Burdensome mandatory supplement listing proposal sparks controversy, CSPI calls for “broader reforms”

05 Aug 2024 --- Many US trade associations representing the supplement industry oppose the recently proposed Dietary Supplement Listing Act of 2024, with reactions ranging from “misguided,” “unnecessary” and “burdensome” to the proposal being “too limited.” The bill, proposed by US Senator Richard Durbin, would introduce mandatory supplement listing in a US Food & Drug Administration (FDA) database. We examine the industry’s feedback and suggestions for alternative and additional reforms.

Although the Council for Science in the Public Interest (CSPI) says the legislation is a “step in the right direction,” the organization calls for much broader reforms.

“It will help the FDA understand what dietary ingredients are on the market and better identify potentially dangerous supplement ingredients, products and emerging trends,” Jensen Jose, CSPI’s regulatory counsel, tells Nutrition Insight.

However, he notes that a more useful FDA database would include summaries of the evidence of products’ safety and effectiveness in addition to the list of products. Moreover, real, comprehensive reform would close a loophole where companies determine that a substance is generally recognized as safe (GRAS), which is not reviewed by the FDA.

“Listing will shine a light on the industry,” Jose expects. “Through the GRAS loophole, many chemicals added to supplements have never been reviewed for safety. Often, the FDA is never even informed that those chemicals are being sold in dietary supplements. This will force companies to list those ingredients with the FDA, so the agency can know which chemicals have not been reviewed and which products merit stricter oversight.”

At the same time, the Natural Product Association (NPA) says the proposed bill takes a “misguided and unnecessary approach to dietary supplements.” The American Herbal Products Association (AHPA) and Council for Responsible Nutrition (CRN) support the goal of improving industry transparency but cannot endorse the bill in its current form, as it “encumbers companies with an ongoing administrative burden.”

Supplement regulation
The FDA states that since the enactment of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the industry has grown from 4,000 to over 95,000 products. The organization aims to modernize the legislation, providing “a transparent marketplace, help facilitate a risk-based regulation of dietary supplements and clarify FDA’s authorities relating to products marketed as dietary supplements.”

The FDA can investigate unlisted supplements to identify which ones are tainted with dangerous chemicals or claims, says Jose.Along with mandatory supplement listing with the FDA, the agency seeks to clarify the FDA’s authority over products marketed as supplements. It says that these amendments would help the FDA know when new products are introduced and quickly identify dangerous or illegal products on the market to take appropriate action.

“Companies are not required to tell the FDA what supplements they are selling or what ingredients they are using in their supplements,” explains Jose. “Dangerous products and illegal claims are often marketed online, making it even more difficult for the FDA to identify problem supplements and claims. Therefore, the agency has no idea what products or ingredients are posing a risk to consumers, and the FDA cannot regulate what it does not know.”

He says that supplements not listed in the proposed FDA database can be used as a red flag for the agency, noting that many bad actors will not list their more dangerous and fraudulent dietary supplements so they can continue operating in the shadows below the agency’s radar.

“When the FDA finds unlisted supplements, it can take enforcement action against those supplements for not listing their supplements as required by this bill. The agency can focus its investigations on unlisted supplements to identify better ones tainted with dangerous chemicals or fraudulently claiming to treat diseases.”

Lack of clear benefits
The NPA highlights that supplements are “safe and heavily regulated.” Dr. Daniel Fabricant, NPA’s president and CEO, says the current proposal has been rejected repeatedly “because it’s bad for consumers and US manufacturers and retailers. It should be rejected again.”

He explains that the FDA already has access to information “regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce and whether any products are associated with serious adverse events.”

The proposed legislation is more stringent than current regulations. It is “entirely at odds with the current regime, which has delivered world-class consumer safety and broad access to important nutritional supplements for over a generation.”

Meanwhile, the AHPA supports the FDA’s quest to address unlawful drug products masquerading as supplements but says that the concept of mandatory product listing for supplements lacks clear benefits. The organization states that the bill would impose “unnecessary, significant and redundant burdens on the industry.”

Robert Marriott, the organization’s director of regulatory affairs, says that the AHPA is not convinced that the bill’s potential benefits would justify its costs to the industry and the FDA. “Even so, AHPA supports more narrowly tailored and effective legal reforms that will reflect the needs of an evolving marketplace.”

Trade organizations oppose the bill as it encumbers companies with an ongoing administrative burden.Enhancing transparency
In a letter to Senator Durbin, Steve Mister, the president and CEO of CRN, says the organization “wholeheartedly” supports the creation of an official registry of supplements sold in the US. He adds that CRN supports the Senator’s commitment to greater transparency in the marketplace and maintains a publicly available label database, the Supplement Online Wellness Library, which its members are required to participate in.

At the same time, Mister says CRN cannot endorse the proposed bill, which requires manufacturers to provide the FDA with a list of “all their website claims for a new product.”

“This additional requirement is burdensome to the industry and exceeds the original objective of the registry, which is to provide the FDA with a current snapshot of products on the market,” he continues.

“Demanding companies submit that information (and keep it up-to-date as websites change) encumbers them with an ongoing administrative burden. This requirement exceeds the goal of giving FDA visibility into the array of dietary supplements in the US market. It could encourage FDA to conduct ‘fishing expeditions’ for marketing activities beyond the scope of their authority.”

At the same time, Mister comments: “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.”

“Not enough”
The Consumer Healthcare Products Association (CHPA), which represents supplements, over-the-counter medicines and consumer medical devices, urges the US Congress to enact more comprehensive improvements. In a statement, Scott Melville, the organization’s president and CEO, says the organization is “disappointed” with the proposal’s limited scope.

“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. 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.”

CSPI proposes several additional reforms, such as closing the GRAS loophole and providing the FDA with additional resources.Melville agrees that mandatory product listing is an excellent first step but underscores that it is not enough as a stand-alone measure.

“Under this bill as currently written, the FDA would still lack the resources and authority needed to quickly and efficiently remove illegal products like tianeptine from the market. Because it fails to present a comprehensive framework, it would do nothing to prevent criminals from simply removing the term ‘dietary supplement’ from their label to avoid the mandatory product listing requirement.”

Additional reforms needed
Jose cautions that an unintended consequence of the proposed mandatory listing is that supplements “might look more regulated than they are.”

“Since the listed supplements are published on an FDA database, consumers may think that the FDA somehow vets supplements for safety and efficacy. Unfortunately, the FDA will not have the resources to review the tens of thousands of supplements that would be listed and take effective enforcement action against problem supplements.”

He emphasizes: “Therefore, it is imperative to give the agency more funding and resources to review and address potentially dangerous supplements listed on its database.”

He proposes several additional reforms, highlighting that the FDA needs more than product information. “It needs to know what evidence companies used to establish that their dietary ingredients are safe and what evidence they use to substantiate that their claims are true.”

“Reforms should close the GRAS loophole and require that companies notify and obtain FDA premarket review of all new dietary ingredients,” says Jose.

In addition, he states that the FDA should receive additional resources so it can increase testing of high-risk supplements, such as supplements for weight loss, arthritis or pain management and sexual enhancement.

“FDA should have the authority to charge civil penalties for violating DSHEA,” he concludes.

By Jolanda van Hal

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