Hundreds of products containing potentially harmful pharmaceutical ingredients are being marketed to consumers as dietary supplements, a study published in October found, raising questions about the Food and Drug Administration’s ability to remove these tainted products from the market.
Dietary supplements cannot legally contain pharmaceutical ingredients. But a study published in the Journal of the American Medical Association found that more than 700 dietary supplements sold from 2007 to 2016 included pharmaceutical ingredients that had been the subject of FDA warnings. Some of the pharmaceuticals were components of FDA-approved prescription drugs, while others were drug ingredients that had been withdrawn from the market or that FDA had never approved. According to the study’s authors, the undeclared drugs represent “an important public health concern.”
A separate study published in December in JAMA Internal Medicine found that several brands of supplements on the market contain at least one of four prohibited stimulants, even though FDA had sent warning letters to their manufacturers and issued public notices about the ingredients. One notice cautioned that supplements containing a stimulant called dimethylamylamine can elevate blood pressure and could lead to cardiovascular problems. It noted that FDA had received 86 reports of illnesses or deaths associated with supplements containing it.
Most American adults take at least one dietary supplement a day, including products such as vitamins, minerals, herbs or other botanicals, amino acids (the building blocks of proteins), or other dietary ingredients. The number of these products on the market has grown from about 4,000 in 1994 to about 80,000 today. The new studies raise serious questions about whether FDA can take effective action when problems with supplements arise.
Although FDA can mandate recalls of dietary supplements, this authority does not extend to drugs (with the exception of certain controlled substances), calling into question the agency’s ability to require a company to recall products marketed as supplements that contain drug ingredients. And unlike the oversight of drugs, the agency has no mechanism to know what dietary supplement manufacturers are producing.
To more efficiently monitor the marketplace and take quick action if needed, FDA should have access to more information about the dietary supplement marketplace, such as the names of specific products, their ingredients, and product labels, as well as the names and contact information for companies selling them. Former FDA Commissioner Scott Gottlieb recently made a similar point, writing that if supplement manufacturers were required to submit information about their products to the agency, it would improve transparency, promote risk-based regulation, facilitate efficient enforcement of the law, and establish new ways to identify dangerous products. Giving FDA more information and clarifying the agency’s recall authority for supplements tainted with pharmaceutical ingredients would better protect Americans.
Sandra Eskin is a director with The Pew Charitable Trusts’ work on food safety, and Elizabeth Jungman is a director with Pew’s work on public health.
This article was previously published on pewtrusts.org and appears in this issue of Trust Magazine.