Dear Friends of AHP,

As a follow up to our previous message about the FDA-proposed new GRAS policies, we are providing the full UNPA commentary (see below). Once again, we encourage you to submit comments regarding this very important issue.

Sincere regards,

Roy Upton, President, American Herbal Pharmacopoeia

Founder, Global Alliance for Integrative Health & Medicine (GAIHM)

For more information about AHP, or if you are interested in becoming an AHP member, please visit herbal-ahp.org. Be sure to follow us on LinkedIn https://www.linkedin.com/company/herbal-ahp/?viewAsMember=true

MEMORANDUM TO UNPA MEMBERS

FROM: Peter Reinecke, UNPA Senior Political Advisor

RE: New FDA GRAS proposal: Summary and Key Issues

DATE: August 24, 2026

As has been reported, recently HHS Secretary Kennedy and Acting FDA Commissioner Kyle Diamantis announced (https://www.hhs.gov/press-room/hhs-announces-ultra-processed-foods-gras-reforms.html) the long awaited draft regulation (https://public-inspection.federalregister.gov/2026-16296.pdf) alter key aspects of the Generally Recognized as Safe (GRAS) pathway to market. As you know, historically, new ingredients have been introduced into dietary supplements both through the New Dietary Ingredient Notification NDIN) process and self-GRAS process. Secretary Kennedy has listed “closing the GRAS loophole” as a key priority as a stated means of protecting consumers from potentially unsafe chemicals being added to the food supply without adequate public disclosure and review. While he has not stated a concern about the safety of dietary supplements, the category will be impacted by any changes to the GRAS process. This memo reviews key elements of the draft regulation. Stakeholder comments must be filed by December 9, 2026 (https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe).

While establishment of a first-ever federal definition of ultra-processed foods was announced at the same time, this proposal is still under review by the White House Office of Management and Budget (OMB) and details have not been made public.

Overview

Generally, the regulation would require manufacturers containing ingredient(s) independently determined to be GRAS to notify FDA of the basis for their conclusion that the substance is GRAS under the conditions of its intended use.

This would include substances already in the food supply and those being marketed for food use for the first time. However, for ingredients already in the food supply, companies would have to provide FDA with more limited information: the conditions of intended use (and not the basis for the GRAS conclusion).

Significantly, FDA recognizes its limited legal authority in this area, stating that their regulations “do not establish a premarket review program for purportedly GRAS substances” nor would products not complying with mandatory GRAS notifications be found misbranded. In previous public statements, the agency has said that they would like to work with Congress to further strengthen their authority, presumably to get statutory authority to find products failing to comply as misbranded.

Process and timing of GRAS submissions to FDA

The regulation provides key process and timing details. These are taken directly from the draft.

• “Upon receipt of a submission, we would continue to follow our existing procedures to conduct an initial evaluation of the submission before determining whether to file it as a GRAS notice, but we are proposing that this initial evaluation will be completed within 45 days (see proposed § 170.265(a)(1)). During this preliminary assessment to determine whether the submission is adequate to file, FDA is not evaluating the GRAS status of the substance’s conditions of intended use, and the filing of a GRAS notice does not mean that the substance that is the subject of the GRAS notice is GRAS under the conditions of its intended use. Upon the filing of a GRAS notice, we will then evaluate the notifier’s basis for concluding that the criteria for GRAS status are satisfied.

• If we file your submission as a GRAS notice, we will send you a letter within two business days that inform you of the date of filing. If we file your submission as a GRAS notice, we will consider the notification requirement of § 170.205 to be met, except as provided by § 170.265(b)(3).

• If we do not file your submission as a GRAS notice, we will send you a letter within 2 business days that informs you of that fact and provides our reasons for doing so.

• During our evaluation of a GRAS notice, we may contact you with questions related to the notice, including the data and information used to support your GRAS conclusion.

• Within 180 days of filing, we will respond to you by letter based on our evaluation of your notice. We may extend the 180-day timeframe by 90 days up to two times on an as needed basis.

• If we extend the timeframe, we will inform you in writing of an initial extension as soon as practicable but no later than within 180 days of filing. If a second extension is needed, we will inform you in writing as soon as practicable but no later than the end of the initial 90-day extension.”

Required elements of new self-GRAS submissions

Practically speaking, these would apply only to new self-GRAS submissions after the effective date of the regulations. As noted below, there is a much-abbreviated reporting requirement for ingredients that use the self-GRAS process (submitted to FDA within a year of the rule becoming final).

“A GRAS notice will include the following information: o signed statements and a certification;

o the identity, method of manufacture, specifications, and physical or technical effect of the notified substance;

o dietary exposure to the notified substance (and human exposures when used in food for food-producing animals);

o self-limiting levels of use in circumstances where the amount of the notified substance that can be added to human food or animal food is limited because the food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical;

o evidence of substantial history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food) prior to January 1, 1958, if a conclusion of GRAS status is based on common use of the substance in food prior to 1958;

o a narrative that provides the basis for the notifier’s conclusion of GRAS status, including why the data, information, methods, and principles described in the notice provide a basis for the conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use; and

o a list of the data and information the notifier cites in the GRAS notice.”

More limited requirement for self-GRAS substances already on the market

The proposed rule gives companies a year after the effective date of the final regulation to file with FDA much more limited (“streamlined”) information about self-GRAS substances. The submission(s) must include:

• the name and address of the submitter;

• the name of the substance, using an appropriately descriptive term;

• the intended conditions of use of the substance, including the foods in which the substance is used or is in contact with, the levels of use, and the purposes for which the substance is used (and the target animal species for animal food as well as human exposures when used in food for food-producing animals);

• evidence of presence in interstate commerce before the effective date of the final rule; and

• if applicable, where FDA sent a cease to evaluate letter in response to a notifier’s previous GRAS notice (GRN or AGRN), provide that file number (GRN No. or AGRN No.) as part of the submission.

