Should FDA create a mandatory product registry for dietary supplements?

August 22, 2018

If FDA had a comprehensive, mandatory, industry-wide database of every single dietary supplement product on the market, would such information help regulators as well as industry better police the dietary supplement market? Also, how could FDA create such a registry?

If FDA had a comprehensive, mandatory, industry-wide database of every single dietary supplement product on the market, would such information help regulators as well as industry better police the dietary supplement market? Also, how could FDA create such a registry? These questions are being debated more often as the dietary supplement industry faces more public scrutiny and ongoing discussion about whether the existing regulatory framework for supplements is effective.

It also should be noted that a voluntary, industry-sponsored dietary supplement product registry was created just last year by industry association the Council for Responsible Nutrition (CRN; Washington, DC). In April 2017, CRN created a product registry called the Supplement OWL (Online Wellness Library). Participation is open to all industry members and is heavily encouraged. CRN says its goal is to build the Supplement OWL into the industry’s comprehensive product registry that could also serve as a regulatory resource for FDA to draw on should the agency choose to do so. To date, the registry includes 10,000 product labels, with CRN aiming to double that number by next year, according to Steve Mister, CRN’s president and CEO.

Mandatory or Voluntary?

The Supplement OWL is a voluntary registry. It is not federally mandated; companies can opt in or out as they choose. One person Nutritional Outlook interviewed recently said he thinks that a mandatory product registry, maintained by FDA at the federal level, would be more effective than a voluntary registry in fulfilling the goal of making sure all products are included in the registry.

In July, Nutritional Outlook interviewed attorney Scott Bass. Bass helped draft the Dietary Supplement Health and Education Act statute of 1994 (DSHEA). Bass said that not having a mandatory registry critically limits FDA’s ability to police the U.S. supplements market. His words: “[There is] no hope for effective fraud prevention unless government knows what is on the market.”

“When FDA says, ‘We want to stop lousy products from China coming in that are spiked with illegal drugs, how do they know what’s on the market? How do they know what to stop? They don’t,” he told Nutritional Outlook in July.

Bass is adamant that a mandatory registry, not a voluntary registry, is needed: “A voluntary listing program is the right idea but by definition will only include the good players who want a clean market. The whole purpose of the listing is to identify those who are on the market and those who shouldn’t be on the market, and a voluntary listing doesn’t do that,” he said.

“Without mandatory listing of dietary supplements, none of it”-FDA’s regulatory framework for supplements-“is going to work,” he told Nutritional Outlook in July. For instance, he said, DSHEA’s requirement that companies submit new dietary ingredient (NDI) notifications to FDA, in order to police new ingredients coming to market is “meaningless” if FDA doesn’t know what companies, products, and ingredients are actually on the market and which companies should be submitting NDI notifications.

Many of the sources Nutritional Outlook interviewed in August, a month after publishing the July interview with Scott Bass, said they support the overall suggestion for a registry because a registry does give regulators, consumers, retailers, and the industry itself a comprehensive view of what’s on the market. Not everyone agrees that a registry should be mandatory (federally mandated and maintained by FDA); some feel it should be voluntary.

Attorney Jason Sapsin, JD, MPH, of counsel at Faegre Baker Daniels LLP (Boulder, CO), supports the general idea of a registry. He told Nutritional Outlook, “Consumers and retailers value transparency. A registry for dietary supplement products would demonstrate industry’s commitment while also offering researchers, regulators, and healthcare providers valuable information about products available in the marketplace.”

A comprehensive registry could even help industry enhance quality right down to its trade shows. Michelle Zerbib, director of standards at New Hope Network (Boulder, CO), producer of the Natural Products Expo East and West trade shows, told Nutritional Outlook that she and her colleagues would find a mandatory product registry beneficial as they work to maintain exhibitor standards and differentiate between good and bad players in the industry. “It would be so great, so helpful, to have a [registry] for what we do in the standards program at Natural Products Expo East and West,” Zerbib said. (Disclosure: Nutritional Outlook and New Hope Network are both owned by Informa plc.)

Zerbib said she supports a mandatory federal registry, stating, “I think the FDA should know what’s on the market.”

CRN’s Mister said he believes a comprehensive registry is important-hence, CRN’s creation of the Supplement OWL with access available to FDA regulators. “If FDA doesn’t know what the industry looks like, it’s much harder for them to regulate,” he told Nutritional Outlook.

