In his quest to overhaul the food system, Health Secretary Robert F. Kennedy Jr. has vowed to close a loophole that allows food and dietary supplement companies to independently determine whether new ingredients are safe.
But the plan is facing stiff pushback from the industry, with lawyers and executives already warning of lawsuits before an official proposal has been unveiled.
The “generally recognized as safe” designation, or GRAS, allows companies to bypass government notification and review. It has ushered an unknown number of substances, believed to be in the thousands, into the U.S. food supply. The GRAS provision was envisioned in 1958 to apply to well-understood ingredients such as vinegar and baking soda.
Though advocates of more thorough food oversight and their allies on the political left have long pushed for such a change, Mr. Kennedy and his team have been able to garner widespread support for food reform and have the power to implement it. Their actions are beginning to push past the industry’s comfort zone.
Lawyers for several food companies and industry groups said that mandating notices, which can exceed 100 pages in length, for all new ingredients are too much to ask. They contend that the Food and Drug Administration moves too slowly and would hamper the innovation that people expect from their food and drinks.
“If F.D.A. would come in and say, You have to file it with us — it’s not what the law says,” said Todd A. Harrison, a lawyer in Washington who represents food and dietary supplement makers for the firm Venable. He added that if the industry sued over such a requirement, “I think F.D.A. loses that case.”
The resistance from companies is emerging as the work of formulating a policy is in full swing, with Mr. Kennedy’s team pivoting from brokering handshake deals to the tedious work of governing.
Mr. Kennedy has not weighed in publicly on the conflict. Instead, he falsely claimed in a podcast that aired on Monday that the GRAS provision had already been eliminated.
“We’ve changed the GRAS loophole so that we’ve closed it,” Mr. Kennedy said in the episode of “The Bossticks.” “So the new ingredients have to show safety studies.”
Richard Danker, a spokesman for the Department of Health and Human Services, said Mr. Kennedy “was referring to our proposed GRAS rule making and its potential application if finalized.”
The effort is still in the early stages, awaiting White House clearance before it is published as a proposed rule. It would then face additional hurdles before it is made final.
States have gone further in trying to regulate food ingredients. West Virginia passed a law that would ban dyes in food in 2028. Texas passed legislation requiring warning labels on food with certain dyes and preservatives. The food industry has challenged both in court.
“I think state action is a tactic that MAHA has leveraged really successfully,” said Melanie Benesh, vice president for government affairs for the nonprofit Environmental Working Group, who has written about problems with the ingredient review. “At the federal level, we just have not yet seen that kind of lasting, enforceable regulatory action.”
A senior F.D.A. official, who requested anonymity to discuss the agency’s internal deliberations, said the agency believed its plan to heighten the oversight of food ingredients was on solid legal ground. The proposal the agency sent to the White House would require notices for new ingredients that would then be reviewed by F.D.A. scientists.
Generally, major corporations have sought an F.D.A. seal of approval for new ingredients by submitting dossiers describing novel substances. The agency has responded to many of these notices with a “no questions” letter, the closest to an approval. In other cases, the agency has asked for additional information. For substances like CBD and tianeptine, known as gas-station heroin, the F.D.A. has determined that the ingredients are not generally recognized as safe.
The F.D.A. official said the new plan would apply a similar level of review to all new ingredients, not just the subset that is voluntarily submitted or that requires approval, like food dyes. The agency would also ask companies to identify substances that they had deemed safe in the past and to make the information available to the public.
Supporters of mandatory new ingredient notices point to what happened with tara flour, an ingredient imported from Peru that was used by a subscription meal service in 2022. The flour sickened more than 300 people, causing fever, nausea, vomiting and, in some cases, liver damage.
When the F.D.A. began to investigate the outbreak, officials discovered that no notice about the new ingredient had been filed. In 2024, they ultimately concluded that tara flour was not “generally recognized as safe.”
“It really concerns me that industry can essentially introduce any kind of chemical or ingredient into the food supply, and we don’t know that it’s there and we don’t know what it is, and we don’t know if it’s going to harm health or not,” said Dr. James Krieger, the founding executive director of Health Food America, a nonprofit organization that met with the White House about the proposal.
Other aspects of the GRAS policy’s evolution have alarmed food safety professionals. Some companies have been questioned by the F.D.A. after notifying it of their intent to introduce a new ingredient but have then proceeded to ignore the agency and market the ingredient anyway.
In other cases, the makers of dietary supplements have put a new chemical in a food or beverage and created an internal file saying that the ingredient was recognized as safe. Some have also gone further, bypassing other agency rules for supplements and marketing the substance in pill form.
“It is an insane regulatory system,” Ms. Benesh said.
Still, a number of companies have alerted the White House to their concerns about changing the policy to require mandatory ingredient notices and reviews. A principal concern is whether the F.D.A.’s food division has enough scientists on staff to review a massive influx of notices.
The agency would be exceeding its authority and would be likely to draw litigation if mandatory notices were required, a letter from trade groups representing bakers, tree nut processors, chemical distributors and others said. Such a change would also create practical problems, the groups said.
“Requiring notifications for every GRAS conclusion would significantly increase administrative and legal burdens, slow innovation, delay market entry and disproportionately affect small and mid-sized firms,” said the letter, which was addressed to White House officials who review proposed rules.
The Consumer Healthcare Products Association, which represents dietary supplement makers, also told the White House that it was on shaky legal ground to require new ingredient reviews: “If F.D.A. seeks to change the structure of the GRAS program, congressional action would be required,” the association wrote in its letter to White House officials.
The organization said the F.D.A. should instead direct its limited resources toward creating a directory of ingredients and working to remove those deemed to be unsafe.
Some federal lawmakers have introduced bills to mandate new ingredient notices and reviews, allowing federal officials to sidestep litigation threats for overstepping the bounds of the 1958 law that implemented the “generally safe” designation.
Whether lawmakers show the resolve to support the effort will be a test, according to Vani Hari, a leader of the “Make America Healthy Again” movement who is known on social media as Food Babe. She wants bans put in place on artificial colors as well as on a dozen more ingredients that are not allowed in other countries.
“This is an interesting moment,” Ms. Hari said. “This will determine how serious our politicians in Washington are about being behind the MAHA movement and getting the chemicals out of our food.”
Julie Creswell contributed reporting.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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