Key Points:
- The FDA has proposed a new rule requiring companies to provide health data and documentation when declaring a new food ingredient or additive safe, moving towards eliminating the voluntary approval process criticized by Health Secretary Robert F. Kennedy Jr.
- Companies would now be mandated to submit notices when declaring an ingredient as Generally Recognized as Safe (GRAS), a change from the current voluntary system strongly encouraged by the FDA.
- This proposal is part of the Trump administration’s regulatory priorities, following Kennedy’s directive to explore rulemaking to eliminate companies’ ability to self-affirm ingredient safety.
Insight:
The voluntary GRAS notification process was established in 1997 due to the FDA’s inability to dedicate extensive resources to affirming the safety of substances. Previously, it took the agency over 72 months to review new petitions for ingredient approval.
Under the current self-affirmation process, food companies can declare their ingredients safe based on public scientific data, aiming to expedite the market entry of new ingredients. However, Kennedy has criticized this process for allowing potentially unsafe chemicals into the food supply without sufficient safety data.
The proposed rule would exempt substances already listed or affirmed as GRAS, as well as those with a “no questions letter” from the FDA indicating safety approval.
While the new requirements are pending publication in the Federal Register for public comments, concerns have been raised about the FDA’s legal authority to mandate GRAS notification. Legal experts suggest the rule may face challenges in court and recommend evaluating existing enforcement mechanisms for safety concerns.