Are You Marketing Unapproved New Drugs?

Can you take a well known product, and market its intended use well beyond FDA approval?  Doing so could lead a Warning Letter from the FDA.  In this case, a marketer advertised a popular product as having the ability to “Help Eliminate MRSA & VRE . . . 100% MRSA & VRE Reduction[] . . . A recent outcome study shows that providing the right products, in a customized solution, along with educational resources for athletes and staff can reduce MRSA and VRE by 100%.”  “Products are Proven to Reduce Absenteeism.”  As if those claims weren’t enough, the marketer claimed that the product also “…may be effective against viruses such as the Ebola virus, norovirus, and influenza.”

The FDA Warning Letter clearly reminds the marketer that “As of today, we are not aware of any (such products) that have been tested against Ebola viruses, including…” this particular product.  “Based on the above claims, (your products) are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.”  “Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d)”

Best business practice is to NOT advertise UNSUBSTANTIATED claims for your products’ use.   Overstating products intended use, as in this case, can potentially lead to costly legal consequences.  Have you recently received a Warning Letter from FDA due to false and misleading advertising, and you are not sure what to do?  Feel free to contact me so I can help you.

#substantiationequalstrust #transparencyformstrust #advertisingandmarketinglawyer #hispanicadvertisingandmarketingattorney

For more information:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020