operating procedure for using the lasershou ld be ou t l i ned be fo rehand .

2. Avoid looking directly into the laser beam at anyt i m e .

3. Do not aim the laser with the eye. Unexpected mirror-like reflection could cause eye damage.

4 . D o n o t l o o k a t m i r r o r - l i k e r e fl e c t i o n s o f t h e b e a m .This could also cause ret inal burns.

5. Remove all rings and watches before changing oraltering the setup. Shiny jewelry could cause damagingr e fl e c t i o n .

6. Never depend on sunglasses to protect your eyes.

7. If laser safety goggles are used, be sure they are designed to be compatible with the laser being used. Neverrely on safety goggles, however, as the primary protectionfor your eyes.

8. Report any after-image to a doctor, preferably anophthalmologist who has had experience with retinalburns, since damage may have occurred.9. Clear all personnel well away from the anticipatedpath of the beam.10. Before operating the laser, warn all personnel andvisitors of the potential hazard. Remind them of the possibility of irreparable damage to their eyes.

The laser, one of the most versatile tools of our time,is appearing in many diversified types and powers andalready has affected our lives in many ways. And undoubtedly lasers will bring even more significant changesin the future, in applications not yet imagined. Theirbeams of light can be powerful. Some can pierce a smalldiamond precisely; others custom-cut a suit of clothesin seconds; "measure" a mountain; and beam straightto the moon, 240,000 miles away, and still return toearth to be measured.

But a beam of light that's that strong can blind you.So never, never look into a laser beam. You might neverlook again—at anything else.

Margaret Morrison is a writer on FDA'sConsumer Education and Information Staff.

24 /February 1973 jFDA Consumer

DishingThe

FoodFDA's suggestions on how toget a better diet for your dogthrough proper use of preparedfoods.

by S. L. McHenry, Ed. D., and G. B. Guest, D.V.M.

Walk down the aisles of yoursupermarket, and you'll findmany shelves of colorful packagedand canned foods devoted just todogs.

Or turn on your TV set. Cuddlypuppies tumble over each other toget to their morning tidbits. Full-grown dogs race across fields to gulphungrily a full bowl of their ownspecial food. And people brag aboutthe brand they feed their dog.

Quite a different scene—isn't it?—from the days when Rover was fedwhatever was left over from the table.

In the past decade, as consumers

have become better informed aboutnutritional values, vitamins, minerals, and other supplements in theirown diets, they have demanded thesame high standards in foods fortheir pets.

This demand has created a vastindustry which provides pet foods inunprecedented quantities—-the largest percent of it for dogs, which nownumber an estimated 33 mil l ion inthe Un i t ed S ta tes .

The proliferation of canned andpackaged foods for these pets has ledto greater involvement by FDA inthe field of pet food safety. The Fed-

FDA Consumer / February 1973 j 25

eral Fcx)d, Drug, and Cosmetic Act,under which FDA operates, requiresthat animal foods be properly formulated and labeled, manufactured inclean plants, and free from poisonousor harmful substances or unapprovedadditives or drugs.

Generally, FDA is not involved inthe regulation of nutritional values incommercially prepared pet foods.But FDA's responsibility for properlabeling necessitates a concern forfood ingredients and nutritionalc l a i m s .

W h a t S h o u l d Yo uKnow About Dog Foods?

First, you should know how important the label is, and what you shouldexpect from it. Naturally the labelwill give you the name and addressof the manufacturer. In addition, itshould include a statement of netcontent, a complete listing of ingredients, and a guaranteed analysis ofthe content. The latter is a listing ofexact amounts of var ious nutr ientsubstances, such as protein, fat,and vitamin and mineral additives.

For example, the list of ingredientsmay show simply "Meat by-products," while the guaranteed analysiswill show a specific amount of protein. The manufacturer guaranteesthat the product has these specifiedamounts of nutrient substances.

A small number of pet food firmsare under U.S. Department of Agriculture inspection, and on their products you will see a USDA certification. This is a voluntary, continuousinspection program paid for by themanufacturer who requests the prog r a m .

A number of products now on themarket are labeled as a "completeand balanced diet" for dogs. Thisterm is generally based on the guidelines of the Subcommittee on CanineNutrit ion of the National ResearchCouncil. The NRC Committee has

published a booklet t i t led NutrientRequirements of Dogs, which outlines the nutrients needed by dogs,such as protein, carbohydrate, fat,vitamin A, vitamin D, and a numberof other vitamins and minerals. Youmay get this booklet by sending$1.50 to the National Academy ofSciences, National Research Council,2101 Constitution Ave., N.W.,Washington, D.C. 20418. Ask forPublication 989, Nutrient Requirements of Dogs.

When the manufacturer of a dogfood uses the term "complete andbalanced diet" on the label, this doesnot mean that the product can beused as the sole diet for every dog.It means the product provides theminimum diet to assure that the animal will maintain its body weightand size, with a normal amount ofexercise. This is called a "maintenance d ie t . "

You may wish, however, to provide your dog with more than a maintenance diet, for a number of reasons. For instance, the proteinneeded for growth is greater than theamount needed for maintenance;

pregnancy, having nursing puppies,or a s i tuat ion o f s t ress o f some k indalso can increase the need for prote in .

Also, since there is such a widevariance in size, body structure, haircoat, and activity in dogs, naturallytheir nutritional requirements vary.A complete and balanced food forone dog may not be complete andbalanced for another. Your veterinarian is your best source of information on nutritional needs of yourparticular animal.

FDA's Bureau of Veterinary Medicine is working closely with the PetFood Committee of American FeedControl Officials in an effort to assure that products labeled "completeand balanced diet" contain all thenutrients needed for proper maintenance. FDA has stressed the need totest experimental animals to determine more specificially whether thesefoods are complete and balanced according to the NRC guidelines. FDAwill continue to monitor such foodsand take corrective measures whereclaims are false or misleading.

In the past few years, there hasbeen considerable controversyamong pet food manufacturers—andquestions in the minds of pet owners—about the relative merits of meat-plus other ingredients versus all meatproducts. At this time, there isno documented evidence that eithertype of food is superior to the otherfor maintaining proper nutrition. Theimportant factor to remember isthat, whether it is all meat or a combination of meat and other products,the diet must be a balanced one,with the protein, carbohydrate, fat,vitamins, and minerals that animalsneed; and it must not contain harmful substances.

Drags in Pet Foods

The use of drugs in pet foods is aseparate question from that of nutri-

26 !February 1973 /FDA Consumer

ent additives. At present, only onedrug is approved for use in commercial pet foods. It is diethylcar-bamazine, a drug intended for use inthe control of large roundworms indogs. If added, it must be listed onthe dog food label.

On occasion, other drugs whichare being incorporated into pet foodsillegally are brought to FDA's attention. In the past, for example, oneparticular dog food was labeled ascontaining methyltestosterone. Thisfood was being sold with the claimthat it should be fed to guard dogs,to increase aggressiveness. FDA initiated action which resulted in removal of the product from the market.

Your Part in KeepingYour Pe t We l l Fed

Wild animals, consuming other animals which they have killed and having access to a variety of foodstuffs,instinctively choose a diet which willas nearly as possible give them abalanced diet. Domesticated animalsmust depend for their nourishmenton foods prepared by someone else—the pet food manufacturer andyou .

Because of the great amount ofnutrient research done in the pastfew years, by industry and government, commercial foods for dogsprobably provide a safer and morecomplete diet than these pets havehad in the past.

But commercial foods for petsvary in nutrient quality, as well as invarious supplements. You shouldread the label on any food you buyfor your dog; you should understandthat each animal has its own requirements for a "complete and balanceddiet"; and you should report to FDAany complaints you may have aboutfalse claims of manufacturers, illegaluse of drugs, or other circumstancesthat could be considered hazardousto an ima l hea l th .

Safeguarding Foods for PetsFDA's responsibility for the safety of animal foods includes guardingagainst contamination of foods by bacteria such as Salmonella, Salmonella organisms occur in the intestinal tract of man, animals, birds,reptiles, and insects, and can cause widespread infection when transferred from one to another.

The symptoms of a Salmonella infection in humans usually are fever,stomach cramps, diarrhea, and sometimes vomiting. Pets suffer similardiscomforts. FDA is working on a program to reduce Salmonella inanimal- and fish-protein products, a major source of foods for pet catsand dogs.

From time to time, chemical contaminants are found in pet foods.When this happens, if it appears to be a one-time incident, it is studiedas such. An investigation is made of the source of the contamination,the species of animal for which the food is intended, and all availabledata on toxicity in this species. FDA then takes appropriate action.

In the event a harmful substance in a food product appears to be aproblem that could continue over a period of time, such as might occurbecause of natural or man-made contamination, FDA initiates a studyto determine how the substance should be controlled.

In 1971, when there was a great deal of alarm about the mercurycontamination of tuna and other fish, FDA became concerned thatsome of these foods might inadvertently be transferred to pet foods.FDA's Bureau of Veterinary Medicine relied on published reports ofwork done in Sweden, Japan, and in this country, which gave some indication of the levels of mercury which might be harmful to dogs andcats. Using this information, and results of work in progress withinFDA, the Bureau was able to determine levels which would not beharmful to the pet even in extreme cases—such as those cases wherepets consumed tuna or fish products as the sole diet.

At the same time, the Bureau sampled and analyzed a number ofcommercially prepared pet foods containing fish, including tuna. Theresults of these samplings indicated there was no alarmingly high mercury content in the products.

Following the initial survey of tuna for human consumption, FDAconducted a large-scale survey of the wholesale fish industry. It wasable to use reports from this survey as an indicator of what might beexpected in pet foods. With the exception of swordfish, there was noproblem with any species of fish tested. None of the swordfish or high-mercury-level tuna was converted to pet food use.

Since fish meal also is incorporated into many foods, a check wasmade of the mercury content of this product. It also appeared safe foruse in animal foods.

S. L. McHenry, Ed.D., is an industry information officerin the Bureau of Veterinary Medicine.

G. B. Guest, D.V.M., is special assistant to the directorof the Bureau of Veterinary Medicine.

FDA Consumer / February 1973/27

News Highlights

New Regulations for Use of MethadoneIn Drug-Addiction Treatment

Tightening of Federal regulations governing use and preventing misuse of methadone in the treatment of heroinaddiction has been announced by three principal Government agencies, including FDA, concerned with drug abuseprevention.

Methadone is being increasingly used in the treatment ofheroin-addiction, both as a detoxification agent and in oralm a i n t e n a n c e t r e a t m e n t .

Highlights of the new rules:(1) Distribution of methadone will be limited to ap

proved treatment-rehabilitation programs and to hospital orspecially authorized community pharmacies in remote areasaproved by FDA and the States. Pharmaceutical firms maysupply methadone only to such facilities. This closed distribution system will help prevent diversion of methadone toi l l ic i t channels.

(2) Eligibility of patients for methadone maintenancewill be limited. One condition will be a documented historyof two or more years of drug dependency. Admission willbe restricted for youths under 18 years. Patients may entertreatment only on a voluntary basis.

(3) Patients entering methadone maintenance will be required initially to receive medication in-clinic at least sixdays per week. Even after two years of treatment and demonstrated progress toward rehabilitation, patients will stillbe limited to a "take home" allowance (in child-proof containers) of a three-day supply at a maximum daily dosage of100 milligrams. Random testing for narcotics and otherdrugs will be required.

(4) Methadone treatment programs will be required toprovide counseling and other supportive services. The aim isto help patients retum to a meaningful life.

The new methadone regulations were issued by FDA inconjunction with the White House Special Action Office forDrug Abuse Prevention and the Bureau of Narcotics andDangerous Drugs of the Justice Department.

Filled Milk Act Unconstitutional;FDA Recommends No Appeal

FDA has recommended to the Department of Justice thatthere be no appeal of a Federal Court decision which declared the Filled Milk Act unconstitutional.

The decision was handed down in a case brought by themanufacturers of Milnot, a filled milk product, against the

Secretary of the Department of Health, Education, andWel fa re .

Judge Robert D. Morgan of the Federal District Court forSouthern Illinois agreed with the argument of Milnot'sproducers that the law unjustly restricted the company'soperations. The company argued that its product was notsubstantially different from many other substitute milkproducts that are freely distributed in interstate and foreigncommerce and not restricted by the Filled Milk Act.

A filled milk is a substitute milk product manufacturedby adding a fat or oil other than milk fat to milk, cream, orskimmed milk. The Filled Milk Act prohibits interstateshipment of filled milk even if wholesome, nutritious, andhonestly labeled.

