A mandatory product listing for dietary supplements—the notion that dietary supplement companies would be required to list all of the retail products they sell in an FDA-operated database—has become an increasingly prevalent topic, one that has made its way to FDA itself. This past spring, FDA included, as part of its 2020 budget request, a proposal for a mandatory dietary supplement product listing. Within the leading dietary supplement associations, however, support for a product listing remains mixed.
At the Council for Responsible Nutrition’s 2019 The Conference in Carlsbad, CA, on Thursday, November 7, FDA speaker Lowell Schiller, FDA principal associate commissioner for policy, spoke about the benefits a mandatory listing poses.
“Today, without mandatory product listing, we lack basic, fundamental information about the dietary supplement market,” he said. “We don’t know how many dietary supplements are on the market, and we have no systematic way of knowing when a new product is introduced. We don’t know how many products contain any given ingredient. If it turns out there is a safety problem over a particular ingredient, or a particular ingredient…we don’t have the basic information to quickly identify which products are affected. We don’t have a reliable way to capture trends in the market so we can anticipate and adapt to new areas of risk. And we don’t have the visibility we need to be able to effectively prioritize our resources. Mandatory product listing would address these problems and help us to more effectively weed out the irresponsible actors from the market who threaten to tarnish the reputations of those who work hard to try to comply with the law.”
The Council for Responsible Nutrition (CRN; Washington, DC) is one association that has announced formal support for a mandatory FDA product listing. The association has already created a voluntary product listing for the industry to use called the Supplement OWL.
At the CRN conference, David Campbell of Bayer Consumer Healthcare, who is also the chair of CRN’s board of directors this year, spoke about how CRN’s board came to the decision to officially back a mandatory FDA listing based on the position of the association’s members. He also spoke to the concern that some who don’t support an FDA-mandated listing have: that providing FDA with more information about products on the market could put supplement companies at risk of increased scrutiny—and potentially increased regulatory enforcement—by the agency.
“CRN’s board took up the issue and continued discussion at each successive board meeting,” Campbell said to the CRN conference audience. “Over time, it became more and more clear that a new era calls for new thinking. Much of the animosity and distrust that we’ve had with our regulators are a thing of the past…”
He continued: “Some have said, ‘Doesn’t a mandatory listing paint targets on our back for FDA to come get us?’ Resoundingly, the answer to that question is no. Those of us who observe the high standards that meet CRN’s membership criteria and who are willing to do things right are not the sort of actors that FDA will be pursuing.”
But not everyone shares that view. The American Herbal Products Association (AHPA; Silver Spring, MD) has voiced its opposition to an FDA-mandated product listing. At the CRN conference, AHPA president Michael McGuffin reiterated the association’s position that the broad range of regulations that dietary supplements already answer to give FDA sufficient tools to police the market, without requiring the creation of a mandatory listing.
“The AHPA board took a formal position a little over a year ago that, given the robust regulatory controls that are already in place for this class of goods, dietary supplements, there’s no need for a mandatory product listing,” he told Nutritional Outlook. “So that’s our position and it has been for a little over a year. We’ve been very public with that.”
McGuffin listed just some of the regulations governing dietary supplements today. “It’s a long list,” he said, that not only includes the Dietary Supplement Health and Education Act of 1994 but also the Bioterrorism Act (the Public Health Security and Bioterrorism Preparedness and Response Act of 2002), the FDA Adverse Event Reporting System law, as well as the Food Safety Modernization Act and FDA’s mandatory recall authority to pull violative supplement products off the shelf.
FDA already has the power to request the same type of information that some have said could be provided in a mandatory product listing database, such as information about a product, its ingredients, and where it was made. For instance, McGuffin said, companies are already required to provide information about their facilities under FDA’s food facility registration rule, and the agency is also able to request data when it performs current good manufacturing practices inspections. Under food labeling laws, companies are also required to provide information such as disclosures about the presence of major food allergens.
