Food and chemical companies are permitted to approve the use of new potentially harmful additives and other substances in snacks, drinks and more without the Food and Drug Administration’s review and approval – all thanks to a regulatory loophole known as the GRAS rule.
GRAS, or “generally recognized as safe,” is a food category created by Congress in 1958. The GRAS designation was intended to apply to ingredients widely recognized to be safe, such as salt, water, yeast and chicken breast. So even though usually the FDA must approve any substance intentionally added to food, that’s not the case if it’s GRAS.
Once declared GRAS, an ingredient can bypass the FDA’s pre-market review process, allowing chemicals to be used in food, even if the FDA has never determined they are safe.
The GRAS rule, finalized in 1997, created a voluntary notification system that lets manufacturers bypass federal regulators’ review. Companies can identify and use new GRAS ingredients but are not required to share this information with the FDA.
This process has led to the addition of hundreds of chemicals to food products without FDA oversight.
Since 2000, food and chemical companies have used the GRAS loophole to approve 99 percent of new food chemicals, according to a 2022 EWG analysis. It leaves both the public and the FDA in the dark about the substances in our food.
“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.
The FDA recommends companies document the data that led to a GRAS determination and provide the information to the agency. But this is a purely voluntary suggestion. The GRAS rule doesn’t require it.
Health effects
Experts estimate more than 1,000 GRAS substances have entered the food supply without FDA or public knowledge. The FDA and the public know little about the safety of these ingredients. And other 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 toxicity in the liver, kidneys and intestine. Even though the FDA acknowledged these dangers in 2008, it accepted EGCG's GRAS status in 2018 with no questions asked.
Companies can also continue using substances they designate as GRAS, even when the FDA does raise concerns about health risks.
When the agency questioned a company’s request to approve theobromine as a GRAS substance, the company withdrew its notification. Instead, it had an independent contractor determine that the substance is GRAS, without ever addressing the FDA’s concerns.
Other potentially harmful GRAS substances include propyl paraben, BHA and BHT, 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 the nation’s consumers at risk. But some in Congress are trying to close it.
Sen. Edward Markey (D-Mass.) introduced the Ensuring Safe and Toxic-Free Foods Act in December 2023. If enacted, food manufacturers would have to inform the FDA of new GRAS designations. The bill would also ban conflict of interests among experts participating in safety evaluations.
And the Food Chemical Reassessment Act, introduced by Rep. Jan Schakowsky (D-Ill.), aims to establish 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.
Avoiding harmful GRAS substances
Here are some tips for avoiding GRAS substances and other food chemicals of concern:
- Use EWG’s Food 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.
- Consult EWG’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.
