FDA keeps heat on adulterated supplements

In an apparent effort to keep the issue of undeclared pharmaceutical ingredients in some “dietary supplements” on the front burner, the U.S. Food and Drug Administration (FDA) issued another consumer warning about adulterated products masquerading as supplements on March 15. The warning linked to FDA’s website, which details the potential dangers of adulterated products in the weight loss, bodybuilding and sexual enhancement categories.

“I don’t know if there’s anything new there. I know it’s an ongoing concern,” said John Endres, chief scientific officer of Seattle-based scientific and regulatory consultancy AIBMR.

Under former FDA Deputy Commissioner Joshua Sharfstein, MD, the agency—working with the leading U.S. supplement trade associations—stepped up its efforts to remove adulterated supplements from the market. But Sharfstein’s departure from the FDA earlier this year had some in the industry wondering whether the agency would turn its attention away from this issue, which threatens consumer safety and the credibility of the many legitimate companies selling dietary supplements in the United States.

This latest warning to consumers demonstrates that the issue remains on the FDA’s radar. The agency’s website says it has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labeled ingredients.

Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance, is quoted on the site as saying, “These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements. Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.”