This is a CRN Associate Member Spotlight. Learn more: www.aibmr.com
As dietary supplement and functional food industry stakeholders respond and regroup to strategize on the impact of U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr.’s call for FDA to re-evaluate its Substances Generally Recognized as Safe (GRAS) Final Rule, CRN associate member AIBMR Life Sciences brings four decades of expertise in toxicology, regulatory submissions, and expert panel coordination to help companies navigate evaluations with transparency and integrity.
What they’re saying: “HHS head RFK, Jr.’s direction that FDA take steps to explore potential rulemaking to revise its GRAS Final Rule and related guidance to eliminate the self-affirmed GRAS pathway presents a conundrum in the face of the reality of limited resources,” observed AIBMR Chief Scientific Officer John Endres, ND.
- This would require hiring numerous FDA scientists (toxicologists, chemists, microbiologists, regulatory specialists, etc.) to evaluate FDA GRAS Notifications who have appropriate training and experience to evaluate the safety of ingredients added to food.
- Assuming that 10% of all GRAS conclusions go through the FDA voluntary program (in place since 1958), this would require an extraordinary effort for the estimated 90% not submitted to FDA.
- Since FDA is already behind on reviewing GRAS notices, this increased burden would slow innovation for new healthy functional food ingredients in the U.S.
“To address eroding public confidence in U.S. food safety, a mandatory program could be put in place requiring companies that attain self-affirmed GRAS for food additives to notify FDA of their GRAS conclusion,” Dr. Endres noted, recommending the following basic information be provided:
- Ingredient name
- Intended uses and resulting 90th % exposure
- The basis of the GRAS conclusion, in brief bullets
- Expert panelists and their qualifications for evaluating ingredients to be added to foods in the U.S.
“This may stop any ‘bad actors’ from ‘GRAS-ing’ any ingredients that should never be in foods,” Dr. Endres suggested.
What’s next: AIBMR is ready to serve as a trusted ally in developing responsible, effective solutions and encourages CRN members to reach out to Dr. Endres with questions or comments.
“In light of recent discussions on the GRAS self-affirmation pathway, AIBMR's expertise positions the team to adeptly guide companies through evolving regulatory landscapes, ensuring both compliance and market success,” Dr. Endres shared.