In Unusual Twist, FDA Warning Letter Cites Potential FTC Act ViolationsFebruary 14, 2011
By Riëtte van Laack –
Over the past two years, we have noted several joint or coordinated actions by FDA and FTC. The agencies issued their own warning letters to the same manufacturers at the same time (here and here), and, on several occasions, FDA and FTC issued joint warning letters (here and here). A recent warning letter by FDA to a dietary supplement company suggests a surprising new joint approach by FDA and FTC.
The February 1, 2011 warning letter to Tennessee Scientific, Inc/Scientific Formulations LLC bears only the signature of the FDA District Director. However, the letter cites not only violations of FDC Act, but also potential violations of the FTC Act, and cites FTC’s substantiation requirement for advertising claims that a product can prevent, treat, or cure human disease. Moreover, the letter includes a threat of potential action by FTC. The letter directs the recipient to respond to these concerns directly to the FTC. The letter is further evidence (as if any were needed) of the close working relationship that has evolved between the two agencies.