The Council for Responsible Nutrition (CRN) plans to visit Capitol Hill in 2020 looking for sponsors for a bill that would require listing of dietary supplement products with FDA, the trade association’s leader said in a recent interview.
FDA also is working on legislative language for Congress’s consideration, said Steve Mister, president and CEO of CRN. Mister noted an FDA official, Lowell Schiller, discussed the issue at CRN’s annual dietary supplement symposium in November in Carlsbad, California.
In 2020, “We will be on the Hill starting to look for bill sponsors and co-sponsors for legislation that would create mandatory listing,” Mister said in a Dec. 19 interview. “It’s very important that the industry have its own version of what that language would look like so that we’re not just in a position of reacting to what FDA may have, but that we actually have a vision of what a mandatory listing bill would look like.”
Asked about a timeframe at CRN's conference for releasing language on a specific legislative proposal, Schiller said, “We’re working on something. You’ll see it soon,” according to Mister's recollection.
Schiller’s remarks, Mister said, reinforced “FDA is working on its own version of language.”
FDA’s support for a mandatory product listing is public record: The agency proposed such a requirement in its FY2020 budget request to Congress.
“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,” the agency explained in its budget request. “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.”
Asked about plans to draft legislative language for Congress’s consideration, an FDA spokeswoman, Lindsay Haake, referenced FDA’s FY2020 budget proposal to require supplements be listed with FDA.
“The FDA strongly supports this policy, which would significantly enhance the agency’s ability to efficiently and effectively protect the public health, and we look forward to working with Congress and other stakeholders to advance this goal,” she added in an email.
Based on annual sales and new products, the supplement industry has exploded over the last 25 years since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). In a 2019 statement, then-FDA commissioner Scott Gottlieb, M.D., reported “more than 50,000–and possibly as many as 80,000 or even more—different products” are available as dietary supplements.
But since dietary supplement products aren’t listed with the government, FDA has no reliable way to know the actual number on the market or track all of them.
“Today, without mandatory product listing, we lack basic, fundamental information about the dietary supplement market,” Schiller, FDA’s principal associate commissioner for policy in the Office of Policy, said during a Nov. 7 speech at CRN’s conference. “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.”
He added, “We don’t know how many products contain any given ingredient. And if it turns out that there’s a safety problem with a particular ingredient, or a particular ingredient supplier, we don’t have the basic information to quickly identify which products are affected.”
Criticisms of proposal
Factions within industry are split on the pros and cons of a mandatory supplement product listing. Some support the idea for reasons identified by FDA, while others assert the requirement would impose another burden on compliant companies while failing to address existing problems, such as “bad actors” who put dangerous ingredients into their “supplements” or otherwise flout their legal obligations.
“I see it as unnecessary make work,” said Marc Ullman, of counsel to Rivkin Radler LLP, in an interview. “FDA already has access to this information.”
For instance, he said FDA has access to information about products when companies that make structure/function claims notify FDA, as required by law.
“So now all we’re going to do is create another regulatory burden for companies that are filing their 30-day notices to no apparent end,” he said.
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), also questioned the prudence of focusing today on creating mandatory product listing via legislation. He said FDA has not adequately used its existing authority and resources to address problems, such as manufacturers’ failure to file new dietary ingredient notifications (NDINs) with FDA.
“If the agency isn’t going to use existing statutory authority like on the NDIs, why are we even talking about additional adds?” asked Fabricant, previously director of the Division (now Office) of Dietary Supplement Programs. “Let’s see it implemented first, and then we can talk additional adds.”
Fabricant acknowledged a dietary supplement product listing may be helpful— “and I use the word ‘maybe’ with emphasis”—but he underscored it’s premature to have the conversation when FDA has failed to hold up one of the pillars of the law: the NDIN requirement.
“It’s rearranging deck chairs on the Titanic to even have the conversation,” concluded Fabricant, who also spoke to Natural Products INSIDER about a dietary supplement product listing during a podcast interview published in December.
