February 27, 2023
FDA Commissioner Robert Califf, M.D., supports a requirement that manufacturers of dietary supplements list their products with his agency.
In an FDA Voices blog published Feb. 24, Califf said he hopes “to see an improved framework to appropriately regulate dietary supplements during my tenure.”
“This enormous industry continues to grow, and it’s now part of everyday life for many families,” the commissioner wrote. “Dietary supplements should be required to list with the FDA and companies should be accountable for revealing what is in the supplement being sold.”
“In the long run, we will have more information about the benefits and risks of dietary supplements as our methods of evidence generation improve, and I hope for a regulatory regime that can encourage better information for consumers to be informed about their choices,” Califf added. “Although it will take some time to achieve the optimal regulatory framework, given the size and impact of the industry, we need to constantly update our internal approach and build awareness.”
In the blog, Califf highlighted various topics of importance to his agency, ranging from supply chain issues and diagnostic testing to supplements, FDA advisory committees and chronic diseases.
Califf discussed his support for a listing requirement after one of his subordinates—Cara Welch, Ph.D., FDA’s Director of the Office of Dietary Supplement Programs—articulated the benefits of mandatory product listing (MPL) and addressed key concerns raised by critics in a column published Feb. 7 by Natural Products Insider.
Industry stakeholders have been divided over MPL, as evidenced by a roundtable video debate that Natural Products Insider moderated in 2022.
Last year, U.S. lawmakers incorporated dietary supplement listing requirements in legislation passed by the Senate Committee on Health, Education, Labor & Pensions, including a requirement for FDA to create a public database of dietary supplement products. Ultimately, though, the 117th Congress did not include dietary supplement reform in a final omnibus spending bill.
MPL critic Natural Products Association reacts strongly
Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), which has vigorously opposed MPL, noted dietary supplements were omitted from a recent review of FDA’s human foods program under Califf’s leadership.
Yet the commissioner “now has all sorts of keystrokes on a new regulatory regime based on exactly zero data points,” Fabricant said in an email. “Isn’t [FDA] supposed to be a science-driven agency?”
Fabricant asked why FDA is discussing growth of the dietary supplement industry “as if that’s a negative,” adding he’s never heard the agency say the same thing about another commodity it regulates.
“Apparently, it’s FDA’s job to restrict the size of the industry?” Fabricant asked.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug & Cosmetic Act (FDCA) “to balance safety and choice,” added Fabricant, who oversaw FDA's Division (now "Office") of Dietary Supplement Programs from 2011 until 2014. “It worked, industry has grown, and dietary supplements are one of the safest commodities FDA regulates.”
According to Fabricant, also concerning was the commissioner did not explain how MPL would protect public health.
He also dismissed contentions from supporters of MPL that FDA cannot adequately regulate the market if all dietary supplement products are not listed with the agency. For instance, Fabricant noted FDA can obtain product labels today through its inspections, and he said there is no public-facing database for such FDA-regulated commodities as infant formula and cigarettes.
Council for Responsible Nutrition supports Califf's statement
Steve Mister is president and CEO of the Council for Responsible Nutrition (CRN), which has been one of the most prominent supporters of a listing requirement for dietary supplement products.
"CRN is pleased that Commissioner Califf included dietary supplement listing high on his list of priorities," Mister said. "This tool will give the agency and consumers increased transparency into the supplement marketplace without unreasonable burden or expense to the industry. It will also provide visibility into the ingredients being used, the claims being made, and who manufactures and markets particular products."
CRN manages a database of dietary supplement products called the Supplement OWL, though it’s a voluntary registry.
"CRN is proud of the Supplement OWL and the companies who participate in it, but accountability can only be achieved if the registry is mandatory," Mister said. "Responsible industry members who want a level playing field and more consistent enforcement should support it."
In 2015, Califf commented on DSHEA, dietary supplement regulations
Eight years ago, in answering questions for the record from the late Sen. Orrin Hatch following Califf’s confirmation hearing, Califf discussed FDA’s commitment to enforcing the law applicable to dietary supplements. Natural Products Insider obtained Califf’s responses from NPA, which received them from Hatch’s office in 2015.
“FDA is committed to fully enforcing DSHEA as vigorously as possible to protect the public health,” stated Califf, who is in his second term as FDA commissioner. “Using these authorities, FDA has been able to take significant steps to protect the public, including recent warning letter initiatives related to products containing BMPEA, DMBA, DMAA and pure powdered caffeine.”
Califf also referenced companies’ obligations to report serious adverse events associated with dietary supplement products to FDA under a law passed by Congress in 2007.
“As we receive adverse event information under this system, our ability to recognize trends and patterns in adverse events is helping us target dangerous products or categories of products,” he said.
“Sounds like the law works just as intended,” Fabricant commented, quoting Califf’s responses above.
In the same responses to Hatch, Califf observed FDA bears the burden of proof to take action against unsafe supplement products. He also noted “dietary supplement manufacturers and distributors are not required to inform the agency of most products they sell prior to marketing.”
“This creates enforcement challenges for FDA in discovering violations within a huge universe of dietary supplements, proving the violation and effectively deterring future bad actors,” Califf concluded.
Former FDA commissioners recommended MPL
Two former FDA commissioners also expressed their support for a listing requirement in an article published last year in the Journal of the American Medical Association (JAMA).
Scott Gottlieb, M.D., 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 in JAMA. “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.
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