FDA WARNING_LETTER - Super Body Care - February 08, 2010

On February 8, 2010, the FDA reviewed the websites http://iloveswineflu.com/ and http://www.superbodycare.com, determining they offered unapproved products for sale intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus. These "Super Body Care products" violate the Federal Food, Drug, and Cosmetic Act (FFDC Act), specifically 21 U.S.C. §§ 331, 351, 352.

The websites' names and claims, such as "I [Heart] Swine Flu," "Rosemary has been known to stimulate the immune system and documented for treating . . . flu," and "Our products . . . are great for cleansing and protecting yourself from . . . viruses," imply H1N1-specific benefits. Given the public health emergency declared for H1N1, marketing unapproved products poses a significant threat.

The FDA demands immediate cessation of marketing these unapproved, uncleared, or unauthorized H1N1-related products. The firm must ensure future compliance with the FFDC Act and FDA regulations, reviewing all promotional materials. Within 48 hours, an email must be sent to FDAFLUTASKFORCE-CDER@fda.hhs.gov detailing corrective actions. Failure to comply may result in enforcement actions like seizure, injunction, or criminal prosecution. The firm will be added to