Josh Long, Associate editorial director, Natural Products Insider

September 22, 2022

3 Min Read
FDA faces 'information gap' on supplements marketplace

An FDA official said Wednesday her agency is continuing to move “forward on some policies to strengthen and modernize FDA’s regulation of dietary supplements,” but she said FDA often faces “an information gap about the marketplace.”

Cara Welch, Ph.D., who directs the Office of Dietary Supplement Programs (ODSP), also mentioned FDA’s proposal requiring dietary supplement products to be listed with FDA.

FDA’s proposal for mandatory product listing (MPL) was reflected in a standalone bill introduced in April by Sen. Dick Durbin (D-Ill.) and incorporated in a larger FDA user-fee bill passed this summer by the Senate Committee on Health, Education, Labor & Pensions (HELP).

Industry stakeholders, however, recently said it's becoming increasingly improbable that mandatory product listing language for dietary supplements will be included in an FDA user-fee bill passed by Congress, making it likely that MPL legislation will be put on the back burner until at least after the Nov. 8 elections. Senate health committee leaders said they are trying to add user-fee reauthorization language to a continuing resolution that would continue to fund the government, Bloomberg Law reported last week.

Speaking Wednesday during the Regulatory, Scientific & Quality Conference hosted by the Consumer Healthcare Products Association (CHPA), Welch said the dietary supplement industry has grown substantially since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), including over the last five years.

Related:Sen. Durbin advocates for dietary supplement product listing in FDA user-fee bill

According to Nutrition Business Journal’s Supplement Business Report 2022, dietary supplement sales in the U.S. grew 7.5% in 2021 to reach nearly US$60 billion.

FDA obtains information on dietary supplement products from various sources. Welch mentioned, for example, databases, facility inspections, reviews of imports, product labels, trade press, websites and old newspapers.

However, 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.”

Welch has publicly mentioned FDA’s support for MPL many times over the last several months.

Greater visibility into the market via a listing regime would enable FDA “to quickly identify illegal products” and “promote a risk-based regulation,” she told Natural Products Insider in an interview in May.

Related:FDA official cites benefits of mandatory product listing regime for supplements

“From the FDA’s perspective, a product listing system would improve FDA’s regulation of dietary supplements by providing that important transparency into the marketplace, and over time, allowing FDA to see how the marketplace changes with new products and new ingredients,” she added.

In the interview, she was asked to specifically address how MPL could promote risk-based regulation. Gaining insight into the ingredients and products on the dietary supplement market—including products being imported into the U.S.—would influence how FDA invests its resources into such work as sampling and testing, as well as activities at the U.S. ports of entry, she suggested.

“If we understand where specific products are being manufactured, whether it’s a higher-risk ingredient or product type, that allows us insight into which facility inspections we should be prioritizing this year versus other years,” Welch continued.

“And I think that’s what we’re getting at with a risk-based regulation,” she added in the interview. “Where is the best use of our resources? What products should we be sampling and testing? … Right now, we don’t necessarily have a lot of insight into the formulation of the products that are being imported.”

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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