Federal regulators areexploring revising the “generally recognized as safe,” or GRAS, system for adding chemicals to the food supply – but what is GRAS, and why is reformoverdue?
GRAS is a regulatory loophole that lets companies add new, potentially harmful additives and other substances to snacks, drinks and more without undergoing the Food and Drug Administration’s safety review. Instead, companies can self-declare their chemicals as safe and bypass federal pre-market review, even if the FDA has never assessed their safety.
When Congress created the GRASfood category in 1958, it was meantto apply only to ingredients widely recognized as safe, such as salt, water, yeast and chicken breast. While the FDA must approve any substance added to food, GRAS ingredients are exempt, leaving food companies to police themselves.
In 1997, the FDA further weakened oversight by creating a voluntary notification system that lets manufacturers bypass federal regulators’ review. Companies can use new GRAS ingredients without informing the FDA. Even if a company does voluntarily notify the agency, it can withdraw the submission for review if the FDA starts asking questions about the company’s safety data – shutting down the review.
Unknown risks
This broken process has led to hundreds of chemicals being added to food products without FDA oversight – and without the public knowing of the potential health risks.
Since 2000, food and chemical companies have used the GRAS loophole and FDA’s voluntary submission process to approve nearly 99 percent of new food chemicals, according to a2022 EWG analysis. But those are just the chemicals we know about. Companies can add substances to food without ever notifying the FDA, leaving both the public and the regulators in the dark.
“We simply do not have the information to vouch for the safety of many of these chemicals,” Michael Taylor, former FDA deputy commissioner for food,said in 2014.
In March, the Department of Health and Human Servicesannounced that the FDA would considerpotentially changing the GRAS system. But the announcement is merely a pledge to “take steps to explore” revising a system that has been broken for more than 60 years, with no concrete proposal.
Health concerns
Experts estimate more than1,000 GRAS substances have entered the food supply without FDA or public knowledge. The FDA and the public know little about their safety, and some known GRAS-designated ingredients are believed to pose significant health risks.
EGCG is a company-determined-GRAS substance often used in food and dietary supplements. It is linked to heart and brain defects, infant leukemia,suppression of estrogen and liver, kidney and intestinal toxicity. Despitethe FDA recognizing these dangers in 2008, it accepted EGCG's GRAS status in 2018 without questioning the health risks.
Companies can also continue using substances they designate as GRAS, even when the FDA expresses concerns.
When the agency questioned the safety of theobromine as a GRAS substance, the company withdrew its notification. Instead, it hired an independent contractor todetermine the substance as GRAS, sidestepping the FDA’s concerns.
Other potentially harmful GRAS substances includepropyl paraben,BHA andBHT, which have all been linked to a range of potential health problems.
Closing the loophole
The GRAS loophole leaves the responsibility of food safety to manufacturers and puts public health at risk. But some in Congress are trying to close it.
Sen. Edward Markey (D-Mass.) introduced theEnsuring Safe and Toxic-Free Foods Act in December 2023. If enacted, it would require food manufacturers to inform the FDA of new GRAS designations. The bill would also ban conflict of interests among experts conducting safety evaluations, prohibit novel substances from claiming GRAS status, and require the FDA to assess certain GRAS substances for safety..
TheFood Chemical Reassessment Act, introduced by Rep. Jan Schakowsky (D-Ill.), would create an FDA Office of Food Safety Reassessment tasked with ensuring the agency reassess the food additives of highest concern and the safety of chemicals already added to the nation’s food supply.
In theNew York legislature, Assemblywoman Anna Kelles and Sen. Brian Kavanaugh have introduced the Food Safety and Chemical Disclosure Act, which would require food and chemical companies to publicly disclose their use of GRAS ingredients and back up their health and safety determinations with scientific data.
The recentHHS announcement could eventually result in changes to the GRAS rule, but without any firm proposals, there’s no real progress toward ensuring our food is safe.
The announcement merely suggests that chemical companies will be required to tell the FDA whenthey, not the FDA, determine that their chemicals are safe to eat. It will not ensure that the FDA will review food chemicals or confirm their safety before they reach our food supply..
Avoiding harmful substances
Here are some tips for avoiding GRAS substances and other food chemicals of concern:
Use EWG’sFood Scores database to find products without GRAS ingredients. It ranks more than 80,000 products on nutrient, ingredient and processing concerns. When you’re on the go, use our Healthy Living app to find products without toxic chemicals.
ConsultEWG’s Dirty Dozen Guide to Food Additives. Many GRAS substances – and their potential harms – are on this list, so try to avoid products that include them.
When possible, choose whole foods to minimize processed and packaged foods to help reduce exposure to chemicals and to plastics in single-use packaging.