New Report Supports FDA Legal Authority to Require Premarket Notification and Procedures for GRAS Substances

By Katharine Stecher, HLS ’27 and report coauthor

As FDA receives comments on its proposed rule to revise the GRAS process, a new report from the Harvard Food Law and Policy Clinic explains why the agency has the legal authority to implement pre-market requirements for food manufacturers before releasing new substances designated as GRAS into the food supply.

On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule that would require companies to notify the agency when they conclude that a substance used in human or animal food is “generally recognized as safe” (GRAS). Under FDA’s current regulations, GRAS notification is voluntary, so companies can add new ingredients to food without FDA, or the public, knowing in advance. The proposed rule is a meaningful step toward closing that knowledge gap by making GRAS notifications mandatory, but as drafted the proposed rule would allow companies to begin or continue marketing a substance before they submit a notice and while FDA reviews it. Public comments on the proposed rule are due December 9, 2026.

A new report from the Harvard Law School Food Law and Policy Clinic (FLPC), FDA’s Statutory Authority to Require Premarket Notification and Review of GRAS Substances Under the Food, Drug, and Cosmetic Act, argues that FDA does not have to leave that gap open. The report concludes that FDA has the statutory authority to require GRAS notifications and to make it mandatory that such notifications be premarket, before a substance is used in food. According to the report’s analysis, a court applying current administrative law jurisprudence should uphold such a rule.

A Narrow Exception That Became the Default

When Congress passed the Food Additives Amendment (FAA) in 1958, it set a default that any substance added to food is a “food additive” and must clear a premarket approval process set out in the statute before its use in food. Congress carved out a narrow exception to the additive definition for substances that are:

[G]enerally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use[.]

The examples in the legislative record were ingredients like sugar, salt, butter, lard, and pepper, with generations of safe use behind them.

However, over time, FDA regulations turned that exception into the main regulatory pathway to market new chemicals in food. Under FDA’s most recent GRAS rule, promulgated in 2016, a company or manufacturer may come to its own determination that a substance is GRAS for its intended use and then choose whether to notify FDA. Many do not choose to notify FDA, a practice sometimes called “self-GRAS” or “secret GRAS.” What was designed to be a narrow exception has become the primary way companies introduce new substances to the market. Between 2000 and 2025, according to a report of the Environmental Working Group (EWG), food and chemical companies used the food additive petition process only 10 times, while 863 were introduced following a voluntary GRAS notice. This does not include those substances introduced via self-GRAS, estimations of which vary. A 2026 EWG analysis identified 111 chemicals added to food through secret GRAS in recent years.

The consequences are not hypothetical. In 2022, a frozen food product containing tara flour, an ingredient a supplier had self-determined to be GRAS without notifying FDA, was linked to 393 reported illnesses and 133 hospitalizations. FDA did not conclude that tara flour was not GRAS until 2024, two years later. The regulatory loophole and subsequent harm to public health is exactly what Congress set out to prevent in 1958.

What the Report Finds

The report answers the question: does FDA have the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to require premarket notification or other premarket procedures for GRAS substances? It concludes that the answer is yes, for four reasons:

1. The statute’s text and history point to premarket oversight. Congress made premarket review the default for new food substances and understood GRAS as a narrow carve-out for familiar ingredients, not an alternative pathway for novel chemicals. A system that lets companies self-certify safety without FDA’s knowledge recreates the very gap the FAA was enacted to close.
2. A premarket rule should survive judicial review after Loper Bright. Courts no longer defer to agency interpretations under Chevron, but the best reading of the FAA supports FDA’s ability to require premarket procedures. Such a rule would also likely receive Skidmore respect, given FDA’s long and consistent assertion of authority over GRAS. In the alternative, a court could determine that Congress delegated FDA broad rulemaking power that covers this kind of procedure.
3. Courts read the FDCA broadly to protect public health. Courts have consistently interpreted the FDCA in light of its public health purpose and have been reluctant to leave gaps that put consumers at risk.
4. FDA cannot police what it cannot see. FDA has a statutory duty to keep unapproved additives out of food and the power to promote “efficient enforcement” of the FDCA. Substances that are not GRAS are unapproved food additives. But FDA cannot make a finding that a substance is an unapproved food additives if it does not know is in the food supply. Requiring premarket GRAS notifications is an extension of FDA’s authority to police unapproved food additives.

The report also identifies a limiting principle. Because Congress expressly exempted GRAS substances from the definition of “food additive,” FDA cannot build a GRAS review process identical to the food additive petition process. Notification and review without a full notice-and-comment rulemaking that would normally be required for an additive, however, is different enough to stay on the right side of that line. Within that limit, the report finds that FDA could:

• Require premarket notification of every GRAS conclusion, along with the evidence that supports it.
• Prescreen substances to decide whether they belong in the GRAS pathway or must go through the additive petition process.
• Define who counts as an expert, and what group of experts is needed to establish “general recognition” of safety.
• Reach substances already on the market, requiring notice for ingredients used under earlier self-GRAS determinations.
• Continue to exercise its postmarket tools, continuing to monitor GRAS substances and revoke their status when the evidence warrants.

Looking Ahead

FDA’s 2026 proposed rule reflects a growing recognition that the voluntary GRAS system is not working. The open question is whether the final rule will go far enough to truly close the loophole in a way that meets the legislative intent and ensures public safety. As the report shows, the law does not stand in the way of a stronger rule. FDA has the authority to require notices about a substance premarket, before consumers eat it, not years after.

The report is intended as a resource for policymakers, advocates, and other stakeholders preparing comments on the proposed rule, and for members of Congress considering legislative reform of GRAS.

Comments on FDA’s proposed GRAS rule are due December 9, 2026, and can be submitted on Regulations.gov under Docket No. FDA-2025-N-3262.