An FDA official on Tuesday expressed her support for a mandatory dietary supplement product listing and said her agency agrees such a requirement should have “teeth behind it.”
As part of a mandatory product listing, Congress should clarify failure to list a dietary supplement is a violation of law, suggested Cara Welch, acting director of FDA’s Office of Dietary Supplement Programs (ODSP).
This would give FDA the chance to enforce against dietary supplement products not listed with the agency.
Welch spoke during the Dietary Supplements Regulatory Summit, a collaboration of five industry trade groups and hosted this year by the Natural Products Association (NPA).
FDA’s proposal for a mandatory product listing has drawn mixed reactions from trade associations in recent years. Some associations are clearly in support of the idea while others are either opposed to it or have expressed reservations about the proposed requirement.
Welch appeared to envision a future regulatory framework in which authorities could monitor dietary supplements coming into the U.S. to ensure they are listed with FDA and be in a position to take action at the ports against non-compliant products.
A mandatory product listing would give FDA visibility into the supplement market, facilitating its “ability to identify products, allocate resources and act more quickly to remove unsafe or otherwise illegal products,” Welch said.
According to FDA, the U.S. market contains up to 80,000 dietary supplement products. That’s 20 times the number of estimated products on the market 27 years ago when Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA).
FDA believes a mandatory listing could be implemented without imposing “significant burdens on responsible industry or even [slowing] the introduction of products to the market,” Welch said.
She added a listing would support her office’s priorities, including protecting consumers.
“I think we can all imagine a scenario where FDA doesn’t even know a particular product—a dangerous product—exists until we hear about it from an adverse event,” Welch remarked. “Thankfully, this isn’t a common scenario. But if we can identify these products as they’re entering the market, we could mobilize our resources and address it immediately.”
Some critics of a mandatory listing have said FDA can already access plenty of information about dietary supplement products—including through FDA inspections of dietary supplement facilities, in-person and online reviews of products and already-existing databases like the National Institutes of Health Dietary Supplement Label Database.
Welch acknowledged her agency has “visibility” into the market.
“We have as much visibility into the marketplace as any consumer,” she said. “The problem is if we don’t know [a dietary supplement product] exists, we have to go search for it … unless something is brought to our attention through other means. Unfortunately, what we don’t want to see is a product brought to our attention through an adverse event or product complaint.”