Resources

A systematic preventive approach to food safety that identifies biological, chemical, and physical hazards. Required for certain food products.

FDA requirement that importers verify their foreign suppliers are producing food safely and in compliance with U.S. standards.

FDA designation for food ingredients that are considered safe by qualified experts based on scientific procedures or common use in food.

Document from testing laboratories certifying that a product meets specifications.

FDA requirement that importers submit advance notification before food shipments arrive in the U.S.

A comprehensive document that details the exact requirements, standards, and attributes of a food product.

Any dietary ingredient not marketed in the U.S. before October 15, 1994. Requires FDA notification 75 days before marketing unless exempt. Common issue for supplement startups using novel ingredients.

FDA regulations establishing minimum requirements for manufacturing, processing, and holding of food and dietary supplements. cGMP requirements are stricter for supplements (21 CFR Part 111) than conventional foods.

2011 law giving FDA authority to mandate preventive controls and food safety plans. Requires most food facilities to have written food safety plans, conduct hazard analysis, and implement preventive controls.

Required FDA-registered representative for foreign food facilities. Must be physically located in the U.S., available for FDA communication, and authorized to respond on behalf of the foreign facility. Cannot be a mailbox or answering service.

Federal law requiring plain-language labeling of the 9 major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Allergens must be declared in ingredient list or "Contains" statement.

Dietary supplement statements describing how an ingredient affects normal structure or function of the body (e.g., "supports immune health"). Must include disclaimer: "This statement has not been evaluated by the FDA." Cannot claim to diagnose, treat, cure, or prevent disease.

The evidence required to support advertising claims, especially health or performance claims. FTC requires "competent and reliable scientific evidence" - typically human clinical studies for health claims. Lack of substantiation is the #1 FTC enforcement issue.

1994 law establishing regulatory framework for dietary supplements as a separate category from drugs and conventional foods. Defines supplements, sets labeling requirements, and establishes FDA's authority to regulate the industry.

Foods with pH above 4.6 in hermetically sealed containers. Requires FDA registration, process filing, and strict processing controls to prevent botulism. Applies to shelf-stable products like sauces, soups, and some beverages.

Health claim that FDA allows with specific disclaimer language because evidence is emerging but not conclusive. Example: "Scientific evidence suggests but does not prove that..." Must use FDA's exact qualifying language to avoid misbranding.