On Jan. 15, U.S. Senator Dick Durbin (D-IL) reintroduced the Dietary Supplement Listing Act, which would require dietary supplement manufacturers to register their products with the U.S. Food and Drug Administration (FDA).
According to Durbin, the law would require companies to provide FDA with critical information about their products including product names, a list of all ingredients, an electronic copy of the label, allergen statements and health and structure/function claims. This information would be accessible to the public through an electronic database.
In 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA), there were 4,000 dietary supplements marketed in the United States. Today, FDA estimates that number has climbed to more than 100,000.
“FDA—and consumers—should know what dietary supplements are on the market and what ingredients are included in them. This is FDA’s most basic function, and the first step to protecting consumers. Americans deserve a transparent supplement market, and it’s past time that we deliver it for them,” Durbin said.
The Council for Responsible Nutrition (CRN) welcomed Durbin’s legislation. CRN said it has long advocated for a registry of products on the market and has been working closely with Congress and federal regulators to advance a commonsense solution that gives consumers and FDA greater visibility into the products and what’s in them.
“In an era when the Administration has rightly called for more transparency about what we eat and how food is made, it makes sense to apply that same transparency to dietary supplements. Consumers deserve to know what products are on the market and what they contain—and FDA needs that same information to do its job effectively,” said Steve Mister, president and CEO of CRN.
The Consumer Healthcare Products Association (CHPA) also welcomed the reintroduction of the act.
“CHPA commends Senator Durbin for the reintroduction of legislation to establish mandatory product listing for dietary supplements. Product listing is a meaningful step in the right direction to support transparency, accountability, and effective oversight in a rapidly evolving marketplace,” said CHPA President and CEO Scott Melville. “While this is an important step forward, product listing is not sufficient as a standalone measure. CHPA continues to stand by its view that additional steps are needed to strengthen consumer protections, enhance product quality and safety, and modernize oversight of today’s supplement market.”
The American Herbal Products Association (AHPA) opposed the latest iteration of the act. The association said advocates have not articulated how this requirement would provide tangible benefit to consumers or meaningfully enhance FDA’s existing authorities to enforce against marketers of products “masquerading as dietary supplements.”
AHPA is not opposed to the concept of mandatory product listing, but it does not support this legislation as it lacks provisions to clearly benefit public health or sufficiently accommodate small businesses.
“AHPA remains committed to protecting public health and fostering a transparent, innovative dietary supplement industry,” said AHPA President and CEO Graham Rigby. “We will continue our direct engagement with FDA and Congress to develop meaningful, common-sense reforms that increase accountability and modernize our regulatory framework to meet the needs of today’s dietary supplement marketplace and consumers.”
The Natural Products Association (NPA) also opposed the law, stating a mandatory product listing (MPL) won’t protect consumers from bad actors or unlawful products. An MPL would burden the industry with a mountain of administrative paperwork and raise costs of everyday health products.
“Congress already established a comprehensive, risk-based framework for dietary supplements under DSHEA, and this proposal blows right past it by creating a backdoor system that was never authorized. This Trojan Horse will hand bureaucrats new leverage over lawful products, cool innovation and punish companies investing in new science and better health solutions,” said Daniel Fabricant, PhD, president and CEO of NPA.
NPA also opposes the proposal for MPL because it “perpetuates the fallacy that labels are not readily accessible today to FDA, or the misconception that dietary supplements in the U.S. are not already subject to FDA oversight and robust regulations.”
“Finally, NPA is perplexed that industry advocates would make mandatory product listing a priority, amid the most pressing opportunities and challenges facing ingredient suppliers, manufacturers of finished products and retailers,” Fabricant said. “NPA remains focused on countering growing threats from state legislatures to restrict and regulate legitimate supplements, addressing the ‘drug preclusion’ clause in DSHEA, expanding consumer access to science-based products that promote health and wellness, and ensuring that FDA moves expeditiously against bad actors. Mandatory product listing will not achieve—and in some cases, will even undermine—those objectives.”
For more information, visit www.crnusa.org, www.chpa.org, www.ahpa.org or www.npanational.org.
