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During the 2021 Dietary Supplements Regulatory Summit, Cara Welch, PhD, acting director of FDA's Office of Dietary Supplement Programs, said that FDA was in favor of a mandatory product registry.
Cara Welch, PhD, acting director of the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs recently spoke at the 2021 Dietary Supplements Regulatory Summit hosted by the Natural Products Association (NPA; Washington, D.C.). During her talk, Welch covered a wide range of topics, including the need to modernize the FDA’s authority over dietary supplements. Notably, Welch expressed FDA’s interest in a mandatory product registry, a topic that the industry is mixed on.
“We think there is a way to successfully implement a mandatory listing requirement that does not impose significant burden on responsible industry, or even slow the introduction of products into the market,” said Welch. “But the simple fact of FDA having visibility of what the marketplace looks like at any given moment, facilitates our ability to identify products, allocate resources, and act more quickly to remove unsafe or otherwise illegal products.
“If we can identify [dangerous] products as they enter the market, we can mobilize our resources and address it immediately. If the firm is purposely trying to avoid FDA awareness of their product, they might not list it at all or list it incorrectly. We’re not ignoring this scenario, but if the listing requirement is designed properly, this should result in an automatic violation.”
One of the advantages Welch outlines for implementing a mandatory product registry is the ability for FDA to use its inspectional resources more efficiently. Currently, FDA might inspect 5% of dietary supplement facilities the agency is aware of, not accounting for reinspection of deficient facilities. “Understanding what new ingredients or new dosage forms are coming to the marketplace can be factored into a risk-based inspectional planning program,” explained Welch. “Our office evaluates and prioritizes ingredients that have been brought to our attention. A product listing database can be a valuable consideration to see how a product is being used: formulation, serving size, and duration of use. But also, how widely it’s being used. An ingredient that is essentially nonexistent in the marketplace might not be a good use of our resources.”
A mandatory product registry would also offer more informed decision-making opportunities for consumers, says Welch. “The idea that a consumer can compare a listing in a product database to a product they are thinking about buying to see if a marketer has complied with at least the basics of the regulatory requirements is really valuable,” she explains. “Additionally, patient-healthcare provider conversations can be vastly improved by being able to pull up a public listing to compare products and highlight the values and consideration of a certain product.”
During a panel with trade association executives, there was some debate about the value a mandatory product registry would have. Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA; Washington, D.C.) and Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, D.C.) both agreed that a mandatory product registry would not only benefit FDA and consumers, but help the industry’s reputation as well.
“To our members on the drug side, it’s not a big deal, and it does provide FDA with that searchable database,” said Melville. He also acknowledges, like Welch, that bad actors may choose not to list their products, there are other ways in which use of the listing can be enforced. “Hopefully this might put pressure on retailers to say, ‘We’re not buying from people not in that database,’” offered Melville. “I think it’s sort of an obvious, easy step for this industry to really enhance its credibility and for FDA, another tool to go after the bad guys.”
Mister supports Welch’s suggestion that not listing a product in the mandatory database should constitute an automatic administrative violation. “It gives FDA a quick administrative reason to go after the product and that’s one of the reasons why FDA sees it as an easy tool,” explains Mister. CRN, seeing the potential for a mandatory product registry, developed the Supplement OWL, a voluntary product registry. The Supplement OWL not only offers industry transparency, but also provides FDA a practical framework for what could be a mandatory product registry.
However, others on the panel were skeptical, believing that the mandatory product registry provides FDA new authority without offering much value to industry stakeholders. “Those skeptical about FDA’s intentions would say that they will use this to go punish companies for minor infractions. So, there is still a trust issue, we believe, with a part of the industry,” said Loren Israelsen, founder and president of the United Natural Product Alliance (UNPA; Salt Lake City, UT). Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD) echoed these concerns, saying that most of AHPA’s members see no value in the mandatory product registry, and therefore oppose it. Moreover, the idea that the mandatory registry may become an enforcement tool gives stakeholders pause.
“If it’s going to immediately drift into an enforcement tool, what’s to stop FDA from saying to a company: ‘You’ve only been in business 10 years, how do you know that chamomile tincture you just listed isn’t a new dietary ingredient, and wasn’t chemically altered from the way chamomile tincture was made in 1993?’” says McGuffin. “When I talk to my members there is an absence of comfort.”
There are also more practical concerns. “Can they really staff this thing, and really operate it as they want to, as an effective tool…designed to separate compliant from non-compliant companies,” asks Israelsen. “The second question that keeps arising is what is exactly going to be submitted to FDA? This has got to be done in a very practical, straight forward way, or small companies will say, ‘We’re not doing this.’ Good small companies won’t do this.”
Ultimately, Israelson’s concern is that if FDA can’t properly implement the mandatory product registry and there will be no substantive change, then what was the point giving the Agency more authority? Other practical concerns are what happens with the states, and how legislation for a mandatory product registry is passed, said Daniel Fabricant, PhD, president and CEO of NPA.
“Someone has to talk about preempting the states. This is going to get misused by the states. That’s probably our biggest challenge,” said Fabricant. “I [also] don’t want to see it happen through appropriations. Let’s not authorize [a mandatory product registry] through appropriations. Let’s have a dialogue, let’s debate the pros and cons.”
There are certainly more questions than answers about the future of dietary supplement regulation, but it’s clear now that ODSP is actively considering the benefits of a mandatory product registry, and the industry must be prepared to negotiate with regulators and lawmakers.