Pacific Naturals – FDA Warning Letter, Apr 28, 2011

On April 28, 2011, the FDA issued a Warning Letter to Pacific Naturals regarding the marketing of its products Herpeset and Wartrol on websites including www.herpeset.com, www.wartrol.com, www.pacificnaturals.com, and www.healthbuy.com.

The FDA determined that Herpeset and Wartrol are misbranded drugs under sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act. Herpeset is further misbranded under section 502(j) as dangerous to health when used as recommended.

The products are considered drugs under section 201(g)(1)(B) and (C) due to claims indicating their intent for diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect body structure/function. Specific claims cited include "Genital Herpes Relief by Herpeset" and "Wartrol Genital Wart Relief," implying treatment for conditions requiring physician diagnosis and treatment.

As prescription drugs under section 503(b)(1), their labels fail to bear the "Rx only" symbol, violating section 503(b)(4). The marketing of these misbranded products violates sections 301(a) and (k). Although labeled as homeopathic, they do not meet the conditions for OTC marketing under the FDA's Compliance Policy Guide (CPG 7132.