FDA Clarifies NDI Notification for Supplements vs Ingredients

One of the more controversial aspects of the FDA's draft guidance on New Dietary Ingredients is the suggestion that a NDI notification is needed for every dietary supplement (finished product) that contains the NDI. Besides being a colossal waste of time and resources without any benefit, this suggestion also seems to be completely out of line with the spirit and intent of DSHEA (my opinion). However, during our Town Hall meeting at SupplySide West last week, I had the opportunity (along with more than 300 others who attended the meeting) to speak with FDA directly. On this topic of who submits the notification, the ingredient supplier or the finished product manufacturer/marketer, the FDA seems to have been clear that the responsibility for the notification falls with the dietary supplement (manufacturer/marketer). For example, if an ingredient supplier submits a notification, each and every one of their customers who come out with a product containing that NDI must also submit a notification specific to their product. I heard something quite different than that from Daniel Fabricant, Ph.D., director of dietary supplement programs at FDA when I asked about it during the Town Hall. Rather than try to paraphrase, I'll let you see it for yourself:

Call it a clarification if you want, but my interpretation of Dr. Fabricant's response is that dietary supplements that stay within the defined parameters (conditions of use, formulation definitions, etc) of a NDI notification submitted by the ingredient supplier DO NOT have to submit their own notification. I don't think I have heard this from the agency prior to this. Just to be clear, this would only apply to a dietary supplement that contains the exact ingredient that is subject of the NDI notification (not a similar ingredient from some other supplier, not some modified or altered version of that ingredient. The exact ingredient). Also, the conditions of use recommended or suggested in the labeling of the dietary supplement must not be different from those conditions of use stated in the NDI notification.

This is a very important point, and one that industry should comment on and request further clarification on. For access to all of the articles, videos, webinars, slide shows, blogs, discussions and surveys we are creating and providing on this NDI issue, visit our NDI Immersion Center. And special thanks to EAS Consulting Group for underwriting both the Town Hall and the Immersion Center. We are investing a lot of resources into this critical issue, and we appreciate the support.

I also encourage each of you to fully understand and consider the actual language related to NDIs that is in DSHEA. Here is what the law says:

§8. New Dietary Ingredients.

Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following:

• "SEC. 413. (a) IN GENERAL.- A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:
• "(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.
• "(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information.
• "(b) PETITION. - Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action.
• "(c) DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.".