Why It Matters

Whether the Food and Drug Administration (FDA) can require companies to disclose substances they determine are generally recognized as safe (GRAS), without additional legislation, is the central question examined in a Congressional Research Service (CRS) report. Under the Federal Food, Drug, and Cosmetic Act, GRAS substances are exempt from the premarket approval requirements applicable to food additives.

On Aug. 11, FDA published a proposed rule requiring notification for certain GRAS substances, including those already marketed. The proposal would not establish premarket approval requirements, allowing companies to market qualifying substances before or during FDA review. Public comments are due Dec. 9.

Critics of the voluntary system argue it allows substances into the food supply without adequate oversight. Others warn mandatory notification could strain FDA resources, hinder innovation or disrupt food supplies.

The Big Picture

In its 2016 final rule establishing voluntary GRAS notification, FDA stated that it lacked express statutory authority to require submissions. A federal district court upheld the voluntary system in Center for Food Safety v. Price, relying partly on judicial deference to agency interpretations under Chevron.

CRS notes that the unpublished ruling is not precedential and did not directly resolve FDA's authority to mandate notifications. The Supreme Court subsequently overturned Chevron in Loper Bright Enterprises v. Raimondo, requiring courts to independently determine statutory meaning.

Under FDA's proposal, the agency would have 45 days to determine whether a submission is adequate for filing, followed by a 180-day review period, potentially extended twice by 90 days.

Failure to submit required notices could influence FDA's post-market enforcement priorities. FDA could determine that a substance does not qualify as GRAS, potentially rendering foods containing an unapproved additive adulterated.

Congress has introduced several proposals addressing GRAS oversight, including the GRAS Oversight and Transparency Act (H.R. 7291), Better Food Disclosure Act (S. 3122), Grocery Reform and Safety Act (H.R. 4958) and Ensuring Safe and Toxic-Free Foods Act (S. 2341).

The Bottom Line

Congress could clarify FDA's authority, change GRAS oversight requirements, or allow the agency to finalize its proposal and defend its interpretation in court. Under the Skidmore framework, courts may consider an agency's expertise and consistency when evaluating its interpretation. FDA's earlier acknowledgment that it lacked express authority could therefore become relevant in litigation challenging mandatory notification.

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