FDA WARNING_LETTER - University of Berkley - January 11, 2013

On January 11, 2013, the FDA reviewed the website http://www.berkley-u.edu/flu-prevention and determined it offers "Berkley-Body-Immune Flu Prevention" for sale. This product is marketed with claims such as "The most effective alternative to the flu shot?" and "Protect yourself with the 'Body-Immune Flu Prevention'," which suggest it is intended to diagnose, mitigate, prevent, treat, or cure the Flu Virus.

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

Berkley-U is required to immediately cease marketing unapproved, uncleared, or unauthorized products for the Flu Virus. The letter emphasizes the firm's responsibility to ensure all marketed products comply with the FFDC Act and FDA regulations, advising a review of websites, labels, and promotional materials to prevent adulteration or misbranding.

Within fifteen working days of receiving the email, Berkley-U must email FDAFLUTASKFORCECBER@fda.hhs.gov detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or referral to FDA