Kennedy closes the GRAS loophole but leaves the back door open

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What Secretary Kennedy’s Proposal Actually Changes

Stripped of the rhetoric, the proposed regulation:

“Requires manufacturers to notify the FDA when concluding that the use of a substance added to human or animal food is GRAS.”

The greater FDA visibility into ingredients, the expanded public inventory, and indeed the radical transparency all follow from that change. You can find a more detailed discussion of GRAS’ history and current regulations here. For this discussion, however, one distinction matters most: there are several routes by which an ingredient can acquire or retain GRAS status, and they do not involve the FDA in the same way.

• FDA-initiated review: The agency can reassess substances already in use when new evidence raises safety concerns. 
• GRAS self-determination: A manufacturer, with outside experts, reaches its own safety conclusion, without notifying the FDA. 
• GRAS notification: A manufacturer conducts its safety assessment and voluntarily submits that conclusion and supporting information to the FDA, creating a public record and allowing agency review. 

The Cup Half Full - Exposing the Loophole

The regulation is designed to close the glaring loophole in GRAS self-determination by now requiring notification. It also establishes a “streamlined time-limited pathway” for these additives, already in use, to notify the FDA of their current use. [1]

This effectively ends the practice of secret self-determination and provides basic visibility into what enters the food supply.

The Cup Half Empty - Mandatory Notification is not Pre-market Approval

Pre-market approval simply means that safety testing occurs before an ingredient enters our food supply. That path, the Food Additive Petition, requires a data safety review [2] by the FDA before the “food additive” enters the marketplace and is consumed. There are no pre-market requirements for any GRAS pathway. FDA review, if conducted at all, begins after the product hits our shelves and we start consuming the ingredient, and is at the FDA's discretion unless it is a voluntary review by the manufacturer. 

The proposal makes the FDA aware of GRAS conclusions; it does not turn GRAS notification into the premarket approval process used for food additives. 

Secretary Kennedy is correct in emphasizing the proposed “radical transparency” because the new regulations do nothing to compel manufacturers to submit to the more rigorous pre-market Food Additive Petition. But another regulatory system reveals why that distinction matters. Dietary supplements can connect with GRAS law in unanticipated ways, leaving our cup emptier still. To understand that problem, we need to go back more than 60 years to review the efforts to isolate the proteins responsible for bioluminescence in jellyfish. 

From Jellyfish to Supplement 

Dietary supplements are treated more like foods than drugs. That is why supplement claims state they “support” brain health or joint flexibility; they cannot claim to cure or treat a disease. Under the 1994 supplement law, a manufacturer introducing certain “new dietary ingredients,” or NDIs, generally must notify the FDA at least 75 days before marketing and provide the basis for concluding that the ingredient is reasonably expected to be safe. That notification is not the same as formal FDA approval. Ingredients marketed in the United States before the statutory cutoff are exempt from review. But the interaction between supplement law and GRAS allowed clever counsel another potential route around NDI notification.

One of those jellyfish proteins, apoaequorin, became the signature ingredient in a highly successful dietary supplement: Prevagen.

Quincy Bioscience, the maker of Prevagen, originally tried to obtain FDA clearance as a supplement, an NDI. However, citing safety concerns, the FDA refused to sign off twice. Quincy pivoted, putting apoaequorin into a “drink,” convened their own expert panel, and voluntarily declared to the FDA that it was GRAS for food use. The FDA again voiced safety concerns, and Quincy withdrew the notification. Self-determined GRAS became Quincy’s next choice, and they quickly reverted to a pill and capsule formulation. Under supplement law, a GRAS ingredient, irrespective of pathway, requires no further review – neatly side-stepping the mandatory pre-market FDA review it had already failed.

Under the proposed regulations, Prevagen, whether safe or not, can continue to be sold until regulators once again evaluate its safety filings. Prevagen will need to join a very long line, illustrating the limitation of mandatory notification: disclosure can give regulators information without guaranteeing immediate regulatory action.

The Political Blind Spot

Prevagen is more than an unusual regulatory history; it tests whether calls for tighter food oversight will be applied equally to the supplement industry.

Prevagen exposes a tension within the MAHA movement. Its advocates have regularly criticized food and pharmaceutical companies for conflicts of interest, inadequate transparency, and regulatory capture. Those concerns deserve scrutiny. But the same standard should apply to the supplement industry, which operates under a different, and in important respects less demanding, regulatory framework. If conflicts of interest and insufficient oversight are problems when they involve conventional food or pharmaceutical companies, they should remain problems when they involve companies aligned with the wellness movement.

A Spotlight Without a Gate

Secretary Kennedy's proposal represents a meaningful structural change: replacing undisclosed self-determination with mandatory notification and creating a public record. Companies would have to show regulators what they are doing without necessarily obtaining affirmative FDA authorization before marketing. Transparency is welcome and necessary, but filing a notice in an FDA database is not the same thing as demonstrating safety to the agency before consumers are exposed.

An ingredient's biological effects do not depend on whether it is classified as a food or a dietary supplement. Yet fragmented statutes can subject similar substances to very different regulatory pathways. If the goal is genuine consumer protection, there is a strong case for substances that present comparable risks to face comparable standards of premarket scientific evidence, whether sold in foods or supplements. Until both Big Food and Big Supplement are held to that single, proactive standard, "radical transparency" illuminates the marketplace without fully guarding its entrance

[1] While the proposal indicates that these notifications will allow the FDA “to prioritize post-market safety evaluations,” the reality is that these reviews are constrained by the FDA’s labor force, which has remained flat, and by additional funding that must come from Congress. In comparison, pharmaceutical review is paid for by the requesting manufacturer. In essence, the new regulation does require the food industry to show their work, but it is doubtful that the FDA will be able to “grade the tests.”

[2] The data may be proprietary, privately held safety data generated by the manufacturer.