Given these existing regulations, McGuffin said, “[W]hat AHPA keeps going back to is: Is there a problem that needs to be solved? And is the fact that FDA can’t say there are [for example] 62,503 products [in the market], is that a problem? We don’t see it as a problem.” Furthermore, he pointed out, FDA does not utilize a listing-type system for products such as food. “FDA also doesn’t know how many brands of potato chips there are,” he said. “FDA doesn’t know how many brands of cookies there are, or the exact kinds of cookies being sold.”
“If it were a problem to be solved, then we would be supportive,” he added.
Supporters of a listing emphasize that a listing would serve merely as a repository for information but would not otherwise be used as a means for FDA to overreach its existing regulatory authority for dietary supplements. At the CRN conference, Campbell said, “Responsible actors have nothing to fear from a mandatory listing.”
During his speech, FDA’s Schiller said: “We’re not talking about imposing a new premarket approval requirement.”
A primary concern for AHPA’s members, however, is that FDA could somehow use the information provided by companies as a means of enforcement, McGuffin said: “Absolutely. That’s a concern that has been clearly articulated by numerous AHPA members.” For instance, he said, if FDA decided that a certain ingredient is a regulatory concern, it could use the mandatory listing database as a searchable way to target industry companies selling that ingredient. “There are concerns,” he said, “that there would be regulatory mischief that would result.”
Would a mandatory listing give consumers more confidence in FDA’s regulatory oversight of dietary supplements? In a recent survey conducted by the PEW Charitable Trusts, consumers who were polled generally said they supported the idea of a mandatory FDA listing. That same survey, however, likewise found that the consumers polled did not know how FDA currently regulates dietary supplements under existing laws.
McGuffin said that that changing FDA laws to add a mandatory listing won’t increase consumer understanding of supplement regulations. What’s more, he said, consumers already have high confidence in the supplement category, as evidenced by data from CRN’s own 2019 Consumer Survey on Dietary Supplements, which showed that up to 85% of U.S. consumers polled were confident in the safety and quality of dietary supplements overall.
“We don’t have a consumer confidence problem,” McGuffin said. “We don’t have people saying, ‘What are these mysterious things, and how could I possibly decide to use this?’ That’s not the experience. The marketplace is content with our products. We’ve been selling them safe products under the Federal Food, Drug, and Cosmetic Act for decades. There’s not a problem there that needs to be fixed.”
Dietary supplement associations often find themselves in agreement on issues, but on the topic of a mandatory product listing, support remains split. Lack of consensus will make it more difficult as supporters and non-supporters lobby their own positions with policymakers.
At the conference, CRN’s president and CEO, Steve Mister, said, “[W]here does that leave us? Should CRN actively push forward with legislation that we know other associations will oppose? Should we actively work to halt the efforts of other groups whose actions we believe are detrimental to this industry? How should we resolve the differences in opinion when everyone seems to be more and more dug in on their positions? This is even more concerning because we find that many of our members are also members of these other associations. They’re paying dues for both efforts.” Being members of two associations working at cross-purposes on an issue like a mandatory listing is a waste of a member’s money, he said.
Mister encouraged industry companies who are members of associations not to be passive and to ensure they understand the position of their associations on issues such as the mandatory listing—and to ensure those positions are in line with their own.
“Let your voice be known,” he said. “If you’re paying dues, you have a right to have a voice, and if your association does not speak for you [and your beliefs], you should be asking, ‘Why not? Who listens to you? Who speaks for you?’”
McGuffin said that AHPA continues to gauge support—or lack of support—for a mandatory listing. Both McGuffin and Mister said they continue to listen to all sides of the argument.
Said Mister: “I don’t mean to suggest here that CRN’s position in all of these cases is infallible, or that the opposing views are necessarily wrong, or even that CRN’s board might not be able to change its mind if they were persuaded to do so.”
McGuffin said: “We’re working hard to see if we can find consensus on this, which would mean either one of us moving completely or each of us moving some. But there already has been quite a lot of movement.”
Short of consensus, he acknowledged the possibility that it could “come to a complete difference of opinion if it gets to where there’s legislation introduced.” However, he said, “I’ll keep taking it back to my board and my members and see if there’s any openness to changing our position, and I know that Steve’s doing the same.”