FDA faces ‘information gap’ in supplement market
An FDA official said Wednesday that her agency continues to move “on certain policies to strengthen and modernize FDA regulations on dietary supplements,” but she said the FDA often faces “a lack of market information”.
Cara Welch, Ph.D., who heads the Office of Dietary Supplement Programs (ODSP), also mentioned the FDA proposal requiring dietary supplement products to be listed with the FDA.
The FDA’s proposal for the Mandatory Product List (MPL) was reflected in a stand-alone bill introduced in April by Sen. Dick Durbin (D-Ill.) and incorporated into a broader health care fee bill. use of the FDA adopted this summer by the Senate Committee on Health, Work & Pensions (HELP).
However, industry stakeholders have recently said that it is becoming increasingly unlikely that mandatory product listing language for dietary supplements will be included in an FDA user fee bill. passed by Congress, making it likely that the MPL legislation will be shelved until at least after the Nov. 8 election. Leaders of the Senate Health Committee said they were trying to add user fee reauthorization language to an ongoing resolution that would continue to fund the government, Bloomberg Law reported last week.
Speaking at the Consumer Healthcare Products Association (CHPA) Regulatory, Science and Quality Conference on Wednesday, Welch said the dietary supplement industry has grown significantly since the law was passed. on Health and Education in Dietary Supplements of 1994 (DSHEA), including the last five years.
According to the Nutrition Business Journal’s Supplement Business Report 2022, US dietary supplement sales grew 7.5% in 2021 to nearly US$60 billion.
The FDA obtains information about dietary supplements from a variety of sources. Welch mentioned, for example, databases, facility inspections, import reviews, product labels, trade press, websites and old newspapers.
However, 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.”
Welch has publicly mentioned the FDA’s support for MPL several times over the past few months.
Greater market visibility through a registration regime would allow the FDA to “quickly identify illegal products” and “promote risk-based regulation,” she told Natural Products Insider in a statement. interview in May.
“From the FDA’s perspective, a product listing system would improve FDA regulation of dietary supplements by providing this important market transparency and, over time, allowing the FDA to see how the market is changing. with new products and new ingredients,” she added.
During the interview, he was asked to explain specifically how MPL could promote risk-based regulation. Gaining insight into the ingredients and products in the dietary supplement market – including products imported into the United States – would influence how the FDA invests its resources in work such as sampling and testing, as well as in activities at US ports of entry, she suggested.
“If we understand where specific products are made, whether it’s an ingredient or a high-risk product type, it helps us know which facility inspections we should be prioritizing this year versus to other years,” Welch continued.
“And I think that’s where we want to go with risk-based regulation,” she added in the interview. “Where is the best use of our resources? What products should we sample and test? …Right now, we don’t necessarily have a lot of information on the formulation of the products that are imported.