On Friday, May 20, 2022, FDA published a policy on enforcement discretion regarding New Dietary Ingredients (NDIs) in the form of a draft guidance. The Dietary Supplement Health Education Act of 1994 (DSHEA) amended the FD&C Act and set up the dietary supplement regulations we know today. The requirement that industry submit a 75-day-premarket notification (NDIN) for New Dietary Ingredients (NDIs) has been confusing, argued over, and often ignored ever since. An historical review of past notifications shows that FDA’s requirements evolved over time. Initially, perhaps FDA accepted notices with little data but eventually it seemed that FDA’s definition of ‘reasonable expectation of safety’ had shifted to such an extent that very few notices were deemed sufficient. In addition, industry and FDA have argued over what dietary ingredients are ‘new’ and FDA has rejected industry-complied lists of pre-DSHEA dietary ingredients that would not be subject to the 75-day-premarket notification requirement. The many twists and turns to the story of the NDIN process are too extensive to review fully in this brief message but please see a past article on the topic here.
The recently-published draft enforcement discretion policy notes that dietary supplements containing NDIs that have not been the subject of a notification are deemed to be adulterated. The policy also acknowledges that some firms “have the information ready to be submitted, but they are afraid of drawing attention to themselves with a late submission.” The draft enforcement discretion policy allows companies that are “late submitting” required NDINs to submit them without fearing enforcement action. It is very interesting to read this and to see that FDA is trying to work with industry while still maintaining the regulations as originally written. What can this mean?? Well, in light of this document and recent warning letters that note the lack of NDINs, it seems that FDA plans to enforce the new dietary ingredient notice requirements. It is also likely that FDA will also finalize the NDIN process, which has been in draft form since 2011.
The draft guidance also contained a very interesting note stating, “FDA recognizes that not every dietary supplement containing an NDI is subject to the notification requirement.” This is very important because the agency had floated the idea in years past that any new combination of dietary ingredients would be subject to the new dietary ingredient notification requirements. It seems that at least one controversy regarding the NDIN process may have been settled in a manner that is not overly burdensome to industry and catastrophically onerous to FDA.
The comment period for the draft enforcement policy guidance is open until July 19.2022. The specific provisions for the proposed enforcement discretion are:
The ‘late’ notices will be due within 180 days of publication of a final guidance.
The submission must include the required information specified in 21 CFR 190.6.
The agency also recommends providing “(1) documentation that the NDI-containing dietary supplement described in [the] notification was marketed in the United States as of [May 20, 2022] and (2) a copy of the current label for the dietary supplement.”
While not perfect, I view this as a step in the right direction and look forward to working with others to submit comments.
