FDA WARNING_LETTER - Chlamydia-clinic.com

On April 28, 2011, the FDA issued a Warning Letter to Chlamydia-Cure, following a December 2010 review of their website, www.chlamydia-clinic.com. The FDA determined that the product C-Cure is promoted for conditions that classify it as a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)], due to therapeutic claims for diagnosis, cure, mitigation, treatment, or prevention of disease.

The marketing of C-Cure with these claims violates the Act. Furthermore, the product is considered a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its intended uses, and lacks prior FDA approval as required by section 505(a) [21 U.S.C. § 355(a)]. C-Cure is also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because its labeling fails to bear adequate directions for use, as conditions like Chlamydia are not amenable to self-diagnosis and treatment by lay