Entering the U.S. market with a dietary supplement or nutrition product requires navigating a complex regulatory landscape overseen by the Food and Drug Administration (FDA). Unlike many international markets, the U.S. has specific requirements that can catch unprepared brands off guard.
Key FDA Requirements for Dietary Supplements
The Dietary Supplement Health and Education Act (DSHEA) of 1994 established the framework for regulating dietary supplements in the United States. Under this act, supplements are regulated as a category of food, not drugs, which means different rules apply.
1. Facility Registration
All facilities that manufacture, process, pack, or hold dietary supplements for consumption in the U.S. must register with the FDA. This includes foreign facilities. Registration must be renewed every two years during the October-December renewal period.
2. Good Manufacturing Practices (GMP)
The FDA requires that dietary supplements be produced in accordance with current Good Manufacturing Practices (cGMPs) as outlined in 21 CFR Part 111. These regulations cover everything from facility design to quality control procedures.
3. Labeling Requirements
U.S. supplement labeling has strict requirements including: Supplement Facts panel, ingredient listing, allergen declarations, net quantity statements, and required disclaimers. The structure/function claim disclaimer is mandatory if any health claims are made.
4. New Dietary Ingredient (NDI) Notifications
If your product contains an ingredient not marketed in the U.S. before October 15, 1994, you may need to submit a New Dietary Ingredient notification to the FDA at least 75 days before marketing the product.
Common Mistakes International Brands Make
The most frequent errors we see include: using ingredient names not recognized by the FDA, failing to convert measurements to U.S. standard units, including impermissible health claims, and not having a U.S. agent designated for the foreign facility.
Taking the time to understand these requirements upfront can save months of delays and tens of thousands of dollars in reformulation, relabeling, and potential product seizures at the border.
Distribution Strategy
