The FDA today released new guidance for sellers of dietary supplements. The guidance addresses how to determine whether an ingredient should be considered a New Dietary Ingredient (NDI), and the requirements for filing a pre-market NDI notification.
FDA said another motivation for providing the guidance is to improve the quality and quantity of NDI notifications. There are an estimated 55,600 dietary supplement products on the market, but FDA has only received about 700 NDI notifications since it began reviewing them 16 years ago. Approximately 1,000 new dietary supplements are introduced to the market each year. The low number of NDI notifications, plus FDA’s concern that some dietary supplements contain undeclared active ingredients, has prompted more attention on using these filings as a preventive monitoring tool.
The agency is inviting response from the dietary supplements industry on today’s guidance.
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Baxam Law Group advises clients on complying with the regulatory requirements for marketing of consumer products.
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