FDA released its 2020 budget request last month, and one item in particular raised the eyebrows of industry members: a proposal for a mandatory dietary supplement product registry. “This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, and improve transparency and promote risk-based regulation,” states FDA in the paragraph titled “Strengthen FDA’s Implementation and Enforcement of DSHEA.”
A voluntary industry-led registry already exists in the form of the Supplement OWL, which was launched by the Council for Responsible Nutrition (CRN) in 2016, but there has been an ongoing debate within the industry about the merits of a mandatory product registry. The Natural Products Association (NPA), for example, does not believe that FDA should impose a mandatory product registry on the industry.
“The agency currently has access to labels via inspections and other means. Does this mean the agency isn’t using that authority or that information? Why is that behavior going to be rewarded? Any discussion of a national registry for nutritional supplements must start with preemption of state laws, otherwise it is a waste of taxpayer dollars, will be significantly burdensome to small businesses, and will do nothing to protect consumers," said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “The FDA should also use the resources it already has to act on things like CBD enforcement and NDI intellectual property protection,” referring to hemp cannabidiol (CBD) and new dietary ingredient (NDI) notifications.
Others, such as Scott Bass, partner and head of Global Life Sciences for the law firm Sidley Austin LLP, believe a mandatory registry would be a positive development. Bass argues that FDA needs a mandatory registry to properly enforce regulations, given the industry’s size compared to when DSHEA passed, and that the dietary supplement industry will benefit from it if it results in increased consumer confidence.
While CRN’s focus is on its voluntary Supplement OWL registry, the trade group does believe it’s a debate worth having, and understands the value of a mandatory registry for enforcement. “If the FDA is charged with oversight of the dietary supplement marketplace, then they need to know who is in that marketplace, and the only way they’re going to be able to see into that black box is if they have some kind of mechanism to require the labels to be sent to them,” says Steve Mister, president and CEO of CRN, to Nutritional Outlook.
So, what would it mean if funds were appropriated for this proposal?
“I’m guessing that [FDA] would like to earmark some money if this comes to be. FDA has acknowledged prior and then again in this document that they are not really sure they have the authority to do this without legislation,” explains Mister. “I think what they’re doing is trying to put some placeholder with some money that, if they can get legislation moving, they could then use to start to implement [a registry].”
While Bass feels that FDA does have the authority under DSHEA to implement a registry through regulation, he does point out that it could be an uphill battle to go that route. “I’m not opposed to legislation, meaning that if [FDA] is going to encounter a huge fight over whether there’s [existing] authority [to create a registry], it’s pointless and there’s a fundamental agreement that it’s a good thing to [draft legislation],” he tells Nutritional Outlook.
That way, says Bass, FDA and industry can come together on crafting the terms. How an FDA registry would work is still speculative, but Bass and Mister both agree that the registry would not be akin to pre-market authorization. For this reason, says Bass, it would be ideal if dietary supplement brands could submit labels simultaneously to going to market. In terms of how FDA can compel brands to submit labels, and know when a manufacturer has not registered, Bass explains there are two ways in which registration can be enforced.
“Number one: A lot of the bad products are imported, so if the import people see it’s not on the list, they’ll be able to easily stop the import and that will be a huge benefit to FDA,” he says. “The second: [a registry] gives retailers an incentive not to take anything without registration and it gives other manufacturers or competing products the ability to notify FDA that these products on the market haven’t been registered. I think it would be very actively ‘policed’ where both the manufacturers, retailers, and certainly FDA would have a much better idea of who was compliant. If you have a master list, you immediately see who’s not on it.”
Although FDA Commissioner Scott Gottlieb is resigning, and his permanent replacement has yet to be chosen, Bass says he’s confident FDA will follow through on this proposal. “I believe that this initiative is going to move forward because it’s strongly supported by the Office of Dietary Supplements and some of the senior leadership of FDA that’s still there,” he says. “So, I do not believe it will die on the vine.”