FDA’s Proposed GRAS Rule Clears White House Review

Proposed GRAS Rule Advances in Federal Rulemaking Process

The White House Office of Management and Budget (OMB), through the Office of Information and Regulatory Affairs (OIRA), has completed its review of FDA’s proposed rule titled “Substances Generally Recognized as Safe (GRAS).”

Completion of OMB review represents an important milestone in the federal rulemaking process and signals that the proposal is moving closer to publication in the Federal Register.

What Happens Next?

Once FDA publishes the proposed rule in the Federal Register, the agency will open a public comment period during which stakeholders may review the proposal and submit comments.

Following the close of the comment period, FDA will evaluate the comments received before determining whether to issue a final rule.

As with other federal rulemaking activities, the proposed rule may be revised before a final regulation is published.

Why This Matters

The GRAS framework plays an important role in how certain food ingredients are evaluated for safety prior to use in food products.

Because the proposed rule has not yet been published, details regarding FDA’s specific proposed changes are not yet available. However, publication in the Federal Register will provide industry with the opportunity to review the proposal and understand its potential impact.

Companies involved in food ingredient development, manufacturing, and regulatory compliance may wish to monitor publication of the proposed rule and consider participating in the public comment process.

EAS Perspective

OMB review is one of the final procedural steps before publication of a proposed federal regulation. As FDA moves forward with its proposed GRAS rule, industry stakeholders should carefully review the proposal once released and evaluate any potential implications for their regulatory and product development activities.

EAS will continue monitoring this rulemaking process and provide updates as additional information becomes available.