Dietary Supplement Health and Education Act (DSHEA)

The Dietary Supplement Health and Education Act of 1994 amended the Federal Food, Drug, and Cosmetic Act to make dietary supplements a subcategory of food rather than of drugs. Manufacturers carry the responsibility for safety and for substantiating claims, there is no pre-market approval, and FDA generally acts only after a product is on the market. Permitted ingredients include vitamins, minerals, herbs, amino acids and other dietary substances used to supplement the diet.

The exclusion clause is the part that governs peptides. An article approved as a new drug, or authorised for investigation as a new drug for which substantial clinical investigations have been instituted and made public, cannot be a dietary ingredient unless it was marketed as a food or supplement first. FDA has invoked that provision repeatedly against individual ingredients, and has separately stated that various synthetic peptides marketed through wellness channels do not meet the statutory definition at all. Ingredient-level determinations are contested and periodically revised, so FDA's current position on a named substance is the one that counts.

What follows is that supplement status is an assertion, not a certification. Nothing on the label was reviewed before sale, and the disclaimer required alongside a structure or function claim says as much in plain words. An amino acid can be a dietary ingredient while a defined-sequence synthetic peptide is not, and physical form matters independently, since nothing intended for injection is a supplement.

The misuse to watch is a peptide dressed in supplement styling to borrow the permissive framing while making what is functionally a drug claim. Labelling a product a dietary supplement does not confer the status; the statutory definition does, and a product outside it is an unapproved new drug whatever the panel says.