FDA WARNING_LETTER - Millennium Bioceutics

The FDA issued a Warning Letter to Millennium Bioceutics on February 17, 2011, following a review of their websites, millenniumbioceutics.com and caplexsupplement.com, in October 2010. The FDA determined that "Caplex Supplement" is promoted for conditions that classify it as 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)] due to therapeutic claims for cure, mitigation, treatment, or prevention of disease.

Violations include claims such as "effective in preventing and/or slowing the development of cancer cells," "anti-tumor," and "inhibiting growth of pancreatic cancer." These claims establish Caplex as a drug. Since Caplex is not generally recognized as safe and effective for these uses, it is an unapproved "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)], violating section 505(a) [21 U.S.C. § 355(a)].

Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]