An FDA official on Tuesday expressed support for a mandatory list of dietary supplement products and said his agency agrees such a requirement should have “teeth behind it.”
As part of a mandatory product list, Congress should make it clear that not listing a dietary supplement is a violation of the law, suggested Cara Welch, acting director of the Office of Dietary Supplement Programs (ODSP). of the FDA.
This would give the FDA the ability to enforce dietary supplement products not listed by the agency.
Welch spoke at the Dietary Supplements Regulatory Summit, a collaboration of five industry trade groups and hosted this year by the Natural Products Association (NPA).
The FDA’s proposal for a mandatory product list has received mixed reactions from trade associations in recent years. Some associations are clearly in favor of the idea while others are opposed or have expressed reservations about the proposed requirement.
Welch appeared to envision a future regulatory framework where authorities could monitor dietary supplements entering the United States to ensure they are listed with the FDA and be able to take action at ports against non-compliant products. .
A mandatory product list would give the FDA visibility in the supplement market, facilitating its “ability to identify products, allocate resources, and act faster to eliminate unsafe or illegal products,” Welch said.
According to the FDA, the US market contains up to 80,000 dietary supplement products. This is 20 times the number of products estimated on the market 27 years ago, when Congress passed the Food Supplement Health and Education Act of 1994 (DSHEA).
The FDA believes that mandatory listing could be implemented without imposing “significant burdens on the responsible industry or even [slowing] introducing products to the market, ”Welch said.
She added that a list would support her office’s priorities, including consumer protection.
“I think we can all imagine a scenario where the FDA doesn’t even know about the existence of a particular product – a dangerous product – until we hear about an adverse event,” noted Welch. “Fortunately, this is not a common scenario. But if we can identify these products as they come to market, we could mobilize our resources and fix them immediately.
Some critics of a mandatory list have said that the FDA can already access a lot of information about dietary supplement products, including through FDA inspections of dietary supplement facilities, in-person and online product reviews, and reviews. existing databases like the National Institutes of Health Dietary Supplement. Label database.
Welch acknowledged that his agency had “visibility” in the market.
“We have as much visibility in the market as any consumer,” she said. “The problem is that if we don’t know [a dietary supplement product] exists, we have to go get it… unless something is brought to our attention in some other way. Unfortunately, what we don’t want to see is a product brought to our attention through an adverse event or product complaint.