Blueone Card Inc. (BCRD)

[elbiatcho1]

FDA Warning against EBOLA-C.com

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm423685.htm

TO: Todd Spinelli
[e-mail]
[e-mail]
www.ebola-c.com

FROM: The Food and Drug Administration and the Federal Trade Commission

RE: Unapproved Products Related to Ebola and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure Ebola Virus



WARNING LETTER


This is to advise you that in October 2014 the U.S. Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) reviewed your website at http://www.ebola-c.com from which you take orders for your product, “Ebola-C®.” We also note that the website at http://www.ebolac.com automatically re-directs consumers to http://www.ebola-c.com. Based on FDA’s review, we have determined that your website promotes your product for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act....