Each week it seems that we read about FDA enforcement action on products marketed as dietary supplements, but are found to contain undeclared drugs without an approved NDA or ANDA. The striking thing is that these 30 products were the subject of enforcement action in the last month and a half. That means that from June 1, to July 15, 2016, 30 different products were reported as Class 1 recalls on the FDA enforcement report (here) over that 6-week span, for an average of 5 enforcement actions per week.
The products contained the following undeclared active drug ingredients:
- Desmethylsibutramine
- Fluoxetine
- Hydroxythiohomosil denafil (an analog of sildenafil)
- Phenolphthalein
- Salicylic Acid
- Sibutramine
Some of these products contained one ingredient and others contained two. The primary therapeutic classes of the products were claimed to treat weight loss, erectile dysfunction, and pain, three well known conditions for which such “dietary supplements” are targeted.
After seeing what I thought was a staggering number of recalls in 45 days, I was afraid to look back further (although I have posted numerous blogs on this topic here, here, here, here, here, here, and ) and wonder where all of these products are coming from.
Whether it be undeclared active drug ingredients or unsubstantiated label claims, consumers must be cautious in selecting a dietary supplement, and the FDA must remain vigilant in an attempt to help protect unsuspecting consumers to these potentially dangerous products. Once the November elections are over (but don’t get me started on that), we will need to see what direction the new administration wants to take on the entire dietary supplement market and what, if any, additional steps or tools the FDA may be given to further enforce existing statutory and regulatory provisions.
