RFK Jr.'s Ingredient ‘Loophole’ Fix Draws Food Sector Pushback

Food and dietary supplement makers are pushing back as the Trump administration considers eliminating a pathway that allows companies to self-assess whether new ingredients are safe without federal review.

In letters and meetings with the White House office responsible for reviewing regulations, industry groups have questioned whether the Food and Drug Administration has the legal authority to change how substances make it into food when they’re designated as “Generally Recognized as Safe,” or GRAS.

Urgency to influence swelled as the Office of Management and Budget’s 90-day review period ended Sunday, though officials haven’t yet cleared the proposal. Industry concern highlights the tension between a generally deregulatory administration and Health and Human Services Secretary Robert F. Kennedy Jr., who’s railed against food industry practices including self-determining GRAS status as a “loophole” the government must close to make the food supply safer.

“Any new ingredient has to go through an approval process and has to have proof of safety,” Kennedy said at a Feb. 26 event in Austin, Texas. “We’re also going back and making all of those companies show the data that they relied on.”

FDA exempts additives experts determine are safe for their intended use under the GRAS standard from undergoing a federal pre-market safety review. The FDA’s first list of GRAS substances released in 1958 included baking soda, vinegar, and common spices.

Today, the list of substances allowed in US food has ballooned to more than 10,000, and food companies can choose whether to notify regulators that they’ve deemed a new additive to be safe. The FDA’s proposal would make notifications mandatory and publish a database of notices.

“What has perhaps taken industry by surprise is the fact that the proposed rule was drafted so quickly,” said Brian Sylvester, a Morrison Foerster partner who leads the firm’s food regulatory work. “It is a key talking point under the MAHA agenda, but at the same time, there are ways to go about doing it in a thoughtful and considered way.”

Industry warned White House officials that the time lost as FDA makes companies wait to roll out new ingredients until the agency responds to a GRAS notification would make innovation untenable.

Some health advocates, however, encouraged the FDA to establish a pre-market safety approval process for any GRAS substance.

Bloomberg Law investigated the GRAS system in 2023 and found several chemicals in food not reviewed by the agency that sickened, and even hospitalized, some people across the US.

Mark Hartman, director of FDA’s Office of Food Chemical Safety, Dietary Supplements, and Innovation, told American Chemistry Council conference-goers on Feb. 24 he hopes his agency can publish the regulation in late spring or early summer.

‘A Veiled Threat’

Food manufacturers warn a mandatory GRAS notification system could exceed the agency’s regulatory powers under the Food, Drug, and Cosmetic Act (FDCA), depending on its scope.

Asking companies to wait for FDA review after submitting GRAS notifications “risks legal challenge,” the International Food Additives Council and nearly a dozen other food groups warned in a Dec. 16 letter. The council declined to comment, referring Bloomberg Law to the National Association of Manufacturers.

The Consumer Healthcare Products Association, which represents dietary supplement makers, said in a Jan. 28 letter Congress should be in charge of restructuring the GRAS pathway.

David Spangler, the association’s senior vice president of legal, government affairs, and policy, said in an interview the group’s concerned about the agency creating “chaos in the market” if industry has to wait to roll out new ingredients.

“We’re not necessarily opposed to a registry—i.e., giving FDA lists—as opposed to some sort of FDA review” with a waiting period, Spangler said.

Consumer advocacy group Center for Science in the Public Interest, on the other hand, pushed the administration during its meeting on the proposal to go further than compiling a list of GRAS substances.

Jensen Jose, the center’s regulatory council, said he highlighted a new ingredient petition process under the FDCA in disagreeing with industry’s interpretation that bolstering GRAS oversight would exceed FDA’s authority.

“What was the purpose of creating an entire food additive petition process if everything can be exempted from it?” Jose said.

Jose said the legal pushback illustrated how accustomed manufacturers have become to self-affirming an ingredient’s safety.

“Who’s going to be the one that’s going to litigate them?” Jose said. “It’s obviously going to be industry.”

“So it’s like a veiled threat,” he said.

Limited Resources

Whether FDA has the resources to handle an influx of notifications is another concern.

A voluntary GRAS notification takes more than a year on average to receive a response from FDA officials, according to a National Association of Manufacturers Feb. 25 analysis of GRAS notices.

Making GRAS notifications mandatory means “the review timeline is going to be not even close to where it is right now,” said Ashish Talati, founder of the FDA-focused Talati Law Firm PLLC.

Eliminating industry’s self-affirmed GRAS pathway could increase the number of new dietary supplement ingredient notifications FDA fields, Cara Welch, who directs the agency’s Office of Dietary Supplement Programs, said during a Jan. 28 webinar with the Natural Products Association.

That’s because some dietary supplement makers have circumvented FDA’s mandate to alert it of new dietary ingredients going to market by self-determining those substances qualify as GRAS, Talati said.

“They would have nowhere near the staff to handle” increased notifications, Spangler said.

The FDA has lost more than 4,000 employees since the start of fiscal 2025 as the Trump administration has moved to shrink the federal workforce, according to federal data.

Amid questions about how FDA will overhaul the GRAS pathway, regulators are still far out from producing a final and enforceable rule.

That hasn’t stopped companies from reassessing their ingredient development pipelines and ensuring paperwork on GRAS-designated substances is in order.

“Many companies are proactively working on this, because obviously no one wants to basically get caught off guard,” Talati said.