It does not apply to other substitute milk and dairy products which do not use milk, cream, or skimmed milk as acomponent. Judge Morgan ruled that this is an irrationaldistinction which denies "due process" (fundamental fairness) to the manufacturer of Milnot, a canned filled milkproduct.

FDA believes that Judge Morgan's decision is essentiallycorrect, and the Agency will cease to apply the Filled MilkAct to Milnot or to other filled milk products. These products will, however, be subject to the requirements of theFederal Food, Drug, and Cosmetic Act, as well as the FairPackaging and Labeling Act.

Consideration is being given to the adoption of a foodstandard for filled milk products and other substitute milkand dairy products. This standard would require fortification with appropriate nutrients.

The Filled Milk Act was enacted by Congress in 1923, ata time when food technology was in its infancy. It soughtto protect consumers from fraudulent products by prohibiting the interstate and foreign shipment of filled milkproducts which looked like milk but were actually a combination of dairy and nondairy products.

Today many dairy substitutes, products of advancedmodern food technology, are fabricated without any milk,cream, or skimmed milk, but often contain componentsderived from milk. They may lawfully be marketed becausethey are not banned by the Filled Milk Act.

Judge Morgan ruled that the appearance and continuedexistence on the market of other substitute milk and dairyproducts not banned by the Filled Milk Act was a significant new factor distinguishing the Milnot case from priorcases. In 1938 and again in 1944, the U. S. Supreme Courthad upheld the constitutionality of the Filled Milk Actwhen Milnot's producers appealed convictions for violatingthe Ac t .

The decision is in accord with a recommendation made in1969 by the White House Conference on Food, Nutritionand Health that the Filled Milk Act be repealed.

281 February 1973 j FDA Consumer

FDA to Limit Strength of Some VitaminsSold Over the Counter

FDA has acted to limit the strength of vitamins A and Dproducts available for self-treatment without a prescription.The objective is to establish safe amounts of vitamins thatcan be effective as dietary supplements for use byc o n s u m e r s .

Based on current scientific knowledge, the Agency hasproposed daily limits of 10,000 International Units (I.U.)for vitamin A and 400 I.U. for vitamin D. These figures arewithin the recommended daily dosages established by theFood and Nutrition Board, National Academy of Sciences-National Research Council, the recognized authorityfor determining vitamins and their nutritional requirementson humans.

The principal effect of the proposed regulations will be tohave makers of multivitamins revise their formulas. Manymultivitamin products are presently below the limits proposed for vitamins A and D. There are on the market, however, vitamin A products in dosages 10 times the recommended daily allowance (RDA) and vitamin D products 60times the RDA.

High-dosage vitamin products prescribed by physiciansfor specific patients will be unaffected.

Both vitamins are recognized as necessary to good humannutrition. However, excess amounts can be dangerous toboth adults and chi ldren.

Reports of misuse of large doses of both vitamins A andD have prompted medical groups and FDA to seek limitations on them. Widespread promotion of both vitaminshas resulted in excessive use for conditions such as acne,night blindness, and arthritis. Neithei vitamin A nor D isproven effective for these conditions in well-nourishedpeople.

Excessive amounts of vitamin A taken over long periodscan increase pressure within the human skull and maymimic a brain tumor. Large doses of this vitamin have alsobeen shown to retard growth in children. Vitamin D hasbeen known to retard mental and physical growth inch i ld ren.

Pregnancy Test Kits Unreliable;FDA Requests Recall

At FDA's request, a distributor and manufacturer of pregnancy test kits have begun nationwide recalls of theirproducts.

Based on its evaluation of the test kits-Ova II and LPTPregnancy Test-FDA believes the products to be inac

curate, unreliable, and prone to give false results. TheAgency warns consumers not to rely on the results.

Distributed by Faraday Laboratories of Hillside, NewJersey, Ova II is sold in drugstores, without a prescription,for use by women at home and is advertised in newspapersand women's magazines with the slogan "When you want tobe the first to know." FDA urges any woman who hasrecently used Ova II as a pregnancy test to see her physicianimmediately for accurate methods of detecting pregnancy.

LPT Pregnancy Test is for professional use only and ismanufactured and distributed by La Mar Laboratories ofOceanside, New York.

Government Orders RestrictionsOn Sale of Small Turt les

The Department of Health, Education, and Welfare hasordered major restrictions on the importation, interstatetransportation, and sale of small (less than four inches), liveturtles, tortoises, and terrapins and their eggs.

The action follows investigations showing that the turtles,purchased mostly as pets, are a significant source ofSalmonella, a bacterium which can cause abdominal pain,nausea, fever, and diarrhea, and may require hospitalization. An estimated 280,000 cases of salmonellosis in thiscountry annually are attributable to turtles.

It is estimated that 15 million small turtles are sold in thiscountry annually. Ninety percent sold as pets are domestically produced on commercial turtle farms or captured inthe wild. The remaining 800,000 to 1,500,000 areimported.

The regulations were sponsored by the Health Servicesand Mental Health Administration (HSMHA) and the Foodand Drug Administration (FDA), both agencies of the Department of Health, Education, and Welfare.

Under the regulations, importation of hve turtles andtheir eggs will be limited to a combined maximum of six,except for bona fide scientific and educational purposes orfor exhibitions. All importation above the maximum hmitwill require a permit from the director of the Center forDisease Control, Atlanta, Georgia.

For interstate commercial shipment and sale of liveturtles or their eggs, a certificate declaring the turtles freeof infectious bacteria will be required from a State healthauthority. If a certified lot is mingled with untested lots, allmust be reinspected by a State health authority beforefurther transport or sale is allowed.

FDA is empowered to seize and order the destruction ofany turtles uncertified or otherwise found endangering thepubUc health.

FDA Consumer / February 1973 j 29

Regional Reports

R E G I O N I

Several charitable institutions in the jurisdictional areaof the Boston Field Office recently received candy, ginger ale, and root beer that had been seized because FDAfound they were either short weight or improperlyl a b e l e d .

During an inspection of a food warehouse at Portsmouth, New Hampshire, an FDA inspector found twolots of candy kisses, one molasses and one peanut butter,which were short weight. The candy had been manufactured and shipped by Salem's Old Fashioned CandyCo., Salem, Massachusetts. FDA had the two lotsseized. Since the candy was not claimed, a default decreewas entered which called for giving the seized goods tocharity.

In Concord, New Hampshire, a U.S. marshal seizedover 200 cases of 32-ounce bottles of ginger ale and rootbeer that had been shipped by the Canada Dry Corp.,Waltham, Massachusetts, and was not labeled in compliance with the Fair Packaging and Labeling Act. Sincethese beverages were not claimed either, a default decreewas entered, and all were donated to public charitableinstitutions within New Hampshire.

R E G I O N I I

Three manufacturers of matzo crackers in the New YorkDistrict area got in trouble recently when they represented the crackers to have special dietary properties.The claims made, which FDA alleged were false andmisleading, were that the matzos were "perfect for lowsugar diets," "diet thin," and had "no sugar added." TheDistrict instituted seizure when it found that the crackers had only slightly less caloric content than regularmatzo c racke rs .

The District went into action following a recent reportto the office from an area consumer. TTie woman reported she had the same allergic reaction to a drug,labeled to contain only acetaminophen, as she has whentaking aspirin. FDA representatives collected the product from the woman, and analysis later showed it contained aspirin at a level of approximately grains pertablet. In addition, spectroscopic examination showedit also contained salicylamide, caffeine, and the claimedacetaminophen. The drug was being repacked by a firmin Brooklyn.

Appropriate follow-up action is now underway by theDistrict's compliance branch.Buffalo District representatives are keeping the AgwayStores in the area under surveillance to insure that they

are putting correct warning labels on antifreeze containers. The action follows reports received earlier by theDistrict that the stores were selling ethylene glycol antifreeze by filling unlabeled, customer-supplied containers. During the ensuing investigation. District inspectorscontacted the firm's office in Syracuse, New York, andwere informed that some of the stores did not have adequate supplies of proper warning labels. The firm issued a "stop sale" order to all its stores without theproper labels until they could be supplied.Entry was refused recently for a 132,000-pound lot offrozen northern pike fillets shipped from Canada. FDA'srefusal was based on a Buffalo District analysis findingthat an import sample of the fish contained levels ofmercury above FDA guidelines. The lot was valued at$48,840.

In line with FDA's cooperative program with theCanadian government, the District contacted the Chiefof Technical Services, Inspection Branch, Departmentof Environment, Ottawa, Canada. He expressed concernthat the shipment had slipped through the Canadian department's monitoring system, and assured the Districtthat the fish would be disposed of under the supervisionof the Canadian government.

R E G I O N I I I

Prior to Christmas the Consumer Deputy Program wasin full swing in the Philadelphia District area. Approximately 50 volunteers were participating, working diligently to get as many unsafe toys off the shelves as possible before many were introduced to unsuspecting children who might be injured from them.

The consumer deputies operate under a pilot programstarted in three FDA Districts—Chicago, Seattle, andAtlanta—in July 1972. They visit retail establishmentsin their areas looking for toys that have been banned byFDA. They have no legal authority and can only pointout to the store manager that he is offering a banned toyfor sale. If he refuses to remove the toy from his shelves,the deputy reports this to the FDA District office, and aninspector begins an investigation. The consumer deputyprogram represents a means by which local consumerscan work with local businessmen to provide increasedprotection and safety by supplementing FDA's inspection capabilities.

The program got a boost from the Philadelphia ModelCities Consumer Protection Program, a federally fundedproject which covers Philadelphia's inner city. In addition to participating in the Consumer Deputy Program,the inner city group was conducting workshops, exhibits, and media programs to pass toy safety informa-

30 /February 1973 / FDA Consumer

tion on to the individual consumers living in the modelcities area—approximately 250,000 of them. The innercity group also held two training sessions for volunteersin the Consumer Deputy Program, one covered November 22 by WCAU-TV, Channel 10, Philadelphia.

The Pennsylvania League of Consumer Protectiontook part in the program in the District area.Vilotti and Marinelli Baking Co., Inc., Philadelphia, hassigned a consent decree of permanent injunction whichdirects the firm to cease manufacturing until it establishes controls and takes preventive measures to eliminate adulteration of its food products. The District's initial inspection of the firm's premises in October revealedheavy insect, bird, and rodent contamination of theplant and its products. After reviewing the inspectionalfindings and conferring with the presiding judge, thefirm signed the decree.

To further improve coordination of joint consumer protection efforts in FDA's Baltimore District and in WestVirginia, two State officials have been detailed to theDistrict for two weeks. Terry Hall, director of the State'sAgriculture Laboratory, will study FDA procedures inthe District laboratory, and Donald James, assistant director of the State's Consumer Protection Division, willstudy inspectional procedures with the District Inspection Branch. These details will complement the assignment of Tom Price, Baltimore District program coordinator, to West Virginia for two weeks in August1972 (see FDA Consumer, November 1972).

R E G I O N I V

The Atlanta Field Office received an adverse reactioncomplaint recently from a consumer after she took thiamine hydrochloride (vitamin Bi). Field Office representatives investigated and discovered mislabeled drugs.The consumer said she had taken the vitamin tablets asdirected, then had noticed flushing and redness of herface and a "warm" feeling for about an hour, followedby chills. The complainant's tablets and follow-up samples were found to contain 100 mg of niacin per tabletand no thiamine hydrochloride. The tablets were repacked by Generix Drug Co., Hollywood, Florida. During the investigation FDA officiais found that 85,000thiamine hydrochloride tablets and 500,000 niacintablets had been shipped at the same time from the samepharmaceutical company to the repacker. By mistakethe repacker put niacin tablets in containers labeledthiamine hydrochloride. A recall was initiated.Several groups within the Region, concerned about toysafety, nutritive labeling, and drugs, are forming consumer action committees. Among these are Georgia'sYWCA's, Duke University Student Committee, GeorgiaTech. Student group, and Beta Sigma Phi InternationalSorority (Delta Upsilon chapter). FDA consumerspecialists in the Region are training group leaders toestablish plans of action. The leaders will then take back

to their respective committees the consumer informationthey have gathered.

R E G I O N V

A recent Consumer Awareness Conference at Rock-ford, Illinois, reached over 300 people, and it seemslikely to be repeated in the near future. The conferencewas sponsored jointly by FDA's Chicago District andthe Harlem High School in Rockford.

