FDA WARNING_LETTER - Amerilab Technologies, