Seventy-seven percent of Americans rely on dietary supplements to help maintain their health and address nutrient shortfalls in their diets. But the realities of today’s market are drastically different than they were a quarter century ago when the Dietary Supplement Health and Education Act was signed into law, conferring the Food and Drug Administration with new authority over dietary supplements. In the years since, the U.S. dietary supplement market has grown more than tenfold, with projections it will exceed $50 billion this year. A transparent and accountable approach to ensuring safety is crucial if our regulatory framework is to remain nimble and adequately keep pace with evolutions in the market.
While the FDA prioritizes product safety, integrity and informed decision making, current law does not authorize the agency to require companies to submit information about marketed dietary supplement products. That leaves the FDA and consumers with limited knowledge about the labels, ingredients, and manufacturers of the estimated 50,000-80,000 products that comprise the U.S. supplement market.
Without such a system, the FDA lacks the transparency to adequately regulate this market. Consider one weight-loss supplement with liver-toxic stimulants that cascaded into 69 cases of severe hepatitis, requiring 32 hospitalizations, escalating into three liver transplants and resulting in two deaths. The manufacturer replaced one dangerous and previously banned stimulant, 1,3-dimethylamylamine, with multiple other stimulants associated with risk. The manufacturer did not inform the FDA – and the FDA had no way of knowing – that this product previously had DMAA or that the company was reformulating to new ingredients.
Voluntary programs for product listing, such as the National Institutes of Health’s Dietary Supplement Label Database and the Council for Responsible Nutrition’s Supplement OWL (Online Wellness Library), already exist and demonstrate that changes to our current system need not be burdensome. To achieve regulatory oversight in the marketplace, however, these programs will need to be expanded.
Mandatory dietary supplement listing will protect public health. It narrows the FDA’s focus so the agency can maximize efficiencies and stretch limited resources. This “risk-based regulation” model enables the FDA to capture trends and prioritize investigations of products that pose the highest risk to the public health.
For instance, 965 of the products tested by the FDA from 2007 to 2019 were identified to include potentially hazardous substances or hidden ingredients. Of these products, most fell into three categories: Fifty-two percent were used for sexual enhancement, 37 percent were used for weight management and 10 percent were used for muscle building. Knowing the universe of these products in the U.S. market, and who manufactures them, allows the FDA to target potentially adulterated supplements.
Many voices have expressed support for a mandatory product listing, including former FDA Commissioner Scott Gottlieb and former U.S. Sen. Orrin Hatch (R-Utah), one of the chief authors of DSHEA. The FDA recently proposed a product listing for dietary supplements as part of the agency’s fiscal year 2020 budget request to Congress. The Dietary Supplements Quality Collaborative, composed of 26 cross-sector organizations committed to advancing the quality and safety of dietary supplements in the United States, recommends a mandatory listing in its recently released policy principles. The idea even has popular support, with a Pew Charitable Trusts survey finding 9 in 10 Americans “favor requiring that manufacturers inform the agency of all supplements they make and their ingredients.”
With widespread support, mandatory product listing may be the measure that encourages the FDA, industry and other stakeholders to work collectively to embrace a new approach to the regulatory framework for dietary supplements. It preserves broad access to safe and beneficial products, one of the hallmarks of DSHEA, but offers transparency for FDA to see products that may pose risks. Three-quarters of Americans take dietary supplements and with more than 50,000 of these products on the market, they deserve to know the products they take are safe, support better health and are visible to the agency charged with their regulation.
Joseph Nadglowski Jr. and Christine Burdick-Bell are the Steering Committee chair and vice-chair, respectively, of the Dietary Supplement Quality Collaborative – a diverse group of 26 national stakeholder organizations across the public health spectrum representing consumers, practitioners, manufacturing industry, research, standard-setting and academic organizations committed to advancing the quality and safety of dietary supplements in the United States.
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