FDA WARNING_LETTER - Ascential Experience Online - December 15, 2009

On December 15, 2009, the FDA reviewed the website http://www.ascentialexperience.ecrater.com and determined it was offering "Swine Flu Kit #7980" for sale. This product is marketed with claims to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus, such as "Swine Flu Kit #7980," "The herbal approach to viral infection is two pronged: ... The specific use of antiviral herbs to disrupt the replication cycle so it cannot survive," and "Take 10-20 drops 3 times a day of all three tinctures at the onset of any flu like symptons [sic] or before as a preventative."

The FDA states this product has not been approved, cleared, or authorized for H1N1 Flu Virus use, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352. Given the H1N1 public health emergency, the marketing of unapproved H1N1-related products poses a significant public health threat.

The FDA demands immediate cessation of marketing unapproved H1N1 products. The firm must email FDAFLUTASKFORCECFSAN@fda.hhs.gov within 48 hours, detailing corrective actions. Failure to comply may result in enforcement actions