Congress Introduces Dietary Supplement Safety Legislation to Protect Consumers

Amid consumers’ rising dietary supplement use, which spiked during the COVID-19 pandemic, Senators Richard Durbin (D-IL) and Mike Braun (R-IN) introduced bipartisan legislation on April 26 that would give the Food and Drug Administration (FDA)—the agency with primary responsibility over such products—greater visibility into the products on the market. Pew urges Congress to swiftly enact the bill and ensure the safety and quality of all supplements on the market.

According to a Pew survey, few people understand FDA’s current limited role in overseeing the industry. The agency lacks the ability to know with certainty what dietary supplement products are reaching consumers and what’s in them. Existing law places the onus on FDA to scan reports of harm from consumers, doctors, and companies. But as the supplement industry has grown exponentially since the last time the law was updated in 1994 (there could be up to 80,000 products on the market, 20 times the amount nearly three decades ago), it has become increasingly difficult for the agency to keep pace.

The Dietary Supplement Listing Act of 2022 would address this dangerous problem by establishing a mandatory product listing rule for all dietary supplements, requiring manufacturers to provide FDA with a comprehensive list of the ingredients their products contain, along with warnings and precautions, and allergen statements, among other information. The agency would then be able to publish the data in a publicly accessible and searchable database on its website for consumers and others to use. This low-cost, low-burden regulatory tool would enable FDA to obtain a complete picture of the marketplace and to provide more robust surveillance and consumer protections.

This legislation is essential because not all dietary supplements are safe. Between 2004 and 2013, FDA received more than 15,000 reports of health problems linked to supplements, including 339 deaths and nearly 4,000 hospitalizations. In a recent Pew survey of American adults, 1 in 8 (12%) said they or an immediate family member had experienced a severe side effect, such as a heart, kidney, or liver problem, from a supplement. Furthermore, between 2007 and 2019, the agency found that 965 products masquerading as dietary supplements illegally contained active pharmaceutical compounds found in prescription drugs. The agency warned that these products likely represented only “a small fraction of the potentially hazardous products with hidden ingredients.”

These public health concerns have been more troubling amid the ongoing COVID-19 pandemic. As consumers sought out products to support their health and wellness, demand for dietary supplements increased significantly in 2020 compared to the previous year. This reality has allowed some businesses to exploit consumers by illegally marketing products to prevent, treat, or cure COVID-19. Since the start of the pandemic, FDA has issued more than 65 warning letters to businesses engaging in illegal marketing of supplement products, and it is unlikely that these limited enforcement actions capture all, or even a majority, of the irresponsible practices in this market. 

A mandatory product listing requirement would help FDA better target such fraudulent practices and ensure that all supplement products on the market are safe. It is also a solution that most Americans support. According to Pew’s survey, 95% of consumers backed requiring manufacturers to report their products and ingredients to FDA.

Without stronger oversight, the risks to consumers from unsafe dietary supplement products will continue to grow. Congress should move quickly to pass the Dietary Supplement Listing Act and empower FDA to better protect consumers from dangerous products, help them make informed decisions, and restore trust in the supplement industry.

Liz Richardson directs The Pew Charitable Trusts’ health care products project.

https://www.pewtrusts.org/research-and-analysis/articles/2022/04/27/congress-introduces-dietary-supplement-safety-legislation-to-protect-consumers