FDA WARNING_LETTER - Bayer Health Care LLC

The FDA's Center for Veterinary Medicine (CVM) issued a Warning Letter to Bayer Corporation, Animal Health Division, regarding a promotional piece (master detailer D08181) for Drontal® Plus Tablets and Drontal® Plus Taste Tabs®. The letter, dated October 28, 2008, states that the promotional material misbrands the products by suggesting unapproved effectiveness, violating section 502(n) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(n)] and 21 CFR 202.1(e)(6)(1).

The products are approved for removing various tapeworms, hookworms, ascarids, and whipworms in dogs. However, the master detailer claims that "A deworming program with Drontal® Plus Tablets or Drontal® Plus Taste Tabs® can help reduce the risk of parasitic zoonosis to your clients and staff," implying effectiveness in reducing human parasitic zoonosis, specifically toxocariasis. CVM states this claim is not approved for labeling and lacks substantial evidence or clinical experience.

Bayer is required to respond in writing within fifteen working days, detailing corrective actions taken or planned to ensure compliance and prevent recurrence. The FDA also requested immediate cessation of the violative master detailer and any similar promotional materials. Furthermore, Bayer must submit a comprehensive plan to disseminate a truthful, non-misleading,