In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.” The Agency noted that the ingredient has been the subject of numerous report of serious adverse drug events.
We have blogged about the issue of illegally marketed dietary supplements numerous times over the years (for example, here, here, here, and here) and have opined that the Agency may begin a more aggressive approach to their review of labeling and marketing claims made by manufacturers and distributors. In the release, the FDA said, “This action is part of a broader effort we have underway to re‑examine our resources and authorities related to products marketed as dietary supplements and outline a new policy on how we intend to more vigorously fulfill our obligations to protect consumers from dangerous products and unlawful claims. We’ll have more to say on our policy efforts very soon.” Commissioner Gottlieb is quoted as saying:
These potentially illegal activities put the entire dietary supplement industry at risk by confusing consumers, harming patients, and tainting good dietary supplement products by associating them with the activities of bad actors. In this case, these companies are preying on vulnerable patients who may be seeking alternative treatments to serious medical conditions like opioid use disorder.
Many dietary supplements marketed for weight loss and erectile dysfunction have been shown to illegally contain either active pharmaceutical ingredients subject of approved applications or drug substances that have been removed from the market for safety reasons and banned by the FDA.
Will these actions by bad actors lead the FDA to totally rethink the dietary supplement market and move further towards some type of preapproval process? Will the time be right for revised legislations once Senator Orin Hatch retires? Senator Hatch, the champion of the industry, is the author of the primary legislations, the Dietary Supplement Health and Education Act of 1994, upon which the modern day dietary supplement industry operates. Only time will tell!