FDA issues long-awaited revised Draft Guidance on new dietary ingredient notifications (NDINs) for dietary supplements.
- The Dietary Supplement Health and Education Act (DSHEA) requires the manufacturer or distributor of a new dietary ingredient (NDI) to submit a pre-market notification called a new dietary ingredient notification (NDIN) to FDA at least 75 days before marketing a dietary supplement that contains an NDI (i.e., one not marketed in the U.S. prior to October 15, 1994) unless that NDI is used in the food supply without chemical alteration. A dietary supplement is considered adulterated if the requisite NDIN is not timely submitted prior to marketing. In 2011, FDA issued a Draft Guidance document intended to assist the supplement industry navigate the NDIN process. However, the 2011 draft was controversially received within the supplement industry and was criticized as overly restrictive and inconsistent with DSHEA’s intent to secure broad consumer access to safe dietary supplements. FDA agreed to reconsider and re-issue the Draft Guidance in the future.
- On August 11, 2016, FDA issued the long-awaited revised Draft Guidance on NDIs and NDINs. Like its 2011 predecessor, the 102-page document takes the form of a Q&A, addressing in detail the circumstances under which an NDIN is required, the contents of an NDIN, and the process and timeline associated with NDIN submission and review. The revised draft indicates FDA’s more liberal/pro-industry positions on certain issues. Although we do not provide a complete summary of the revised draft in this blog post, we highlight a few key revisions below:
- FDA has expanded its discussion of what constitutes “chemical alteration” (relevant to determining whether a substance is an NDI that does not trigger notification) and expressly indicates that the few examples provided in DSHEA do not constitute an exhaustive list of processes that do not effect chemical alteration.
- The 2011 version had indicated that synthetic botanicals could not be “dietary ingredients” at all. The revised version clarifies that synthetic botanicals may qualify as dietary ingredients depending on the circumstances, e.g., synthetic copies of botanical ingredients that have been used as ingredients in the conventional food supply.
- FDA has clarified its willingness to accept a single NDIN that covers multiple dietary supplements and includes safety data for a range of doses, daily intake levels, and/or other variations in conditions of use (e.g., serving size, duration of use, frequency of intake, target population, dosage form, or different formulations of pre-DSHEA ingredients in combination with the NDI). If a dietary supplement manufacturer or distributor knows that a NDIN has been submitted to FDA that covers the conditions of use under which the NDI will be used in a particular supplement, a separate NDIN need not be submitted.
- Unfortunately, the revised version still indicates FDA’s unwillingness to accept an ingredient’s inclusion on industry-maintained “grandfathered lists” as evidence that a substance is not an NDI. However, the Agency now indicates that it would consider GRAS and food additive regulations as documentation of pre-DSHEA marketing status if the regulation covers the use of the substance as a supplement, became effective prior to October 15, 1994, and contains identity specifications that the ingredient meets. FDA also has indicated its willingness to develop an authoritative list of pre-DSHEA ingredients, based on “independent and verifiable data” supplied by industry.
- Individual supplement manufacturers and distributors are encouraged to review the Draft Guidance for issues that may be specifically relevant to their product lines and marketing practices. Keller and Heckman LLP has significant expertise in advising the dietary supplement industry; interested parties are encouraged to email us at email@example.com with any questions regarding the implications of FDA’s revised Draft Guidance.