FDA WARNING_LETTER - Quadex Pharmaceuticals, Llc - June 28, 2011

The FDA issued a Warning Letter to Quadex Pharmaceuticals, LLC, following a June 21-28, 2011, inspection. The letter states that the firm's product, "Viroxyn Professional," marketed on viroxynstore.com, is an unapproved new drug and is misbranded.

"Viroxyn Professional" is deemed a drug under sections 201(g)(1)(B) and (C) of the Act due to claims like "Cold Sore/Fever Blister Treatment," "Pain Relief During Application," and "To help guard against infection," indicating intent for disease treatment or affecting body function. It is classified as a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its labeled uses. The product's active ingredient, benzalkonium chloride, for cold sore/fever blister treatment, is not covered by existing or developing OTC monographs. Additionally, claims related to herpes treatment and guarding against infection are not covered by any monograph. Therefore, marketing "Viroxyn Professional" without an FDA-approved New Drug Application (NDA) violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is misbranded under section 502(a) because its labeling, which discusses herpes and warns against transferring the virus to genitals, is misleading by conflating