FDA WARNING_LETTER - Telledant LLC - August 31, 2010

The FDA and FTC issued a Warning Letter to Apurve Mehra of Telledant LLC, citing violations observed on their websites (biogetica.com, fixdisease.com, quantumcure.com, fixherpes.com, quantumfix.com) in August 2010.

The FDA determined that 21 specific Biogetica products, including "Deliverance From Herpes Kit," "Epilepsy Essentials-Kit," "Diabetes Brittle Essentials-Kit," "Deliverance From Gonorrhea," "Syphilis Formula 1," and "Deliverance From Chlamydia Kit," are promoted for conditions that classify them as drugs 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, including product names and testimonials, establish their intent for use in the cure, mitigation, treatment, or prevention of disease, violating the Act.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval under section 505(a) [21 U.S.C. § 355(a)]. Furthermore, these products