Food Legislation

This lecture was originally developed by Dr. Jennifer

McEntireEnhanced, updated, and

expandedBy Dr. Tom Montville

http://www.cfsan.fda.gov/~lrd/cfsan4.html

The scope of food50,000 food establishments

30,000 U.S. food manufacturers and processors

20,000 food warehouses

600,000 restaurants and institutional food service establishments

235,000 supermarkets, grocery stores, and other food outlets

Who cares?

Regulatory agenciesCompanies The Public

The publicWant safe foodWant honesty in labelingLobbying groups, as above, plus want to stay “in business.”

CompaniesWant safe foodIncludes US producers and our trading partnersMust abide by lawsWant a say in regulations that will affect them

Packaging/labelingStandard of identityHealth claimsMicrobial testing

The RegulatorsWant safe foodMust abide by laws, stay within jurisdiction Regulate US producers and our trading partners (USDA has granted “equivalency” for only 9 countries)Must work with consumers, producers, politicians, and other regulators

Who are the RegulatorsFDA (CFSAN)- all foods, except meat and poultry

Department of Health and Human Services

USDA (FSIS)- meat and poultryDepartment of Agriculture – also ARS, ERS

Codex Alimentarius Globalization, Regulatory Harmonization EPA pesticidesState and local agencies Laws divide responsibility and authorityCDC advises but has no regulatory authority

Do ties to industry invalidate a scientist’s

credentials?

History of Food Laws Why?

Illness Adulteration

mixing tea leaves with other leavesmixing chicory with coffeemilk in MexicoMelamine?

Food regulations is dynamic and evolutionary

New regulations address new issues, i.e. biotech

History of Food Law1784 first food law in Massachusetts1862 Department of Agriculture formed1906 Food and Drug Act (Dr. Harvey Wiley, chief chemist, USDA, preservative safety). Didn’t give authority to inspect 1938 Federal Food Drug and Cosmetic Act (passed after 100 people died due to diethylene glycol in a medicine) – “THE ACT” 1958 Food Additives Amendment1990 NLEA 1994 DSHEA

http://www.cfsan.fda.gov/~lrd/cfsan4.html

FDA FactsTwenty-five cents on every dollar spent in US is on products regulated by the FDA.

75 percent is spent on foods.

$240 billion worth of domestic food.

$15 billion worth of imported foods.

FD&C Act (“The Act’)DefinitionsProhibited acts and penaltiesFoodDrugs and DevicesCosmeticsGeneral AuthorityImports and Exports

What does FDA regulateSec. 201. (f) Food: (1) articles used for food or drink* for man or other animal, (2) chewing gum, and (3) articles used for components of any such articleThe courts have extended the definition: “intended for nutrition, taste or aroma”*Excludes alcoholic beverages, regulated by Bureau of Alcohol, Fire Arms and TobaccoUSDA regulates meat and poultry

When does FDA have jurisdiction?

Interstate commerce Sec. 201. (b)commerce between any State or Territory and any place outside thereofinsect infested flour mill, flour transported to make bread. Does FDA have jurisdiction over bread (final product) (alternate scenario)

medical marijuana issue, States Rights v FederalIs it medical practice, or is it a drug?

What does FDA enforce?Labeling: all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such articleAdulterationMisbrandingFDA can inspect, usually leaves it up to states

Sec. 402. Adulteration- food which…

bears or contains any poisonous or deleterious substance which may render it injurious to health; includes pesticides and food additives (safety must be established in advance). StarLink corn was recalled (2000) not because it was dangerous, but because it hadn’t been proven safe.has been prepared, packed or held under insanitary conditions where by it may have become contaminated with filth, or whereby it may have been rendered injurious to health.any valuable constituent has been in whole or in part omitted or abstracted therefrom.has inadequate labeling.contains an unsafe dietary supplement. (Gov must prove unsafe).

Sec. 403. MisbrandingOffered for sale under the name of another foodDoes not conform to standard of identityLabeling is false or misleading

Where does this leave dietary supplements?

What is a Dietary Supplement?Legal definition:

a vitamin,

a mineral,

an herb or other botanical,

an amino acid,

a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or

a concentrate, metabolite, constituent or extract.

Dietary SupplementsSec. 403. (6) Not regulated as a food nor a drug as long as labeling is truthfulCan make a claimManufacturer must have substantiation that the statement is truthful and not misleadingManufacturer must notify FDA within 30 days of marketing“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

Potential Dietary Supplement Problems

Doesn’t need FDA approval unless it contains a new dietary ingredientNo standardizationNo manufacturing regulationsData showing effectiveness is not publicNo public source of informationEphedra

Tell the FDA: HANDS OFF my dietary supplements!

Responsible members of the dietary supplement industry were all too glad to see ephedra taken off the market. However the FDA established a new legal standard that gives it unlimited authority to swoop down and ban any product it chooses, without proving that the product is harmful. (Eminent threat)As you know, dietary supplements, derived from entirely natural sources, are not drugs. The DSHEA reflected the consensus that supplements should not be forced to endure prohibitively expensive and time-consuming trials before being approved.With its new ephedra rule, the FDA violated that agreement. Supplement manufacturers can now be required to "prove" that the benefits associated with a particular supplement outweigh its alleged risks.

