With the increased federal focus on healthfulness, the potential impact on dietary supplements is being closely watched, with particular wariness around the potential elimination of self-affirmed GRAS and the FDA’s recently increased communication on the New Dietary Ingredient Notification (NDIN) review process.
To ease the process of bringing a new ingredient to market, dietary supplement manufacturers will sometimes first introduce the substance in a food. This is done because the Substances Generally Recognized as Safe (GRAS) Final Rule includes an option allowing for the use of the new ingredient or chemical in a food product without FDA review, if it is self-affirmed as GRAS. Although the original intent was that this would involve the same scientific rigor as a submission to FDA, there is no requirement to share with FDA the result or that the process was undertaken.
The same is not allowed for dietary supplements. Rather, a New Dietary Ingredient Notification must be submitted to FDA with supporting information such as the level of the new ingredient in the product, conditions of use of the product, and history of use or evidence of safety. FDA requires that this information be submitted at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, but the full process can take many months.
The counter to having to submit an NDIN is that once the ingredient the dietary supplement manufacturer wants to use is included in a food product that is on the market, the ingredient can be used in other foods … and in dietary supplements. So, by introducing the ingredient first in a food (e.g., through self-affirmed GRAS), such as in a protein bar or energy shake, the manufacturer can circumvent the NDIN process and then legally use the ingredient in a dietary supplement. It is important to note, however, that an NDIN for one manufacturer’s product does not eliminate the need for another manufacturer to submit an NDIN for their product.
But with Robert F Kennedy Jr directing the FDA to look at closing the self-affirmed GRAS “loophole,” this avenue would no longer be open to dietary supplement manufacturers, limiting their quick route to market. With RFK long been opposed to what he has called FDA’s “aggressive suppression” of dietary supplements, the industry is seeing mixed signals coming from HHS and are actively lobbying against the removal of self-affirmed GRAS.
It is in this environment that the FDA released two NDIN educational videos and a supplemental fact sheet with a goal to “broaden the dietary supplement industry’s awareness and understanding” of the NDIN process.
The fact sheet and first video focus on common issues that can cause delays in FDA’s processing of an NDIN or lead to a negative response, including lack of category specification of the dietary ingredient and the basis for that categorization; insufficient identity information and supporting science; the inclusion of irrelevant or extraneous information; and lack of proper references and copies of these that support the safety of the NDIN.
The second video describes what to expect once an NDIN is submitted:
- FDA will acknowledge receipt and notify you of the official filing date which starts the 75-day review clock, during which the product cannot be introduced into interstate commerce.
- The notification is then reviewed by FDA science, technical, and policy experts. If FDA has questions or needs more information, you will be contacted. If the information requested by FDA is substantial, the filing date and related 75-day period may be reset to start over.
- Once FDA completes the review, you will receive a response letter with one of the following:
- acknowledging the notification without objection.
- acknowledging the notification but raising concerns with the identity or safety information.
- discussing deficiencies that make the NDIN incomplete according to regulation.
- raising other regulatory issues with the ingredient or product.
- Although the NDIN and response letter are kept confidential for 90 days from the filing date, both are then publicly posted, with trade secret or confidential commercial information (CCI) redacted.
FDA encourages electronic submission through the online portal, which provides a step-by-step walkthrough, enables status updates, and can expedite communication. If the NDIN is submitted on paper, three copies of the entire notification are required, including references. If you are considering submission of an NDIN, you can request a pre-submission meeting with FDA to ask questions or attain assistance.
As the above steps and notes show, an NDIN submission can take a lot of time and effort both in the submission and in awaiting, and responding to, FDA’s response. But the more complete the information submitted at the front end, the more likely the request is to be acknowledged “without objection” without numerous back-and-forth communications.
With TAG’s newly hired dietary supplements expert, we can now offer guidance and assistance in the NDIN process and other areas of dietary supplement compliance, labeling, claims, and FDA liaising. Give us a call!
All written content in TAG articles, newsletters, and webpages is developed and written by TAG experts, not AI. We focus on the realities and the science to bring you the most current, exacting information possible.
