The Major Federal Food Regulatory Agencies (Final) · 2019. 12. 7. · Regulatory Agencies Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018 Disclosures § Think Healthy Group, Inc

3/21/18© INSTITUTE OF FOOD TECHNOLOGISTS 1

The Major Federal Food Regulatory Agencies

Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018

Disclosures§ Think Healthy Group, Inc.§ George Mason University, Department of Nutrition and Food Studies§ Journal of the American College of Nutrition§ Dr. Taylor Wallace – Food & Nutrition Blog

• Additional information on conflicts of interest as well as a PDF of this presentation can be found at www.drtaylorwallace.com

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED2

http://www.drtaylorwallace.com/


A Few Clients…


Presentation Overview§ Structure of Government§ History of Food Regulation§ Government Agencies with Roles Related to Food Regulations

• The Government Accountability Office (GAO) identifies 15 federal agencies administering no less than 30 laws related to food safety.

• Some agencies laws serve only an administrative role, while others stand at the heart of food regulation.

• The U.S. Food and Drug Administration (FDA) and U.S Department of Agriculture’s (USDA) inspection arm, the Food Safety Inspection Service (FSIS) compose the bulk of federal funding and staffing of our government’s food regulatory system.

• Other agencies take minor responsibility for food regulation but are tertiary to the efforts of FDA and FSIS.



Structure of Government§ The USA is a union of several sovereign states; sovereign that is to the extent

allowed by the US Constitution. The Constitution plays three pivotal roles:1. In its absence there would neither be federal agencies or federal laws.2. In its absence there would be no grounds for any entity other than a state to

regulate within its borders.3. If never ratified, many individual rights and freedoms, such as protection from

unreasonable search and seizure, would be missing.

§ The Constitution, therefore provides a framework for federal regulation that plays a role in interstate commerce and individual and corporate freedoms and liberties.


Structure of Government§ The USA is a union of several sovereign states; sovereign that is to the extent

allowed by the US Constitution. The Constitution plays three pivotal roles:1. In its absence there would neither be federal agencies or federal laws.2. In its absence there would be no grounds for any entity other than a state to

regulate within its borders.3. If never ratified, many individual rights and freedoms, such as protection from

unreasonable search and seizure, would be missing.

§ The Constitution, therefore provides a framework for federal regulation that plays a role in interstate commerce and individual and corporate freedoms and liberties.



The FDA’s authority over foods derives from the FDCA of 1938, which replaced the Pure Food and Drug Act of 1906, prior to which there was a long history of ineffective state regulations in the US.• “Embalmed beef scandal” so named

because Commander of the Army described beef as having an “odor like an embalmed dead body” to Congress. Many claimed tainted meat killed more soldiers than Spanish bullets.

• Elixir of Sulfanilamide - toxic chemicals in products.

Merrill, First Principles of Instruction

History

The Major Federal Food Regulatory Agencies


Food and Drug Administration§ Housed under the Department of Health and Human Services (HHS).

§ Major regulatory activity is within the Center for Food Safety and Applied Nutrition (CFSAN).

• Center for Veterinary Medicine (CVM) - animal-human food connection.

§ Primary statutes governing FDA activities:• Federal Food Drug & Cosmetic Act (21 U.S.C. 301 et. Seq.)

• Public Health Service Act (42 U.S.C. 201 et seq.)

• Egg Products Inspection Act (21 U.S.C. 1031 et seq.)

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED9https://www.fda.gov

Food and Drug Administration§ Regulates and ensures safety and accurate labeling for:

• Food products (USDA Food Safety Inspection Service (FSIS) plays lead role in regulating aspects of some meat, poultry and egg products)

• Bottled water• Dietary supplements• Food additives • Infant formula

§ CFSAN is responsible for: • 1) food safety research; 2) overseeing enforcement; 3) evaluating surveillance and

compliance programs; 4) coordinates with state activities; and 5) develops and implements regulations, guidance documents and consumer safety information.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED10https://www.fda.gov

https://www.fda.gov/

https://www.fda.gov/


Food Safety Inspection Service§ Housed under the U.S. Department of Agriculture.