Participants in the various sessions included WilliamR. Clark, deputy regional food and drug director forFDA's Region V; Dr. Philip L. White, director. Department of Foods and Nutrition, Amercian MedicalAssociation; Marie A. Ekvall, consumer specialist,FDA; and local businessmen, bankers, insurance executives, and representatives from food stores in the Chicago area.

Consumer Specialist Marie A. Ekvall and InspectorRichard P. Spiller of the Chicago District conducted aseries of workshops in the Chicago area for the Industrial Safety and Health Training Classes of the UnitedSteelworkers of America. The men attending appearedto be vitally concerned about toy safety, food sanitation,nutrition, and food additives. They came out in inclement weather to hear what FDA had to say.

C i n c i n n a t i D i s t r i c t i n i t i a t e d r e c e n t s e i z u r e o f a t w o - t o nlot of potato flakes in possession of Markin-Blanton Co.,Ironton, Ohio. The lot was rodent-adulterated and hadbeen stored under insanitary conditions. FDA inspectorsfound the adulterated potato flakes while conducting asanitary inspection of the wholesale warehouse.Detroit District inspectors accompanied three U.S. marshals for recent simultaneous seizures of lots of prescription veterinary drugs in the possession of three Michigandealers. The drugs were being sold for use without thesupervision of a licensed veterinarian and were therefore held to be misbranded under the Food, Drug, andC o s m e t i c A c t .

The seizure actions followed up an investigation theDistrict began after the Michigan Department of Agriculture reported finding antibiotic residues in milk.Six fisheries in the Minneapolis District area have beenpermanently enjoined from shipping DDT-adulteratedfish in interstate commerce, ending almost two years oflegal seesawing in the courts. All are in Wisconsin, andinclude Goodman Fish Co., Kenosha; Ewig Bros. FishCo., Inc., Port Washington; Strege & Rousar Fish Co.,Racine; Ray's Fish Co., Racine; Robert Strege Co.,Racine; and G and M Fisheries, Racine.

Early in 1971, FDA's Minneapolis District attemptedto bring injunction proceedings against the fish dealers,found to be shipping fresh and smoked chubs containingDDT in amounts exceeding the 5 parts per million interim tolerance established for this pesticide by the Secretary of Health, Education, and Welfare.

FDA Consumer / February 1973 131

After months of preliminary conferences betweenU.S. and defense attorneys, a hearing was held November 2, 1972, in Milwaukee, before U.S. District JudgeMyron L. Gordon. On November 6, Judge Gordonruled in favor of the Government, stating that such foodstuffs must be regarded as adulterated, because they contain a pesticide chemical which is unsafe.

Since the defendants had contested the Secretary'sauthority to establish the 5 p.p.m. interim tolerance forDDT in fish. Judge Gordon also ruled that the Secretarydoes have such authority, and there is a judicial obligation to enjoin the distribution of unsafe foods, even inthe absence of a formally promulgated regulation. Thejudge then signed the order for permanent injunctionagainst the six firms." F D A B a n s S a n t a G l a u s " w a s t h e n e w s h e a d l i n e o nChannel 4 WCCO-TV, Minneapolis, on its "ConsumerInquiry" program one evening shortly before Christmas. The story originated from a mother's complaint tothe TV station about a stuffed toy Santa Claus she hadpurchased for her son, on which he had cut his finger.TV station officials suggested she call FDA's Minneapolis District office, which she did.

District inspectors investigated, collected a samplefrom Target Stores, from which the consumer hadbought the toy, and sent it to FDA's Bureau of ProductSafety, where it was promptly examined. The examination revealed large, sharp staples positioned in a waythat would allow the stuffed Santas to inflict severe cutswhen handled. Target Stores cooperated fully in removing all Santas from sale in the company's nine-Stateterritory. Shortly afterward, the Santas, which werebeing shipped by a Kansas City firm, were seized by aU.S. marsha l .

The entire matter, from the time of the consumercomplaint to the seizure action, was completed withina week.

The Federal Executive Board of the Minneapolis area issponsoring a Consumer Information Center February22-23 in an auditorium at the Dayton Company in Minneapolis. Government agencies, businesses, and consumer groups will have displays, demonstrations, andspeakers to let the public know what assistance is available to meet consumer problems.

R E G I O N V I

Joe P. Durham, deputy regional food and drug director,and Raymond V. MIecko, food and drug officer, DallasDistrict, visited Mexico recently in a "hands across theborder" approach to heading off a problem involvingpossible shipment of pesticide-contaminated strawberries to the United States in 1973. The trip's immediatepurpose was to establish avenues of communication withboth government and industry for corrective action inthe event the problem does develop. Both men conferredwith top government and industry officials.

As a result, the National Commission for Strawberries (composed of representatives from government,strawberry-growing associations, packers, etc.) agreedto revoke the exportation licenses of growers who shippesticide-adulterated strawberries to the United States.The Commission also indicated it will set up a pesticidelaboratory in the strawberry-growing State of Michoa-can to check berries intended for exportation to thiscountry.

The Commission, as well as a number of governmentagencies, expressed a desire to send chemists to DallasDistrict for training in pesticide residue analysis and tocontinue, the dialogue with FDA.In the New Orleans District, Sars of Louisiana, Inc., arendering plant at Baton Rouge, and its vice president,Felix Sapp, were sentenced in a Federal Court at NewOrleans on charges of shipping Salmonella-contami'-nated meat-scrap meal in interstate commerce. Thecorporation had pleaded guilty and was fined $5,000 oneach of three counts; the sentence was suspended on oneof the counts. Mr. Sapp, who had pleaded guilty to onecount of the charge, was placed on two years' probationon condition that he not violate any local. State, or Federa l laws.

R E G I O N V I I

The Kansas City Field Office is actively involved in enforcement of the permanent injunction handed down bythe court in May 1972 against Diapulse Corp. ofAmerica forbidding sale of its Diapulse device. Not onlyis the firm enjoined but all persons involved in the distribution and promotion of the Diapulse unit. Diapulseis an electromagnetic generator similar to conventionalmedical diathermy, but differing in that its output ispulsed and it lacks the energy output of conventionalmedical diathermy.

FDA investigators are visiting all known consigneesor users of the devices, and affording them the opportunity to voluntarily dispose of them. If the devices arenot destroyed voluntarily or released to the FDA fordisposition, seizure is recommended.

Over 125 practitioners in Iowa, Kansas, Nebraska,and Missouri are involved. To date, approximately 35units have been voluntarily destroyed or surrendered,and Federal seizure action has been initiated against approximately 50 additional devices. Kansas State healthofficials are assisting in this activity.

Over 4,000 Diapulse devices have been distributedthroughout the United States and in several foreigncountries. Purchasers include hospitals, clinics, medicaldoctors, chiropractors, and other practitioners, whohave paid $2,400 to $3,000 for each machine.

R E G I O N V I I I

Mike Kuchta, consumer safety officer with the DenverField Office, found recently that a large bakery in Den-

32 / February 1973 j FDA Consumer

ver was producing bread packaged 5 percent short oflabeled weight. When contacted, the bakery voluntarilydestroyed 2,650 pounds of the bread on hand. It alsodestroyed raw material contaminated with water thathad condensed on the equipment.

R E G I O N I X

In the San Francisco District, F. G. Wool Packing Co.,San Jose, California, consented to an injunction November 1 prohibiting shipment of its 1971 pack of cannedfruit cocktail into interstate commerce. FDA had foundthat the product contained mold from canning machinery and had been packed under insanitary conditions.The firm was further enjoined from shipping any contaminated products, or products packed under insanitary conditions, into interstate commerce at any time inthe future.

Lassen Foods, Inc., Paradise, California, and WayneW. Schlotthauer, president, and Conrad L. Craft, manager, were each fined $500 October 31 by Judge PhilipC. Wilkens, U.S. District Court, Sacramento. The twoindividuals were also placed on a year's unsupervisedprobation. All had pleaded guilty earlier to an FDAcharge of holding wheat-germ meal under insanitaryconditions in the firm's plant after receiving it in interstate commerce, thereby causing it to become adulterated by rodents.

Elaine Roentgen, consumer specialist with the LosAngeles District, conducted a series of three workshopsin Tucson, Arizona, recently, designed to meet the special needs of senior citizens. Food and nutrition was thetheme of the first workshop. Mrs. Roentgen discussednutritional value, calorie content of foods, food con

tamination in a home environment, and food purchasing pointers relating to packaging and labeling, amongother things.

The second and third workshops dealt with the useof OTC and Rx drugs, cosmetics, and medical devices;and selection and care of fabrics, flammable fabrics,and toy safety.

Also in Arizona, Mrs. Roentgen addressed threeclasses in contemporary nutrition concepts at the StateUniversity in Tempe. As an indication of the tremendous interest in nutrition that currently prevails on college campuses, 90 students were registered in each ofthese classes. Only a small percentage are nutritionmajors, and the students represent a variety of ageleve ls .

R E G I O N X

The Seattle Field Office is helping conduct a six-monthconsumer education workshop on the Indian reservations in Washington, Oregon, and Idaho. The workshopis aimed at community action program aides, health"outreach" workers, coordinators, counselors, and other"help-oriented" people working with Indian families.

The first workshop was presented November 16 inLapwai, Idaho, for representatives from the Nez Perceand Coeur d'Alene tribes. Program topics included useof ads in shopping, health frauds, aerosol sniffing, purchase of nonprescription drugs, purchase of meat andconvenience foods, door-to-door sales, and credit. Representatives of the FDA, the Federal Trade Commission, the Idaho State Attorney General's office, and theCooperative Extension Service participated in the prese n t a t i o n s .

F D A R E G I O N A L A N DD I S T R I C T O F F I C E S

ATLANTA 880 W. Peachtree St., N.W.At lanta, Ga. 30309B A L T I M O R E 9 0 0 M a d i s o n A v e .Bal t imore, Md. 21201B O S T O N 5 8 5 C o m m e r c i a l S t .Boston, Mass. 02109B U F F A L O 5 9 9 D e l a w a r e A v e .Buffa lo , N.Y. 14202CHICAGO Main Post Office Bldg.Rm. 1222/433 W. Van Buren St.Chicago, 111. 60607C I N C I N N AT I 11 4 1 C e n t r a l P k w y.Cincinnat i , Ohio 45202D A L L A S S u i t e 4 7 0 - B500 S. ErvayDallas, Tex. 75201DENVER New Customhouse B ldg.R m . 5 0 0 / 2 0 t h & C a l i f o r n i a S t s .Denver, Colo. 80202D E T R O I T 1 5 6 0 E . J e f f e r s o n A v e .Detro i t , Mich. 48207KANSAS CITY 1009 Cherry St.Kansas City, Mo. 64106

L O S A N G E L E S 1 5 2 1 W . P i c o B l v d .Los Angeles, Calif. 90015M I N N E A P O L I S 2 4 0 H e n n e p i n Av e .Minneapol is , 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 .New Orleans, La. 70130N E W Y O R K 8 5 0 3 r d A v e .B r o o k l y n , N . Y. 11 2 3 2N E W A R K R m . 8 3 1 / 9 7 0 B r o a d S t .Newark , N .J . 07102P H I L A D E L P H I A U . S . C u s t o m h o u s eRm. 1204/2nd & Chestnut Sts.Phi ladelphia, Pa. 19106SAN FRANCISCO Federal Office Bldg.R m . 5 4 4 / 5 0 F u l t o n S t .San Francisco, Calif. 94102S A N J U A N P . O . B o x 4 4 2 7Old San Juan S ta t i onSan Juan, P.R. 00905SEATTLE Federal Office Bldg.R m . 5 0 0 3 / 9 0 9 F i r s t A v e .

Seattle, Wash. 98104

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

BOSTON J. F. Kennedy Federal Bldg.Boston, Mass. 02203N E W Y O R K 2 6 F e d e r a l P l a z aNew Yo rk , N .Y. 10007P 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 .Phi ladelphia, Pa. 19108ATLANTA Rm. 404/ 50 7th St. , N.E.At lan ta , Ga. 30323C H I C A G O 3 0 0 S . W a c k e r D r .Chicago, 111. 60606D A L L A S R m . 9 1 1 / 1 1 1 4 C o m m e r c e S t .Da l las , Tex . 75202K A N S A S C I T Y 6 0 1 E . 1 2 t h S t .Kansas Ci ty, Mo. 64106DENVER Federa l Office B ldg .19th & Stout Sts.Denver, Co lo . 80202SAN FRANCISCO Federa l Office B ldg.R m . 4 1 6 / 5 0 F u l t o n S t .San Francisco, Calif. 94102SEATTLE Arcade P laza B ldg .1 3 2 1 2 n d A v e .Seattle, Wash. 98101

FDA Consumer / February 1973 133

State Actions

Home-Processed Food RegsWhen food is processed in a domestic kitchen for sale to the public,says the Oregon Department ofAgriculture, persons allowed in thekitchen at the time of processing,preparation, packaging, or handlingo f t he commerc ia l f oods w i l l bel imi ted to the l icensee and thoseworking on the product, directlyunder supervision of the licensee.

