Two Bills in Congress Seek to ‘Close GRAS Loophole’

Two separate, distinct bills introduced in the Senate and in the House of Representatives seek, proactively or retroactively, to eliminate the GRAS (Generally Recognized As Safe) self-affirmation pathway to market for food ingredients. This pathway to market enables firms to market new ingredients without providing documentation for the U.S. Food and Drug Administration (FDA) to conduct a pre-market review.

The Senate Bill

A bill introduced by Senators Ed Markey (D-MA) and Cory Booker (D-NJ), the Ensuring Safe and Toxic Free Foods Act, would eliminate the self-affirmation GRAS pathway. Instead, it would require that manufacturers seeking a GRAS designation provide the U.S. Department of Health and Human Services (HHS) with information on new ingredients 90 days prior to going to market.

The information would be publicly available, and the law prohibits carcinogenic substances or those that show evidence of reproductive toxicity from receiving a GRAS designation.

None of the more than 1,000 substances that are already marketed through the self-affirmed GRAS pathway would be exempt; the bill would allow firms two years to provide appropriate information to FDA for review. Further, the bill prohibits people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations.

“Our legislation ensures the FDA has the authority it needs to fulfill their responsibility to guarantee the food we eat is safe, free from substances that cause cancer and harm development,” stated Markey. “It is long past time that we revise existing food safety measures and close the loophole that allows manufacturers to self-regulate which new substances enter our food supply and our bodies.”

“It is unacceptable that hundreds of new chemicals have entered the food supply without the FDA requiring an independent, scientific review of their safety. This has led to the use of ingredients that have evidence of carcinogenicity or endocrine disruption in thousands of food products,” said Booker.

The bill was endorsed by the Environmental Defense Fund, the Environmental Working Group, and Center for Science in the Public Interest.

“We must not allow toxic additives to slip through the GRAS loophole and stay in the food supply for decades without getting reassessed for safety. EDF appreciates Senator Markey’s years of leadership on this critical issue to protect Americans’ health,” said Maria Doa, senior director of chemicals policy at the Environmental Defense Fund.

“EWG applauds the reintroduction of the Ensuring Safe and Toxic-Free Foods Act. For too long, food and chemical companies have exploited loopholes that allow them, not the FDA, to decide what is safe. This bill restores common sense to our federal food chemical regulations and will help ensure that the chemicals added to our food are safe,” said Melanie Benesh, vice president of government affairs at the Environmental Working Group.

 “The Ensuring Safe and Toxic-Free Foods Act of 2025 will finally close the GRAS loophole by requiring meaningful independent, science-based safety review by the FDA,” said Anupama Joshi, vice president of programs for the Center for Science in the Public Interest.

The House Bill

Separately, Reps. Jan Schakowsky (IL-09) and Rosa Delauro (CT-03) introduced the Food Chemical Reassessment Act of 2025, which would require FDA to study 10 chemicals that went through the self-affirmed GRAS pathway in the past, every three years.

The reviews would start with:

• Tertbutylhydroquinone (TBHQ)
• Titanium dioxide
• Red No. 40
• Yellow No. 5
• Blue No. 1
• Blue No. 2
• Green No. 3
• Perchlorate
• Butylated hydroxyanisole (BHA)
• Butylated hydroxytoluene (BHT)
• Trichloroethylene
• Methylene chloride
• Benzene
• Ethylene chloride
• Propyl gallate
• Sodium nitrite
• Sodium benzoate

The bill would re-establish the Food Advisory Council to advise FDA on the best methods to review food chemical safety.

“Consumers deserve to know that the foods they are eating are safe, but right now, thousands of harmful chemicals in our food are going unchecked and the food industry is regulating itself,” said Schakowsky. “That is why I am reintroducing the Food Chemical Reassessment Act with my colleague, Rep. Rosa DeLauro, to require the FDA to consistently assess the chemicals that are added to our food. It’s time to put the ‘F’ back in the FDA, and this bill is an important step in ensuring we get toxic chemicals out of our food.”

“Food safety is a second-class citizen at the Food and Drug Administration (FDA). Unlike other common products and chemicals such as fertilizer or pesticides, the FDA is not required to reassess approved food substances even as new science emerges,” said DeLauro. “It is time for the FDA to fully commit to its mission of protecting public health and ensuring the food we eat is safe for consumption, especially as the Trump Administration seeks to decimate the agency by firing 3,500 staff.”

The House bill was endorsed by the Center for Science in the Public Interest, Consumer Reports, Environmental Working Group, Environmental Defense Fund, and Food and Water Watch.

These two bills come shortly after HHS Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking to eliminate the self-affirmed GRAS process, also expressing willingness to work alongside Congress on the matter.