Governmentally Recognized as Safe

That’s a play on an old acronym, in service of a point. A few weeks ago, HHS released a press release stating that FDA had been directed “to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” That seems like an unenviable task in light of the clear language of the statute and the agency’s prior concessions that it lacks explicit authority to require premarket approval or even notification of GRAS status.

Under § 201(s) of the Federal Food, Drug, and Cosmetic Act, GRAS is a state of being, based on expert consensus or on common use in food prior to January 1, 1958, not a status conferred by FDA.  If you never got around to reading Center for Food Safety v. Becerra, now would be a good time to catch up. In that pre-Loper Bright case, FDA successfully defended its 2016 GRAS final rule. FDA and the court agreed that “the law does not require manufacturers to get preapproval before using a substance the manufacturer believes to be GRAS.” Instead, FDA has the power to take enforcement action if it does not agree with a person’s GRAS determination. Some highlights from the opinion are quoted below (citations and internal quotations omitted):

• As the Government correctly points out, the FDCA does not impose mandatory GRAS notification on manufacturers or require FDA to review industry GRAS conclusions in advance of marketing.
• The Government argues that the FDCA is silent on whether the manufacturer must notify FDA of GRAS conclusions.
• [A]s amicus curiae SFIC points out in its brief, FDA has a long-standing record of interpreting the FDCA to exempt GRAS substances from premarket review. Indeed, the system in place before the GRAS Rule was also voluntary. Similarly, as the Government notes, Congress has amended the Food Additives Amendment but has never amended the language to require mandatory GRAS submissions.
• Plaintiffs argue that the statutory text specifically speaks on the issue because the Food Additives Amendment requires that in order to determine whether a food additive is safe, the FDA shall consider … the cumulative effect of such additive in the diet of man or animals, taking into account any chemically or pharmacologically related substance or substances in such diet, and the FDA cannot make this determination without information about current exposures to substances already present in food. Plaintiffs’ strained interpretation is unpersuasive—this language does not have an unambiguous meaning; it is dubious to think that Congress used such language to require manufacturers to inform FDA of GRAS determinations without explicitly saying so. Congress does not, one might say, hide elephants in mouseholes.

The court ultimately sided with FDA, based in part on a Chevron analysis that somehow proceeded to step two, at which the court deferred to FDA’s interpretation of the statute as reasonable. Cue Loper Bright, which we’ve blogged about here and here. Under the standard of review articulated in that decision, one can reasonably wonder how a regulation to eliminate GRAS self-affirmation could survive judicial review, given the underlying statutory text and the government’s concessions highlighted above.

In short, GRAS looks like it’s here to stay, absent an amendment to the FD&C Act. Pressure for such an amendment is building, in part because states are considering jumping into the fray (see, e.g., New York’s Senate Bill S1239A a/k/a the Food Safety and Chemical Disclosure Act, which would require reporting of GRAS substances). As they say, be careful what you wish for. Among the merits of the existing framework is its efficiency, and that merit now looms larger than ever. As the HFP continues to bleed personnel, it will become even harder for the program to maintain its core functions, let alone take on new ones.