February 25, 2019
In December, FDA announced the formation of a working group to improve oversight of the dietary supplement industry. The industry immediately wondered about the working group’s participants and objectives, including whether it would make substantive changes affecting dietary supplements without outside input.
In an interview, an FDA official explained the internal working group is focused on improving the agency’s internal processes and procedures, and he emphasized FDA would continue to solicit input from stakeholders on substantive policy changes.
The working group is “a simple self-reflection and acknowledgement that we have an obligation as an agency to make the best use of the resources and the authorities that we have,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs.
Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the “market has evolved,” and FDA must ensure it has “evolved appropriately,” Tave added in a phone interview.
He suggested it is time to examine practices and procedures that his agency established long ago. For example, Tave noted, depending on a variety of factors, a product that contains an ingredient FDA has determined doesn’t belong in dietary supplements could fall under the jurisdiction of two different entities at FDA: the Center for Food Safety and Applied Nutrition, or the Center for Drug Evaluation and Research.
“When you have these products that label themselves as dietary supplements but actually contain unlawful drug ingredients … [under the law] that takes them out of the definition of dietary supplement and takes them out of the definition of food,” Tave explained. “Within FDA operationally, that makes them drug products, so what’s happening is we’re splitting up authority internally over the commodity.”
FDA is looking at whether there is a better way to ensure the agency’s units are “working together utilizing our resources effectively” and handing problems ‘’in a coordinated and strategic” manner, he added.
After FDA commissioner Scott Gottlieb, M.D., announced formation of the dietary supplement working group, industry representatives said they wanted the opportunity to engage the agency. The industry was generally supportive of the working group, although sources interviewed by INSIDER seemed to have some reservations about the initiative.
“Our questions are: Who’s going to be a member of that [working group]? And what is the end result of that?” asked Frank Lampe, vice president of communications and industry relations with the United Natural Products Alliance (UNPA), in an interview in December. “What’s the deliverable? Are they going to go to Congress and try to amend DSHEA?”
Tave said his agency has sought to be “open and transparent with stakeholders on any kind of policy changes,” such as those related to new dietary ingredient notifications. For example, FDA is planning a public meeting this spring following a recent announcement by Gottlieb that his agency intends to modernize its regulation of dietary supplements.
FDA intends to continue to be “transparent” with stakeholders “on matters of substance,” Tave said.
Commenting on the dietary supplement working group, he concluded, “This is really about operations and procedures and processes and practices, and whether we as a government agency are doing things in the best, most modern, most efficient way.”
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