RFK Jr. pushes to close a food additive loophole – but is a gutted FDA up to the task?

The GRAS system originated with a 1958 amendment to the existing Federal Food, Drug, and Cosmetic (FD&C) Act, which is the bedrock for the federal government’s authority to regulate food and drugs. The Food Additives Amendment was an adjustment that recognized the rapidly increasing complexity of the postwar food system and the dramatic expansion in processed and packaged foods which, thanks to advances in food science, contained new and unfamiliar ingredients like synthetic emulsifiers and preservatives.

Prior to the Food Additives Amendment, new additives were essentially considered safe until proven otherwise, leaving consumers at risk from potentially harmful substances that hadn’t been adequately tested. The amendment flipped that around, requiring safety testing, documentation and approval from the FDA before ingredients could be used in food. However, that threatened to bog down the agency with a backlog of approvals for common ingredients that had been used for years without incident. With this in mind, they created an exemption for ingredients that were “generally recognized as safe among qualified experts” to be exempted from the definition of additives, allowing long-used ingredients such as salt, vinegar or baking powder to skip the approval process.

Initially, GRAS substances were limited to a short, fixed list, one that food manufacturers complained did not reflect the more extensive range of ingredients they had been using widely and that were also considered safe. For the first few years, manufacturers could send letters to the FDA requesting GRAS designation for substances they were already using, though these informal waivers didn’t extend to other manufacturers. Initially, substances new to food still had to undergo the formal approval process laid out in the Food Additives Amendment.

That process changed with the Nixon administration, which ordered a more formal review of GRAS substances. The review committee published detailed reports on the safety of more than 100 substances on the GRAS list, a time-consuming endeavor that nevertheless produced high-quality safety data.

Around this time, companies also started to change their approach to GRAS, viewing it as an alternative route to get new ingredients approved without having to go through the formal additive approval process. To keep up with the volume of new and old substances needing review, the FDA introduced a process called GRAS affirmation, allowing companies to present detailed scientific data for new substances to the FDA rather than waiting for the agency to conduct its own review. While this process was still slow, it marked the beginning of companies using GRAS designation differently from how it was intended.

That shift accelerated in the 1990s, thanks to a wave of deregulatory actions from the Clinton administration that sought to speed up the work of agencies like the FDA, removing costly obstacles for food companies in the process. The FDA dropped the affirmation process in 1997, handing GRAS designation back to the companies and giving them the option — rather than the requirement — to notify the FDA that they had decided a substance was GRAS.

The GRAS loophole

The 1997 decision essentially eliminated the government’s direct oversight of the GRAS designation. The GRAS process now works in the opposite way from how it was intended: Rather than being a time-saving measure for old, well-known ingredients that freed up FDA scientists to conduct thorough reviews on new additives, GRAS has become the preferred way for companies to introduce new ingredients to the food supply without getting bogged down in the formal additive approval process, which companies almost never use today.

While companies are still legally barred from adding harmful substances to food — which theoretically motivates them to behave responsibly to avoid lawsuits — the current GRAS rules allow them to skip the original review process and simply declare new additives GRAS. The fact that notifying the FDA about a GRAS designation is optional means that new substances can make their way into food without any kind of regulatory review or public awareness. Many substances that have self-determined GRAS status might not even appear on an ingredient list because they’re used as processing aids that don’t appear in the final product, even if they do modify the food.

Companies are more likely to submit a GRAS notice when a substance will be listed as an actual ingredient or is a significant part of the product’s marketing, like the soy-derived “heme” that Impossible Foods uses to give its plant-based meat alternatives a bloody taste. But even when companies do file GRAS notifications, there are big problems with the process.

First, they don’t have to provide detailed safety data to the FDA, only summaries and justifications of their own reviews. And those reviews are often conducted by parties that are far from objective. One analysis looked at 451 GRAS notifications submitted from 1997 to 2012, and found that only 64 percent had an external expert panel perform a safety assessment — and all of those panel members had been selected directly by the companies or paid consulting firms. In 22 percent of cases, the safety assessments had been performed by employees of the company themselves. That represents a clear conflict of interest between companies, who want to get products to market quickly, and the safety of the public, who deserve transparent and thorough testing of the food they buy.

About 75 percent of the time that the FDA receives a GRAS notification, the FDA responds with a letter stating they have “no further questions,” essentially rubber stamping the manufacturer’s GRAS declaration. In rare cases where they deem the notification insufficient, they request further information. In most of these cases, companies receive the “no further questions” letter after submitting additional data. Companies can also opt to withdraw their GRAS notification altogether, but this doesn’t keep the ingredient out of food: Though it puts them at risk of fines and other legal action if the ingredient is subsequently found to be unsafe, companies can continue using it, and others could even self-determine GRAS status without notification. In short, there’s no real way for the GRAS notification process to keep additives out of the food supply.

In the decades since the notification process became the standard, companies have overwhelmingly transitioned to using the GRAS system to introduce new ingredients rather than the more time-consuming process of petitioning FDA review. A 2022 report from the Environmental Working Group (EWG) found that since 2000, food companies had only filed ten petitions to recognize and approve new additives. In the same time period, the FDA had received 756 GRAS notices from companies. That number doesn’t include undeclared GRAS designations that companies didn’t bother to report to the FDA, which some estimates put at more than 1,000 substances.