U.S. Senate Majority Whip Dick Durbin (D-IL), introduced the Dietary Supplement Listing Act of 2022 on Tuesday. The bipartisan legislation, co-sponsored by Senator Mike Braun (R-IN), would require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration.
U.S. Senate Majority Whip Dick Durbin (D-IL), introduced the Dietary Supplement Listing Act of 2022 on Tuesday. The bipartisan legislation, co-sponsored by Senator Mike Braun (R-IN), would require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration (FDA). The legislation would require companies to provide FDA with information about their products, including product names, a list of ingredients, an electronic copy of the label, allergen statements, and structure/function claims.
“Seventy percent of people in America take a dietary supplement, including me. I also believe that Americans who take vitamins, minerals, and herbs for their health and well-being have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true,” said Durbin on the Senate floor. “Our bill will give the FDA the information it needs to protect Americans from dangerous products being sold as health supplements. Our bill will give them the information and the power. We urge our colleagues to join us in passing it as soon as possible. It is a commonsense, bipartisan comprise that will protect consumers’ health and save lives.”
In his speech on the Senate floor, Durbin focused on an ingredient called tianeptine, an unapproved drug ingredient sold illegally as a dietary supplement, and sometimes referred to as “gas station heroin” for its opiate-like effects. The Natural Products Association (NPA; Washington, D.C.) took umbrage with Durbin’s speech for characterizing the dietary supplement industry as unsafe by focusing on a single adulterated product. Nor does NPA believe that a mandatory product listing is the right solution for ensuring the safety of dietary supplements. The association has established a grassroots campaign to oppose the legislation, which NPA says is tantamount to premarket approval.
“NPA is deeply concerned with the Dietary Supplement Listing Act of 2022, which would establish premarket approval for dietary supplements. The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” said Daniel Fabricant, PhD, president, and CEO of NPA, in a press release. “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 Durbin-Braun approach will hurt consumers and needlessly damage the industry. It mirrors over-the-counter premarket drug regulations and is more stringent than current regulations, including the NDI provision, a notification rather than a pre-market approval. The Dietary Supplement Listing Act 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.”
NPA contends that the federal government is not doing enough with its existing powers to combat adulteration and get dangerous products off the market. “We support transparency, but this legislation fails to recognize the deficiencies of the FDA by making them less accountable to the industry,” said Fabricant. “Congress should be more focused on performing an in-depth performance review and analysis of the FDA’s current authorities to determine if they are effectively using those which they currently have before creating a pre-market approval process for dietary supplements that FDA will only misuse to create problems as we’ve seen with NAC and CBD. As proposed, there are only two groups we can see who would benefit from this approach: 1) the trial-attorney industry through additional frivolous class action lawsuits based on alleged injuries caused by foods or supplements, and 2) disreputable individuals looking to create counterfeit products based on the ingredients and formulations in the database, hoping they can turn a quick profit.”
The American Herbal Products Association (AHPA; Silver Spring, MD) does not see the value of creating a mandatory product listing either. “AHPA has a significant track record of supporting statutory amendments to the Federal Food, Drug, and Cosmetic Act when they clearly benefit consumers and when such amendments achieve their ends in a manner that minimizes burdens on the regulated trade. But, to date, neither the U.S. Food and Drug Administration (FDA) nor other advocates for MPL have clearly articulated the need for this premarket product listing requirement. In addition, the legislation introduced by Senators Durbin and Braun would create unnecessary, significant, and redundant burdens on industry,” said Michael McGuffin, president of AHPA, in a press release. “AHPA has emphasized for several years that the current federal regulatory framework for dietary supplements supports the industry and consumers. Further, AHPA has stated this framework provides FDA with all of the authority needed to properly regulate dietary supplements, and thus an MPL requirement is unnecessary. Nothing in this newly introduced legislation has modified these views.”
However, there is not consensus on this issue. The Council for Responsible Nutrition (CRN; Washington, D.C.), for example, has seen a mandatory product listing as a real possibility, and decided to embrace the concept by creating the Supplement OWL, a voluntary product registry used by its members. The Supplement OWL, CRN believes, can serve as a model for a potential federal mandatory product listing, giving industry a say into how it may be implemented.
“This [Supplement OWL] has demonstrated the ability of companies, both large and small, to provide product labels and general information about their products as a routine part of bringing their products to market without being overly burdensome or an obstacle to introducing new supplements. Quite simply, the registry is a birth certificate, not a driver’s license,” said Steve Mister, president and CEO of CRN in a letter to Durbin and Braun in support of the legislation. “FDA cannot regulate what it cannot see. That’s why CRN strongly supports the Dietary Supplement Listing Act of 2022. It creates a similar mandatory repository of supplement labels—something FDA needs to appropriately oversee this industry—without becoming a barrier to entry. This legislation will provide FDA and consumers a more complete understanding of the marketplace and the range of products and ingredients currently marketed as dietary supplements. In addition, this new registry should assist FDA in taking enforcement actions against irresponsible companies marketing products as dietary supplements inappropriately.”
The Consumer Healthcare Products Association (CHPA; Washington, D.C.) also believes that a mandatory product listing is a necessary part of modernizing dietary supplement regulation but wants a more comprehensive approach. “Mandatory Product Listing is an important component of modernizing DSHEA, but more needs to be done to enhance quality, ensure safety, and provide the transparency and predictability needed to promote innovation in the dietary supplement industry. We look forward to continuing to work with the bill sponsors on our shared commitment to provide greater oversight of products that 77 percent of Americans have used over the past calendar year,” said Scott Melville, president and CEO of CHPA in a statement. “Now, more than ever, consumers are depending on dietary supplements to address nutritional gaps and promote their overall wellness. The industry has grown from $4 billion in 1994 – when the regulatory framework that oversees supplements was first enacted – to more than $50 billion today. However, regulation has not kept pace with changes in the marketplace. The time is ripe for a more comprehensive approach to modernizing DSHEA and CHPA remains committed to working with Congress to share ideas and proposals that will further promote consumer safety and enhance public health.”
The legislation still has a long way to go before becoming law, and just as it has provoked a hearty debate within the industry, the potential mandatory product listing will no doubt experience a similar debate within Congress. Now that legislation has been introduced, stakeholders will be hard at work to either kill the bill or negotiate an outcome that will be satisfactory to both regulators and industry alike.