FDA official cites benefits of mandatory product listing regime for supplements

The top U.S. official charged with regulating dietary supplements reiterated FDA’s support for a system requiring companies in the fast-growing sector to list their products with the agency.

In FDA’s justification for its FY23 budget proposal to Congress, the agency said the listing requirement would allow the agency to know when new dietary supplement products are introduced.

FDA has estimated the U.S. market contains more than 50,000 dietary supplement products and perhaps as many as 80,000 or more, compared to an estimated 4,000 products in 1994 when Congress passed the Dietary Supplement Health and Education Act (DSHEA).

Dietary supplements are not subject to pre-market approval, though manufacturers generally have a duty to notify FDA before marketing new dietary ingredients (NDIs) in their products under a provision in DSHEA intended to ensure supplements containing the NDIs are reasonably expected to be safe.

Greater visibility into the market via a listing regime would enable FDA “to quickly identify illegal products” and “promote a risk-based regulation,” Cara Welch, who oversees FDA’s Office of Dietary Supplement Programs (ODSP), said in an interview that explored various initiatives within her office.

“From the FDA’s perspective, a product listing system would improve FDA’s regulation of dietary supplements by providing that important transparency into the marketplace, and over time, allowing FDA to see how the marketplace changes with new products and new ingredients,” added Welch, who has worked at FDA since 2014 and was tapped a few months ago to serve as ODSP’s permanent director.

Related:Food lawyer espouses virtues of mandatory product listing for supplements

Welch was interviewed by Natural Products Insider on May 26. That was just one day before the FDA Safety and Landmark Advancements (FDASLA) Act was introduced in the U.S. Senate.

The bill is considered a piece of must-pass legislation since it reauthorizes FDA’s prescription drug, generic drug, biosimilar and medical device user fee agreements. The FDASLA Act also incorporates provisions affecting cosmetics and dietary supplements, including requirements that dietary supplement products be listed with FDA and that FDA create and maintain a database of the listed products.

Several industry trade associations criticized the bill last week, including those that have generally supported the MPL concept. Provisions in the FDASLA Act affecting dietary supplements differ in some respects to a standalone MPL bill previously introduced by Sen. Dick Durbin (D-Ill.) and co-sponsored by Sen. Mike Braun (R-Ind.).

Related:Dietary supplement trade groups criticize MPL language in Senate bill

Welch said FDA doesn’t comment on specific legislation being discussed on Capitol Hill. However, she outlined in broad strokes the benefits of MPL and addressed some of the criticisms by industry stakeholders opposed to FDA’s proposal.

Information obtained through an MPL regime “would be able to strategically impact the FDA’s risk-based activities, including product analysis, inspectional activities and imports,” she said. “And as we understand how the marketplace is evolving, we can adjust accordingly.”

Under an MPL system, FDA would have “insight into new ingredients or new product types being introduced to the market, as well as where products are being manufactured,” Welch said. “And the location information is clearly helpful to apply to FDA’s facility inspections.”

FDA could apply this information to its sampling and testing programs and activities at the U.S. ports of entry, Welch said. She concluded information obtained through an MPL regime would help FDA prioritize its “limited resources on the areas that make the biggest impact.”

Cara Welch, Ph.D., is director of FDA's Office of Dietary Supplement Programs, where she is responsible for regulating a market with as many as 80,000 dietary supplement products, or more. Since 2014, Welch has served in different roles working on compliance, regulatory and scientific matters for FDA's regulation of supplements. She also has worked in the Office of the Commissioner, providing expertise on food policy issues.

In the interview, she was asked to specifically address how MPL could promote risk-based regulation. Gaining insight into the ingredients and products on the dietary supplement market—including products being imported into the U.S.—would influence how FDA invests its resources into such work as sampling and testing, as well as activities at the U.S. ports of entry, she suggested.

“If we understand where specific products are being manufactured, whether it’s a higher-risk ingredient or product type, that allows us insight into which facility inspections we should be prioritizing this year versus other years,” Welch continued.

“And I think that’s what we’re getting at with a risk-based regulation,” she added. “Where is the best use of our resources? What products should we be sampling and testing? … Right now, we don’t necessarily have a lot of insight into the formulation of the products that are being imported.”

Welch was also asked to address criticism from MPL naysayers that companies selling adulterated products marketed as dietary supplements—or so-called bad actors already violating the law—will not list their dietary supplement products with FDA, even if it’s required.

She said a listing requirement would apply to everyone, "leveling the playing field."

“Those that choose not to comply with that requirement would be that much more obvious to really the entire marketplace,” Welch responded.

“I think it ties somewhat to the concept of whether or not the mandatory product listing has a public-facing database and whether or not it requires a listing number or identifier on the product label,” she continued.

All that information would enable “FDA, as well as consumers, retailers [and] other industry members, to act as a gatekeeper to these products,” Welch said.

The FDASLA Act would require FDA to provide each listed product a listing number. The legislation specifies the listing number “may apply to multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives or flavorings, including dietary supplements offered in a single package size or in multiple package sizes.”

If a product is introduced to the market but does not match the listing in a public database, “that’s something that can be easily identified,” Welch said.

FDA would not be the only one with access to such information under an MPL regime. Retailers, for example, could check a public database of listed dietary supplement products before deciding to carry a particular supplement, Welch said.

MPL “levels the playing field for everyone so that information is out there in the public sphere, all in one place, in a public-facing database—again assuming that’s part of the system,” she concluded.