This is one of the requirements inthe regulations now covering processing of commercial foods in domestic kitchens. The regulations further require:

That al l domestic ki tchen doorsor openings to other rooms or structures be kept closed and no otherdomestic activities of any kind becarried on in the kitchen while thecommercial food is being processed,prepared, packaged, or handled.

That no pets be allowed at anytime in the structure or building inwhich the domest ic k i tchen is loc a t e d .

That there be separate storagespace for ingredients, the finishedproducts, containers, and labels forthe commercial foods.

That household cleaning materials, other chemicals, toxic substances, or medical supplies not bestored in the domestic kitchen.

The regulations also require thatlicensed operations be available forinspection by officials of the OregonDepartment of Agriculture at rea--sonable working hours and on weekends or holidays, if necessary.

New Food-Labeling LawHot dogs, sausage, sandwich meat,bologna, scrapple, and other popular staples manufactured from meatproducts for sale to consumers,must have their ingredients clearly

labeled, according to a food-labelinglaw now in effect in Pennsylvania,and enforced by the State's department of agriculture.

The regulations stem from theState's Meat and Poultry Hygienelaw of 1968. Although the meat industry has had a good record ofvoluntary compliance with labelingrequirements, violations have occurred when retail outlets buy manufactured meat products in bulk andrepackage the meat for sale insmaller quantities.

The regulations now in effect require that unpackaged meat products such as sausage and bolognasold in bulk to retail stores must beidentified to the consumer by a wall-board or chart, or a card for eachitem in the display case. Prepackaged meat items with two or moreingredients also must be labeled toidentify these ingredients.

All meat retailers, wholesalers,and distributors had been asked toremove from sale all unlabeled prepackaged meats prior to the effective date of the new regulation. Ifany was found after that time, it wassubject to seizure by the department's food inspectors, and prosecution was initiated. Any stores foundin violation of the new regulationsare subject to fines from $50 to$300. A second violation will carrya fine of $500 to $1,000.

Embargo 'Dotto Rings'The Special Services & Plant Inspection Section of the Pennsylvania Department of Health has embargoed,because of false claims, three therapeutic devices used by the Biophysics Research Foundation at Pittsburgh. The devices, called "DottoRings," were invented by GianniDotto, and are claimed to "stop the

spread of cancer and deter the body'saging process." Consumers havebeen charged $5 for each dose of"Ring Treatment" applied by theDotto Ring.

Training SessionT h e B u r e a u o f C o n s u m e r A f f a i r sand Marketing Services of the Pennsylvania Department of Agricultureheld a two-day training session atHarrisburg recently for its consumercoordinators representing all sevenregions in the department. The purpose of the event was to instruct thecoordinators in forming consumercouncils throughout the State andeducating council members.

Consumer councils wil l be composed of citizens, representatives ofconsumer organizations, and otherqualified persons interested in theconsumer protection aspects of foodproduction, food processing, andfood marketing. The council members will be responsible for infonn-ing the public about consumer protection laws and existing consumerprograms. They will be direct linesto the department for registeringconsumer complaints in matters ofhigh prices, deceptive advertisingand labeling, and inferior quality off o o d c o m m o d i t i e s .

Con tam ina ted Nu tsState Inspector Lawrence Burns ofthe Food Inspection Division of theMichigan Department of Agriculture recently supervised the destruction of approximately nine tons ofcontaminated nuts. The departmenthad cooperated with FDA's DetroitDistrict, in mid-November, by seizing all lots of nuts in possession ofthe Rocky Peanut Co., Detroit, afteran FDA inspector observed a general rodent problem at the firm.

34 /February 1973 / FDA Consumer

Seizures and Postal Service Cases

SEIZURE ACTIONS charging violation of the Federal Food, Drug, and Cosmetic Act and the Federal Hazardous Substances Act are published when they are reported by the FDA District Office.

A total of 43 actions to remove from the consumer market volved charges concerning contamination, and 6 involvedproducts charged to be violative was reported in October, charges concerning economic and labeling violations. OtherThese included 20 seizures of foods: 2 involved charges seizures included 1 of vitamins and dietary food, 1 of drugs,concerning poisonous and deleterious substances, 12 in- 17 of medical devices, and 4 of hazardous substances.

PRODUCT, PLACE & DATE SEIZED MANUFACTURER (M), PACKER (P),SHIPPER (S), DEALER (D) C H A R G E S

FOOD/Poisonous and Deleterious SubstancesAlfalfa hay, baled/Chino, Calif. 10/11/72 Arie Breedyk Dairy/Chino, Calif. (D)

Seed corn, treated/Louisville, Ky. 10/11/72

Arie Breedyk Dairy/Chino, Calif. (D) Contains a pesticide chemical, toxaphene, in excessof established tolerance of 1 ppm.

Caudill Seed and Warehouse Co./Louisville, Contains a pesticide chemical, captan, for which noK y . ( D ) t o l e r a n c e h a s b e e n p r e s c r i b e d .

Actif-8, flour salt/Henderson, N.C. 10/25/72Beans, green, canned, "Lake Region,"

"Spring Valley'VArlington, Minn.10/26/72

garbanzo/Modesto, Calif. 10/17/72Great northern, navy/Toledo, Ohio

10/18/72mung/San Francisco, Calif. 10/12/72

pinto, ML brand. Ma Hat Ma Texas patnarice/Fresno, Calif. 10/4/72

Chili peppers, dried, brazil nuts/El Paso,Tex. 10/17/72

Coffee beans, green/San Francisco, Calif.10/2/72

Popcorn/Charlotte, N.C. 10/3/72Rice, brown/Penns Creek, Pa. 10/26/72Shrimp meat/San Francisco, Calif. 10/26/72

Wheat germ, hulled sunflower seeds, hulledsunflower chips/Spokane, Wash. 10/2/72

Contamination, Spoilage, Insanitary HandlingSanford Milling Co./Henderson, N.C. (D) Held under insanitary conditions.Indianhead Food Products, Inc./Bloomer, Prepared and packed under insanitary conditions;

Wis. {M,S)

Ed J. Lyng Co., Inc./Modesto, Calif. (D)The Hartley Co./Toledo, Ohio (D)

contain machinery mold.

Held under insanitary conditions; rodent contaminated.Held under insanitary conditions.

South End Warehouse/San Francisco, Calif. Held under insanitary conditions; rodent contaminated.(D)

H o b b s - P a r s o n C o . / F r e s n o , C a l i f . ( D ) "

Brown's Refrigerated Warehouse, Inc./ElPaso, Tex. (D)

Thompson Bros., Inc./San Francisco, Calif.(D)

John Purvis Co./Charlotte, N.C. (D)Arrowhead Mills, Inc./Hereford, Tex. (M,S)

; rodent contaminated (chili peppers).

John Purvis Co./Charlotte, N.C. (D) Held under insanitary conditions; insect contaminated.Arrowhead Mills, Inc./Hereford, Tex. (M,S) Insect-infested rice.Blanco Fisheries, Inc./Port Orford, Oreg. Prepared, packed, and held under insanitary conditions.

(P,S)Pilgrim Fine Foods, Inc./Spokane, Wash. (D) Held under insanitary conditions; rodent contaminated.

Coffee mix, Luzianne Instant/New Orleans,La. 10/6/72

Molasses kisses, peanut butter kisses/Portsmouth, N.H. 10/17/72

Olives, Durkee Spanish/Denver, Colo.10/12/72

Pelures De Truffes, Truffes Brossees/Denver, Colo. 10/12/72

Pepper, black, ground/Jackson, Miss.10/12/72

Tortillas/Seattle, Wash. 10/19/72

Economic and Labeling Violations

Luzianne Coffee Co., Inc./New Orleans, CLa. (D)

Salem's Old Fashioned Candy Co./Salem,Mass. (M,S)

SCM Corp./Cleveland, Ohio (M); SCMGlidden-Durkee/Brooklyn, N.Y. (S)

Liberty Import Corp./Carlstadt, N.J. (S)Unknown (M)

Macgowan Coffee Co./Jackson, Miss. (D)

Ashley's Inc./El Paso, Tex. (M,S)

Chicory and malto-dextrin was substituted in part forcoffee; label fails to bear the common or usualname of article.

Short weight.

Not in conformity with the Fair Packaging and Labeling Act; no dual declaration; quantity of contentsstatement not in proper type size.

Not in conformity with the Fair Packaging and Labeling Act; identity of product not in English; declaration of net quantity of contents not located onprincipal display panel.

No accurate statement of quantity of contents.

Not in conformity with the Fair Packaging and Labeling Act; weight not expressed in ounces andpounds; letters and numerals not as required byregulations.

FDA Consumer / February 1973 / 35

PRODUCT, PLACE & DATE SEIZEDM A N U F A C T U R E R ( M ) , PA C K E R ( P ) ,

S H I P P E R ( S ) , D E A L E R ( D )C H A R G E S

PENTA-VIRON tablets/San Francisco, Calif.10/2/72

VITAMIN—DIETARY FOOD

Leo Linden Laboratories, Inc./Los Angeles,Calif. (M,S)

Deficient In vitamin B-1 (thiamine); false and misleading label statements representing article tobe necessary and useful as a dally dietary supplement; not In conformity with the Fair Packagingand Labeling Act.

Verased tablets, Analgestlne capsules/Detroit, Mich. 10/4/72

DRUGS/Human Use

Mallard, Inc./Detrolt, Mich. (M) Not in conformity with good manufacturing practice.

DIapulse/Medford, Oreg. 10/17/72

Portland, Oreg. 10/3/72Charlotte, Vt. 10/18/72Franklin, Pa. 10/24/72

i Quakertown, Pa. 10/16/72Columbus, Ohio 10/3/72Louisville, Ky. 10/5/72Louisville, Ky. 10/5/72Selma, Ala. 10/12/72Lake City, Fla. 10/11/72Sacramento, Calif. 10/2/72Chehalls, Wash. 10/4/72

Tacoma, Wash. 10/4/72Fverett, Wash. 10/5/72Fverett, Wash. 10/5/72Hope, Ark. 10/6/72

Palm Springs, Calif. 10/1/72

M E D I C A L D E V I C E S

Diapulse Corp. of America/New Hyde Park,N.Y. (M,S)

Inadequate directions for safe use by laymen.

Remington Rand DIv., Sperry Rand Corp. forDiapulse Corp. of America, New York,N.Y. (M)

Remington Rand Div., Sperry Rand Corp. (M);Diapulse Corp. of America/New York, N.Y.(S)

Remington Rand Div., Sperry Rand Corp.(M); Diapulse Corp. of America/New HydePark, N.Y. (S)

Cllmalene detergent booster/Fort Wayne,Ind. 10/17/72

Re-Silvering polish/Pittsburgh, Pa.10/26/72Silver Replate/Clnclnnati, Ohio 10/18/72

Des Moines, Iowa 10/11/72

HAZARDOUS SUBSTANCES

Cllmalene Co./Canton, Ohio (M,S) Toxic, corrosive, and an Irritant; no adequate warnings.

Ag Bond International, Inc./Batavia, N.Y. Banned hazardous substance containing soluble cya-( M , S ) n i d e s a l t s .

U.S. POSTAL SERVICE actions taken In medical cases as authorized in the Mail Fraud Statute (18 U.S.C. 1341)and/or the False Representation Statute (39 U.S.C. 3005) as reported by the Assistant Postmaster General—Inspection Service.

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

August 30, 1972: False Representation Order Issued against HealthActivators and Arnold King Distributors, 7008 S. W. 4th Street,Miami, Florida, and Personal Professional Products, P.O. Box493, Miami, Florida. Advertising and sale by mall of "P.F.P.P.,"

represented to be effective as a sex stimulant, wrinkle remover,and bust developer.

August 30, 1972: False Representation Order Issued against HealthActivators and Arnold King Distributors, 7008 S. W. 4th Street,

36 I February 1973 I FDA Consumer

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

Miami, Florida, and Personal Professional Products, P.O. Box 493,Miami, Florida. Advertising and sale by mail of a product called"Instant Erecto Cream," represented to be an effective sexstimulant for men.

