Under the Dietary Supplement Listing Act of 2022,companies would be required to provide FDA with vital information about their products that would also be made public to Americans, including:
- product names
- a list of all ingredients
- an electronic copy of the label
- allergen statements
- health and structure/function claims
Sen. Durbin went on the question the safety of supplements and point to his concerns with the Dietary Supplement Health and Education Act of 1994 (DSHEA), stating, "Manufacturers of those vitamins and minerals that are for sale in all those shops and all those drugstore are not required to tell the Food and Drug Administration what products they're selling in the United States under what names. They're not required to disclose to the FDA what is in those products are where they are manufactured. And believe me, a lot of them are manufactured outside the United States. So when it comes to dietary supplements, the Food and Drug Administration and the American consumers are pretty much flying blind."
He also called out the work of the late Senator Orrin G. Hatch and his work on dietary supplement legislation, stating: “My nemesis, my challenger on the whole issue, was the late Senator from Utah, Orrin Hatch. Eventually we worked out an agreement, Adverse Event Reporting was required,” which Durbin added, “I might argue never worked.”
On his efforts to make change, leading up to this latest bill, Sen. Durbin said, "I proposed a change about 10 years ago and the dietary supplement industry hated me. They fought me tooth and nail. They hated my idea like the devil hates holy water. In the years Senator Braun and I started talking to them about this new bill, there's been a significant change, and I want to salute the industry for this change. A strong majority of dietary supplement industry now supports responsible reporting requirements and stronger protections. Hats off to them. The industry's largest trade association, the Council for Responsible Nutrition [CRN], has endorsed our bill. Other trade associations supporting enhanced reporting requirements."
Sen. Durbin also accused the industry of selling “gas station heroin,” though he concluded, "the vast majority of these supplements will not harm people, and the dietary supplement manufacturers know that and that's why they're supporting our effort."
Industry groups quickly weighed in on the proposed legislation.
As Sen. Durbin noted,CRN is in support. “Transparency is the best disinfectant, and a mandatory product listing will give FDA and consumers visibility into the dietary supplement marketplace,” said Steve Mister, President & CEO Council for Responsible Nutrition, in apress releasefrom the Office of the U.S. Senate. “CRN member companies produce a large portion of the dietary supplements marketed in the United States, so we know responsible industry supports mandatory product listing for supplements. We appreciate the opportunity to work with Sens. Durbin and Braun on this critical legislation.”
TheConsumer Healthcare Products Association(CHPA) alsoexpressed support, with CHPA President and CEO Scott Melville calling it fitting that attention is being placed on DSHEA following the passing of former Senator Orrin Hatch, the author of DSHEA. “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, Melville said. "We look forward to continuing to work with the bill sponsors on our shared commitment to provide greater oversight of products that 77% of Americans have used over the past calendar year. 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.”
Others in the industry expressed strong opposition. TheNatural Products Association(NPA) has fought against the proposalfor several years. “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 Dr. Daniel Fabricant, NPA President, and CEO. “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.”
TheAmerican Herbal Products Association (AHPA) alsoannounced its opposition. "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."
AHPA added its position that the current federal regulatory framework for dietary supplements supports the industry and consumers and provides FDA with all of the authority needed to properly regulate dietary supplements, rendering MPL requirement unnecessary.
NPA's Dr. Fabricant commented on this as well. “The late Senator Hatch, Congressman Waxman, President Clinton, and others unanimously passed DSHEA in 1994 because they understood the importance of an appropriately regulated industry for dietary supplements. The federal government has a wide variety of enforcement powers and a significant track record of punishing criminals who break the law. We support transparency, but this legislation fails to recognize the deficiencies of the FDA by making them less accountable to the industry. 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 withNACand 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.”
On the diverging views within the industry, AHPA stated that it "recognizes the interest of FDA and the support of some trade associations and others in establishing an MPL requirement for dietary supplements. We have therefore communicated with FDA, numerous Congressional offices, industry colleagues, and other stakeholders to share alternate suggestions for modernizing the federal laws under which FDA regulates dietary supplements. We look forward to future opportunities to engage in robust and transparent discussions about how we can work cooperatively to advance health with increased education and broad access to a wide range of safe and well-regulated dietary supplement products."
NPA called it unfortunate and surprising that some in the industry offered support of the "misguided" legislation, maintaining that such support creates "a great risk that Members of Congress may be led to believe that it is supported by industry when that couldn’t be further from the truth." To counter this: "NPA has activated its industry-leading grassroots operation to elevate our concerns. Still, we also strongly encourage our friends in the industry to join our growing movementand to convince elected officials that this is the wrong path at exactly the wrong time.”