Support for mandatory product listing
Schiller, the FDA official, rejected concerns that a product listing would impose undue burdens on industry.
“We’re not talking about imposing a new pre-market approval requirement,” he said during his speech at CRN’s conference. “If manufacturers and distributors were just to provide us with certain basic information—information that in many cases already appears on product labels—it would be a big win for public health and legitimate industry, while imposing only minimal new costs.”
Scott Bass, an attorney who helped draft DSHEA, is a vigorous proponent of a mandatory product listing.
“How can FDA use any of its tools to protect the public or enforce the law if they don’t know what’s out there?” asked Bass, a partner in Washington with Sidley Austin LLP, in an interview. “I mean it’s just logic.”
Loren Israelsen is president of the United Natural Products Alliance (UNPA) who worked closely with Bass in the negotiations on Capitol Hill leading up to passage of DSHEA. He also expressed support for a mandatory product listing.
“UNPA supports the concept of mandatory product registration,” he said in a statement, “as a logical step to provide a central database for FDA to know how many products of what kind are available to consumers.”
In an article recently published in the New England Journal of Medicine (NEJM), Bass and Dr. Pieter Cohen of Harvard Medical School explained their support for a mandatory product listing.
“Mandatory submission of product labels would enhance transparency and advance the FDA’s ability to use its authority under DSHEA to regulate products,” Bass and Cohen wrote. “The agency could be required to provide each product with a unique bar code or quick response code and could use these codes to track adverse effects, manufacturing problems and adulteration.”
The system would enable FDA to “determine whether a labeled ingredient is new and lacking adequate evidence of safety before a product appears on the market,” Bass and Cohen stated. “The agency could flag products containing such ingredients in the label database so that retailers would be able to easily confirm that a product was properly listed with the FDA before making it available in retail stores or online.”
Ullman, however, questioned how FDA could ascertain whether an ingredient is new based on a dietary supplement product listing with FDA.
Adulteration, misbranding proposals
Enter Robert Durkin, of counsel to Arnall Golden Gregory LLP and, until recently, deputy director of FDA’s Office of Dietary Supplement Programs. He supports a mandatory product listing, but one erected with “teeth.”
Durkin articulated some of the challenges facing his former employer in actively policing the supplement market.
“Because there’s no premarket approval because it’s a completely post-market paradigm, FDA has no idea if a product’s on the market and adulterated until they have a reason to know that,” he said in an interview. “Unfortunately, the reason to know that is the product hurts somebody.”
James Prochnow, a partner in Denver with Greenberg Traurig LLP, acknowledged the challenges facing FDA in identifying new dietary ingredients on the market.
“There’s got to be some mechanism for the government to be aware of a new dietary ingredient that’s being introduced to the marketplace, and currently there isn’t,” Prochnow said in an interview.
Durkin proposed dietary supplement firms that list their products with FDA answer specific questions, including (among others) whether they have a basis for concluding an ingredient does or doesn’t require an NDIN to FDA, and whether a manufacturer has submitted an NDIN to the agency or established an ingredient is GRAS (generally recognized as safe).
Durkin also proposed incorporating provisions in the code of federal regulations that if a product isn’t properly listed with FDA, it’s adulterated and misbranded in violation of the law.
“If FDA has reason to think or can show that any of their [manufacturers’] prior attestations were false, FDA can pull a listing,” Durkin said in an interview, further explaining his proposal. “FDA pulls a listing—the product’s automatically misbranded and adulterated. It can be seized. It can be taken out of commerce.”
Counselor Todd Harrison shared a similar proposal that if dietary supplement products aren’t listed with FDA, they are adulterated as a matter of law. If a manufacturer failed to list any products, all of its products would be considered adulterated under the lawyer’s proposal.
“Mandatory product registration and listing doesn’t work unless it has bite to it,” said Harrison, a partner with Venable LLP, in an interview. “There’s too many people willing to skirt the laws.”