The FDA Needs More Information on Supplements

The COVID-19 quarantine changed everyday life for Americans, including many aspects of our diet, health, and exercise regimens. One change that has not received enough scrutiny is that during the pandemic, millions of Americans turned to dietary supplements. In 2020, sales of dietary supplements were 14.5% higher than the previous year—the largest growth spurt since 1997, according to the Nutrition Business Journal’s 2021 report on supplement sales.

Today, nearly three-quarters of U.S. consumers take regular doses of vitamins, fish oil, herbs, and similar products, the Council for Responsible Nutrition reports. The Food and Drug Administration is tasked with overseeing the booming supplement industry, but the agency has less insight and exerts far less oversight than many Americans say they want and expect.

A national survey conducted for The Pew Charitable Trusts showed about half of adults overestimate the regulatory scrutiny that dietary supplements receive. The reality is that the FDA doesn’t know for certain what products are on the market or what’s in them. This is a serious challenge—one that Congress can address by passing Senate Bill 4090, known as the Dietary Supplement Listing Act of 2022, a bill recently introduced by Senator Dick Durbin (D-IL) and co-sponsored by Senator Mike Braun (R-IN).

The FDA’s lack of insight stems from a gap in a 1994 law that put the agency in charge of, and in a reactive stance on, supplement safety. The agency scans the internet and evaluates reports from consumers, doctors, and companies for signs of products that put people’s health at risk or have already done them harm. However, for such post-market oversight to work, regulators need accurate, timely data about the products being sold. They don’t have that data now because current law doesn’t require supplement manufacturers to provide the FDA with even the most basic information, including product names, ingredients, and directions for use.

The potential risks have grown exponentially over the past 25 years. When Congress first gave the FDA responsibility for supplements, there were about 4,000 on the market, generating about $4 billion a year in sales. Now, the FDA believes that the total could be as many as 80,000 products, bringing in more than $40 billion annually.

Many, if not most, supplements are well known to consumers and have a well-documented safety record. However, from 2007 to 2019, the FDA found almost 1,000 products masquerading as dietary supplements that actually contained active and potentially harmful pharmaceutical compounds from prescription drugs, most commonly erectile dysfunction treatments, steroids, and weight loss drugs—including one that was removed from the market in 2010 because it significantly increased risk of heart attack and stroke.

The FDA cautioned that in the 12 years of data it studied, the agency had likely identified only “a small fraction of the potentially hazardous products with hidden ingredients.” Durbin and Braun’s legislation would require supplement manufacturers to provide the agency with a comprehensive list of each product’s ingredients, the amount of each ingredient, warnings and precautions about the product, and allergen statements, among other information. These lists would help the agency quickly and efficiently identify potentially dangerous products and remove them from the market. The FDA would also provide the data in a searchable public database for consumers and others to use to make more informed decisions about the dietary supplements they consume.

Industry leaders, medical societies, and public health and consumer advocates strongly support the legislation and have worked together to help policymakers develop an effective and pragmatic proposal. There is bipartisan support on Capitol Hill, and the public wants action. In Pew’s survey, when consumers were informed that the FDA did not review or approve dietary supplements before they hit the market, 71% of respondents said they believed the agency was unable to keep consumers safe. Nearly all—95%—supported requiring manufacturers to report their products and ingredients to the FDA.

The FDA is tasked with stopping dangerous supplements marketed by unscrupulous companies, but it doesn’t have the information and resources it needs to fully protect the public. The Dietary Supplement Listing Act would allow the FDA to shine a light on dietary supplements and empower the agency to act quickly to protect consumers when threats arise. It would help consumers make informed decisions about how to stay well. And it would help the supplement industry by leveling the playing field for responsible manufacturers and preserving consumer confidence.

Congress should pass this important legislation quickly to ensure that the FDA has the tools to fully protect consumers who use dietary supplements.

Liz Richardson is the former director of The Pew Charitable Trusts’ health care products project.

A version of this article appeared in the Chicago Tribune on May 17, 2022.