Former FDA commissioners support listing requirement for supplements

Over three years ago, then-FDA commissioner Scott Gottlieb, M.D., announced the agency’s efforts to strengthen its regulation of dietary supplements through modernization and reform.

Gottlieb continues to support efforts to increase FDA’s oversight of the industry, as reflected in an article published last week in JAMA (Journal of the American Medical Association) Health Forum. In the article, Gottlieb and another former FDA commissioner highlighted reforms needed to modernize FDA oversight of cosmetics, diagnostic tests and dietary supplements.

Gottlieb, a senior fellow at the American Enterprise Institute (AEI), and Mark McClellan, M.D., Ph.D., director of the Margolis Center for Health Policy at Duke University, noted FDA does not review or test dietary supplement products before they reach the market, despite a recent survey finding consumers concluded otherwise and conducted by The Pew Charitable Trusts. They also said manufacturers often fail to reveal to consumers and regulators the ingredients in their products.

“The provision to reform the FDA’s oversight of dietary supplements would address this gap by giving the agency authority to require manufacturers to list the ingredients that each product contains,” Gottlieb and McClellan wrote. “Under the new provision, all manufacturers would be required to notify the FDA when a product is introduced or modified and to disclose the composition of ingredients and factors such as a product’s intended dosage and serving size.”

Citing The Pew Charitable Trusts, the former FDA commissioners also said roughly 80% of consumers report using dietary supplements. “Many of them help improve people’s health, but some contain dangerous or unexpected ingredients or may be used in unsafe ways,” Gottlieb and McClellan warned.

They cited an article showing FDA had received about 15,000 adverse event reports linked to dietary supplements between 2004 and 2013, including nearly 4,000 hospitalizations. According to FDA and other experts familiar with post-market surveillance of FDA-regulated commodities, such reports may signal a potential issue with a dietary supplement but do not prove a product caused, or contributed to, a health problem.

FDA’s proposal for mandatory product listing (MPL) for dietary supplements was not included in a recent bill negotiated by Congress to reauthorize FDA-user fee programs and more broadly fund the U.S. government, effectively killing MPL for the time being. But Washington insiders said MPL could be resurrected in an omnibus bill after the Nov. 8 elections.

Other FDA reforms, including those requiring manufacturers of cosmetics to follow good manufacturing practices, also did not make it into a final spending bill signed last month by President Joe Biden.

Gottlieb and McClellan conceded the legislative proposals for reform of supplements, cosmetics and diagnostic tests “are not perfect.”

“Both Democrats and Republicans have raised legitimate concerns, as have some stakeholders, but the relatively small issues that remain could be worked out through the congressional committees that authorize the FDA,” Gottlieb and McClellan concluded. “Congress should seize this opportunity to achieve long-awaited reforms that will modernize FDA’s regulation, promote innovation and provide U.S. consumers greater assurance that the products they use are safe and reliable.”

In February 2019, in a comprehensive statement on FDA’s efforts to strengthen regulation of dietary supplements, Gottlieb said his agency would “engage a public dialogue around whether additional steps to modernize DSHEA [Dietary Supplement Health and Education Act] are necessary.”

He mentioned, for instance, a suggestion by stakeholders to amend the law to add a product listing requirement. At the time, Gottlieb said the market was worth $40 billion and contained as many as 80,000 dietary supplement products.

“A mandatory listing requirement could provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation,” Gottlieb said in the 2019 statement. “It could also help facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.”

Current FDA officials also are in support of MPL, based on comments from Cara Welch, Ph.D., who oversees the Office of Dietary Supplement Programs (ODSP). Speaking at an industry conference in September, Welch said her agency often faces “an information gap about the marketplace.”

She noted FDA doesn’t have a list of all the product labels in the market.

“And to be clear, FDA believes we have a data gap in understanding the extent of the dietary supplement marketplace,” Welch said. “We don’t know all the products that are out there.”

MPL, she added, “would go a long way to address that data gap.”

Industry stakeholders are divided on whether MPL is a good idea. Some stakeholders proclaim a listing requirement will promote transparency, help FDA better monitor and police the marketplace and facilitate the role of responsible retailers in removing harmful products from their brick-and-mortar stores and online platforms. Critics have raised fears that FDA will misuse a label database to restrict access to legitimate dietary supplement products. MPL also will burden responsible manufacturers and is unnecessary considering FDA’s ready access to labels, according to naysayers of the proposal.

Natural Products Insider emailed McClellan directly and the American Enterprise Institute for additional comment from Gottlieb on dietary supplement modernization. Neither email was immediately answered.

Council for Responsible Nutrition (CRN) President and CEO Steve Mister said he welcomed the support of Gottlieb and McClellan for including MPL in an end-of-year omnibus bill.

“As former FDA commissioners, they appreciate more intensely than most that FDA really can’t regulate the industry if it doesn’t have visibility into the market,” Mister said in an email to Natural Products Insider. “The statement by these former commissioners, both of whom served under Republican presidents, underscores the bipartisan nature of this tool. Hopefully it encourages more members of Congress to look at the straightforward nature of the legislation—just show the FDA your labels.”

Natural Products Association (NPA) President and CEO Dan Fabricant, Ph.D., whose organization has been vigorously opposed to MPL, described the article by the former FDA commissioners as “much ado about nothing.”

“With all due respect to Drs. Gottlieb and McClellan, the supplement section of the paper doesn’t have much meat on the bone and is a copy [and] paste from Pew and others,” Fabricant said in an email. “Dr. Gottlieb had the opportunity to advance supplement reform during his time at the agency and didn’t.”

Fabricant, who oversaw what was then called FDA’s Division of Dietary Supplement Programs from 2011 until 2014, said proponents of MPL have failed to explain why a listing is necessary for public health and essential to FDA’s job. He also described as “rhetoric" the idea that FDA “can’t see” what’s in the supplement market.

“[The] reality is that, for those in the trenches, if we look at items like NAC (N-acetyl-L-cysteine) and CBD, FDA can see just fine, but chooses to look at items out of focus or just shut their eyes all together,” he added.

Duffy MacKay, senior vice president of dietary supplements with the Consumer Healthcare Products Association (CHPA), offered a different perspective on MPL and the paper co-authored by Gottlieb and McClellan, who was FDA commissioner from November 2002 until March 2004.

“When experienced and influential health care policy leaders like former FDA commissioners Drs. Gottlieb and McClellan publish statements about the need to reform FDA’s oversight of dietary supplements, it further highlights the urgent need for comprehensive DSHEA reform,” he said in an email. “Responsible parties need to continue working with outside stakeholders on meaningful and rational DSHEA modernization to position the industry for another 30 years of scientific innovation and growth while balancing consumers’ access to safe and beneficial supplements.”

American Herbal Products Association (AHPA) President Michael McGuffin noted the dietary supplement, cosmetics and diagnostic tests reforms Gottlieb and McClellan expressed support for have little in common other than the fact they were ultimately removed from an FDA reauthorization user-fee bill passed this summer by the Senate Committee on Health, Education, Labor and Pensions. 

“If the Congress wishes to consider meaningful reforms for dietary supplements, this should be done in the bright light of day, and not as a product of the time-sensitive dealmaking that will accompany the omnibus legislation’s enactment,” McGuffin said in an email after this article was first published. “The 118th Congress will present ample opportunities to reconsider what amendments, if any, are needed to make sure that Americans have informed and unobstructed access to a wide range of safe and well-regulated dietary supplements—that should be the ultimate goal for consumers, the Congress and the dietary supplement industry.”