Health Secretary Robert F. Kennedy Jr. has said he takes so many dietary supplements that he can’t recall all of them.
The makers of those vitamins say they could be collateral damage in Kennedy’s campaign to Make America Healthy Again.
Four major dietary supplement makers and trade associations that represent them have been lobbying and meeting with Food and Drug Administration regulators over a pending regulation to close or narrow a loophole Kennedy has called a “scandal.”
He’s referring to a system where processed food makers can skip FDA review of thousands of ingredients merely by declaring an ingredient is “generally recognized as safe,” or GRAS. But manufacturers of supplements – which sell a range of products from traditional vitamins to things like protein powders or peptides – also rely heavily on the GRAS loophole.
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The White House has been reviewing a regulation for six months that could narrow or close the GRAS loophole, prompting a surge of lobbying by companies along the U.S. food supply chain. Supplement makers told NOTUS that requiring the FDA to review GRAS ingredients could hamper their ability to quickly bring new products to market.
“I think it’s quite possible [the administration] was not aware of how important GRAS is to dietary supplements,” said Steve Mister, president of the Counsel for Responsible Nutrition, which represents dietary supplements and the functional food industry.
“If done wrong, this could create a really big mess,” said David Spangler, a senior vice president at the Consumer Healthcare Products Association, which represents over-the-counter medicines including supplements.
An FDA spokesman noted the agency held a public stakeholder meeting in March on the dietary supplement marketplace but didn’t answer a question about whether dietary supplement makers would get a carve-out in the pending regulation.
Once a GRAS ingredient has been used in a food, it can also be used in a supplement, sometimes in much larger quantities. Supplement makers have been known to introduce a new ingredient into a food just so they can then use it in a pill or powder as little as one month later.
Yet MAHA leaders and Kennedy, whose daily regimen includes vitamin D and omega-3 fatty acids, champion supplements even as they lament too little oversight of food. Kennedy adviser Calley Means cofounded a company that helps people buy supplements using tax-free health savings accounts. Wellness influencers including Andrew Huberman and Mark Hyman regularly praise them.
“This has been morphed and twisted into a way to introduce any type of chemical the company wants into a dietary supplement,” Pieter Cohen, a professor of medicine at Harvard Medical School, said of the GRAS loophole.
“There’s been this cognitive dissonance,” Cohen said. “When we take large amounts of unproven chemicals and put them in supplements, that is seen as universally good.”
Executives with both trade groups met with FDA officials about the proposed rule in January and February, according to meeting records posted on the White House Office of Management and Budget website.
So did executives with three major supplement makers: Proctor & Gamble, which sells several supplements including the Metamucil; Pharmavite, maker of Nature Made, the largest line of dietary supplements in the United States; and DSM-Firmenich, a Dutch company that supplies the vitamins that go into virtually every multivitamin sold in the U.S.
Proctor & Gamble and Pharmavite started lobbying on GRAS in the past year. So did pet supplement maker Nutramax. That company paid lobbying firm Alston & Bird $50,000 in the first quarter for the services of lobbyist Sam Jockel, previously a fellow at FDA and a trial attorney in the Agriculture Department’s Office of General Counsel.
And DSM-Firmenich has been paying the firm Invariant $80,000 each quarter to lobby the FDA, HHS, the White House and Congress on “the importance of domestic vitamins to food security” and other issues.
None of the companies nor Jockel replied to a request for comment.
The dietary supplements industry has ballooned over the past few decades, largely unregulated. While drugmakers must prove to the FDA their medicines are safe and effective, supplement makers largely operate under the radar. A 1994 law intended to regulate the industry instead gave them pathways to put new products on the market with virtually no government review.
Mister and Spangler, with the trade groups, said they’re in favor of more transparency, like the FDA requiring companies to publicly list new supplements and the ingredients in them. That’s similar to the position taken by the larger processed-food industry, which says it’s fine with transparency but doesn’t want the FDA to demand to review products.
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