The self-affirmed GRAS pathway is closer than ever to being eliminated. On March 10, 2025, U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. announced that the FDA was exploring rulemaking to close the long-standing option for companies to self-affirm the safety of food ingredients.
This month, the Trump administration’s Spring 2025 Unified Regulatory Agenda confirmed that the FDA is preparing a Notice of Proposed Rulemaking (NPRM). Scheduled for publication in October, the rule would mandate that all Generally Recognized as Safe (GRAS) determinations be submitted directly to the FDA, effectively ending the self-affirmation route.
What the Proposed Rule Means for Industry
Under current rules, businesses may either submit a GRAS notice to the FDA or self-affirm that their ingredient is safe without notifying the agency. If finalized, the new rule would remove this choice. Companies would be legally required to submit a GRAS notice before marketing ingredients as safe for use in food or animal feed.
The NPRM (Unified Agenda Entry RIN 0910-AJ02) explains that the proposal will amend 21 CFR parts 170 and 570. This change would significantly increase FDA oversight of food ingredient safety, aiming to enhance consumer protection and transparency.
Why the FDA Is Taking Action
For years, critics have raised concerns that self-affirmed GRAS determinations lack transparency and may compromise consumer safety. By requiring mandatory notification, the FDA will have more visibility into food ingredient safety decisions and a stronger ability to intervene if risks are identified.
This move aligns with broader food safety initiatives in both the U.S. and Canada, where regulators like Health Canada emphasize oversight in ingredient approval processes.
How Businesses Should Prepare
If your company currently relies on self-affirmation for GRAS determinations, you should begin planning for FDA submissions now. Waiting until the rule is finalized could delay product launches or create compliance risks.
Practical steps include:
- Reviewing current GRAS determinations and supporting data
- Preparing documentation aligned with FDA submission standards
- Consulting regulatory experts to ensure readiness for the proposed changes
Quality Smart Solutions can help you navigate these new requirements with tailored GRAS and ingredient compliance services.
Key Takeaways
- The FDA self-affirmed GRAS pathway may end as early as October 2025.
- A proposed rule would require all GRAS determinations to be submitted to the FDA.
- The change would amend 21 CFR parts 170 and 570 for human and animal food ingredients.
- Companies must prepare for stricter oversight and mandatory submission requirements.
- Partnering with regulatory experts can ensure smooth compliance.
FAQs
Is the FDA self-affirmed GRAS pathway still valid today?
Yes. Until the proposed rule is finalized, businesses may still use self-affirmation. However, this option may be eliminated soon.
Will this affect both human and animal food ingredients?
Yes. The NPRM covers GRAS determinations for both categories.
Can small businesses handle this on their own?
While technically possible, FDA submissions are complex. Many businesses rely on consultants to prepare accurate, compliant notices.
How can I get ahead of the changes?
Start reviewing your ingredients and GRAS processes now. Submitting proactively or seeking expert guidance can help you stay compliant.
Moving Forward
The FDA’s proposed elimination of the self-affirmed GRAS pathway will reshape how companies bring food ingredients to market. Businesses that adapt early will minimize disruptions and gain an edge over competitors.
Quality Smart Solutions offers complete medical device and food compliance services to help you prepare. Connect with our team today to ensure your GRAS submissions meet FDA expectations and keep your products moving forward.
