Dietary supplement trade groups oppose Durbin’s Dietary Supplement Listing Act

When I learned yesterday that U.S. Sen. Majority Whip Dick Durbin (D-Ill.) had reintroduced the Dietary Supplement Listing Act, I anticipated the responses from the major dietary supplement trade associations would reflect a mixture of support, opposition and even some neutrality.

I was wrong. When it comes to legislation, the devil is always in the details.

The five major trade groups expressed their opposition to Durbin’s 2024 bill in its present form at least—for myriad reasons.

Let’s start with the Council for Responsible Nutrition (CRN), which has been generally supportive of mandatory product listing (MPL). CRN President and CEO Steve Mister let the senator know in a July 29 letter that his organization could not endorse the bill in its current form.

CRN President and CEO Steve Mister

The bill “contains the expanded requirement that manufacturers provide FDA with a list of all their website claims for a new product—beyond the label and package insert information,” Mister wrote to Durbin. “This additional requirement is burdensome on industry and exceeds the original objective of the registration to provide FDA with a current snapshot of products on the market.”

Mister cautioned the requirement “exceeds the goal of giving FDA visibility into the array of dietary supplements in the U.S. market and could encourage FDA to conduct ‘fishing expeditions’ for marketing activities beyond the scope of their authority.”

Mister added that “requiring companies to submit copies of their website claims does little to address your concerns over tianeptine, which we understand is one of the reasons you are reintroducing the legislation at this time.”

Durbin and Sen. Richard Blumenthal (D-Conn.) in April introduced a bill aimed to stop the sale of tianeptine products, which have been marketed as dietary supplements, raised concerns among U.S. regulators and earned the nickname “gas station heroin.” When announcing the bill, the lawmakers cited data from America’s Poison Control Centers (based on a New York Times story) that 391 tianeptine cases were reported nationwide last year. 

The Consumer Healthcare Products Association (CHPA) has been generally pro-MPL as well as part of its proposals for comprehensive reform to the Dietary Supplement Health and Education Act of 1994 (DSHEA). The organization, however, expressed its disappointment with the bill’s “limited scope.”

CHPA President and CEO Scott Melville

“Having worked closely with federal lawmakers to underscore the critical need for dietary supplement regulatory reform, CHPA remains hopeful a more comprehensive approach that cracks down on illegal activity and better protects consumers is achievable in this or the next Congress,” CHPA President and CEO Scott Melville said in a statement. “Unfortunately, this bill would not have that effect. This is especially disappointing considering the senator’s recent attention to resolve issues such as tianeptine, which this bill would not address.”

The United Natural Products Alliance (UNPA) also does not support the current version of Durbin’s Dietary Supplement Listing Act.

Patricia Knight and Peter Reinecke, senior political advisers for the United Natural Products Alliance.

UNPA indicated in April to Durbin’s staff that its “members could be generally supportive of a reasonably designed product listing requirement, but that we could not support inclusion of the two ‘poison pill’ amendments the HELP [Health, Education, Labor and Pensions] Committee had included when it considered similar legislation in 2022 (a new prohibited act and requirement for FDA to finalize their NDI guidance),” according to a July 30 memo from its senior political advisors, Patricia Knight and Peter Reinecke. “Among specific concerns with the draft are a requirement to include website claims (which can change frequently) and questions about the protection of proprietary blends from public disclosure. In addition, it has been our consistent message that advancement of an MPL bill must be contingent on FDA actually receiving the resources needed to implement the program without taking away from existing enforcement against bad actors.”

The American Herbal Products Association (AHPA) previously had taken a neutral stance generally on MPL. It was neither a vigorous supporter of FDA’s legislative proposal nor a vociferous opponent.

AHPA yesterday took a firm stance, announcing its opposition to Durbin’s 2024 bill.

Robert Marriott, AHPA Director of Regulatory Affairs

“We have yet to be convinced that the potential benefits of MPL requirements would justify their costs—both to industry and FDA—as well as the potential unintended consequences that would result from the establishment of such a system,” said Robert Marriott, AHPA director of regulatory affairs, in a statement. “Even so, AHPA supports more narrowly tailored and effective legal reforms that will reflect the needs of an evolving marketplace. We will continue our work across the herbal products community, in cooperation with federal decisionmakers, to advance public health and ensure broad access to safe and well-regulated dietary supplement products.”

The Natural Products Association (NPA) has made no bones about its opposition to MPL, and the 2024 bill introduced by Durbin hasn’t changed its position. NPA President and CEO Dan Fabricant expressed extreme disappointment in Durbin’s introduction of a bill that he said was opposed by the industry and attacks its integrity.

“We look forward to working with our willing industry and consumer partners to set the record straight and defeat this legislation once again,” Fabricant noted in an email. “Our position has been unwavering on this. Legislative proposals of this ilk that are developed in bad faith and designed solely to damage the industry’s reputation aren’t to be negotiated and to be improved upon, they’re to be laid to rest. I don’t think we’d be in this position today if some had learned that basic lesson and previously lent their support to this malignant attack.”

Mandatory product listing: The path forward

It’s expected that at least some—if not all—of the major dietary supplement trade associations will try to work with the U.S. senator to engage in some metaphorical horse-trading, perhaps resulting in amendments to the bill that industry considers burdensome.

“CRN remains hopeful that further discussions will lead to a compromise that addresses these concerns, ensuring transparency and targeting bad actors in the marketplace, as intended,” Mister wrote to Durbin. “We remain committed to transparency through a listing program, as well as other common-sense reforms that address our shared goals of creating an even safer dietary supplement marketplace, fostering innovation and scientific research for these products, and assuring consumers of the quality and benefits of dietary supplements.”

Whether such talks bear fruit remains to be seen.

Of course, organizations outside the industry that have expressed interest in dietary supplement issues may fully support the bill’s current language and view the requirement to disclose health and structure/function claims, for example, as a benefit to consumers.

Center for Science in the Public Interest called for broader reforms beyond mandatory product listing.

Jensen Jose, regulatory counsel, Center for Science in the Public Interest

CSPI regulatory counsel Jensen Jose called Durbin’s bill “a step in the right direction,” though not enough considering “the problems rampant in the industry.”

“A more useful FDA database wouldn’t just include a list of products, it would also include summaries of the evidence for those products’ safety and effectiveness,” he said. “And real, comprehensive reform would close the loophole that lets supplement companies bypass FDA premarket review and determine for themselves that new dietary ingredients are ‘generally recognized as safe,’ or GRAS.”

Given that it’s an election year with the White House up for grabs, it’s unlikely this bill gets passed by Congress in 2024. But as Duffy MacKay, CHPA SVP of Dietary Supplements, told me earlier this month, introduction of Durbin’s bill will get it into the news and foster a conversation.

“And then of course, 2025 will come around and people will be more educated about it,” he noted. “We’ll probably see it again.”

This piece originally appeared on Natural Products Insider, a New Hope Network sister website. Visit the site for information on the nutrition industry—from supplements and functional foods to sports nutrition and manufacturing.