§ Primary statutes governing FSIS activities:• Federal Meat Inspection Act (21 U.S.C. 601 et seq.)• Poultry Products Inspection Act (21 U.S.C. 451 et seq.)

§ Regulates and ensures safety and labeling of:• Traditional (non-game) meats• Poultry• Certain egg products (e.g., products of egg-breaking operations)


https://www.fsis.usda.gov/

Food Safety Inspection Service§ Currently houses the U.S. CODEX Office.

• An interagency partnership that engages stakeholders in the development and advancement of science-based food standards for the benefit of the United States and worldwide community.







Poultry

Red Meat

Eggs

Meat Products

USDA: Domestic, such as domesticated chickens, and turkeys. Also inspects ratites and squab, including emus.

FDA: Non-specified, such as wild turkeys, ducks, and geese.

USDA: Cattle, sheep, swine, goats, horses, mules, and other equine, as well as carcasses and parts.

FDA: Non-specified red meats such as bison, rabbits, game animals, zoo animals, and members of the deer family

USDA: Egg products such as dried, frozen or liquid eggs. Regulates egg processing plants that break and pasteurize.

FDA: Shell eggs of domestic chickens, turkeys and etc. Regulates plants that wash, sort and package eggs.

USDA: Products with >3% raw meat, >2% cooked meat, or >30% fat, tallow or meat extract. Products >2% poultry, or >10% poultry skins, giblets, fat, and poultry meat in any combination.

FDA: Products with <3% raw meat, <2% cooked meat, or <30% fat, tallow or meat extract. Products <2% poultry, or <10% poultry skins, giblets, fat, and poultry meat (limit to <2%) in any combination.

Secondary Agencies§ Three additional agencies through not as big or deeply involved as FDA or FSIS

offer ancillary services that play a significant role in food regulation.• National Marine Fisheries Services (NFMS)• Environmental Protection Agency (EPA)• Center for Disease Control and Prevention (CDC)



National Marine Fisheries Services§ Housed under the U.S. Department of Commerce

§ Seafood, with the exception of catfish falls under the jurisdiction of FDA.

§ Primary statute governing NFMS activities:• Agriculture Marketing Act of 1946 (7 U.S.C. 1621 et seq.)

§ NFMS conducts a fee-for-service voluntary seafood inspection and grading program for US fish and shellfish.


http://www.seafood.nmfs.noaa.gov

Environmental Protection Agency§ Mission is to protect human health and the environment.

§ EPA known for clean air and water regulations also regulates chemicals used on food crops.

§ EPA Office of Pesticide Programs task is to ensure chemicals used on food crops do not pose a risk to public health.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED16https://www.epa.gov

http://www.seafood.nmfs.noaa.gov/

https://www.epa.gov/


Centers for Disease Control and Prevention§ Housed under the Department of Health and Human Services.

§ Primary statutes governing NFMS activities:• Public Health Service Act (42 U.S.C. 201 et seq.)

§ CDC takes on an investigational role in foodborne disease and outbreaks and research.

• It works in conjunction with Agencies and state/local health departments to monitor, identify, investigate and research foodborne illness.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED17https://www.cdc.gov

Other Agencies with Food Policy and/or Regulatory Authority

https://www.cdc.gov/


Alcohol and Tobacco Tax and Trade Bureau § Housed under the U.S Department of the Treasury.

§ Regulates aspects of alcohol production, importation, wholesale distribution, labeling and advertising.

§ Federal Alcohol Administration Act (FAAA) regulates interstate and foreign commerce of wine, sprits and malt beverages and bestows general authority to TTB.

