A veteran lawyer in Washington supports a requirement that companies register their dietary supplement product labels. The general idea—incorporated in legislation introduced in previous years on Capitol Hill—could lead to reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“I really believe that this movement has picked up speed this year,” said Scott Bass, an attorney who heads the Global Sciences team at Sidley Austin LLP.

Based on his discussions with myriad groups, the lawyer revealed, the idea’s “time has come.” He said it was possible to see “activity on this front as early as the fourth quarter” of 2018.

“And I don’t mean activity in the sense of the law passed,” Bass acknowledged, “but I mean serious legislative attention.”

In an interview during an annual symposium in California for the dietary supplement industry hosted in October by the Council for Responsible Nutrition (CRN), Bass laid out his support for a mandatory product registry.

“Unless we have a system where FDA can say, ‘We know what’s on the market in the list’ [of registered products] and then can easily find out what is not on that list and can easily enforce, we’re not going to be able to stem the rising tide of illegal products,” he asserted. “There really is no choice because FDA can never enforce against outliers unless they know what’s on the market legitimately.”

Added Bass: “Second, how can a company offer a product to consumers that is supposedly a health product and then say, ‘But I don’t want the government to know about it.’ It just makes no sense.”

Self-Regulation

The lawyer’s proposal has elicited mixed reactions. Anthony Young is a partner with Kleinfeld Kaplan & Becker LLP and general counsel of the American Herbal Products Association (AHPA).

He said information about products is already available through CRN’s Supplement OWL (Online Wellness Library)—a dietary supplement product registry, a self-regulatory initiative—as well as a dietary supplement label database maintained by the National Institutes of Health (NIH)’s Office of Dietary Supplements (ODS).

The Supplement OWL launched in April 2017, and according to CRN’s president and CEO, Steve Mister, nearly 11,000 supplement labels are visible in the voluntary product registry.

Uploading label information to the Supplement OWL is a condition of membership. The registry also is open to the entire dietary supplement marketplace—in other words, non-members can participate as well.

However, there is no requirement under the law or FDA regulations to do so.

NIH’s Dietary Supplement Label Database (DSLD) was introduced in the summer of 2013 and had 20,000 labels at the time, ODS said in an email. As of November 2018, it contained 80,456 labels, nearly 28,000 of which are “off market,” labels of products no longer being sold but kept for research purposes, disclosed ODS, which reported an average of 1,000 labels are added each month to the database.

ODS has a contract with a company, Therapeutic Research Center of Stockton California (TRC), for collecting, coding and transmitting dietary supplement labels to include in its DSLD. The dietary supplement label collection program is known as Manufacturers Connect for DSLD.

TRC obtains dietary supplement labels for ODS through various means, but primarily through the roughly 5,500 dietary supplement manufacturers who currently participate in the collection program.

FDA—the agency chiefly responsible for regulating and policing the dietary supplement industry—is aware of both initiatives.

“The NIH Dietary Supplement Label Database and the Supplement OWL both serve valuable purposes in the dietary supplement marketplace, and we appreciate the efforts of responsible industry leaders to promote compliance through self-regulation,” Corinne Newhart, an FDA spokeswoman, said in an emailed statement. “FDA remains focused on working to ensure that products that are labeled as dietary supplements comply with all applicable laws." 

A voluntary system, Young opined in a phone interview, “would become very … robust” if it received further encouragement from trade associations and retailers, including those selling products via the web.

He also suggested there’s precedent for an effective voluntary product registry. FDA has a Voluntary Cosmetics Registration Program.

“Because product filings and establishment registrations are not mandatory,” FDA explains on a webpage devoted to the above program, “voluntary submissions provide FDA with the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution.”

The voluntary system for the cosmetic industry, Young said, “has worked and it’s matured, and many companies use it.”

Marianna Naum, an FDA spokeswoman, said there are 3,308 registered establishments and 62,907 active products on file to date in the agency’s Voluntary Cosmetics Registration Program.

Criminal Behavior

Bass doesn’t have a problem with voluntary programs like CRN’s Supplement OWL. In fact, he lauded the initiative, but he pointed out a dilemma: “[L]ike most good lists like that, only the people who are behaving want to participate.

“So while that’s an asset to retailers who say, ‘Do you have a listing,’ it doesn’t really solve the basic problem,” Bass argued. “How do you get rid of the companies that have illegal products, spiked products, products that don’t meet good manufacturing practice [GMP] standards? And the only way to do that is to make it mandatory because you’re not going to get the bad guys … to sign up.”

Young, however, doesn’t believe a mandatory list would have any effect on products spiked with undeclared pharmaceutical drugs fraudulently marketed as dietary supplements.

“They would not come to the registration table and register their products if it were required because their entire modus operandi is to avoid all of the places where … their enterprise might be interfered with,” the lawyer said.

Bass responded to the argument that scofflaws wouldn’t comply with a mandatory registration system.

