Health and Human Services Secretary Robert F. Kennedy Jr.'s directive to the FDA to revamp the GRAS (Generally Recognized as Safe) program has garnered significant attention as the first initiative in the secretary’s commitment to "radical transparency" regarding food ingredients.
While concerns about GRAS substances are becoming more widespread, state-level animal food regulators have been sharing concerns for years. Most state animal food programs in the U.S. recognize GRAS substances that have been formally filed and reviewed by the FDA's Center for Veterinary Medicine, but some states do not accept or recognize substances deemed self-affirmed GRAS by independent panels.
This situation has caused frustration within the feed industry, but many state programs lack the expertise or manpower to thoroughly review these independent conclusions and, therefore, err on the side of caution and choose to recognize only GRAS notices that have been reviewed by the FDA to avoid relying on potentially biased industry conclusions.
Consumer groups are advocating for more transparency in the FDA's GRAS Notice program, but significant legal hurdles exist, and industry support is uncertain. The FDA also faces significant challenges in implementing any necessary changes with budget and staffing limitations. So, is there a viable alternative?
The Association of American Feed Control Officials recently partnered with Kansas State University’s Olathe Innovation Campus to establish a new ingredient review process that meets the federal GRAS program requirements while simultaneously addressing some of the concerns that have given consumers and policymakers reason to pause.
This state-led process would require that all submissions adhere to the GRAS requirements listed in the CFR. However, submitters would be required to utilize a neutral academic institution (K-State Olathe) to convene a panel of experts from across the country to review and issue a conclusion related to the safety of the substance within 60-90 days. The final K-State Olathe expert panel GRAS conclusion would be reviewed and voted on by AAFCO membership (state regulators) and recognized across the U.S.
This addresses three key concerns that are posed by the current rules:
- First, the process brings transparency and an unbiased review to ingredients that could have previously flown under the radar without notification to the FDA.
- Second, it cuts the current review time in half, allowing for both safety and speed to market for new products.
- Third, it creates a deep talent pool of qualified experts who can verify the safety and efficacy of new substances, rather than relying on dedicated staffing within the FDA.
GRAS reform is necessary, and state regulators have been leading the charge to address the concerns that have been brought up around the FDA’s GRAS notice program in a way that supports food safety and consumer protection while affording innovation and confidence for the animal food industry.
This timely solution should be considered as the conversation around GRAS reform continues to move forward so that we can “Make America Healthy Again” and continue to keep animal food healthy and safe.
Austin Therrell is the executive director of the Association of American Feed Control Officials (AAFCO).