However, Mister said that a self-regulatory registry like the Supplement OWL, which CRN created with industry input, is preferable at this point in time. Importantly, he pointed out, if industry builds a registry itself, as CRN has with the Supplement OWL, at least the industry-built registry would have been created exactly the way the industry wanted it to be, “rather than having [a registry model] foisted upon us.” Currently, the Supplement OWL collects label information such as allergen statements, serving-size information, dosage data, ingredients, instructions for use, Nutrition/Supplement Facts, and more.

For now, Mister said, he would prefer that the registry be created to the industry’s taste-and that someday, perhaps, industry’s registry could serve as a solid framework for a federal registry if FDA should ever be tasked with creating one. “One of the advantages of the Supplement OWL, and the fact that it’s being created by the industry through our association, is that it gives us the opportunity to create a registry the way we want to so that if it did ever become mandatory, there is a very clear template for what it would look like,” Mister said. “FDA would not have to start from scratch and potentially put things in there or put in requirements that we don’t like.” Mister said that CRN has not, however, discussed with FDA the notion of using the Supplement OWL as a template for a possible federal registry.

The biggest drawback to a voluntary registry is, of course, that participation is not legally enforceable, meaning there are no teeth to force a company to register. Some feel that in order to be effective and all-encompassing, the registry needs to be federally mandated so that FDA can require the entire industry to participate and punish companies that don’t.

Mister acknowledged that a voluntary registry might not capture all companies, but he said that CRN is trying to create some pretty strong “market-based incentives” to encourage companies to participate in the Supplement OWL-namely, by asking retailers to make participation in the Supplement OWL a requirement for the brands whose products they sell. “Hopefully, some retailers will very soon be announcing that you must be in the Supplement OWL if you want to be in their stores.” Many of the industry’s large dietary supplement companies are already participating in the Supplement OWL. Still, he said, “there will still be companies that won’t.” But, he said, “We continue to believe that a voluntary registry is the best way to get the most participation at this point. We really feel like the industry needs to own this, at least initially.”

Not everyone believes a registry is needed. “People have been talking about this kind of thing”-a federal registry-“for years, but it’s a nothingburger. It’s a big nothingburger,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC).

FDA already has the power to gather the same information that would be included in a registry, Fabricant said, and already receives that information in other ways. “FDA already gets labels. They get labels through certificate-of-free-sale applications-when you want to ship things to foreign countries-and they get them through cGMP [current Good Manufacturing Practices] inspections. So the notion that somehow if FDA had all the labels that it’s a tighter-regulated market-FDA already has that information at their fingertips, or should.”

Fabricant was director of FDA’s Division of Dietary Supplement Programs in 2011-2014. “We certainly gathered labels when I was at the agency,” he said. “We used them for preliminary [work] looking at things to see what was out there.”

Some Misgivings

When asked to describe their idea of a product registry (whether mandatory or voluntary) and what information it would include, many of those I interviewed listed a lot of the same, basic information that is captured by the Supplement OWL: basic label information such as dosages, ingredients, manufacturer name and contact information, etc.

But some in the industry have misgivings of how FDA would use even basic data included in an FDA-mandated and -maintained registry. They fear the agency could one day leverage that information to impose new regulations on industry. Some of their questions include: How much data would FDA demand? What kind of data would it require?

Some of those questions stem from a historic fear of many in the supplements industry that FDA will overstep its authority and over-regulate the industry. Bass acknowledged that there is such mistrust among those who believe that FDA has tried to suppress the supplements industry in the past. “What led to DSHEA was the underlying premise that FDA abused its authority, which it did, and that they couldn’t be trusted because they were constantly out to kill the industry. But that’s history,” he added, expressing his belief that those currently overseeing the Office of Dietary Supplements “are not against the dietary supplement industry.”

If a federal registry were ever created, “I think [all of industry’s concerns] would have to be worked out up front with assurances that FDA understood what the purpose of that registry was and would commit that it would live by those expectations,” said Mister. “There’s this long history of tension between the industry and the agency that if the agency is allowed to regulate, will they go too far?”

There is, for instance, the question of what kind of system a federal registry would be. Would it simply be a notification-based system with no FDA judgment on whether a product is acceptable in the marketplace? Or, if a product were accepted in the registry, would that somehow imply that FDA tacitly or directly endorsed the product-or vice versa?

Mister used the analogy of a birth certificate to highlight the differences between those two scenarios. “I sort of look at it like the difference between a birth certificate and a driver’s license,” he said. “Everyone who is born gets a birth certificate. The government cannot deny you of your birth certificate. It’s a legal document; if you’re born, you get one. But with a driver’s license, they can control and they can limit who gets a driver’s license and who doesn’t.”