August 30, 1972: False Representation Order issued against HealthActivators and Arnold King Distributors, 7008 S. W. 4th Street,Miami, Florida, and Personal Professional Products, P.O. Box493, Miami, Florida. Advertising and sale by mail of a productcalled "La Fem Climax Cream," represented to be effective asa sex stimulant for women.

August 30, 1972: False Representation Order issued against StatureHouse, P.O. Box 146, Brampton, Ontario, Canada, and P.O. Box 550,Mississauga, Ontario, Canada. Advertising and sale by mail of acourse which will allegedly effect a significant increase inheight.

September 5, 1972: False Representation Order issued against HairGrowth Bureau, P.O. Box 146, or 158 Kennedy Road, South,Brampton, Ontario, Canada. Advertising and sale by mail of acourse which will allegedly reverse a balding condition and restore hair to balding areas of the head.

September 6, 1972: False Representation Order issued against Fun

House, P.O. Box 239, Gary, Indiana. Advertising and sale by mailof a product called "Mexican Spanish Fly in Liquid Form," represented to be effective as a sex stimulant.

September 7, 1972: False Representation Order issued againstInformation Resources Co., P.O. Box 173, Encinitas, California92024. Advertising and sale by mail of "U.S. Women's Ski TeamDiet," which promised a weight loss of 20 pounds in two weeks.

September 7, 1972: False Representation Order issued against J.Carlton's and Inchaway Wrap, 176 Madison Avenue, New York,New York 10016. Advertising and sale by mail of "Inchaway Wrap,"represented as enabling users to lose three inches off theirwaistlines in just one hour without having to diet or exercise.

September 14, 1972: False Representation Order issued againstAnn Jones, 324 S. First Street, Alhambra, California 91802. Advertising and sale by mail of "Spanish Fly Love Pills," represented to be an effective aphrodisiac or sexual stimulant.

September 20, 1972: False Representation Order issued againstObadiah, 324 S. First Street, Alhambra, California 91802. Advertising and sale by mail of "Sex Stimulant," represented to bean effective aphrodisiac or sex stimulant.

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

August 25, 1972: Dyna Power, Ltd., Dyno-Power, and P.O. Box 239,Gary, Indiana 46401. Advertising and sale by mail of "Dynamite"and "Prolong Tablets," represented to be effective as sex stimulants.

August 29, 1972: Citrus Publishers, P.O. Box 47, Northridge, California91324. Advertising and sale by mail of a diet plan which promisesa weight loss of 10 pounds in 10 days.

August 29, 1972: Gwendolyn, 152 West 42nd Street, Suite 536, NewYork, New York 10036. Advertising and sale by mail of "FrenchLove Powder," represented to be an effective aphrodisiac orsexual stimulant.

August 30, 1972: Hernandez, 324 S. First Street, Alhambra, California91802. Advertising and sale by mail of "Pseudo Spanish FlyChewing Gum," represented to be an effective aphrodisiac orsexual stimulant.

August 31, 1972: Nina of Germany, 152 West 42nd Street, Suite 536,New York, New York 10036. Advertising and sale by mail of "SuperNature Tablets',' or "Spark Pills," represented to be an effectiveaphrodisiac or sexual stimulant.

August 31, 1972; Thornton and Thornton Lab., 152 West 42nd Street,Suite 536, New York, New York 10036. Advertising and sale bymail of "Mad Dog Weed," represented to be an effective aphrodisiac or sexual stimulant.

September 1, 1972: Products of Ann Lee, 9864 Bird Road, Miami,Florida 33165. Advertising and sale by mail of a product called"Up and Atom," represented to improve sexual ability of men.

September 1, 1972: Products of Ann Lee, 9864 Bird Road, Miami,Florida 33165. Advertising and sale by mail of a product called"Dynamic Kaps," represented to be effective as a sex stimulantand to restore good health.

September 5, 1972: United Distributors, 152 West 42nd Street, Suite536, New York, New York 10036. Advertising and sale by mailof "Frenchie's Spanish Fly Chewing Gum," represented to be aneffective aphrodisiac or sexual stimulant.

September 6, 1972: Harco Distributors, Inc., Elmhurst, New York, NewYork 11373. Advertising and sale by mail of "Slimming Caps,"guaranteed as enabling subscribers to lose 10 pounds in 10 days.

September 6, 1972: United Distributors, 6915, 6919, and 6921 S.Vernon Avenue, Chicago, Illinois 60637. Advertising and sale bymail of products called "Spanish Fly," "Knockout Drops," "SpanishFly Chewing Gum," and "Spanish Fly Candy," represented to beeffective as sex stimulants.

September 20, 1972: Brentwood Research, 1800 N. Highland Avenue,Los Angeles, California 90052. Advertising and sale by mail of"Report 43," alleged to be a weight reduction tonic.

September 22, 1972: Lockwood Distributors and P.O. Box 798, Miami,Florida. Advertising and sale by mail of a product called "InstantErecto Cream," represented to be an effective sex stimulant form e n .

September 22, 1972: Lockwood Distributors and P.O. Box 798, Miami,Florida. Advertising and sale by mail of a product called "P.E.P.P.,"represented to be effective as a sex stimulant, wrinkle remover,and bust developer.

September 22, 1972: Lockwood Distributors and P.O. Box 798, Miami,Florida. Advertising and sale by mail of a product called "LaFem Climax Cream," represented to be effective as a sex stimulant for women.

FDA Consumer / February 1973 137

Notices of JudgmentNOTICES OF JUDGMENT on Seizure Actions

FOOD / Poisonous and Deleterious Substances

Cottonseed meal, at Albuquerque, Dist. N. Mex.Charged 3-22-72: while held for sale, the article contained the added poisonous and deleterious substance aflatoxin; 402(a)(1). Default decree ordereddestruction. (F.D.C. No. 57859; S. No. 32-323 F; N.J. No. 1)

Meat and bone meal, at Lake Charles, W. Dist. La.Charged 3-6-72: when shipped by Barvin Packing Co., Houston, Tex., thearticle, which was in burlap bags that had been used for poison-treatedseed rice, contained the pesticide chemical aldrin, and its use and intended use were not in conformity with a regulation or exemptiontherefrom; the article had been prepared, packed, and held underinsanitary conditions; the label statement on the bags of "seed rice"was false and misleading; the label lacked the name and place ofbusiness of the manufacturer, packer, or distributor; and the label lackedthe common or usual name of the food; 402(a)(2)(c), 402(a)(4), 403(a),403(e)(1), 403(i)(l). Default decree ordered destruction. (F.D.C. No.5 7 8 5 3 ; S . N o . 5 3 - 2 0 2 F ; N . J . N o . 2 )

FOOD / Contamination, Spoilage, Insanitary HandlingAlmonds, at Chicago, N. Dist. III.

Charged 3-21-72: while held by Flavour Candy Co., Chicago, III., the articlecontained rodent filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 57876; S.N o . 2 0 - 3 4 7 F ; N . J . N o . 3 )

Caraway seeds, at St. Louis, E. Dist. Mo.Charged 3-16-72: while held by American Bakeries, St. Louis, Mo., thearticle was held under insanitary conditions; 402(a)(4). Default decreeauthorized delivery to a Government commission for use as a wildlifefodder. (F.D.C. No. 57866; S. No. 42-630 F; N.J. No. 4)

Co f fee beans , a t New Or leans , E . D i s t . La .Charged 3-17-72: while held by Kentucky Warehouse, Inc., New Orleans,La., the article contained moldy and insect-infested coffee beans; 402(a)(3).Default decree ordered destruction. (F.D.C. No. 57875; S. No. 53-108 F;N.J. No. 5)

Cookies, at Round Lake, Dist. Minn.Charged 1-12-72: when shipped by American Wafer Co., Joplin, Mo., thearticle, labeled in part "Sather's Creme Delite . . . Distr. by SatherCookie Co., Round Lake, Minn.," contained rodent filth and had been prepared, packed, and held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. (F.D.C. No. 57735; S. No. 64-958E; N.J. No. 6)

Cookies, at Tulsa, N. Dist . Okla.Charged 1-10-72: when shipped by American Wafer Co., Joplin, Mo., thearticle, labeled in part "Mama's Wafer Stix [or "Sugar Wafers"] . . .Baked for Mama Cookie Bakeries, Inc., Tulsa, Okla. . . . Div. of Mickel-berry's Food Products Co.," contained rodent filth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).Default decree ordered destruction. (F.D.C. No. 57739; 8. Nos. 52-959/60 E;N . J . N o . 7 )

Fruit cocktail, canned, 2 seizure actions at Montgomery, M. Dist. Ala., andGreenv i l l e , D is t . S .C .Charged 1-27-72 and on or about 2-2-72: when shipped by InstitutionalWarehouses, Inc., East Stockton, Calif., the article, labeled in part "AstorFruit Cocktail . . . The Monterey Canning Co. San Francisco, Cal. . . .Distributors," contained mold from unclean machinery and had beenprepared and packed under insanitary conditions; 402(a)(3), 402(a)(4).D e f a u l t d e c r e e o r d e r e d d e s t r u c t i o n . ( F. D . C . N o s . 5 7 7 8 6 , 5 7 7 8 8 ; S . N o s .16-938/9 E; N.J . No. 8)

Fruitcake, Fiesta, at Omaha, Dist. Nebr.Charged 3-22-72: when shipped by Promotional Fruit Cake Bakers, Inc.,D a v e n p o r t , I o w a , t h e a r t i c l e c o n t a i n e d m o l d , a n d t h e l a b e l s t a t e m e n t" R u m a n d B u t t e r " i n c o n j u n c t i o n w i t h t h e s t a t e m e n t o f i d e n t i t y " F r u i tCake" was fa l se and m is lead ing as app l i ed to an a r t i c l e con ta in ing im i tation rum and butter flavor—402(a)(3), 403(a); and the article was inviolat ion of the Fair Packaging and Label ing Act, s ince the label 's statemento f i d e n t i t y o f t h e a r t i c l e w a s h i d d e n u n d e r t h e c a n l i d a n d t h e p r i n c i p a ld i s p l a y p a n e l ( i . e . t h e p o r t i o n o f t h e l a b e l d i s p l a y e d u n d e r c u s t o m a r yconditions) failed to bear a statement of identity of the article; and thequantity of contents, appearing on the principal display panel area ofmore than 25 square inches, was in a type size less than 3/16 inchhigh—15 U.S.C. 1453(a)(1), 1453(a)(3)(c)(i). Default decree ordereddestruction. (F.D.C. No. 57815; S. No. 42-021 F; N.J. No. 9)

Mushroom chips, canned, 2 seizure actions at Kansas City, Dist. Kans., andTampa , M . D i s t . F l a .C h a r g e d 2 - 1 - 7 2 a n d 3 - 9 - 7 2 : w h i l e h e l d f o r s a l e , t h e a r t i c l e s w e r e u n d e rgoing progressive decomposition; 402(a)(3). Default decrees ordereddestruction. (F.D.C. Nos. 57791/2,- S. Nos. 65-160- E & 1-200/1 E; N.J.No. 10)

Peas, dried, lima beans, dried. Great Northern beans, dried, and marrow beans,dried, 4 seizure actions at Marcellus, N. Dist. N.Y.Charged 3-29-71: while held by Allen V. Smith, Inc., Marcellus, N.Y., thearticles contained rodent filth and were held under insanitary conditions;4 0 2 ( a ) ( 3 ) , 4 0 2 ( a ) ( 4 ) . C o n s e n t d e c r e e a u t h o r i z e d r e l e a s e t o d e a l e r f o r r econditioning. (F.D.C. No. 57055; S. Nos. 78-425/6 E et al; N.J. No. 11)

Pecans , she l led , a t Mansura , W. D is t . La .Charged 1-7-72: when shipped by Keathley's Baking Co., Memphis, Tenn.,the article contained E. coli; 402(a)(3). Consent decree authorized releaseto shipper for reconditioning. (F.D.C. No. 57748; S. No. 35-727 E; N.J.No. 12)

Pecans, shelled, Azalea, at Cincinnati, S. Dist. Ohio.Charged 2-25-72: when shipped by H. M. Thames Co., Inc., Mobile, Ala.,the article contained E. coll; 402(a)(3). Default decree ordered destruction. (F.D.C. No. 57840; S. Nos. 26-284/5 F; N.J. No. 13)

