September 22, 2022
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.
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.
“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.”
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