More than three years ago, then-FDA Commissioner Scott Gottlieb, MD, announced the agency’s efforts to strengthen its regulation of dietary supplements through modernization and reform.
Gottlieb continues to support efforts to increase FDA oversight of the industry, as evidenced in an article published last week in the JAMA (Journal of the American Medical Association) Health Forum. In the article, Gottlieb and another former FDA commissioner outlined the reforms needed to modernize FDA oversight of cosmetics, diagnostic tests, and dietary supplements.
Gottlieb, principal investigator at the American Enterprise Institute (AEI), and Mark McClellan, MD, Ph.D., director of the Margolis Center for Health Policy at Duke University, noted that the FDA does not review or test dietary supplements before they hit the market, despite a recent survey that consumers concluded otherwise, conducted by The Pew Charitable Trusts. They also said manufacturers often fail to reveal the ingredients of their products to consumers and regulators.
“The provision to reform FDA oversight of dietary supplements would close this gap by giving the agency the power to require manufacturers to list the ingredients in each product,” Gottlieb and McClellan wrote. “Under the new provision, all manufacturers would be required to notify the FDA when a product is introduced or changed and to disclose the composition of ingredients and factors such as a product’s intended dosage and the size of the product. portion.”
Citing The Pew Charitable Trusts, former FDA commissioners also said that about 80% of consumers report using dietary supplements. “Many of them help improve people’s health, but some contain dangerous or unexpected ingredients or can be used in dangerous ways,” Gottlieb and McClellan warned.
They cited an article showing that the FDA received about 15,000 reports of adverse events related to dietary supplements between 2004 and 2013, including nearly 4,000 hospitalizations. According to the FDA and other experts familiar with postmarketing surveillance of FDA-regulated products, such reports may signal a potential problem with a dietary supplement, but do not prove that a product caused or contributed to a problem. health.
The FDA’s mandatory product list (MPL) proposal for dietary supplements was not included in a recent congressional-negotiated bill to reauthorize FDA user fee programs and fund the broader US government, thus killing the MPL for the time being. But Washington insiders said the MPL could be resurrected in an omnibus bill after the Nov. 8 election.
Other FDA reforms, including those requiring cosmetics makers to follow good manufacturing practices, were also not part of a final spending bill signed last month by President Joe Biden. .
Gottlieb and McClellan conceded that legislative proposals to reform supplements, cosmetics and diagnostic tests “are not perfect.”
“Democrats and Republicans have raised legitimate concerns, as have some stakeholders, but the remaining relatively minor issues could be addressed by congressional committees that authorize the FDA,” Gottlieb and McClellan concluded. “Congress should seize this opportunity to deliver long-awaited reforms that will modernize FDA regulations, foster innovation, and provide American consumers with greater assurance that the products they use are safe and reliable.”
In February 2019, in a detailed statement on the FDA’s efforts to strengthen regulation of dietary supplements, Gottlieb said his agency would “engage in a public dialogue on whether additional steps to modernize the DSHEA [Dietary Supplement Health and Education Act] are necessary.”
He mentioned, for example, a stakeholder suggestion to amend the law to add a requirement for product registration. At the time, Gottlieb said the market was worth $40 billion and contained as many as 80,000 dietary supplement products.
“A mandatory registration requirement could provide significant benefits by improving market transparency and promoting risk-based regulation,” Gottlieb said in the 2019 statement. “It could also help facilitate effective enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence across the industry.”
Current FDA officials also support the 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 his agency often struggles with “a lack of market information.”
She noted that the FDA does not have a list of all product labels on the market.
“And to be clear, the FDA thinks we have a lack of data to understand the scope of the dietary supplement market,” Welch said. “We don’t know all the products that exist.”
MPL, she added, “would go a long way to filling this data gap.”
Industry stakeholders are divided on whether MPL is a good idea. Some stakeholders claim that a listing requirement will promote transparency, help the FDA better monitor and police the market, and facilitate the role of responsible retailers in removing harmful products from their physical stores and online platforms. Critics have raised concerns that the FDA is misusing a database of labels to restrict access to legitimate dietary supplements. The MPL will also burden responsible manufacturers and is unnecessary given the FDA’s easy access to labels, say opponents of the proposal.
Natural Products Insider emailed McClellan and the American Enterprise Institute directly for additional feedback from Gottlieb on the dietary supplement modernization. Neither email received an immediate response.
Council for Responsible Nutrition (CRN) President and CEO Steve Mister said he welcomes Gottlieb and McClellan’s support for the inclusion of MPL in a year-end omnibus bill. .
“As former commissioners of the FDA, they appreciate more intensely than most that the FDA really can’t regulate the industry if it doesn’t have market visibility,” Mister said in an email. at Natural Products Insider. “The statement from these former commissioners, who both served under Republican presidents, underscores the bipartisan nature of this tool. Hopefully this will encourage more members of Congress to consider the simple nature of the legislation – just show the FDA your labels.
The president and CEO of the Natural Products Association (NPA), Dan Fabricator, Ph.D., whose organization vigorously opposed MPL, described the paper by former FDA commissioners as “much noise for nothing”.
“With all due respect to Drs. Gottlieb and McClellan, the supplements section of the journal doesn’t have much meat on the bone and is a copycat [and] paste from Pew and others,” Manufacturer said in an email. “Dr. Gottlieb had the opportunity to advance supplement reform while at the agency and failed to do so.
Manufacturer, who oversaw what was then called the FDA’s Dietary Supplement Programs Division from 2011 to 2014, said MPL supporters have not explained why a list is necessary for public health and essential to the FDA work. He also called “rhetorical” the idea that the FDA “can’t see” what’s on the supplement market.
“[The] the reality is, for those in the trenches, if we look at things like NAC (N-acetyl-L-cysteine) and CBD, the FDA can see just fine, but chooses to look at the fuzzy things or just close our 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 article co-authored by Gottlieb and McClellan, who served as FDA commissioner from November 2002 to March 2004.
“When experienced and influential health care policy makers, such as former FDA commissioners Drs. in addition to the urgent need for a comprehensive reform of DSHEA,” he said in an email. “Responsible parties must continue to work with external stakeholders on a meaningful and rational modernization of DSHEA in order to position the industry for another 30 years of scientific innovation and growth while balancing consumer access to safe and beneficial supplements.”
American Herbal Products Association (AHPA) President Michael McGuffin noted that dietary supplement, cosmetic, and diagnostic testing reforms Gottlieb and McClellan expressed support for having little in common other than that they were eventually removed from an FDA reauthorization user fee bill passed this summer by the Senate Committee on Health, Education, Labor and Pensions.
“If Congress wishes to consider meaningful dietary supplement reforms, it should be done in broad daylight, not as the product of the urgent deal that will accompany the enactment of the omnibus legislation,” McGuffin said in an email. after this article was first published. “The 118th Congress will provide ample opportunity to reconsider amendments, if any, necessary to ensure that Americans have informed and unimpeded access to a wide range of safe and well-regulated dietary supplements – that should be the goal. ultimate for consumers, Congress and the dietary supplement industry.