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The Food and Drug Administration (FDA) regulates all food and food ingredients introduced into or offered for sale in the U.S. except for meat, poultry, catfish, and some egg products (which are regulated by the U.S. Department of Agriculture, or USDA). This includes dietary supplements; bottled water; food additives; infant formula; and prepared foods like breads, cereals, canned and frozen foods, snacks, desserts, and drinks. Raw fruits and vegetables are generally regulated by USDA, while processed fruits and vegetables are under the purview of FDA.
The FDA regulates pet food in the U.S. under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Pet food must be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.
The FDA also ensures the safety and effectiveness of all drugs; biological products (including blood, vaccines, and cellular and gene therapy products); medical devices; and animal feed and drugs; and ensures that cosmetics and radiation-emitting medical and consumer products are safe. The agency also regulates tobacco products.
Scope
Companies involved in the production, distribution, and sale of food, drugs, medical devices, and other regulated products must comply with FDA regulations. This includes food manufacturers and processors, pharmaceutical companies, medical device manufacturers, cosmetic manufacturers, tobacco product manufacturers, retailers and distributors, and companies that import FDA-regulated products into the U.S.
Regulatory citations
- 21 CFR Parts 1 to 1499, Food and Drugs. This range includes various regulations related to food, drugs, medical devices, and other FDA-regulated products. It covers a broad spectrum of topics under the FDA’s jurisdiction.
- 21 CFR Parts 100-199, Food for Human Consumption. This specific range primarily focuses on food for human consumption, including standards for food safety, labeling, and various regulatory requirements.
- Bioterrorism Act of 2002
- Food Safety Modernization Act
Key definitions
- Bioterrorism Act of 2002: This Act directs the Food and Drug Administration (FDA) to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. To carry out certain provisions of the Act, the FDA requires that food facilities register with FDA and that FDA be given advance notice on shipments of imported food.
- Current Good Manufacturing Practice (CGMP) Regulations: These regulations, at 21 CFR Part 117, contain requirements for good manufacturing practice, hazard analysis, and risk-based preventive controls for human food.
- Fair Packaging and Labeling Act (FPLA): Consumer protection legislation implemented in 1966 that requires food manufacturers to disclose truthful information about food on packages and labels. The FDA administers the FPLA with respect to foods, drugs, cosmetics, and medical devices.
- Food and Drug Administration (FDA): The FDA, part of the U.S. Department of Health and Human Services, regulates the safety of food, cosmetics, devices that emit radiation, and tobacco products. It also ensures the safety and effectiveness of human and veterinary medicines, biologics, and medical devices.
- Food Safety Modernization Act (FSMA): Implemented in 2011 to focus on preventing foodborne illness and provide authority to oversee and enforce food supply chains. Enforcement includes preventative controls for human and animal food, food production and growth, global supply chains, vulnerability protection, and sanitary transportation.
- Foreign Supplier Verification Programs (FSVP): A regulation established under the Food Safety Modernization Act (FSMA) that requires U.S. importers to verify that foreign suppliers of food products are producing safe food that meets U.S. safety standards.
- Hazard Analysis and Critical Control Point (HACCP): A management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution, and consumption of the finished product.
Summary of requirements
Companies involved in the production, distribution, and/or sale of food must:
- Become familiar with the regulations at 21 CFR Parts 100-199 (as applicable), as well as the Food Safety Modernization Act (FSMA).
- Register with the FDA. FDA facilities that manufacture, process, pack, or store food for human consumption are generally required to register with the FDA. This requirement helps the FDA maintain oversight of food safety and ensure compliance with regulations. Facilities must register under the Bioterrorism Act of 2002, and they need to renew their registration every two years. Additionally, specific exemptions may apply based on the type of facility or products handled, so it’s important for facilities to review their obligations carefully.
- Ensure sanitation practices are in place to ensure food safety. This includes developing written sanitation standard operating procedures that outline how facilities will maintain cleanliness and hygiene to prevent contamination.
- Develop a food safety plan, which includes a hazard analysis, preventive controls, monitoring procedures, corrective actions, and regular review of the plan.
- Follow Current Good Manufacturing Practices (CGMPs), including proper sanitation, employee hygiene, and equipment maintenance.
- Develop labels (including nutrition information) that meet legal food labeling requirements. (This requirement applies only to food manufacturers.)
- Train employees in food safety practices.
- Maintain detailed records of their food safety plan, monitoring activities, and any corrective actions taken.
- Be prepared for FDA inspections, which can be routine or triggered by specific issues. Inspections focus on verifying regulatory compliance and identifying potential risks.
- Comply with the FDA’s Foreign Supplier Verification Programs (FSVP) (if applicable). This requires U.S. importers to verify that foreign suppliers of food products are producing safe food that meets U.S. safety standards. Key components of FSVP include:
- Risk Assessment: Importers must assess the risk associated with the food products and the foreign suppliers.
- Supplier Verification: Importers need to verify that foreign suppliers have implemented appropriate safety controls. This can include on-site audits, reviews of food safety records, and testing of food products.
- Written Program: Importers must develop and maintain a written FSVP that outlines their verification activities and procedures.
- Recordkeeping: Importers are required to keep records of their verification activities to demonstrate compliance with the regulation.
State and local requirements, such as licenses and permits, also apply.
Note: The FDA also recognizes the role of third-party assessments, especially under the Food Safety Modernization Act (FSMA). Importers are required to conduct third-party audits of foreign suppliers through the Foreign Supplier Verification Programs (FSVP) to ensure that imported food meets U.S. safety standards. Additionally, certain FDA regulations may allow or encourage third-party certifications for food safety systems.