In-Depth Analysis of the FDA’s Proposed Rule: How Long Can Self-GRAS Continue?

On August 10, 2026, the U.S. Department of HHS officially issued a proposed rule on mandatory GRAS notifications. The FDA proposes to change the current voluntary GRAS notification process to a mandatory system, directly targeting the Self-GRAS pathway. To help clients better cope with the regulatory change, CIRS has summarized the frequently asked questions as follows:

Q: Is it still necessary to pursue Self-GRAS now, or should companies directly submit an FDA GRAS notification?

It depends on the company’s commercialization timeline:

Companies shall put their products in the US market urgently: They can first pursue Self-GRAS, which can generally be completed in approximately six months, with three expert signatures allowing the product to be marketed. At the same time, they can prepare and submit an FDA GRAS notification. The two pathways can use essentially the same dossier, and the company may potentially obtain an FDA “no questions” letter before the proposed reforms take effect, thereby avoiding the impact of the subsequent changes.

Companies without an urgent launch timeline: They can skip Self-GRAS and directly prepare the dossier for submission to the FDA, then wait for the FDA’s “no questions” letter.

Q: If a GRAS determination has already been completed, is an NDI notification still required before the ingredient can be used in dietary supplements?

Not necessarily. NDI exemptions are available. If the substance has not undergone a change in chemical form and has already entered the food supply — meaning that it has completed GRAS and has been marketed in conventional foods — it may qualify for an NDI exemption and can be used in dietary supplements without a separate NDI notification.

However, two key points should be noted:

The intended use section of the GRAS dossier must not include dietary supplements. GRAS applies only to conventional foods.

The company must have interstate sales records for conventional food products. Sales records limited to dietary supplements do not satisfy the exemption requirements and could potentially result in the product being considered “adulterated.”

Q: Will GRAS for animal food, including feed and pet food, also be affected by the proposed reform?

Yes. The impact is essentially the same as for human food. Under the broad U.S. definition of “food”, both human food and animal food are covered. Therefore, the proposed reform also applies to animal food GRAS.

Q: Are there any special exemption pathways for animal food?

Yes. In addition to exemptions applicable to both human and animal food, animal food has two additional specific exemption pathways:

AFIC (Animal Food Ingredient Consultation): If a company completes the AFIC process and the FDA issues a consultation response indicating that it has no questions regarding the safety of the ingredient, the ingredient may be exempt from submitting a GRAS notification. AFIC is a procedure introduced by the FDA after its memorandum of understanding with AAFCO expired in 2024, providing companies with a more streamlined pathway to enter the U.S. market.

AAFCO SRIS: Ingredients included in Chapter 6 of the 2024 Official Publication of AAFCO, for which the FDA has not publicly expressed safety concerns, may be exempt. It is worth noting that the proposed rule specifically refers to the 2024 edition of the OP and does not mention the subsequently published 2026 edition. This is likely because the FDA–AAFCO agreement expired in October 2024, and the FDA only recognizes versions that underwent technical review before the agreement expired.

Q: What about SRIS? Will the proposed rule affect it?

The proposed rule does not explicitly mention SRIS. SRIS is a scientific review process established by AAFCO in collaboration with universities. It does not have direct federal endorsement, so whether the FDA will recognize SRIS remains uncertain. Companies should continue to monitor subsequent statements and regulatory developments from the federal government.

Driven by a global wave of food innovation, regulatory compliance and market access for novel food ingredients and additives have become critical hurdles for companies expanding internationally. Under this circumstance, CIRS Group has prepared the White Paper Series on Global Novel Food and Feed Ingredient Submissions, with the aim to help businesses navigate the evolving global regulations and accelerate global expansion.

Our inaugural release - Guide to U.S. GRAS Notification -  delivers an actionable, in-depth breakdown of the US FDA's Generally Recognized as Safe (GRAS) pathway. Please click here to view more details.

What Can CIRS Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, and R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.