FDA WARNING_LETTER - www.bestswinefluvaccine.com - October 20, 2009

On October 20, 2009, the FDA reviewed the website http://www.bestswinefluvaccine.com and found it was marketing "Best Swine Flu Vaccine" for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus in people. This product is unapproved, uncleared, and unauthorized by the FDA for such uses, despite a declared public health emergency for H1N1. The marketing of this product, with claims like "the first Vaccine for Swine Flu epidemy [sic]," violates the Federal Food, Drug, and Cosmetic Act (FFDC Act) (21 U.S.C. §§ 331, 351, 352) and the Public Health Service Act (PHS Act) (42 U.S.C. § 262). The FDA considers the sale of such unapproved H1N1-related products a significant public health threat. The firm is required to immediately cease marketing these unauthorized products and ensure future compliance. Within 48 hours, an email must be sent to FDAFLUTASKFORCE-CBER@fda.hhs.gov detailing corrective actions. Failure to comply may lead to enforcement actions like seizure, injunction, criminal prosecution, and inclusion on a public FDA warning list. Unapproved products offered for importation will be detained.