The dietary supplement market is notorious for issues associated with the inclusion of not-permitted ingredients in marketed supplements. Kratom is a recent poster child for this issue, but the erectile disfunction and weight loss markets both seem to have extraordinarily bad compliance and enforcement histories. These two disease states comprise the lion’s share of Warning Letters issued over the last few years and, in addition, they have captured the attention of the FDA, which has published 383 Public Notifications (here) from May 16, 2012 through July 15, 2022. In addition, the FDA has published 1,895 notices in its Health Fraud Database (here) over the period of March 2007 to July 15, 2022. These Public Notifications and fraud warnings alert consumers of the hidden drug ingredients in the specific illegal products. (Just imagine the number of products that slip through the FDA’s safety net!)
Besides being illegal, inclusion of these ingredients poses a clear and present danger to unsuspecting consumers who may have certain underlying health conditions that could be exacerbated by ingesting the hidden drug ingredients, or which could cause severe adverse interactions with prescription or over‑the‑counter medications the consumers may be talking.
These issues continue to taint the dietary supplement industry and this is precisely why the FDA and Congress have been looking at changes in policy as well as potential statutory changes or further regulation of dietary ingredients. The actions of some bad actors that are seeking profits on the backs of consumers desperately seeking treatment for such conditions, need to be addressed.