4.2.2: The FDA and USDA
The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) are two distinct federal agencies in the United States, each with its own set of responsibilities related to the regulation of food and drugs for public health purposes.
The FDA is a federal agency within the U.S. Department of Health and Human Services, responsible for protecting and promoting public health by regulating various products, including food, drugs, medical devices, vaccines, and other health-related items. This agency was created with the 1906 Pure Food and Drugs Act, and its role was more defined with the Federal Food, Drug, and Cosmetic Act in 1938. When it comes to the regulation of food and drugs, the FDA has the following key roles:
- Drug Regulation: The FDA evaluates and approves new drugs for safety and efficacy before they can be marketed and sold to the public. It also monitors and regulates prescription and over-the-counter medications to ensure ongoing safety.
- Food Safety: The FDA is responsible for regulating and ensuring the safety of most of the food supply in the United States, except for meat, poultry, and egg products, which are regulated by the USDA (see below). The FDA establishes and enforces standards for food labeling, inspections, and safety measures to prevent foodborne illnesses and ensure food products meet established quality and safety standards.
- Medical Devices: The FDA regulates medical devices to ensure their safety and effectiveness, from simple devices like bandages to complex ones like pacemakers. The agency classifies medical devices into different categories based on risk, and each category is subject to specific regulatory requirements.
- Vaccines and Biologics: The FDA evaluates and approves vaccines and biologic products to ensure they are safe and effective for use in preventing and treating diseases.
- Cosmetics and Dietary Supplements: The FDA regulates cosmetics and dietary supplements, ensuring that they are safe for consumer use and that product labels provide accurate information to consumers. Supplements don't have to go through the same rigorous testing for safety and efficacy that drugs do. Although manufacturers can state evidence-based claims about physiological function, for example: "calcium builds strong bones." But most nutritional supplements also have the caveat on their label that the supplement is not intended to “diagnose, treat, cure or prevent any disease”. The FDA can take action against any company that sells misbranded or adulterated products (Center for Food Safety & Nutrition, n.d.).
The USDA is a federal agency responsible for overseeing various aspects of American agriculture, including the production and safety of meat, poultry, and egg products. In the context of food and drug regulation, the USDA primarily focuses on the following areas:
- Meat and Poultry Inspection: The USDA's Food Safety and Inspection Service (FSIS) is responsible for inspecting and regulating meat, poultry, and egg products. FSIS ensures that these products are safe for consumption and that processing plants meet established safety standards.
- Food Labeling: The USDA sets labeling standards for meat, poultry, and egg products, ensuring that product labels provide accurate information to consumers.