As US authorities prepare to end the Generally Recognised As Safe (GRAS) self-affirmation loophole, we look at the history of this “major flaw” in food policy and the implications for food safety going forward.
The EU Novel Foods authorisation process often comes under fire for being lengthy and complex and for thwarting innovation. But, across the Atlantic, growing dissatisfaction with the Food and Drug Administration’s (FDA) laissez-faire approach to the introduction of new ingredients into the food chain and with loopholes in the regulatory framework has led to a backlash and prompted US authorities to finally act.
On 25 September, Congresswoman Rosa DeLauro introduced the Toxic Free Food Act to tackle the ‘General Recognised as Safe’ (GRAS) loophole. The decision comes after long-standing efforts to demonstrate that the loophole’s presence, which allows companies to declare their ingredients as safe without necessarily conducting rigorous safety testing, puts food safety and public health at risk.
The legislation requires the Food and Drug Administration (FDA) to close the GRAS loophole and ensure chemical food additives receive FDA approval and oversight. It would include specific restrictions on substances that cause cancer or human reproductive or developmental toxicity. The FDA is now working to create an assessment system for food chemicals.
Emily Leib, clinical professor of law and founding director of the Harvard Law School Food Law and Policy Clinic, has co-authored several papers on this subject. Talking to Fi Global Insights, she summarised the issues at stake: “I think the root issue is that the current system allows for the use of substances that are GRAS without the need for any pre-market approval by the FDA and does not require companies to notify the FDA when they introduce a new ingredient onto the market,” she said.
“This is providing a really strong incentive on the part of some companies to use substances, and to say they are GRAS to avoid the additive approval process, knowing full well that the FDA isn’t really keeping track of what all those substances are or when and how they are used.”
Whilst the rationale behind the original creation of the exemption was that substances like sugar, flour and pepper did not have to go through an additive approval process, over time, it has increasingly been exploited as a loophole, Leib explained.
“Now, I think that exemption is being over-used,” she said.
The legal framework governing the introduction of new food substances in the US is based on the 1958 Food Additives Amendment (FAA) to the Federal Food, Drug, and Cosmetic Act. The FAA requires that all food additives be vetted for safety by the FDA before their introduction into the food supply.
However, there is also an alternative pathway that has permitted manufacturers to bypass the FDA approval process: substances that are GRAS aren’t required to be approved by the FDA. Manufacturers may determine for themselves that a substance is GRAS, meaning that it has ‘been adequately shown to be safe under the conditions of its intended use’.
The GRAS notification programme provides a voluntary mechanism whereby a company may inform FDA that they have determined a substance as GRAS for a defined use. The FDA may respond with a ‘letter of no objection’ or by stating there is insufficient evidence to substantiate a GRAS designation. If the agency requests additional safety data, the company may comply or withdraw the notification.
“Remarkably, even if a company withdraws a GRAS notification, the manufacturer may still introduce the new ingredient into the food supply as a GRAS substance,” wrote Leib and colleagues, in The New England Journal of Medicine.
Leib’s suspicion is that smaller, less visible companies are less likely to go through the voluntary GRAS notification process, whereas large companies and household brands are following the rules.
“The biggest brands are going through the GRAS notification process because they want to protect themselves but there are so many other food manufacturers and labels that you wouldn’t see in a typical grocery store but who are serving a lot of people through corner shops and other independent outlets. I think there is this huge equity issue around the safety and quality of food,” she said.
The high profile tara flour case exposed this legal loophole and the potential health risks of allowing substances to enter the food chain in this way.
In 2022, a leek and lentil crumble product produced by Daily Harvest was linked to roughly 400 adverse events. An investigation determined that a new ingredient listed on the label - tara flour - was the most likely cause, prompting the FDA to evaluate the regulatory status of the ingredient.
In May this year, the FDA formally published its determination that tara flour in human food does not meet the GRAS standard and is an unapproved food additive. However, critics of the system argue that that this kind of retrospective action just serves to demonstrate how difficult it is to identify any associated risks using passive surveillance.
The advent of technologies such as cellular agriculture, precision fermentation and molecular agriculture are likely to provide further impetus for the FDA to tighten up its approaches for the products of these technologies to enter the food supply.
At present, Leib said that because the FDA has not been clear about which novel technologies GRAS applies to, companies are proactively engaging in dialogue with the agency to make sure they are doing the right thing.
“The more novel processes and products there are out there, the more everyone would benefit, including those companies developing the products, from having clearer pathways,” she said.
“I think we should be investing more in the long-term safety of foods; because there is no tracking of ingredients, we don’t know whether they are causing harm to people’s health over time, or whether substances that are fine in small quantities are problematic when eaten in larger amounts,” noted Leib.
