The regulatory landscape for food and dietary ingredients in the United States may be on the verge of a major shift. The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would convert the long-standing, voluntary Generally Recognized as Safe (GRAS) notification process into a mandatory requirement.
To unpack what these changes mean for ingredient suppliers, food manufacturers, and brand owners, Dr. Timothy S. Murbach, Technical Director at CIRS USA, recently sat down with Jeff Crowther, Executive Director of HPA-Global, on HPA Global Insights. Together, they discussed the nuances of the proposed rule, the distinction between statutory law and agency enforcement, and strategic steps companies must take to prepare.
Is Self-GRAS Going Away?
The answer is no.
A common concern across the food and dietary supplement sectors is that the FDA is eliminating independent "Self-GRAS" conclusions entirely. However, GRAS status was established by Congress under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Because federal law created the GRAS pathway, the FDA lacks the statutory authority to eliminate it—only Congress can do that.
Instead, what changes is the reporting requirement. Under the proposed rule, notifying the FDA of a GRAS conclusion will no longer be optional—it will be mandatory. The FDA's rationale is straightforward: without formal notifications, the agency has no way of tracking which unnotified ingredients are entering the food supply, making it difficult to evaluate whether those substances are truly safe or essentially unapproved food additives.
What This Means for Your Ingredients
|
Current Status of the Ingredient |
What You Need to Do Under the Proposed Rule |
|---|---|
|
Unnotified "Self-GRAS" (Currently on the market) |
You get a 1-year window after the final rule takes effect to submit a simplified, abbreviated notification. If you miss this window, you will have to submit a full GRAS notice. |
|
Existing "No Questions" Letter (Already reviewed by FDA) |
Nothing. Ingredients that have already completed the voluntary process and received a "no questions" letter are exempt from re-filing. |
|
New Ingredients or New Uses (Future launches) |
You must still build a solid safety dossier and reach expert consensus. However, you will now need to budget time and money for a mandatory FDA submission before launching. |
Key Dates and Next Steps
Public Comment Period: The proposed rule was published on August 11, 2026, with public comments open through December 9, 2026.
Review & Final Rule: Once the comment period closes, the FDA must review the feedback before deciding whether to revise the proposal, drop it, or move directly to a final rule.
Congressional Activity: Beyond agency rulemaking, Congress is also considering several bills aimed at broader food safety and GRAS reforms. While major legislative changes are unlikely in the immediate term, bipartisan interest signals that oversight will only tighten in the coming years.
How Companies Can Prepare Now
Audit Your Portfolio: Identify any ingredients you currently sell that rely on unnotified Self-GRAS conclusions. Gather your safety data so you are ready for the 1-year transition filing.
Submit Public Comments: If this rule impacts your business operations, consider voicing your input before the December 9, 2026 deadline.
Plan Ahead: Factor FDA notification timelines and regulatory budgets directly into your upcoming R&D projects.
How CIRS Can Help
CIRS Group is a leading global product safety and regulatory consulting firm. Our technical experts assist food, beverage, and supplement companies with U.S. FDA compliance—including GRAS notice, New Dietary Ingredient (NDI) notifications, and global market access strategies spanning China, Japan, South Korea, and the European Union.
Our services include but are not limited to:
- 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;
- 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.
Moderator
Jeff Crowther, Executive Director of HPA-Global
CIRS Expert
Timothy S. Murbach, Technical Director of CIRS USA, ND, DABT, Senior Regulatory Affairs Consultant
Dr. Timothy S. Murbach, ND, Diplomate of the American Board of Toxicology (DABT), Full Member of Society of Toxicology and American College of Toxicology, accomplished professional with 15+ years of experience in regulatory toxicology (specializing in safety assessment submissions, including Generally Recognized as Safe (GRAS) dossiers and notices, and new dietary ingredient notifications (NDIN)), labeling compliance, and claim substantiation across the food, beverage, and dietary supplement industries.
Get In Touch
For tailored guidance on how the proposed GRAS rule impacts your ingredient portfolio or to prepare your regulatory submission strategy, contact our regulatory experts at CIRS Group today or via service@cirs-group.com.
Watch the full interview
Further Reading
In-Depth Analysis of the FDA’s Proposed Rule: How Long Can Self-GRAS Continue?
