FDA Needs Better Tools From Congress to Monitor Dietary Supplement Safety

At a time when most Americans say they have taken dietary supplements, the Food and Drug Administration just does not have the tools to effectively ensure that these products are safe. In a recent survey, a majority of adults echoed this concern: 7 in 10 said they think the agency cannot protect consumers from harmful supplements.

The core problem lies in FDA’s lack of a reliable mechanism to know what supplements are being sold, the ingredients they contain, and who is manufacturing and marketing specific products. This severely restricts the agency’s ability to monitor for public health risks and the illegal use of ingredients such as cannabidiol (CBD), a chemical derived from cannabis plants.

That’s why Congress should require that supplement manufacturers give FDA basic product information. Such a requirement, together with the ability to swiftly act against companies that fail to comply, would help the agency protect consumers.

For example, major questions have not been answered about whether and how dietary supplements and other products can safely include CBD, according to the leaders of the FDA’s internal working group on CBD issues. Dozens of companies have drawn warnings from the agency for adding the substance to supplements, foods, and drinks.

“We don’t know how many dietary supplements are on the market, and we have no systematic way of knowing when a new product is introduced,” Lowell Schiller, a co-chair of the working group, told supplement manufacturers at a conference in late 2019. “And if it turns out that there’s a safety problem with a particular ingredient, or a particular ingredient supplier, we don’t have the basic information to quickly identify which products are affected.”

FDA’s challenges with CBD illustrate how this crucial gap in its oversight can expose consumers to risks. At a January summit sponsored by the Collaborative for CBD Science and Safety, Dr. Amy Abernethy, the other co-chair of the working group, said that the limited scientific research on CBD use raises concerns about its potential to harm the liver, brain development, the male reproductive system, and women who are pregnant or breastfeeding. The available evidence also leaves unclear what dosages or duration of continuous use might trigger health problems.

“There’s a massive human experiment going on,” she cautioned, noting that people are ingesting CBD in multiple forms, sometimes simultaneously.

The agency, other public health stakeholders, and the public all need more complete information about the ingredients in these and other supplements. Even major online retailers, with tools to collect and analyze vast amounts of product information, struggle to understand the origins and contents of specific supplements. Lacking basic data, FDA staff must track down unsafe or illegal supplements and their makers one at a time, often relying on internet searches to identify products that have harmed, or may endanger, people.

The agency has repeatedly cautioned businesses and the public that CBD has only one FDA-approved use: as an active ingredient in a prescription drug for people with certain seizure disorders. Its most recent warning letters also noted that, based on the available evidence, FDA “cannot conclude that CBD is generally recognized as safe (GRAS).” This regulatory term refers to a process through which manufacturers can assert the safety of food additives and use them in products without FDA review or notification.

Many consumers misjudge oversight, health risks

About half of adults (52 percent) incorrectly think that before dietary supplements go on the market, their safety is proved to the FDA by manufacturers or confirmed by agency testing. In truth, companies are only required to tell the FDA of plans to use an ingredient new to the supplement market and, even in that case, need only offer evidence that a substance “will be reasonably expected to be safe.”

Many Americans have been harmed by unsafe supplements, and those that illegally contain pharmaceutical ingredients are particularly dangerous. Between 2004 and 2013, the FDA received more than 15,000 reports of health problems linked to supplements, including nearly 4,000 hospitalizations.

Along with its warning letters in November, FDA published updated guidance for consumers about risks and unanswered questions surrounding the use of CBD.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” Abernethy said in a statement at the time.

Complete and up-to-date data about all supplements on the market would help the agency answer outstanding safety questions about CBD or any other potential new ingredients. This information would also improve agency communications with companies and the public when concerns arise. For example, if FDA found evidence of health risks tied to an ingredient, officials could alert businesses and consumers about specific supplements known to contain it. And by making the data publicly available, FDA would give retailers and customers a way to verify that a supplement comes from a manufacturer known to the agency.

An overwhelming 95 percent of American adults support requiring that manufacturers give FDA details about the supplements they make and their ingredients. Congress should act soon to enhance data-driven oversight of supplement safety.

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