The Future of GRAS: Proposed Changes and Industry Impact

A proposed rule aiming to eliminate the self-affirmed Generally Recognized as Safe (GRAS) pathway is currently under review by the Office of Management and Budget (OMB) since December 1. A Notice of Proposed Rulemaking (NPRM) is expected to be released shortly.

Significance of the Proposed Changes

According to the Department of Health and Human Services (HHS), this proposed rule would mandate the submission of GRAS notices for human and animal food substances that are claimed to be GRAS. Notably, substances already listed or affirmed as GRAS by regulation or those that have received a ‘no questions’ letter from the FDA would be exempt from this requirement.

The rule aims to establish a public-facing GRAS notice inventory, allowing FDA to maintain and update records for substances needing mandatory GRAS submission. It will also clarify the FDA’s criteria for determining whether a substance is not GRAS.

Industry Reactions

Legal experts, including Bob Durkin from Amin Wasserman Gurnani, report significant pushback regarding these changes. With an OMB meeting scheduled for April 20, experts suggest that no immediate updates can be expected.

Discussions with Durkin and other specialists shed light on the implications of the proposed changes and how firms can prepare themselves. A key legal question persists: Does the FDA have the authority to eliminate self-GRAS without Congressional amendments? Notably, Congress is considering two bills addressing similar issues (see here and here).

Understanding GRAS

The GRAS (Generally Recognized as Safe) designation applies to substances added to food deemed safe for their intended usage. Unlike food additives, GRAS substances are not subject to FDA pre-market approval, although they must meet equivalent safety standards.

Currently, companies can either self-affirm their ingredients as GRAS or submit a dossier for FDA review, which may result in a ‘no questions’ letter—the latter of which is publicly accessible on the FDA’s website. The self-GRAS pathway, however, lacks a public database or notification requirement, leading some commentators to label it a significant regulatory loophole.

Preparation for Change

Brian Sylvester from Morrison Foerster advises companies to ensure their GRAS determinations are well-documented and defensible, emphasizing that their dossiers should withstand FDA scrutiny. The equivalency of standards for self-GRAS and FDA GRAS notices means that using a well-executed self-affirmed GRAS as a basis for a GRAS Notice should involve a minimal burden.

As for self-GRAS ingredients already on the market, the proposed rule is ambiguous. Experts believe that existing self-affirmed ingredients may need to notify the FDA in the future or be listed for agency review based on risk factors.

Legal Implications and Authority

There are credible legal questions regarding whether the FDA can legally mandate submissions without amending the Food, Drug, and Cosmetic Act (FDCA). Sylvester warns that if the FDA requires blanket submissions, it may unintentionally transform the GRAS process into a mandatory pre-market review, which contravenes existing statutes.

Durkin concurs, suggesting that the legality of eliminating self-GRAS will become a pressing issue if the proposal is pursued. Any such rule could likely invoke significant legal challenges.

FDA Resources and Industry Concerns

On a practical level, FDA would need considerable resources to implement any proposed changes. Jonathan Emord, legal counsel for the Alliance for Natural Health, highlights that a pre-market approval system would not only cause bottlenecks but also hamper consumer access to historically safe ingredients.

He suggests that should the proposed rule pertain only to notification requirements, it may alleviate industry concerns unless it incorporates new, burdensome proof of safety demands.

Potential Middle Ground Solutions

Emord proposes a risk-based evaluation for self-GRAS listings, where substantial weight is given to historical usage, only requiring further evidence if a risk is identified. Durkin adds that a feasible compromise could be to require listing self-GRAS ingredients to the FDA, allowing for strategic reviews to mitigate risks.