FDA Registration of New Dietary Ingredients Detailed
(Thursday, April 11, 2024) New Dietary Ingredient (NDI) registration has been required for almost 30 years but the regulations for such registration are one of the hardest to enforce and frequently less understood. There are many perceptions, right or wrong, about the definition of an NDI, the contents of the application for registration, the FDA review process, and other issues. In its 30th year of regulation, the FDA released a highly detailed guidance document last week to answer the most common questions it has been asked over the years. According to the FDA, there are about 29,000 dietary supplement products in the US, and about 1000 new products are introduced everywhere. Most of the dietary supplements are imported into the US. There is no reliable number of NDIs being introduced but with a highly diverse population and hence exposure to highly diverse ethnic foods, there are potentially numerous NDIs being introduced in the US market every year. The bulk of the dietary supplement regulation, including NDI, is self-regulated. There are no reliable numbers about how many NDIs are introduced in the US every year. There is no official list of allowed dietary ingredients, and most manufacturers do not try to identify if they have NDIs as ingredients in their products or hide them, till there is a complaint or an FDA audit. This makes the NDI registration is very gray area of regulation. The FDA guidance tries to answer many questions about what is an NDI, when and how should it be registered with the FDA and the FDA review process. The 102-page guidance contains 107 questions and their detailed answers organized into 3 major categories and 9 sub-categories. The guidance also provides links to outside documents such as the list of existing dietary ingredients published by a professional group. It adds to the general information available on the FDA website. NDI regulation is the canonical black box with lots of unknowns and related lax enforcement. The guidance goes in the right direction in educating manufacturers about the process. How much of it will be used will depend on how the FDA enforces these laws. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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