• Some beverages fall outside of FAAA purview and are thus regulated by FDA. Such as wine containing less than 7% ABV and beers not made from both malted barley and hops.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED19https://www.ttb.gov

Federal Trade Commission§ Responsible for ensuring accurate and truthful advertising of consumer

products, including food.• FDA regulates the food label.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED20https://www.ftc.gov

https://www.ttb.gov/

https://www.ftc.gov/


U.S. Customs and Border Patrol§ Housed under the Department of Homeland Security.

§ Ensures all items entering and exiting the country comply with U.S. laws and regulations.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED21https://www.cbp.gov/trade

Agriculture Research Service§ Housed under the U.S. Department of Agriculture.

• USDA’s chief scientific in-house research agency. Its vision is to lead America towards a better future through agricultural research and information.

§ Conducts research to develop and transfer solution to agricultural problems of high national priority and provide information access and dissemination to:

• Ensure high-quality, safe food, and other agricultural products.• Assess the nutritional needs of Americans.• Sustain a competitive agricultural economy.• Provide economic opportunities for rural citizens, communities, and society as a

whole.• Provide the infrastructure necessary to create and

maintain a diversified workplace.© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED22

https://www.ars.usda.gov

https://www.cbp.gov/trade

https://www.ars.usda.gov/


Food and Nutrition Service§ Housed under the U.S. Department of Agriculture.

§ Works to end hunger and obesity through the administration of 15 federal nutrition assistance programs including:

• Women, Infants and Children (WIC) Program, Supplemental Nutrition Assistance Program (SNAP), National School Lunch and Breakfast Programs, etc.

§ Center for Nutrition Policy and Promotion (CNPP)• Works to improve the health and well-being of Americans by developing and

promoting dietary guidance that links scientific research to the nutrition needs of consumers.

• Projects include the Dietary Guidelines for Americans (coproduced with DHHS), MyPlate, Nutrition Evidence Library, and etc.

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED23https://www.fns.usda.gov

Agriculture Marketing Service§ Housed under the U.S. Department of Agriculture.

§ Administers programs that create domestic and international marketing opportunities for U.S. producers of food, fiber, and specialty crops. AMS also provides the agriculture industry with valuable services to ensure the quality and availability of wholesome food for consumers across the country.

§ Oversees:• The National Organic Program• Science and Technology Program• Transportation and Marketing Program

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED24https://www.ams.usda.gov/

https://www.fns.usda.gov/

https://www.ams.usda.gov/


Foreign Agriculture Service§ Housed under the U.S. Department of Agriculture.

§ Links US agriculture to the world to enhance export opportunities and global food security:

• Trade policy• Market development and export assistance• Data and analysis• Food security (improving agriculture systems and trade capacity in developing

countries)

© INSTITUTE OF FOOD TECHNOLOGISTS | ALL RIGHTS RESERVED25 https://www.fas.usda.gov

Helpful References§ Food Law and Regulation for Non-Lawyers. Sanchez (ed.) Springer International

Publishing: Geneva, Switzerland: 2015

§ Johnson R. The Federal Food Safety System: A Primer. Congressional Research Service. 7-5700 (RS22600).

§ Dietary Supplement Regulation in the United States. Wallace TC, MacKay D, Al-Mondhiry R, Nguyen H, Griffiths JC (ed). Springer International Publishing: Geneva, Switzerland: 2015.


https://www.fas.usda.gov/


Contact Information:Taylor C. Wallace, PhD, CFS, FACN

Think Healthy Group, Inc

George Mason University

P: 270.839.1776

E: [email protected]

W: www.drtaylorwallace.com

*Slides available via website.

Questions?

Merrill, First Principles of Instruction

mailto:[email protected]

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The Major Federal Food Regulatory Agencies (Final) · 2019. 12. 7. · Regulatory Agencies Taylor C. Wallace, PhD, CFS, FACN, March 22, 2018 Disclosures § Think Healthy Group, Inc