FDA WARNING_LETTER - Ebola-C Inc - October 31, 2014

In October 2014, the FDA and FTC reviewed the website http://www.ebola-c.com, which sells "Ebola-C." The product is promoted with therapeutic claims, such as "DEFEND YOURSELF NOW!!!!! EBOLA-C" and "Specifically formulated for Ebola-C," establishing it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The FDA determined "Ebola-C" is an unapproved "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering this product into interstate commerce without prior FDA approval violates sections 505(a) and 301(d) of the Act.

Furthermore, the product is misbranded under section 502(f)(1) of the Act because it is intended for a condition not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. Introducing a misbranded drug into interstate commerce violates section 301(a) of the Act.

The FDA requires immediate action to cease distributing unapproved Ebola Virus-related products. The firm must respond within 15 working days via email to EbolaTaskForce-CFSAN@fda.hhs.gov, detailing corrective actions. Failure to comply may result in enforcement