The U.S. Food and Drug Administration (FDA) recently updated language on several pages of its website to more accurately describe illegal, drug-spike products and to remove references to these as dietary supplements after the American Herbal Products Association (AHPA) requested the changes.
FDA usually uses terms such as “marketed as dietary supplements” or “masquerading as dietary supplements” when describing products found by the agency to contain undeclared drugs, drug analogs, or other illegal ingredients. This is in line with a March 2011 public statement by FDA’s Deputy Director for Policy and Analysis Mike Levy who said, “These products are masquerading as dietary supplements–they may look like dietary supplements but they are not legal dietary supplements.”
The recent changes made by FDA were to two webpages that were inconsistent with this standard language. For example, the title on a Center for Drug Evaluation and Research (CDER) webpage was changed from “Tainted_Supplements_CDER” to Tainted Products Marketed as Dietary Supplements_CDER. Similarly, FDA’s Medication Health Fraud page was updated to replace the term “Tainted Dietary Supplements” with the more accurate, “Tainted Products Marketed as Dietary Supplements.” Several links on this page were also updated in a similar manner.
“The regulated dietary supplement industry greatly appreciates FDA’s efforts to provide consistency and help reduce confusion between illegal, drug-spiked products and lawfully marketed dietary supplements,” said AHPA President Michael McGuffin. “Far too often, supplement industry critics and the media inaccurately represent these illegal, misbranded drugs as dietary supplements causing confusion among consumers and policymakers. Hopefully FDA’s clarification will result in more accuracy from these voices.”