FDA WARNING_LETTER - Aregenius Worldwide LLC - November 12, 2009

On November 12, 2009, the FDA reviewed the website http://stasafesanitizer.com and determined that staSAFE Hand Sanitizer was being marketed with unapproved claims to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or authorized by the FDA for such uses, violating the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352.

Examples of violative claims included "Effective against SWINE FLU VIRUS H1N1," "[P]roduct testing against swine flu," and "The Hand Sanitizer that is effective against the H1N1 Virus." The FDA emphasized that the marketing of unapproved H1N1-related products, especially during a public health emergency, poses a significant threat to public health.

The FDA demanded immediate cessation of marketing unapproved products for H1N1. The firm was required to email FDAFLUTASKFORCECDER@fda.hhs.gov within 48 hours, detailing corrective actions. Failure to comply could result in enforcement actions like seizure, injunction, or criminal prosecution. The firm would also be added to a public list of non-compliant companies. Unapproved products offered for import into the U.S. are subject to detention.