The Food and Drug Administration (FDA) is gearing up to introduce a rule that could shake up the food and beverage industry. This new rule is aimed at changing how certain substances get approved for market use. Currently, companies can decide if something is “Generally Recognized As Safe” (GRAS) without getting the FDA’s approval. If the proposed rule goes through, businesses would need to submit these GRAS notices to the FDA for review, marking a significant shift from the current practice.
Health and Human Services Secretary Robert F. Kennedy Jr. has emphasized this change is vital for enhancing the FDA’s oversight and improving transparency for consumers. The FDA’s draft has been submitted to the Office of Management and Budget, but the full details aren’t out yet.
Experts are weighing in on this issue. Some argue that the FDA may not have the authority to eliminate the self-GRAS pathway through new rules without Congressional approval. A federal court previously upheld that companies had the option of submitting GRAS notices voluntarily. However, as legal interpretations often evolve, this may not be the same case if challenged in court today.
In Congress, two key proposals are being discussed that could also impact the self-GRAS pathway. The Ensuring Safe and Toxic-Free Foods Act of 2025 aims to classify substances relying on self-GRAS determinations as unsafe. Meanwhile, the Better Food Disclosure Act of 2025 seeks to require GRAS notices to be submitted for FDA approval, pushing for the agency to maintain a public inventory of these substances.
Similar initiatives are happening at the state level, with states like New Jersey, New York, and Pennsylvania proposing legislation that would require companies to disclose any self-GRAS determinations. This state-level action could complement or influence federal legislative efforts.
As these changes loom, it’s crucial for companies to prepare. They should review and document all substances used in products, assess the sufficiency of evidence supporting any self-GRAS determinations, and strategize for potential ingredient swaps if necessary.
The food and beverage sector is on the brink of transformation, driven by health and safety concerns of consumers and regulators alike. Although it may be unclear how the final regulations will shape up, one thing is certain: the industry’s landscape is set to change in the near future.
For more information, you can explore the FDA’s Human Foods Program to stay updated on these developments.
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preemption,federal health care legislation,alcohol and beverage regulation