LipoKinetixDietary supplement marketed for weight loss, supposed to increase metabolismcaused serious liver injuries after 2 weeks -3 months of usageFDA got involved (Office of Nutritional Products, Labeling and Dietary Supplements), warned consumers, sent letter to company urging them to remove product

“Laws” vs. “Regulations”FD&C Act is the LAW, passed by Congress, signed by the President, upheld and interpreted by the courts.Regulations – must go through appropriate legal channels (public comment), authority is delegated to FDA, have the force of the law.Guidelines: Agency creates = “best practices.”

New topic, biosecurity

Weapons of Mass Destruction

Hamilton, NJ Post Office Closed: October 2001 Opened: October 2005 Remediation costs: $20-50 million

Mass destruction or mass disruption?disruption?

The “experts” have 20/20 hindsight (only)

Who’d have predicted that men armed with box cutters could bring down the World Trade Center?Prior to the Amerithrax attack

anthrax was considered a poor choice, not contagious.mail was never considered as a vehicle.

Bio-terrorism is a Real Concern

Assault on animal agricultureAssault on agricultural cropsUse of processed food as terror tool

By individualOrganized terrorist group(Tylinol® tampering)

Bio-terrorism DefinedOsterholm, Emerging Infections 5, p 213, 2001

“the use of biological agents to intentionally produce disease or

intoxication in susceptible populations to meet terrorists’

aims”Morbidity, Mortality, Economic Loss, Sheer Terror

Diffuse Inputs

Diffuse Outputs

Diffuse Inputs

Diffuse Outputs

The Food Industry

Food Bio-terrorismLow tech

High impactInexpensive

Hits “at home”Easy to transport

Diffuse inputs and outputs Hard to detect (before or after)

Unlike chemical or radiological threat

“For the life of me, I cannot understand why the terrorists

have not attacked our food supply, because it is so easy to do.” —

Secretary of Health and Human Services Tommy Thompson, in

announcing his resignation.

Accidental:250,000 cases of

salmonellosis

100 cases of listeriosis

Could have just as easily been caused by bio-terrorist.

Bio-terrorism in Oregon, 1984

Salmonella Typhimurium751 cases, 45 hospitalizationsIntentional contamination of salad barsRajneeshee cult seeking electoral influenceNot identified as bio-terrorism until two years later

Bacterial AgentsClostridium botulinum, or its toxinStaphylococcus aureus, or its toxinSalmonella enteriditis or typhiE. coli O157:H7Bacillus anthracis

Operational Risk Management

(Food Safety and Security: Operational Risk Management Approach, Nov. 26,

2001; www.cfsan.fda.gov)

Operational Risk Management1. Identify the Hazards - what if?2. Assesses the Risk –hazard x severity3. Analyze Risk Control Measure, includes risk/benefit mitigate, eliminate, delay, transfer4. Make Control Decision – what will we do?5. Implement Risk Controls – inform, motivate6. Supervise and review – inspect, interview, quiz

“Guidance for IndustryFood Producers, Processors, Transporters, and Retailers:

Food Security Preventive Measures Guidance” -FDA

Guidance for IndustryManagement of food securityPhysical securityEmployeesComputersRaw materials Air and waterFinished product

Finished ProductKeep track of it – missing or extra stockWarehouse and transportation securityMonitor food in open display areasCounterfeiting

EmployeesPre-hiring screeningDaily work assignmentsIdentificationRestricted accessPersonal itemsSecurity trainingUnusual behavior

FDA Food Bioterrorism Act of 2002

The Public Health Security and Bioterrorism Preparedness and

Response Act of 2002

Components of the Act1. Registration of Facilities – by Dec 12, 2003 Factories, warehouses, “establishments,” must register even if regulation not issued. Food service and nonprofits exempt.

2. Record Keeping – need to ID previous and subsequent holder of the food. Records allow FDA to address credible threats. Entities that manufacture, process, pack, transport, distribute, receive, hold, or import are subject to these rules.

3. Prior notice – of importation. Various time requirements, but not more than 5 days, in advance.

4. Administrative detention of product

“FSIS Safety and Security Guidelines for the Transportation and

Distribution of Meat, Poultry, and Egg Products”

On the ”Security” sideAssess Vulnerabilities (hazard analysis)Develop and Implement Procedures (identify & control vulnerable points) – tracking, recall, evacuation, shippers, sealsEmergency Operations ProceduresTraining and Testing (for response)Screen and Educate EmployeesSecurity & monitoring of facility, shipping and receiving, and employees

For the most part, these are common sense things

that we should be doing anyway.

Conclusions and summaryGreat strides have been made to improve the security of the food supply.

BUTFederal Officials still speak of “when an attack occurs,” not “if”.“We” have to succeed 100% of the time. “They” only have to succeed once.

Be prepared to take care of yourself for 5-7 days

Stock of canned or shelf-stable ready-to-eat foods.Stock of water and/or juices (1 gal/day).Stock of high energy foods, power bars, nuts, etc.Gallon of bleach. 16 drops per gallon to disinfect water.Have a family emergency plan- communications and meeting place.

Have a nice day!