When it comes to selling or distributing food products in the United States, compliance with the regulatory requirements of the U.S. Food and Drug Administration (USFDA) is essential. The FDA is responsible for ensuring the safety, labeling accuracy, and quality of food products to protect public health. Whether you’re a domestic food manufacturer or an importer, understanding and meeting these requirements is critical for market success.
On October 10, 2003, the Food and Drug Administration (FDA) issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894).
Section 415 of the FD&C Act (21 U.S.C.350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act.
All domestic and foreign food manufacturers, processors, and packers must register with the FDA. Registration must be renewed every two years.
Good Manufacturing Practices (GMPs)In 1969, FDA established cGMPs in the Code of Federal Regulations (CFR) (21 CFR Part 110). In September 2015, the agency modernized the cGMPs and established them in new Part 117 (21 CFR Part 117), along with new requirements for hazard analysis and risk-based preventive controls which were issued as part of the implementation of the FDA Food Safety Modernization Act (FSMA).
Food facilities must follow Current Good Manufacturing Practices (CGMPs) to ensure clean, safe, and sanitary production. This includes hygiene, equipment maintenance, and pest control.
Hazard Analysis & Critical Control Points (HACCP)HACCP is 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.
HACCP is a systematic approach to identifying, evaluating, and controlling food safety hazards.
Labeling RequirementsFood labels must follow strict guidelines, including:
- Product name
- Net quantity
- Ingredients (by weight)
- Nutrition Facts
- Allergen information
- Manufacturer details
- Country of Origin
- Handling/Storage Instructions
Claims like “organic” or “low fat” must meet specific rules.
Allergen DisclosureNine major allergens, including milk, nuts, and sesame, must be clearly declared on the label.
Import RulesImported food must meet the same FDA standards. U.S. importers must verify their foreign suppliers follow FDA regulations through the Foreign Supplier Verification Program (FSVP).
The purpose of this program is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP) in 21 CFR part 1, subpart L, that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded with respect to allergen labeling.
Food AdditivesOnly FDA-approved additives or GRAS (Generally Recognized as Safe) substances may be used.
ConclusionFollowing FDA rules helps ensure your product is safe, legal, and trusted in the U.S. market. Staying informed and compliant protects both your brand and consumers.
Reference https://www.fda.gov/food