The self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking to remove the option for companies to self-affirm that food ingredients are safe. If implemented, this shift will require all GRAS determinations to undergo FDA review, significantly altering the regulatory landscape for food manufacturers.
This decision follows concerns that self-affirmed GRAS has allowed food ingredients into the market without FDA oversight, raising questions about transparency and safety. If this change moves forward, it could bring significant shifts for businesses like yours. Understanding what this means now can help you stay ahead of the curve and ensure compliance. Keep reading to find out what steps you should take next.
Why Is FDA Reviewing the Self-Affirmed GRAS Pathway?
The self-affirmed GRAS process enables companies to determine ingredient safety based on publicly available scientific data without requiring FDA review. While voluntary GRAS notifications exist, they are not mandatory, meaning some ingredients enter the market without FDA awareness.
HHS has cited concerns that this “loophole” undermines consumer confidence and creates risks due to insufficient transparency. Under the proposed rule change, companies would need to formally notify the FDA of GRAS determinations and await review before marketing their ingredients.
Potential Delays Due to FDA Staffing Cuts
One major concern surrounding this change is the FDA’s ability to manage the increased workload. Recent federal employee cuts have significantly reduced staffing at the FDA, which could lead to prolonged review times for GRAS determinations.
For businesses relying on timely approvals for new food ingredients, these delays could disrupt product launches and supply chains. Planning ahead and seeking expert regulatory guidance will be essential to mitigate potential slowdowns.
How to Prepare for the GRAS Rule Change
1. Stay updated on FDA announcements
Regulatory changes can move quickly. Regularly check the FDA website and industry sources for updates.
2. Proactively submit GRAS notifications
If your company relies on self-affirmed GRAS, consider voluntarily submitting GRAS notices now to avoid potential compliance challenges later.
3. Strengthen safety documentation
Ensure that all safety data, toxicology studies, and scientific evidence for your ingredients are well-documented and ready for FDA review.
4. Work with regulatory experts
Navigating GRAS compliance can be complex. Partnering with regulatory consultants, like Quality Smart Solutions, can help streamline the process and avoid costly delays.
Final Thoughts
The FDA’s potential elimination of the self-affirmed GRAS pathway marks a major shift in food ingredient regulation. While aimed at increasing transparency, this change may also result in longer review times due to reduced FDA staffing. Businesses must act now by staying informed, proactively submitting GRAS notices, and strengthening compliance strategies.
For expert support in navigating these regulatory changes, reach out to Quality Smart Solutions: fill out the form below or contact us today to ensure compliance. Our team is here to help you stay ahead in a rapidly evolving regulatory landscape.
