Potential Dietary Supplement Statutory Changes
FDA principal deputy commissioner for policy Lloyd Schiller told the Council for Responsible Nutrition 11/7 that FDA is looking at possible changes to law that would enable the agency to keep pace with changes in the dietary supplement market that has grown significantly in the last 25 years under the Dietary Supplement Health and Education Act (DSHEA). He said the agency’s FY 2020 budget request includes a proposal for mandatory product listing. Under the proposal, he said, DSHEA would be amended to require all products marketed as dietary supplements to be listed with FDA and to give the agency authority to act against non-compliant products and their manufacturers or distributors.
According to Schiller, without mandatory product listing FDA doesn’t know how many dietary supplements are on the market or how many products contain any given ingredient. He said mandatory product listing would address the problems and help the agency to more effectively weed out irresponsible actors in the market who threaten to tarnish the reputations of those who work hard to try to comply with the law.
“We’re not talking about imposing a new pre-market approval requirement,” he said. “If manufacturers and distributors were just to provide us with certain basic information — information that in many cases already appears on product labels — it would be a big win for public health and legitimate industry, while imposing only minimal new costs.”
Schiller also talked about the potential regulation of CBD (cannabidiol) products as drugs or as dietary supplements.
“We also need to think hard about what it might mean in practical terms to create an exception for CBD in foods or supplements,” Schiller said. “The CBD market is growing rapidly and I’m concerned that in many cases the excitement is outpacing capability. Many of the manufacturers entering this space lack experience with FDA or DSHEA, and we have serious concerns about issues like harmful contaminants such as pesticides, heavy metals, or other drugs like THC. We’re also seeing some egregiously irresponsible behavior, like marketing CBD products for use by infants or promoting them to treat serious conditions like cancer or opioid use disorder…. So we have to ask: If we were to create some kind of exception for CBD, what would that do to our ability to identify and address these kinds of violations…. Simply put, we can’t talk about updating dietary supplement authorities without also thinking about what’s happening in the world of CBD, and what it tells us about our ability to deal with novel products exploding in the marketplace. And in thinking about CBD, we can’t ignore broader questions about whether FDA’s dietary supplement program has all the tools it needs. We need to do both.”