“Number one, once FDA has the universe of what is registered, it’s very easy for them to focus on any products brought to their attention [that aren’t] registered,” he said. “Second, probably half or some significant proportion of dietary supplements imported would be stopped at the border if they’re not on the list. And third, if there is suspect raw material coming in, FDA can immediately trace it to manufacturing plants that might have some legitimate products and some illegitimate products.”

A mandatory system, Bass concluded, “increases FDA’s ability to focus … on the companies that are problematic instead of spending a lot of their time on companies that really don’t need the scrutiny.”

But Young, who has been practicing food and drug law for decades, said FDA approaches enforcement based on an evaluation of whether a product is suspicious or unsafe, not whether it’s registered.

“Enormous Bureaucracy”

Young described a mandatory registration system as an “enormous bureaucracy” that would place economic burdens on small companies.

“And we continue to be an industry with a lot of different-sized players,” he said.

He also highlighted a growing category of products FDA contends are unlawful in dietary supplements: those containing cannabidiol (CBD), a compound sourced from the hemp plant.

“Do we believe companies marketing CBD-containing dietary supplement products are going to … register their products with FDA?” Young asked. “The answer is ‘probably not,’ even though I think those companies are held in greater esteem right now in the market generally than spiked products, for example—products spiked with prescription drugs.”

Concluded the attorney: “I just think that the whole concept here is more regulation, and it’s more regulation that’s going to put burdens on the industry that could be dealt with by self-regulation and … recognition by FDA through a voluntary system.”

A voluntary system certainly has its proponents, but does it go far enough?

“There [are] some people who feel like, ‘Gee, the voluntary registry is nice, but it’s never going to get the percentage of compliance that we need,’” CRN’s Mister said. “And I’m not sure I agree with that. I think there’s still a lot more that can be done to incentivize participation in the Supplement OWL.”

If upwards of 75 percent of the industry participated in the product registry, “then I think that’s a pretty good number because what’s left really are the bottom feeders,” Mister added. “And then the companies that are not in, that will say something about the fact that they’re not there.”

Arguments from Consumer Advocates

FDA has acknowledged it is unaware of all the dietary supplement products on the market. Without such information, “it’s very hard for them to police,” said Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School, whose research on potentially hazardous products marketed as dietary supplements has been widely reported. “That’s one of the reasons the FDA gives me for their not being able to effectively police this space.”

Does the physician believe a mandatory product registry would help FDA more effectively track or remove products?

“It’s hard for me to imagine you can regulate health products without even knowing what’s available … or what’s being sold,” Cohen, a general internist with Cambridge Health Alliance in Somerville, Massachusetts, responded in a phone interview.

A product registry, Cohen said, could grant consumers access to important information, enabling them, for example, to check on the web or through a store whether a supplement like a weight loss product is registered or not.

He highlighted a challenge facing consumers: identifying products that may be illegal but are nonetheless marketed as dietary supplements.

“To the consumer, they look just like the weight loss supplements next to them,” the physician said. “Obviously, the consumer is not doing analytical chemistry on the compounds.”

But Cohen said a mandatory system must have teeth. For example, he cited the ability of FDA to vet labels during the registration process to confirm products marketed as supplements don’t contain prohibited ingredients. He also said FDA should be able to unregister a product that is adulterated or poses a hazard to consumers.

“I’m not for registration just so we learn that there’s actually 75,000 products on the market,” he observed. “That’s useless. Who cares if there’s 50,000 or 100,000?

“What we really care about is, are the products that are a harm to consumers available on store shelves, available on major websites, and what’s FDA doing about [it], and can the FDA remove these products … in an efficient and effective manner?” Cohen continued.

If a mandatory product registry doesn’t help FDA in its task above, Cohen suggested, “then it would be a useless exercise, and everyone is [investing] a lot of money and time and added bureaucracy with no benefit.”

Peter Lurie, M.D., is the president of the Center for Science in the Public Interest (CSPI), a consumer advocacy group in Washington. He previously served as associate commissioner for public health strategy and analysis at FDA.

Lurie is in favor of a system requiring dietary supplement products to be registered.

“The fact is that FDA cannot hope to do its job adequately if it doesn’t know what products are on the market, particularly given the ever-changing nature of this industry,” he said in a phone interview. “Moreover, the companies that are most likely to comply with a voluntary listing requirement are probably the ones that are less likely to be manufacturing problematic products from a safety point of view. In all likelihood, the most fly-by-night of the dietary supplement industry is going to be that same fraction … that won’t list if it’s only voluntary.”

Lurie addressed the counter argument that companies already flouting FDA regulations or lacing their products with hidden pharmaceutical ingredients aren’t likely to comply with yet another requirement in the law.

“That’s like saying, ‘Well, people don’t stop at red lights, and therefore it would be a good idea to do away with a speed limit,’” he said. “I don’t really see the logic of this. I mean what you need to do is enforce more strongly and comprehensively across the board, and maybe the industry will finally come to its senses and start complying [and] start manufacturing responsibly.”

