Months after the coronavirus first appeared in the United States, COVID-19, the disease caused by the virus, has claimed more than 180,000 American lives. According to the Natural Marketing Institute, vitamin and supplement usage has increased by 28 percent in the U.S. and by 25 percent worldwide since the start of COVID-19. More Americans are seeking products to support their health and wellness.
This growing demand has taxed supply chains and made room for some businesses to exploit the pandemic by marketing products as dietary supplements that illegally claim to prevent, treat, or cure COVID-19.
The U.S. Food and Drug Administration (FDA) — the federal agency that oversees dietary supplements — has no systematic way to track what is being sold under the banner of a dietary supplement. This needs to change so the agency can quickly find and remove these bogus and potentially dangerous products from the market.
The 1994 passage of the Dietary Supplement Health and Education Act (DSHEA) created a framework for regulating supplements. Still, it didn’t require supplement manufacturers to list their products with the agency or provide basic information — such as product names, ingredients, and labels — before coming to market. As a result, FDA largely relies on an intermittent and reactive strategy to clamp down on illegal supplements — internet searches, routine monitoring of its voluntary adverse event reporting database, and proactive notifications from industry to identify products that have harmed or may endanger consumers. This has limited the ability of the FDA to see what is going on in the marketplace and allowed rogue players to stay in the shadows while forcing the agency to play an endless game of catch-up.
To further complicate oversight of the industry, FDA is often unaware of changes, reformulations, or discontinuations of supplement products, and even when FDA becomes aware of a potentially harmful supplement or ingredient, limited agency resources mean it could take years to see enforcement action. Meanwhile, the market continues to grow exponentially, from about 4,000 products in 1994 to more than 50,000 today.
The COVID-19 pandemic has only heightened the need for more transparency in the supplement marketplace. From Jan. 31 — the day the White House declared a public health emergency — until the end of July, FDA and the Federal Trade Commission (FTC) sent 106 joint warning letters to supplement producers for selling products with fraudulent claims of treating or preventing COVID-19. During the same period, FTC separately issued 62 warning letters and the Department of Justice obtained injunctions against three supplement producers for selling products that made drug-like claims to treat serious diseases, including COVID-19. These enforcement actions against companies mark a significant increase compared to the same period in 2019 when the FDA issued just 13 warning letters to supplement producers for making drug-like health claims. However, it is unlikely that the recent uptick in FDA enforcement actions captures all, or even a majority, of the irresponsible actors in the market.
Congress could enhance FDA’s ability to protect the public by passing legislation authorizing the agency to require supplement manufacturers to list their products and ingredients with it — a requirement known as the mandatory product listing. Such a move would permit the FDA to obtain a complete picture of the growing supplement marketplace and allow the agency to prioritize its resources and expertise based on a risk assessment of the thousands of products being sold.
Mandatory product listing would also strengthen the FDA’s ability to respond effectively to emerging safety concerns and to exercise its authorities under DSHEA. If, for example, the agency learned that a particular ingredient was dangerous, it could easily identify all listed supplements that contain that ingredient and take rapid action to warn consumers, mandate a recall, or both.
President Donald Trump has expressed support for mandatory product listing and included a request in the administration’s budgets for fiscal years 2020 and 2021 that Congress grant FDA this authority. And a recent survey found that 9 out of 10 American adults would back a mandatory product-listing requirement.
Seventy-seven percent of Americans take dietary supplements, and at a time when demand for these products is growing, FDA must have the tools and resources necessary to ensure the safety and quality of all dietary supplements on the market—and to protect consumers from potentially harmful products. That was necessary before COVID-19; it’s even more urgent now.
Liz Richardson is director of The Pew Charitable Trusts’ health care products project, which focuses on strengthening and improving medical product regulation to safeguard patients and consumers.
Julia Gustafson is vice president, government relations of the Council for Responsible Nutrition, the leading trade association for the dietary supplement and functional food industry.
This article originally published in The Hill on Sept. 3, 2020.
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