FDA also indicates that it will publicly post all filings made within 2 weeks of receipt to provide for transparency and public awareness.

Effective/enforcement dates

If/when the draft rule is finalized (there is always a chance it might not be finalized if it proves too controversial—however, given the Administration’s strong support, it will likely be finalized in some form), it will become effective 60 days after the publication of the final rule. Companies would have 18 months from the effective date to come into compliance.

Non-compliant products/substances would not be misbranded

FDA was careful to recognize that it lacks the statutory authority to enforce this new “mandatory” GRAS requirement. The agency stated that it looks forward to working with Congress on the issue with the implication that they will seek new authority to penalize companies that don’t file these submissions. The regulation states:

“Importantly, the proposed GRAS notification program generally, and proposed § 170.205(a), do not establish a premarket review program for purportedly GRAS substances. The FD&C Act allows a person to introduce a substance into interstate commerce if the substance is GRAS under the conditions of its intended use (see sections 201(s) and 409 of the FD&C Act). Thus, a company may continue marketing a purported GRAS substance before submitting a GRAS notice or after submitting a GRAS notice before it is filed by FDA. Similarly, a company may reach a GRAS conclusion about a new use of a substance and introduce the substance into interstate commerce before submitting a GRAS notice. However, the proposed GRAS notification program would assist FDA’s post-market review of purported GRAS substances, enabling FDA to determine whether these substances are not GRAS and therefore require FDA review and approval under section 409 of the FD&C Act.”

Key Questions/Issues regarding the regulation

Are substances “in or intended for use in” dietary supplements eligible for the GRAS pathway to market?

The draft regulation could be read as an attempt by FDA to explicitly exclude dietary supplement ingredients from being eligible from the GRAS pathway to market. As many dietary supplements currently on the market contain ingredients that went through the self-GRAS pathway to market, this is an important issue that must be carefully reviewed and addressed. Below is the regulation provision in question:

• “Uses of substances that are excepted from the definition of a food additive under section 201(s)(1) through (6) of the F D&C Act cannot be the subject of a GRAS notice. Specifically, the term “food additive” does not include: …or (6) an ingredient described in section 201(ff) of the FD&C Act in, or intended for use in, a dietary supplement (section 201(s)(1) through (6) of the FD&C Act). As such categories are excepted from the definition of “food additive” in section 201(s) of the FD&C Act, they are not eligible for classification as GRAS under the GRAS provision included in the definition of “food additive” (see proposed § 170.205(c)).”

UNPA has consulted organizations and legal experts to get their opinions on this issue. While there is not uniformity of opinion, the general view of those we consulted is similar to the analysis (publishedhttps://www.sidley.com/en/insights/newsupdates/2026/08/shifting-expectations-fda-takes-a-first-step-toward-making-gras-notifications-mandatory) by senior staff of the prominent law firm Sidley and Austin finding that any statement that the GRAS process is not available to dietary supplements runs counter to previous FDA guidance and actions:

• “Dietary supplement companies have come to rely on the voluntary self-affirmed GRAS process as a practical tool for bringing an ingredient to market, given that in draft guidance, FDA indicates that a GRAS conclusion may take the place of an NDI notification “as long as the … direct food additive or GRAS substance [] has been used in the food supply … and [] is to be used as a dietary ingredient without chemical alteration.”16 In that context, FDA affirms that a supplement company may market a substance that it determines is GRAS without informing the Agency. Consistent with this position, FDA has issued “no questions” letters in response to GRAS notices that expressly contemplate use of the notified substance in dietary supplements. The GRAS Proposal reminds the industry that dietary supplements are not food additives, consistent with the Dietary Supplement Health and Education Act, but, confusingly, states that therefore the GRAS process is not available to dietary supplement ingredients.” Sidley and Austin concluded, “It will be important for the dietary supplement industry to clarify that the GRAS pathway is available to food ingredients, broadly, including those used as dietary ingredients or “other ingredients” in dietary supplements.”

This is an important issue for the dietary supplement industry to discuss and present united views on. Any final guidance (and any future legislation taken up by Congress on this topic) should make clear that it does not alter current FDA policy that allows for substances in the food supply to be used as dietary ingredients via the GRAS pathway. There is a question, however, about whether ingredients with little or no evidence of actual presence in the food supply as an article used for food will continue to be able to point to GRAS status alone or will now have to file an NDIN. Also, there is the question of the standard of evidence that should be expected.

Does FDA have adequate staff/resources to implement the regulation?

There is a real question whether FDA has adequate staff and other resources to meet these deadlines. If there are hundreds of submissions, the answer is likely no. As such, this could be a substantial concern warranting comment and challenge.

What about Dietary Supplements containing self-GRAS ingredients already on the market?

As stated above, the draft regulation sets a more limited reporting requirement for self-GRAS substances already on the market before the effective date. The provision noted above seeming to exclude dietary ingredients from the GRAS process could call into question the status and reporting requirements of such ingredients contained in dietary supplements. Can they be reported using this more limited information? Final guidance and any legislation should clarify whether self-GRAS substances currently on the market—which were in the food supply prior to their use as a dietary ingredient—are eligible for the more limited GRAS reporting and are not required to file an NDIN.

We continue to gather views and opinions about the draft regulations, and we look forward to hearing your perspective and helping to answer your questions on this important new regulation.