New Dietary Ingredient (NDI) Notification

The Dietary Supplement Health and Education Act split supplement ingredients by date. Anything marketed in the United States before 15 October 1994 is an old dietary ingredient needing no filing; anything later is new and, unless already in the food supply unaltered, requires notification to FDA at least seventy-five days before marketing. The filing sets out identity, conditions of use and the basis for concluding the ingredient is reasonably expected to be safe. FDA does not approve it; it may file the notification without objection or object, and marketing proceeds at the firm's risk either way.

For peptides the prior question is harder: whether the substance is a dietary ingredient at all. The statutory categories are vitamins, minerals, botanicals, amino acids and dietary substances used to supplement the diet. FDA has concluded in responses to notifications that certain synthetic peptides, BPC-157 among them, fall outside those categories, which puts them outside the supplement framework entirely. Those positions and the associated advisory lists have moved recently, so the current stance should be read from FDA.

This changes what a supplement label means. No product sold under the Act has had premarket review of effectiveness, and if its active ingredient is not a lawful dietary ingredient the product is an unapproved drug wearing a supplement label. The notification file is public, making it one of the few checkable facts about a novel ingredient.

Two errors recur. The first treats NDI-notified as an endorsement, when it means only that the agency did not object within the window. The second is the grandfather claim: no official list of pre-1994 ingredients exists, industry lists are self-assembled, and a peptide described in the literature decades ago was not thereby sold as a supplement in 1994.