Multivitamins. Probiotics. Protein powders.
Many of us turn to these and other dietary supplements to help maintain good health. New studies increasingly show many of these products can boost our immunity, improve digestive health, reduce the risk of osteoporosis and high blood pressure, protect our cardiovascular health and prevent birth defects and a host of other health concerns. According to a 2021 consumer survey by the Council for Responsible Nutrition, 4 out of 5 Americans use at least one dietary supplement.
Because the U.S. Food and Drug Administration is charged with regulating the dietary supplement marketplace, we would think that federal agency would have a pretty good idea of how many products are available for sale, what ingredients are in which products and how to identify and contact the makers of a particular product in the case of a health crisis. However, we would be wrong.
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It’s true that FDA has requirements for quality manufacturing of supplements, restrictions on what claims can appear on the label, prohibitions on certain ingredients and even requirements that manufacturers report serious adverse events associated with their products. But when it comes to knowing exactly what products are on the market, the FDA comes up empty-handed. When recently asked about the size of the marketplace, the FDA responded “somewhere between 50,000 and 80,000 products.” Despite mandates for how supplements are manufactured and marketed, FDA can’t effectively regulate what it can’t see.
A few weeks weeks ago, Indiana Sen. Mike Braun and Illlinois Sen. Dick Durbin introduced bipartisan legislation that will provide a new high-water mark of safety for American consumers. The bill will require manufacturers and marketers of dietary supplements to provide FDA a copy of their products’ labels and ingredients. The Dietary Supplement Listing Act also directs the FDA to create a searchable database from this information, accessible to the public. If passed, this bill will create a new level of transparency so regulators can identify products, ingredients and the companies responsible for marketing them.
Some view this legislation with skepticism, concerned that mandatory listing could be burdensome to smaller manufacturers or that the registry could be used to prevent new products from coming to market. However, many companies large and small already provide this information on a voluntary basis to an industry-run product registry, called the Supplement OWL.
The legislation does not give the FDA the ability to reject labels presented for inclusion or exclude products from the public database if it suspects they don’t comply with the legal requirements for dietary supplements. Rather, the database will become a window for the FDA to finally see the breadth of the industry that is relied on by 80 percent of Americans.
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A 2019 survey by the Pew Charitable Trusts found the majority of consumers were surprised to learn the FDA does not know specifically what products are on the market. About nine in 10 said they favored requiring manufacturers to inform the agency of all supplements they make and their ingredients. Consumers rely on the FDA to protect public health by monitoring the supplements on store shelves and online, so the agency ought to have a comprehensive listing of those products and get a “heads-up” when new ones come to market.
As more people look to take a proactive role in their health and take preventative steps to stay well, we need to know the FDA can do its job with a clear view of the products we use for better health.
Steve Mister is the president and CEO of the Council for Responsible Nutrition.
