Closing the GRAS Loophole is a Good Idea

On March 11, Health and Human Services Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration (FDA) to “consider” revisions to its Generally Recognized as Safe (GRAS) Rule and related guidance. He noted that “[f]or far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public.”

Given that the Trump administration is moving aggressively to rollback air, water, and climate pollution limits, as well as firing staff and withdrawing support for pollution reduction, and plans to reverse key safeguards that protect people from chemical exposure, we remain deeply skeptical that FDA actually intends to adopt rules that would lead to more regulation of the chemical industry and thus greater food safety,  But, if FDA really does intend to revise its GRAS Rule and to take seriously its responsibility to protect the safety of our food, we are sharing our expertise on what it can and should do.

The federal Food Drug & Cosmetic Act requires that anything added to our food be found to be “safe”, which is defined as meaning a “reasonable certainty of no harm.” This standard, in theory, is very strong. Indeed, the law establishes a comprehensive process for the premarket review of all proposed “food additives,” requiring FDA to assess safety and prescribe conditions for safe use.

But the law’s definition of the term “food additive” contains a giant loophole: if chemical manufacturers decide for themselves that a substance they’ve synthesized is “generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures … to be safe under the conditions of its intended use,” then it is not a “food additive,” and it can be added to food without any FDA review — even without notifying the FDA.

This is the Generally Recognized As Safe (GRAS) loophole. And this loophole has swallowed the rule — virtually all new food chemicals have been added to our food through this provision.

We sued the FDA several years ago over the rule it adopted to implement this GRAS loophole. We argued that the loophole is an illegal and overly vague delegation of food safety oversight authority to private parties with a financial stake in the outcome. Relying on the now overruled Chevron doctrine of deference to agencies, the Court upheld the rule but acknowledged the concern about the secrecy allowed by the rule given “the increase in the number of food additives over the last five decades.”

The FDA has the clear authority to significantly strengthen oversight of food additives in five major ways:

1. The FDA can and should require companies to give FDA notice whenever they use the loophole to self-certify that their products are GRAS. Currently, the FDA does not require notice to FDA — but only “encourages” it — and it appears that most companies do not give notice, but rather self-certify in secret, based on secret data, that the substance is “safe.” This secrecy impairs the FDA’s ability to enforce the food safety law and ensure that the certification of safety was scientifically supported and not compromised by conflicts of interest. This secrecy further impedes the ability of the FDA or the companies themselves to examine the impact of a food additive in conjunction with many other (perhaps secret) food additives. Even Secretary Kennedy noted that the FDA can require this notice under existing law; it need not wait for Congress to act.
2. The FDA should establish stricter standards for what qualifies as the “expert opinion” companies rely upon when seeking to use this self-certification GRAS pathway. Now, there are virtually no criteria. FDA should require that the certification is done by true experts, without conflicts of interest, basing their opinion on publicly available data. None of that is required now — the FDA does not limit who can serve as an “expert”, exclude “experts” with conflicts of interest, or preclude GRAS determinations to be based on unpublished data corroborated by unpublished data. Indeed, a 2011 study found that of 451 GRAS determinations voluntarily filed with the FDA, all expert opinions were made by either an employee of an additive manufacturer, an employee of a consulting firm selected by a manufacturer or by an expert panel selected by the manufacturer or a firm that was a consultant to the manufacturer.
3. The FDA can and should impose limits on what substances can be self-certified as GRAS. Critically, it should preclude self-certification of cancer-causing additives or novel or newly synthesized substances.
4. The FDA should provide that manufacturers cannot determine a substance to be GRAS after the FDA raises safety concerns about that substance. And the FDA should not permit companies to withdraw GRAS notices. If the FDA has safety concerns, it should not encourage or permit the company to submit a “cease to evaluate” letter that effectively withdraws notice to the FDA and lets the company proceed in total secrecy. Rather, the FDA should issue a “no basis letter” indicating that there is no basis for a GRAS determination. If there are new studies or new data in the future, the company can resubmit a new GRAS notice at that time.
5. Finally, while the above changes would improve the process going forward, the FDA must also address the dangers to our food from the past many decades of secrecy. The FDA should compile a database of all substances (that it knows about) that have been certified as GRAS since the program started in 1958, so that future certification analyses can address the cumulative impact of the over ten thousand food additives now in use. And it should carefully review all self-certified GRAS determinations to date.

These changes are clearly within the legal authority of the FDA under the Food, Drug & Cosmetic Act and thus do not require Congressional action. And they are fully justified by numerous studies documenting the harmful substances that are slipping through this loophole into our food.

If this administration truly wants to protect people from chemical additives in food that are leading to chronic disease, it will adopt the commonsense measures we have laid out. And while these are far from the only measures FDA must take to improve the safety of our food, they are an important step in the right direction.