Frequency of unapproved drug ingredients in supplements indicates need for reform

Statement of CSPI president Dr. Peter G. Lurie

A new analysis published today in JAMA Network Open confirms what we’ve known for some time—that the supplement industry and the Food and Drug Administration have their work cut out to keep unapproved pharmaceutical ingredients out of supplements.

Dietary supplements promising weight loss, sexual enhancement, or muscle building were the overwhelming majority of supplements identified by the FDA as adulterated. Given the lax regulation of this category of products, consumers already have ample reason to be wary of whether a given supplement contains the expected, advertised ingredients. But it’s a far more serious thing for a consumer to find unexpected, unadvertised ingredients, such as laxatives, amphetamines, Viagra-like drugs, steroids, or other pharmaceuticals in supplements freely available over-the-counter or online. And these JAMA findings are just the tip of the iceberg; the database analyzed included only those infractions that FDA detected in online sales and import screenings, not retail sales.

There is more that Congress and the FDA can do to ensure supplements are free from pharmaceutical contamination. First, Congress could give FDA new authority to require registration of specific products, so the agency would know what it is regulating. The agency could pick up its pace issuing warning letters and taking other enforcement actions (its last warning letter for a tainted dietary supplement was in 2009, despite detecting hundreds of tainted products since then). And Congress could require pre-market third-party testing of supplements—particularly of supplements advertised as weight loss, sex enhancement, or body building aids—to assure that they don’t contain unsafe or unlabeled ingredients.