‘A Lobster Trap’ for Chemicals: Critics Slam New Efforts To Close GRAS Loophole

Over the past few weeks, both politicians and Big Food have taken initial steps to influence the future of the GRAS process, and their efforts have immediately drawn criticism as industry watchdogs call out the contradictory nature of those proposals.

Politicians and non-profits alike have long argued that the Generally Recognized As Safe (GRAS) self-certification process, also known as the GRAS loophole, should be closed. The process allows food manufacturers to introduce new ingredients to the market without informing the U.S. Food and Drug Administration (FDA) or making public disclosures about the safety of those inputs.

On Thursday, Senator Roger Marshall (R-KS) introduced the Better Food Disclosure Act (The Better FDA), claiming the legislation would require food companies to inform the FDA about new ingredients being used and strengthen the post-market review process for ingredients already in the food supply.

“While we remain committed to working with everyone to establish a strong national standard of ingredient safety, we cannot ignore the reality that our current federal oversight is inadequate – and states have stepped up to hold both food companies and Washington accountable,” Marshall said in a statement. “If food truly is medicine, then it’s time we treat it with the urgency and seriousness it deserves.”

Marshall is also founder and co-chair of the Make America Healthy Again (MAHA) Caucus, a group of legislators responsible for developing policy to address the goals of Health and Human Services Secretary Robert F. Kennedy Jr.’s MAHA Coalition. Senators Rick Scott (R-FL) and Katie Britt (R-AL) co-sponsored the bill, and the action received praise from MAHA influencers such as Vani Hari (Food Babe) and Food Is Medicine Institute director Dr. Dariush Mozaffarian.

However, critics claim the bill would do the opposite of what it proposes and “actually cements the current ineffective loophole into law,” said Sarah Sorscher, director of regulatory affairs at The Center for Science for the Public Interest (CSPI). Marshall claims the Better FDA would allow Americans to petition the FDA to review ingredients already in the food supply, but that feature has always been permitted under the current GRAS process, Sorscher noted.

The organization, as well as the Environmental Working Group (EWG), highlighted that while food companies will be required to submit notices about new ingredient uses, if FDA does not take action within 180 days then the additive is automatically approved for use in food. The Better FDA amends GRAS so that in order to remove a chemical from the food supply, the FDA would have to go through a public notice and comment period before removing the ingredient, rather than just withdrawing it and making a public statement, which has been the process until now.

That means it will be just as easy for new ingredients to enter the market, but much more difficult for them to be removed, CSPI and EWG argue. The bill does not set quality or quantity standards around the safety information required to make a GRAS notification, including no recognizable provisions for disclosures made by experts who may have a conflict of interest. According to EWG, the bill also follows a 19% staffing reduction at the FDA and does not include any funding mechanism to ensure safety review teams are staffed and resourced.

“The bill is like a lobster trap: Chemicals slide in easily by default, but a ton of process is needed to ban them, ensuring an exhausted FDA will struggle to take effective action,” said Sorscher. “This bill is not meaningful chemical safety reform. It’s a trap to kill a chemical safety movement.”

The proposed legislation follows a wave of action at the state-level where laws have been passed to restrict the use of various food additives such as synthetic dyes and preservatives. According to EWG, 17 MAHA initiative-based bills have been adopted at the state level so far this year, with 50 bills still currently active in statehouses around the country.

That has left behind a patchwork of regulation for manufacturers to navigate. Just a week before Marshall’s bill was introduced, major conglomerates including Nestlé, Coca-Cola, General Mills, Hormel and PepsiCo formed the Americans for Ingredient Transparency coalition.

This group’s primary, stated goal is to eliminate those preemptive state-level efforts, meaning that the federal government would have the final say on ingredient safety, assessments, registration, reporting and labeling requirements.

“Let’s be clear, [Americans for Ingredient Transparency] has nothing to do with transparency. This is about protecting corporate profits and keeping consumers in the dark about toxic chemicals in their food,” said Scott Faber, SVP of government affairs at EWG. “Families deserve the truth about what’s in their food, not another slick PR campaign cooked up by industry to deceive the public and roll back state food safety laws. If this group is being honest, it would call itself ‘Corporations for Ingredient Toxicity.’”