He continued, “And that’s the distinction for us. As long as it’s a registry, I think that the industry is fine with that and it does what we talked about. It gives FDA that window to see what the dietary supplement marketplace looks like. But if it starts to look more like a driver’s license and they get to tell you whether or not you can be on the market or not, that sounds like premarket approval and that is something that the industry has always been very concerned about, FDA’s potential ability to keep you off the market if they don’t agree with your science or if they don’t like your ingredient.”

New Hope’s Zerbib said another fear could be whether FDA would eventually start charging companies a lot of money to register their products, much like the agency does for medical devices in part to cover administrative costs. She noted that registration fees could be “pretty expensive,” and that for medical devices, “it’s a couple thousand dollars” per device.

The Power to Create a Registry

Thanks to the Supplement OWL, we’ve already seen how the industry can create its own product registry. But what would it take for FDA to create a mandatory registry? Does the agency currently have existing statutory power to mandate registration, or would doing so require new legislation? Industry opinions are mixed.

In July, Bass said he believes FDA “has the power under its current statutory mandate.” As Nutritional Outlook reported: “When asked which parts of the Federal Food Drug and Cosmetic Act today would allow FDA to mandate listing, Bass points to two. First, he points to 21 CFR 402(f)(1)(A), which makes it illegal to market an adulterated dietary supplement. This provision, he says, could be interpreted as requiring FDA to know the full scope of products on the market…The second existing statute Bass points to is the FD&C Act’s new dietary ingredient regulation (Section 413(a)(2)). This regulation could be interpreted to mean that in order to establish and maintain an NDI process, FDA would need to know which companies need to file an NDI notification. ‘And to be able to know who has to file, you need to have a listing,’ Bass said.”

New Hope’s Zerbib said another existing route could be the FD&C Act’s structure/function claims notification law that requires dietary supplement companies to notify FDA within 30 days of marketing a product if that product is making a structure/function claim.

“This current regulation is a great place for FDA to step in and get dietary supplement information,” she said. “All a company would need to do is submit the label, and the label already has all the information” you would enter into a registry, including the list of ingredients, the statement of identity, and who the manufacturer is, she said. “So, the information would be there. Companies could simply submit to FDA [their label] with the claims they’re going to make, and FDA could drop [that information] into a registry, no new regulation required.”

Zerbib did, however, acknowledge that in this scenario, companies not making structure/function claims would not be required to submit a 30-day notification and thus would not submit labels, meaning this system might not capture every product on the market. But it could be a place to start.

“We don’t need new regulation; we need FDA resources to enforce the current law,” Zerbib added.

Mister, on the other hand, said he does not believe FDA has existing authority to mandate registry. “The FDA probably does not have the authority under the current law to create a registry, and if they did try to do it by regulation or something like that, it would likely be challenged by someone in the industry, which would tie it up in litigation for years,” he added. “So if it were going to be done, for expediency it would probably need to be done through legislation.”

NPA’s Fabricant said that although FDA “can grab labels on inspections” at present, if the agency wants to “mandate that people send them their labels, they would definitely need statutory authority for that.”

He added that if the dietary supplement industry were held to a new mandatory registry requirement, it could “put another target [on the industry’s] back.” He explained that in the same way that California’s Proposition 65 regulation has made companies more vulnerable to predatory lawsuits as well as to class action suits and lawsuits from states “that will sue off of consumer protections," a registry requirement could make dietary supplement companies more legally vulnerable.

“You can bet your bottom dollar that somebody will FOIA [Freedom of Information Act] the information of who submitted and who didn’t, and there would be a lawsuit against those companies who didn’t,” Fabricant said. “You could set up an environment where someone goes, ‘Whoops, FDA didn’t get your labels on time,’ so then states start suing you. That’s crazy, and that will be exactly what will happen.”

A federal law would need to “preempt the states,” he said. “Unless [a registry requirement were] done legislatively with some kind of preemption for the states, why would the industry even contemplate [the creation of a federal registry]? It’s just adding to our burden, which is already pretty substantial.”

 

Anytime Soon?

How likely is mandatory registration to happen? In July, Bass said, “I don’t think it’s a dream far away. Let’s just say there’s a lot in motion now. This is not just some idea for five years from now.”

Mister and Fabricant told Nutritional Outlook that they haven’t heard of any developments regarding mandatory registry.

“As far as I know, there is nobody who has drafted legislation or shopped anything like that on Capitol Hill,” Mister said. “As you know, even things that are not controversial in Washington take a long time to get through Congress.”

Fabricant said he doesn’t foresee anything happening “at least not this Congress, and likely not next Congress either. Nothing’s happening legislatively to make this move along.”