Most American adults take at least one dietary supplement, such as vitamins, minerals, or herbs, but relatively few know that these products are sold to the public without testing or review by the Food and Drug Administration (FDA). In fact, FDA currently has no mechanism to know what products are on the market or the ingredients they contain, and the law does not require manufacturers to report this information to the agency.
While some manufacturers argue that FDA should make better use of existing enforcement tools to improve consumer protections, then-FDA Commissioner Scott Gottlieb expressed concerns earlier this year that “changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks.”
In the 25 years since Congress enacted the Dietary Supplement Health and Education Act, which set up the regulatory framework, the industry has grown from a $4 billion market with about 4,000 unique products to $40 billion with more than 50,000. Some estimate there are as many as 90,000 different products available to consumers.
A recent survey for The Pew Charitable Trusts found that less than a third of respondents know that FDA is largely limited under current law to acting after a supplement product on the market has been shown to be harmful. The same survey indicated that nearly all respondents—95 percent—agreed that the agency should be responsible for the safety of supplements; 71 percent thought retailers should be responsible.
Some prominent retailers recognize the need for greater transparency, ensuring the accuracy of listed ingredients, and confirming product safety. For example, CVS Pharmacy—the largest retail pharmacy chain in the U.S.—launched an effort earlier this year that requires third-party testing of all supplements sold in-store and online, to determine whether products contain the ingredients as labeled and are not contaminated with heavy metals or other toxins. So far, 7 percent of products have failed the testing, resulting in either an update to the supplement facts panel on the packaging or removal from company shelves.
Consumers who take dietary supplements should be able to trust that these products are safe, well-manufactured, and accurately labeled. Yet research shows many can pose safety concerns. For example, one study attributes over 23,000 emergency room visits each year to adverse events related to supplements. Another published last year found that many of these products contain some of the potent active pharmaceutical ingredients found in prescription drugs, which could cause serious adverse health effects from accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.
At a minimum, supplement manufacturers should be required to provide FDA with basic information such as the product name, ingredients, and label for every product sold, a change that would require congressional action. Known as product listing, this requirement would increase transparency and boost FDA’s ability to respond to emerging concerns. And there’s overwhelming support for such a policy: 9 in 10 adults surveyed by Pew said they favor requiring that manufacturers inform the agency of all supplements they make and their ingredients. Consumers, who spend tens of billions of dollars annually on these products, would have information about ingredients as well as assurances that action could be taken to weed out bad actors.
Michael D. Thompson is a vice president at The Pew Charitable Trusts, overseeing work ranging from building fiscally sound government budgets to protecting public safety, consumers, and health.