FDA WARNING_LETTER - HUMAN SCIENCE FOUNDATION - January 16, 2014

On August 18, 2014, the FDA issued a Warning Letter to Human Science Foundation, following an inspection from January 8-16, 2014, at their Gardena, CA facility. The inspection and subsequent laboratory analysis revealed that "Pro ArthMax" and "Super Arthgold," labeled as dietary supplements, contained undeclared active pharmaceutical ingredients (APIs).

"Pro ArthMax" contained Chlorzoxazone, Diclofenac, Indomethacin, Ibuprofen, Naproxen, and Nefopam. "Super Arthgold" contained Chlorzoxazone, Diclofenac, and Indomethacin. These ingredients are APIs in FDA-approved drugs (e.g., Parafon Forte DSC, Voltaren, Indocin, Motrin, Naprosyn) and, in the case of Nefopam, unapproved for use in the U.S.

The FDA determined that these products are unapproved new drugs under sections 505(a) and 201(p) of the FD&C Act, as they are not generally recognized as safe and effective and lack FDA-approved applications. They are also misbranded under sections 502 and 503(b)(1)(A) because they are prescription drugs lacking adequate directions for use and their labeling is false and misleading due to the undeclared ingredients. The undeclared APIs, particularly NSAIDs, pose