Pepper, black, lima beans, dried, and peas, dried, at Carrollton, N. Dist. Tex.Charged 3-16-72: while held by Arrow Food Products, Inc., Carrollton, Tex.,t h e a r t i c l e s c o n t a i n e d r o d e n t fi l t h a n d w e r e h e l d u n d e r i n s a n i t a r y c o nditions; 402(a)(3), 402(a)(4). Consent decree authorized release to thedealer for salvaging. (F.D.C. No. 57867; S. Nos. 31-804/8 F; N.J. No. 14)

Potato flour, at Kansas City, W. Dist. Mo.Charged 3-15-72: while held by Adams Transfer and Storage, Kansas City,Mo., the article contained insect filth and was held under insanitary conditions; 402(a)(3), 402(a)(4). Default decree ordered destruction. F.D.C.No. 57874; S. No. 41-307 F; N.J. No. 15)

Potatoes, diced, dehydrated, Idahoan Ready Diced, at Forest Park, N. Dist. Ga.Charged 1-17-72: when shipped by Idaho Fresh Pak, Inc., Lewisville, Idaho,the article contained insects and insect larvae; 402(a)(3). Default decreeordered destruction. (F.D.C. No. 57767; S. No. 3-701 E; N.J. No. 16)

Rice and pinto beans, at Fresno, E. Dist. Calif.Charged 2-15-72: while held by Marbo Quality Foods, Inc., Fresno, Calif.,who had repacked some of the rice into 1-lb. bags from 100-lb. bulk bags,the pinto beans and the bulk rice were held under insanitary conditions—402(a)(4); and the repacked 1-lb. bags of rice were in violation ofthe Fair Packaging and Labeling Act, since the quantity of contentsstatement was not separated from other printed label information appearing above and below the declaration, the quantity of contents was expressed as "Net Wt. 1 lb." instead of "Net Wt. 16 oz. (1 lb.)," and thequantity of contents statement, appearing on the principal display panelarea of more than 25 square inches, was in a type size less than 3/16 inchhigh—15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Consent decreeauthorized release to the dealer for reconditioning. (F.D.C. No. 57802;S. Nos. 73-406/8 F; N.J. No. 17)

Soups of various kinds, canned, Bon Vivant and Ancora, 2 seizure actions atDal las , N. D is t . Tex . , and handover, D is t . Md.C h a r g e d 9 - 8 - 7 1 a n d 9 - 1 5 - 7 1 : w h e n s h i p p e d b y B o n V i v a n t S o u p s , I n c . ,Newark, N.J., the articles were unfit for food in that some cans of thesef o o d s h a d b e e n f o u n d t o b e d e f e c t i v e a n d a b n o r m a l a n d i n t h a t t h e m a n uf a c t u r i n g p r o c e d u r e s u s e d d i d n o t a s s u r e t h e p r o p e r s e a l i n g o f t h e c a n sand adequa te hea t t r ea tmen t o f t he sea led cans t o p reven t con tam ina t i onand spo i lage , and the a r t i c les had been p repared , packed , and he ld underinsanitary conditions; 402(a)(3), 402(a)(4). The articles were claimedby the shipper. However, the shipper failed to file answers as requiredby the Fede ra l Ru les o f C i v i l P rocedu re ; and upon mo t i on o f t he Gove rnme n t , d e fa u l t d e c re e s o f co n d e mn a t i o n o rd e r i n g d e s t r u c t i o n w e re e n te re d .( F. D . C . N o s . 5 7 4 3 7 & 5 7 4 6 5 ; S . N o s . 5 3 - 4 4 5 / 7 E . e t a l & 5 2 - 4 4 4 E ;N.J. No. 18)

Soups of various kinds, canned, Bon Vivant and other brands, 3 seizure actionsat Kansas City, Dist. Kans., Philadelphia, E. Dist. Pa., and Kalamazoo, W.D i s t . , M i c h .Charged on or about 8-18-71, 11-8-71, and 2-15-72: when shipped byBon Vivant Soups, Inc., Newark, N.J., the articles were unfit for food In thats o m e c a n s o f t h e s e f o o d s h a d b e e n f o u n d t o b e d e f e c t i v e a n d a b n o r m a land in that manufacturing procedures used did not assure the propersealing of the cans and adequate heat treatment of the sealed cans toprevent contamination and spoilage, and the articles had been prepared,packed, and held under insanitary conditions; 402(a)(3), 402(a)(4).Default decrees ordered destruction. (F.D.C. Nos. 57400, 57576 & 57812;S. Nos. 65-041/2 E, 25-722 E & 35-223 F; N.J. No. 19)

Tuna , canned , a t New Or leans , E . D is t . La .Charged 2-25-72: while held for sale, the article was undergoing chemicaldecomposition; 402(a)(3). Default decree ordered destruction. (F.D.C.No. 5781 ; S. No. 53-443 F; N.J^ No. 20)

Vegetable noodles, wheat and soya noodles, vegetable shell macaroni, vegetableelbow macaroni, vegetable spaghettini, and whole wheat macaroni, at NorthB e r g e n , D i s t . N . J .Charged 2-9-72: when shipped by Florence Macaroni Manufacturing, Co.,Los Angeles, Calif., the articles, labeled in part "Old Stone Mill WholeWheat Cut Macaroni . . . Packed for Balanced Foods, Inc., N. Bergen,N.J.," and "Balanced Artspinach Noodles . . . Distributed by BalancedFoods, Inc . , Nor th Bergen, N.J . , " and a 92-case lo t o f the e lbow macaron ilabeled in part "Balanced Artspinach Elbow Macaroni . . . Distrib. byBalanced Foods, Inc., North Bergen, N.J.," contained insects and insectfragments; all of the articles (except a 150-case lot of the vegetableelbow macaroni labeled as above) had been prepared and packed underinsanitary conditions; the label statement "Balanced" appearing in thelargest print on the labels of all the articles (except the whole wheatmacaroni and the similarly labeled wheat and soya noodles) in associationwith the label statement "No preservatives, coloring or additives used"were false and misleading in representing and suggesting that the articleswere nutritionally balanced foods and were nutritionally superior to otherm a c a r o n i a n d n o o d l e p r o d u c t s o n t h e m a r k e t t h a t c o n f o r m e d t o t h edefinitions and standards of identity for such products; the statement"No preservatives, coloring used" on the labels of all articles (exceptthe whole wheat macaroni and wheat and soya noodles) and similar statements on the labels of the whole wheat macaroni and wheat and soyanoodles were false and misleading in representing and suggesting thatby reason of the absence of preservatives and artificial color the articleswere djstinctly different from other macaroni and noodle products, whenthe articles were not distinctly different from other macaroni and noodleproducts, since preservatives and artificial color are not permitted bythe definitions and standards of identity for such products; the state-ment 'Ingredients . . . Dehydrated Artspinach Powder," on the labelsof all articles (except the whole wheat macaroni and wheat and soyanoodles) was false and misleading in representing and suggesting thatdehydrated artspinach powder was the common or usual name of aningredient; and all of the articles (except the whole wheat macaroni)failed to bear the name of the food as specified in the definition and

Identity for the articles^02(a)(3), 402(a)(4), 403(a),403(g)(2); and the articles were also in violation of the Fair Packagingand Labeling Act, since the quantity of contents declaration was notseparated from other printed label information appearing above thedeclaration of all the articles and below the declaration of all articles

38 / February 1973 jFDA Consumer

except the wheat and soya noodles; and the quantity of contents statement appearing on the principal display panel area of more than 25square inches of all articles (except the wheat and soya noodles and thewhole wheat macaroni) was in a type size less than 3/16 inch high—15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decree ordered destruction. (F.D.C. No. 57803; S. Nos. 83-274/80 E; N.J. No. 21)

FOOD / Economic and Labeling Violations

Cookies, at San Lorenzo, N. Dist. Calif.Charged 1-19-72: when shipped by Bakkers Royal Dutch Cookies (HawkEye Investment Corp.), Draper, Utah, the article was in violation of theFair Packaging and Labeling Act, since the quantity of contents declaration was not separated from other printed labeling appearing above thedeclaration, and since the quantity of contents statement, appearing onthe principal display panel area of more than 25 square inches, was ina type size less than 3/16 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(C)(i). Default decree authorized donation to a charitable institution.(F.D.C. No. 57766; S. No. 17-538 E; N.J. No. 22)

Dates, Sunripe, and mixed nuts, Sunripe, at Detroit, E. Dist. Mich.Charged 1-26-72: when shipped by D. DeFranco & Sons, t/a New EnglandTomato Co., Los Angeles, Calif., the articles were in violation of theFair Packaging and Labeling Act, since the quantity of contents declaration of the dates was not placed within the bottom 30 percent of theprincipal display panel area; since the quantity of contents statement ofthe mixed nuts was expressed as "Net Wt. 1 lb." instead of "NetWt. 16 oz. (1 lb.)"; and since the quantity of contents statement, onthe principal display panel area of more than 25 square inches, was in atype size less than 3/16 inch high; 15 U.S.C. 1453(a)(2), 1453(a)(3)(A)(i), 1453(a)(3)(C)(i). Default decree ordered destruction. (F.D.C. No.57778; S. Nos. 81-311/2 E; N.J. No. 23)

Oysters, smoked, canned. Empress, at Denver, Dist. Colo.Charged 1-24-72; when shipped by Bien Trading Co., Inc., New York,N.Y., the article, labeled in part "Empress Brand Smoked Oysters inCotton Seed Oil . . . Product of Japan Packed for Mitsui & Co., Ltd.,Tokyo, Japan Importers: Bien Trading Company, Inc., New York, N.Y.,"was in violation of the Fair Packaging and Labeling Act, since the quantityof contents declaration was not within the bottom 30 percent of theprincipal display panel area; 15 U.S.C. 1453(a)(2). Consent decreeauthorized release to shipper for relabeling. (F.D.C. No. 57751; S. No.34-208 E ; N .J . No . 24)

Peach halves, canned, Greer, at Little Rock, E. Dist. Ark.Charged 2-17-72: when shipped by Jones Bros. Canning Co., Greer, S.C.,article fell below the standard of quality for canned peach halves, sincethe weight of the largest peach half unit was more than twice the weightof the smallest unit; 402(h)(1). Default decree authorized donation to acharitable institution. (F.D.C. No. 57834; S. No. 53-328 F; N.J. No. 25)

Various Mexican food products, at San Antonio, W. Dist. Tex.Charged 1-7-71: when shipped by Herdez Commercial, Mexico City, Mexico,the articles, labeled in part "Dona Maria Hot Sauce ["Mole Poblano,""Mole Verde," "Adobo en Pasta," or "Pipian en Pasta"] . . . Made inMexico by Productos Marpe, S. A. . . . San Luis Potosi, S.L.P.," werein violation of the Fair Packaging and Labeling Act, since the principaldisplay panel of the label of the Mole Verde, Adobo en Pasta, andPipian en Pasta, lacked a quantity of contents declaration; the quantityo f c o n t e n t s d e c l a r a t i o n o f t h e h o t s a u c e a n d M o l e P o b l a n o w a s n o twithin the bottom 30 percent of certain principal display panel areas;the quantity of contents statement, appearing on the principal displaypanel areas of the hot sauce and Mole Poblano which had areas of morethan 5 square inches, was in a type size less than Ve inch high; and certainquantity of contents statements of the Mole Poblano and the hot sauce,were qualified by the word "approx." or "aprox." appearing in conjunction with such statements; 15 U.S.C. 1453(a)(2), 1453(a)(2), 1453(a)(3)(C)(i), 1453(b). Default decree as to the Mole Poblano and Pipian enPas ta o rde red des t ruc t ion . Consen t dec ree as to the o the r a r t i c les au tho rized release to Texas International Imports, Inc., San Antonio, Tex., forexport to original foreign supplier. (F.D.C. No. 56932; S. Nos. 36-464/8D; N.J. No. 26)

VITAMINS / SPECIAL DIETARY FDODS

Inositol, choline bitartrate, and methionine capsuies, at Miami, S. Dist. Fla.Charged 1 -27-72 : when sh ipped by R ich lyn Labora to r ies , Inc . , Ph i lade lph ia ,Pa., the labeling of the article, labeled in part "Pink Trilipol Capsules. . . Distributed by La Prime Pharmaceuticals Miami, Florida . . . Use:As a dietary supplement," contained false and misleading claims represent ing and suggest ing that i ts ingredients were nutr ients wi thspecial dietary properties; 403(a). Default decree ordered destruction.(F.D.C. No. 57774; S. No. 23-085 E; N.J. No. 27)

Matzo crackers. Strait's Diet-Snax, at Cleveland, N. Dist. Ohio.Charged 11 -10 -71 : when sh ipped by A ron S t re i t , I nc . , New York , N .Y. , t hearticle's name "Diet-Snax" and the label statement "No Salt, No Sugar,No Spices, No Shortening Added" were false and misleading in representing and suggesting that the article was of significant value in weight control diets as a means of restricting the intake of calories; 403(a). Defaultd e c r e e a u t h o r i z e d d o n a t i o n t o a p u b l i c / c h a r i t a b l e i n s t i t u t i o n . ( F. D . C . N o .57578; S. No. 8-398 E; N.J. No. 28)

F O O D A D D I T I V E

Aloe vera juice, Alvera, and aloe vera gel, Alvera, at Compton, C. Dist. Calif.Charged 2-18-71: when shipped by Aloe Products, Inc., Houston, lex., thearticles contained the nonconforming food additive aloe vera—402(a)(2)(C); and the aloe vera gel was a new drug without an effectiveapproved New Drug Application—505(a). Default decree ordered destruction. (F.D.C. No. 56993; S. Nos. 66-742/3 E; N.J. No. 29)

ANIMAL FEED

Animal feed concentrate liquid, at Aberdeen, Dist. S. Dak.

