FDA WARNING_LETTER - Calcomp Nutrition Llc

The FDA issued a Warning Letter to CalComp Nutrition, Inc. after reviewing their website, www.calcompnutrition.com, and determining that their products ?Herbal Vigor Quick Fix? and ?Arize?, marketed as dietary supplements, are unapproved new drugs and misbranded drugs. Laboratory analysis confirmed ?Herbal Vigor? contains undeclared tadalafil and ?Arize? contains undeclared sulfoaildenafil, both PDE-5 inhibitors. Consequently, ?Herbal Vigor? is not considered a dietary supplement. Both products are deemed drugs under section 201(g)(1) due to their intended use claims and are new drugs under section 201(p) as they lack general recognition of safety and effectiveness and have no FDA-approved applications. They are also classified as prescription drugs under section 503(b)(1)(A) due to potential harmful effects requiring medical supervision. The products are misbranded under sections 502(f)(1) for lacking adequate directions for use, 502(f)(2) for lacking adequate warnings, and 502(a) for false or misleading labeling regarding safety and failing to reveal material facts. The introduction of these misbranded products into interstate commerce violates section 301(a) of the FD&C Act. CalComp Nutrition must take prompt action to correct these violations and prevent recurrence, responding within fifteen working days with documentation of corrective actions. Failure to comply may result in FDA enforcement actions, including product seizure and injunctions.