Skepticism from Former FDA Official

Daniel Fabricant, Ph.D., is president and CEO of the Natural Products Association (NPA). He previously led FDA’s Division of Dietary Supplement Programs. (Fabricant departed FDA in 2014 before the agency late the following year announced the creation of the Office of Dietary Supplement Programs).

Fabricant reacted to the idea of a mandatory product registry with skepticism.

“How does it help public health?” the former regulator asked. “What are you really doing?”

He questioned whether “illegitimate” companies would register their products or make “honest” submissions.

“You don’t think that that database is going to be chock-full of some fraudulent products?” he said.

He argued there could be unintended consequences to having a mandatory product registry. For example, Fabricant referenced possible glitches in FDA’s electronic capabilities for accepting product labels, such as a systems shutdown, that could result in companies being penalized, even if they followed the proper registration procedures. And would a company be punished, Fabricant asked, if it changed the size of its product or incorporated a different formula?

He also noted that while companies must register their food facilities, FDA doesn’t release the names of those registrants.

“Until that’s done, who cares about product?” he said.

Moreover, FDA obtains ample labels during its review of internet websites, inspections of facilities and on certificates of free sale when companies plan to export products, Fabricant said.

“If you don’t think FDA uses those, you’re mistaken,” he continued.

Still, Fabricant concurred a mandatory product registry could be somewhat helpful to regulators in its enforcement against products notorious for containing undeclared pharmaceutical drugs, such as certain products that advise consumers to take the product 45 minutes before sexual activity

“That’s kind of a tipoff that something may be there, but FDA still has the burden of going out, collecting the product and showing that it’s there,” he said.

FDA already can zero in on certain sexual enhancement claims for products sold at various outlets, Fabricant said, such as a claim that the product works like Viagra, the prescription drug for erectile dysfunction.

“Now, it [product registry] may give them a targeted place to hunt from, but that’s all it would do,” he continued. “It would refine a target a little more, but I think that target is pretty well defined already.”

Legislation: Strategy & Challenges

Mister said his organization remains committed to the Supplement OWL and has not taken an official position regarding a mandatory product registry.

In 2013, Sens. Dick Durbin (D-Illinois) and Richard Blumenthal (D-Connecticut) reintroduced the Dietary Supplement Labeling Act, which would give FDA authority to require manufacturers to register their products and ingredients, as well as provide evidence of health benefit claims. The legislation was first introduced in 2011.

Although the bill quickly died, it started a conversation over FDA’s visibility into the products on the market, Mister said.

“I can say fairly confidently that if we were to come around and support … a product listing, a part of that conversation would have to be that all the parties would agree that this would not become a Christmas tree with lots of other things on it,” Mister said, explaining his position that other reforms to the law would be off the table in negotiations. “And that would be sort of the terms of our support.”

Representatives for Blumenthal and Durbin did not respond to requests for comment for this article by the publication date.

Mister said a similar strategy as the one he endorsed worked effectively more than a decade ago when the industry supported a mandatory adverse event reporting law.

“It was understood by all the parties that this was only about very narrow adverse event reporting,” he explained. “We were going to have to amend DSHEA to add it, but we could not let other things come on, and the moment other things started coming on, and people started to use it as a Christmas tree, the industry walked, and we would oppose it.”

A mandatory product registry, Bass said, doesn’t represent a first step toward premarket approval of dietary supplements and would not undermine DSHEA.

“Once debate starts, could opponents throw in other things that would undermine the freedoms we won?” Bass asked before answering “no.” “I think there is sufficient popular support that Congress would never get away with taking away those freedoms, and certainly the current administration is the last that is going to impose heavier regulation.”

He explained further: “Is it possible there will be those who propose new restrictions? Yes, and I think we will be prepared for that and have our allies—including I think in this case FDA—not want that in order to get this very basic provision.”

Newhart, the FDA spokeswoman, said, “We are aware of recent discussions about the merits of mandatory product listing, and we look forward to hearing stakeholder perspectives on this issue and to participating in this conversation.”

Loren Israelsen, president of the United Natural Products Alliance (UNPA), who played a role in the negotiations leading to the passage of DSHEA, also weighed in on the concept of a mandatory product registry.

“If the objective is to solve some or all of the chronic problems with rogue companies going around the regulatory system, and if it gives FDA authority to go after these violators, we’re behind mandatory registration,” he said in an emailed statement. “But how do you accomplish it? It’s clear that a registration program would require federal legislation, and no one underestimates the effort that would be required to get this legislation passed in the current political environment.”

Israelsen also questioned how such a registry would be funded.

“Do the costs become the responsibility of responsible industry?” he asked. “While today we question if this is all realistic, we invite a robust industry discussion about this important topic with the goal of removing adulterated and otherwise illegal products from the marketplace.”

Editor-in-chief, Sandy Almendarez, contributed reporting to this article.