Charged 1-27-72: while held for sale, the article contained the new animaldrug diethylstilbestrol, and there was no approval of a New AnimalDfug Application in effect with respect to the use and intended useof the drug; 402(a)(2)(D). Consent decree authorized release to HubCity Feed & Seed Co., Aberdeen, S. Dak., for reconditioning. Thereafter,pursuant to stipulation, the article was destroyed. (F.D.C. No. 57772; S.No . 63 -925 E ; N .J . No . 30 )

Animal feed concentrate liquid, at Greenleaf, Dist. Kans.Charged 2-9-72: while held for sale, the article contained diethylstilbes -trol for which no approval of a New Animal Drug Application was effectivefor such use and intended use; 402(a)(2)(D). Default decree orderedd e s t r u c t i o n . ( F. D . C . N o . 5 7 7 9 5 ; S . N o . 4 1 - 9 8 5 F ; N . J . N o . 3 1 )

Cattle feed supplement liquid, Prot-A-Lass, at Sioux City, N. Dist. Iowa.Charged 2-24-72: when returned to Kay Dee Feed Co., Sioux City, Iowa,who had manufactured the article, the article contained diethylstilbestrol,a new animal drug for which there was no approval of a New AnimalDrug Application in effect with respect to the use and intended useof the drug; 402(a)(2)(D). Consent decree authorized release to them a n u f a c t u r e r f o r s a l v a g i n g . ( F. D . C . N o . 5 7 8 3 8 ; S . N o . 4 1 - 6 6 7 F ; N . J .No. 32)

Feed supplement liquid. Compensator PR, at Rock Port, W. Dist. Mo.Charged 1-14-72: when shipped by Allied Chemical Corp., Omaha, Nebr.,the article contained diethylstilbestrol, a new animal drug without an effective approved New Animal Drug Application for use in the article; 402(a)(2)(D). Default decree ordered destruction. (F.D.C. No. 57737; S. No. 97-8 9 2 E ; N . J . N o . 3 3 )

Feed supplement liquid. Compensator PR, at Stamford, Dist. Nebr.Charged 1-7-72: while held for sale after manufacture by Allied ChemicalCorp., Omaha, Nebr., from ingredients shipped in interstate commerce,t h e a r t i c l e c o n t a i n e d d i e t h y l s t i l b e s t r o l , a n e w a n i m a l d r u g w i t h o u t a neffective approved New Animal Drug Application for use in the article;402(a)(2)(D). Default decree ordered destruction. (F.D.C. No. 57738;S. No . 97 -891 E ; N .J . No . 34 )

M e d i c a t e d l i q u i d a n i m a l f e e d , a t L o v e l a n d , D i s t . C o l o .C h a r g e d 3 - 1 0 - 7 2 : w h e n s h i p p e d b y P r e s c r i p t i o n P r e m i x , M i n a t a r e , N e b r. ,the article, labeled in part "Puregro Company P-M-S Feed Initiator . . .O x y t e t r a c y c l i n e . . . N e o m y c i n . . . D i s t r i b u t e d B y P u r e g r o C o m p a n yDenver, Colo.," contained the drugs diethylstilbestrol, oxytetracycline,a n d n e o m y c i n w h i c h i n c o m b i n a t i o n w i t h e a c h o t h e r i n t h e a n i m a l f e e dwere new animal drugs for which there was no effective approved NewAnimal Drug Application for use in such animal feed; 501(a)(6). Consentdecree ordered destruction. (F.D.C. No. 57861; S. No. 33-960 F; N.J.No. 35)

D R U G S / H u m a n U s e

A n a l g e s i c c a p s u l e s , a t K a l a m a z o o , W. D i s t . M i c h .Charged 3-15-72: while held by Kapco, Inc., Kalamazoo, Mich, (whomanufactured the article, labeled in part "PONODYNE . . . Aspirin . . .Ace to -para -amino-pheno l . . . ca f fe ine . . . Ascorb ic Ac id (Vi tamin C) . . .Ca l c i um G lu tama te . . . Ana lges i c . . . Capsu les Fe l l ows Tes taga r D i v. o fFellows Med. Mfg. Co. Inc. Oak Park, Mich. . . . Anaheim, Calif.," usingc a f f e i n e a n d a c e t a m i n o p h e n s h i p p e d i n i n t e r s t a t e c o m m e r c e ) , t h e l i s t i n gon the label of ascorbic acid as an active ingredient falsely and mis-leadingly represented and suggested that the ascorbic acid was of valuef o r t h e a r t i c l e ' s i n t e n d e d p u r p o s e s f o r t e m p o r a r y r e l i e f o f h e a d a c h e ,neuralgia, pain accompanying common cold, relief of muscular aches andpains, and discomfort associated with common colds; and the articlelacked adequate directions for use and was not exempted therefrom,since it was a new drug without an effective approved New Drug Application and without a notice of claimed investigational exemption; 502(a),502(f)(1). Consent decree ordered destruction. (F.D.C. No. 57873; S.N o . 3 4 - 6 4 9 F ; N . J . N o . 3 6 )

Chorionic gonadotropin for injection, U.S.P., at Van Nuys, C. Dist. Calif.Charged 3-2-72: when shipped by Glogan & Co., Chicago, III., the circumstances of the article's manufacture, processing, packing, and holdingfailed to conform with current good manufacturing practice; and the article's strength differed from the U.S.P. standard; 501(a)(2)(B), 501(b). Default decree ordered destruction. (F.D.C. No. 57846; S. No. 46-364 E; N.J.No. 37)

Sodium iodide and foreign protein injection, at St. Louis, E. Dist. Mo.Charged 3-15-72: when the article, labeled in part "PROZYDE . . .Sodium Iodide . . . Purified Beef Protein (lodinated) . . . ManufacturedFor Fleming & Co. St. Louis, Mo.," was shipped by Maizel Laboratories, Div. Myers-Carter Laboratories, Inc., Chicago, III., the circumstances of the article's manufacture, processing, packing, and holdinglacked conformity with current good manufacturing practice; and thearticle was a new drug without an effective approved New Drug Application;501(a)(2)(B), 505(a). Default decree ordered destruction. (F.D.C. No. 57871;S. No. 43-357 F; N.J. No. 38)

Vaginettes hydroquinone and boric acid combination tablets, at New York, S.

Charged 2-19-71: when shipped by Whitehall Laboratories, Hammonton, N.J.,t h e ' a r t i c l e w a s a n e w d r u g w i t h o u t a n e f f e c t i v e a p p r o v e d N e w D r u gApplication—505(a); and while held by Vaginettes, Inc., New York, N.Y.,the article's accompanying leaflets contained false and misleading claimsfor vaginal hygiene, prevention of pregnancy, stopping and protectingagainst vaginal odors, and relief from vaginal odor problems; the labell a c k e d t h e e s t a b l i s h e d n a m e o f t h e a c t i v e i n g r e d i e n t h y d r o q u i n o n e ( w h i c hwas declared as Quinol); the box label lacked adequate directions for use,and the labeling lacked adequate warnings against unsafe use—502(a),502(e)(l)(A)(ii), 502(f)(1), 502(f)(2). Default decree ordered destruction.(F.D.C. No. 56964; S. Nos. 62-668/9 D; N.J. No. 39)

V i t a m i n B c o m p l e x i n j e c t a b l e , a t D e a r b o r n , E . D i s t . M i c h .Charged 3-13-72: when shipped by Maizel Laboratories, Div. Myers-CarterLabora to r i es , Ch i cago , I I I . , t he c i r cums tances fo r t he a r t i c l e ' s manu fac tu re ,p r o c e s s i n g , p a c k i n g , a n d h o l d i n g f a i l e d t o c o n f o r m w i t h c u r r e n t g o o d

FDA Consumer / February 1973 j 39

manufacturing practice; and the quality and purity of the article weredeficient, since it contained particulate matter; 501(a)(2)(B), 501(c).Default decree ordered destruction. (F.D.C. No. 57869; S. No. 35-358 F;N . J . N o . 4 0 )

DRUG / Veter inary

Dipyrone iniections for cattle, at Muleshoe, N. Dist. Tex.Charged 3-14-72: when shipped by Wittney & Co., Inc., Denver, Colo.,the articles, labeled in part "Hi-Pro Dipyrone . . . Manufactured for Hi-Pro Feeds, Inc., Friona, Texas" and "AVC Dipyrone Veterinary . . . Manufactured for Affiliated Supply Company Tulia, Texas," were new animaldrugs, and no approval of a New Animal Drug Application was in effectwith respect to the use and intended use of the drugs; 501(a)(5). Defaultdecree ordered destruction. (F.D.C. No. 57854; S. Nos. 32-510/1 F;N.J. No. 41)

M E D I C A L D E V I C E S

Diapulse electromagnetic energy generators, 3 seizure actions at Natchez, S.Dist. Miss., New Orleans, E. Dist. La., and Fort Smith, W. Dist. Ark.Charged 8-25-72, 8-29-72, 8-25-72: when shipped by Diapulse Corp. ofAmerica, New Hyde Park, N.Y., the labeling of the articles lacked adequate directions for their intended purposes, since adequate directionscould not be written for use of the articles by laymen; and the articleswere not exempted therefrom, since adequate information for use bylicensed practitioners could not be furnished; 502(f)(1). Default decreesordered destruction. (F.D.C. Nos. 58211/3; S. Nos. 4-681 F, 53-725 F &53-309 F; N.J. No. 42)

OzoneAir ozone generators, at Atlanta, N. Dist. Ga.Charged 3-16-72: when shipped by Air and Water Purification, Inc., Akron,Ohio, the articles lacked adequate directions for their intended purposefor the destruction of odors and bacteria, and adequate directions for safeuse of the articles by the laity could not be written; and the articleswere dangerous to health when used as directed, since the articlesemitted ozone at levels unsafe for human exposure; 502(f)(1), 502(j).Default decree authorized, in lieu of destruction, delivery to FDA forexamination and/or exhibit purposes. (F.D.C. No. 57879; S. Nos. 2-246/8E; N.J. No. 43)

S o o t h e r b e a d s f o r t e e t h i n g b a b i e s , a t S e a t t l e , W. D i s t . Wa s h .Charged 5-10-72: when shipped by Nippy Manufacturing Co., Jamaica,N.Y., and subsequently reshipped by Tidy Ties Corp., Monroe, La., thep u r i t y a n d q u a l i t y o f t h e a r t i c l e w e r e d e fi c i e n t , a n d t h e l a b e l s t a t e m e n t s"Terminal Sterilization of Contents Eliminates Possibility of HarmfulBacteria and is Safe for Drinking" and "Unconditionally (Guaranteed forYo u r B a b y ' s H e a l t h a n d C o m f o r t " w e r e f a l s e a n d m i s l e a d i n g , s i n c e t h efluid in the beads conta ined yeast , mold, and other v iab le micro-organisms;501(c), 502(a). Default decree ordered destruction. (F.D.C. No. 57884;S . No . 78 -561 F ; N .J . No . 44 )

COSMETIC / Beauty Product

H a i r b r u s h e s , a t B l a d e n s b u r g , D i s t . M d .Charged 3-1-72: when shipped by B & S Industries, Inc., New York, N.Y.,the article, labeled in part "Scalpmaster 100% Pure Boar Bristles MadeIn France," contained nits; 601(b). Default decree ordered destruction.(F.D.C. No. 57843; S. No. 8-366 F; N.J. No. 45)

HAZARDOUS SUBSTANCES

Cherry bombs and Super Cherry H-Bombs firecrackers, at Jackson, E. Dist. Mo.Charged 7-1-71: while held by Kinder Fireworks, Jackson, Mo., the articlesw 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 s i n t e n d e d t o p r o d u c e a u d i b l e e f f e c t sby a charge of more than 2 grains of pyrotechnic composition; 2(q)(1)(B). Default decree ordered destruction. (H.S.L. No. 1150; 8. No.27-839 E; N.J. No. 46)

C o n c e r n d e t e r g e n t l i q u i d , 5 s e i z u r e a c t i o n s a t M e l r o s e P a r k a n d C h i c a g o , N .D is t . I I I . , S t . Lou is , E . D is t . Mo. , and Mi lwaukee , E . D is t . Wis .Charged 9-22-71, 9-23-71, 10-14-71, 10-22-71, and 10-22-71: when sh ippedby H. T. Developments, Inc., Buffalo, N.Y., the article was toxic andw a s a n i r r i t a n t , a n d i t l a c k e d a n u m b e r o f r e q u i r e d c o n s p i c u o u s l a b e ls t a t e m e n t s ; 2 ( p ) ( l ) ( B , C , E , F, G & J ) . D e f a u l t d e c r e e s o r d e r e d d e s t r u ction. (H.S.L. Nos. 1184; 1185; 1187; 1192; 1193; S. Nos. 7-591 E; 25-005/6E , 6 5 - 3 9 4 / 5 E ; 3 5 - 2 1 2 E ; 3 5 - 2 1 4 E ; N . J . N o . 4 7 )

Dyes for internal carving of plastics, at Godfrey, S. Dist. III.Charged 7-19-71: while held by Cope Plastics Illinois, Inc., Godfrey, III.,who had packed the article into 1-oz. bottles from the bulk article shippedi n i n t e r s t a t e c o m m e r c e , t h e a r t i c l e w a s a fl a m m a b l e s u b s t a n c e w h i c hc o n t a i n e d o v e r 8 0 p e r c e n t m e t h a n o l a n d o v e r 1 5 p e r c e n t a c e t o n e a n dw h i c h p r e s e n t e d a s p e c i a l h a z a r d , a n d i t s l a b e l l a c k e d a n u m b e r o frequired conspicuous label statements—2(p)(l)(B, F, G & J); the statement "Flammable" failed to appear in capital letters on the main panelin type size not less than 12 point type—2(p)(2); and the label lackedt h e s i g n a l w o r d " D a n g e r, " t h e s k u l l a n d c r o s s b o n e s s y m b o l , a n d c e r t a i no the r s ta temen ts requ i red by regu la t i on f o r subs tances p resen t i ng spec ia lhaza rds—3 (b ) . De fau l t dec ree o rde red des t ruc t i on . ^ (H .S .L . No . 1164 ; S .No. 8-809 E; N.J . No. 48)

I r o n M a g i c l a u n d r y c l e a n e r, a t F l i n t , E . D i s t . M i c h .Charged 8-17-71: when shipped by Iron Magic, Inc., Fort Wayne, Ind., thea r t i c l e w a s a t o x i c s u b s t a n c e c o n t a i n i n g a p p r o x i m a t e l y 9 9 p e r c e n t o x a l i ca c i d , a n d i t s l a b e l l a c k e d a n u m b e r o f r e q u i r e d c o n s p i c u o u s l a b e l s t a t em e n t s — 2 ( p ) ( l ) ( B , E , F , G , I & J ) ; a n d i t s l a b e l l a c k e d t h e w o r d"Poison" as required by regulations for articles containing oxalic acidin a concentration in excess of 10 percent—3 (b). Consent decree authorized release to shipper for relabeling. (H.S.L. No. 1175; S. No. 13-622 E;N.J. No. 49)

Jumping Frogs fireworks, at Fort Worth, N. Dist. Tex.Charged 8-21-71: while held by Atlas Enterprises, Inc., Fort Worth, Tex.,the articles were banned hazardous substances intended to produce ana u d i b l e e f f e c t b y a c h a r g e o f m o r e t h a n 2 g r a i n s o f p y r o t e c h n i c c o mposition; 2(q)(l)(B). Default decree ordered destruction. (H.S.L. No.11 6 6 ; S . N o . 1 9 - 5 6 2 E ; N . J . N o . 5 0 )

1 - 11 / 1 6 " fi r e c r a c k e r s , a t M e r c e r , W. D i s t . M o .Charged 6-29-71: wh i le he ld a t a fi reworks s tand. Mercer, Mo. , the ar t i c lesw 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 s i n t e n d e d t o p r o d u c e a u d i b l e e f f e c t sby a charge of more than 2 grains of pyrotechnic composition; 2(q)(1)(B). Default decree ordered destruction. (H.S.L. No. 1134; S. Nos.27-648/9 E; N.J. No. 51)

Silver salutes and cannon-cracker salutes, at Harlem, Dist. Mont.Charged 7-30-71: while held by Hi-Way Grocery, Harlem, Mont., the articlesw 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 s i n t e n d e d t o p r o d u c e a u d i b l e e f f e c t sby a charge of more than 2 grains of pyrotechnic composition; 2(q)(1)(B). Default decree ordered destruction. (H.S.L. No. 1172; S. No.76-312 E; N.J. No. 52)

NOTICES OF JUDGMENT on Criminal Actions

F O O D

American Seaway Foods, Inc., and Jerome Borstein, vice president, BedfordHe igh ts , N . D is t . Oh io .C h a r g e d 2 - 2 - 7 2 : fl o u r w a s h e l d i n a b u i l d i n g a c c e s s i b l e t o r o d e n t s a n dwas contaminated with rodent filth; 402(a)(3), 402(a)(4). Guilty plea bycorporation; fine and probation. Guilty plea by individual; fine suspended,and probat ion . (F.D.C. No. 57725; S . No. 31-301 D e t a l ; N .J . No. 51)

Continental Nut Co., Gerald W. Stiefvater, president, and Frank M. Pangburn,p l a n t m a n a g e r , C h i c o , E . D i s t . C a l i f .C h a r g e d 2 - 1 4 - 7 2 : w h e n s h i p p e d , c u t w a l n u t p i e c e s c o n t a i n e d i n s e c t fi l t hand had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Guilty pleas by corporation and individuals; fines. (F.D.C.No. 57726; S. No. 6-570 E; N.J . No. 54)

Hoody Corporation, Valentine Brown, president and general manager, andJ a m e s A . C a r r, p r o d u c t i o n m a n a g e r, B e a v e r t o n , D i s t . O r e g .Charged 6-21-72: peanut butter, labeled in part "HOODY Chunky StylePEANUT BUTTER . . . HOODY CORPORATION BEAVERTON OREGON," wasp r e p a r e d f r o m p e a n u t s w h i c h w e r e c o n t a m i n a t e d w i t h r o d e n t u r i n e a n dwere packed in burlap bags bearing rodent filth, resulting in the peanutbutter containing rodent filth and being prepared under insanitary condi t ions—402(a) (3) , 402(a) (4) ; and peanut but ter, labe led in par t"Lady Hudson Creamy Peanut Butter . . . DISTRIBUTED BY HUDSON HOUSE,INC., PORTLAND, OREGON," was prepared from peanuts which were contaminated with rodent urine and were packed in burlap bags bearingrodent filth, resulting in the peanut butter being prepared under insanitary condit ions—402(a)(4). Guil ty plea by corporation; f ine. Guil typleas by individuals; imprisonments. (F.D.C. No. 57826; S. No. 39-347 Ee t a l ; N . J . N o . 5 5 )

Keeton Wholesale Grocery Co., a partnership. Mount Sterling, E. Dist. Ky.Charged 10-30-71: self-rising flour, corn flakes, wheat flakes, and all-p u r p o s e fl o u r w e r e h e l d i n a b u i l d i n g a c c e s s i b l e t o r o d e n t s a n d w e r econtaminated with rodent filth; 402(a)(3), 402(a)(4). Guilty plea; fineplus costs, and probation. (F.D.C. No. 57323; S. No. 1-904 E; N.J. No. 56)

Reed-Harlin Co., t/a Central Cash & Carry Wholesale Grocer, James E. Hard,president and general manager, and Bobby G. Burtrum, warehouse manager.Wes t P la ins , W. D i s t . Mo .Charged 3-3-72: popcorn was held in a building accessible to insects andwas contaminated with insect filth; 402(a)(3), 402(a)(4). Guilty pleas;fines. (F.D.C. No. 57730; S. No. 27-742 E; N.J. No. 57)

William Norman Sharp, t/a American Water Co., Joplin, W. Dist. Mo.Charged 5-15-72: when shipped, cookies contained rodent and/or insectfilth and had been prepared and packed under insanitary conditions; 402(a)(3), 402(a)(4). Guilty plea; fine. (F.D.C. No. 57831; S. No. 52-959 Fet a l ; N .J . No. 58)

D R U G

Dr. Mayfield Laboratories, Inc., and Orley J. Mayfield, Sr., D.V.M., president,Char les Ci ty, N. Dis t . Iowa.Charged 8-16-72: when shipped, Oxy-Tet oxytetracycline hydrochloride injectable veterinary drug was a new animal drug without an effectiveapproved New Animal Drug Application; 501(a)(5). Guilty pleas; fines.(F.D.C. No. 57829; S. No. 42-735 D et al; N.J. No. 59)

HAZARDOUS SUBSTANCES

C h a r l i e M u r r y, D e n h a m S p r i n g s , E . D i s t . L a .Charged 2-18-72: cherry bombs, silver salutes, and block buster firecrackers intended to produce an audible effect by a charge of morethan 2 grains of pyrotechnic composition were sold, and such fireworkswere not intended for use solely for bona fide crop protection purposes,and complete records of receipt and distribution were not maintained; 2(q)(l)(B). Guilty plea; fine and probation. (H.S.L. No. 1200; S. Nos.24-137/8 E; 24-785/6 E; N.J. No. 60)

Notices of Judgment are given pursuant to section 705 of the Federal Food,D r u g , a n d C o s m e t i c A c t a n d s e c t i o n 1 3 o f t h e F e d e r a l H a z a r d o u s S u b s t a n c e sAct. Notices of Judgment report cases involving seizure proceedings, criminalproceedings, and injunction proceedings. Seizure proceedings are civil actionstaken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, cosmetics, orh 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 d o r m i s b r a n d e d o ro 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 d i n t o a n d w h i l e i n i n t e r s t a t ecommerce , o r wh i le he ld fo r sa le a f te r sh ipment in in te rs ta te commerce .

Notices of Judgment are prepared by Food, Drugs, and Product Safety Division,Office of the General Counsel, DHEW.

Published by direction of the Secretary of Health, Education, and Welfare.Charles C. Edwards, M.D., Commissioner of Food and Drugs

Washington, D.C. February 1, 1973

40 I February 1973 j FDA Consumer t ^ U . 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 : 1 9 7 3 — 5 1 5 - 0 7 8 / 4 6

It takes morethan sajBety packaging.

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In 1970, Congressenac ted the Po ison P reven t i on

Packaging Act to require safetypackaging for householdproducts that could be injuriousto children. The Food and DrugAdministration's Bureau ofProduct Safety is enforcingth is law.

But safety packaging willwork only if you, the consumer,let it.

Don't forget to storepotentially hazardoussubstances out of children'sreach. A locked cabinet or highshelf is appropriate.

Keep close watch onyoung children.

And when safetypackaging is available, get itand use it. Preventingaccidental poisonings is yourresponsibility as well as ours.

U n i t e d S t a t e sG 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

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o f fi c i a l b u s i n e s sP O S TA G E A N D F E E S PA I D

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S U B S C R I P T I O N O R D E R F O R MENTER MY SUBSCRIPTION TO FDA CONSUMER @$6.50. Add $1.75 for foreign mailing. No additional postage isrequired for mailing within the United States, its possessions, Canada, Mexico, and all Central and South American countriesexcept Argentina, Brazil, British Honduras, French Guiana, Guyana, and Surinam. For shipment to all other foreign countriesinclude additional postage as quoted.S e n d S u b s c r i p t i o n t o : —

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□ HEW Publ icat ion No. (FDA) 73-1022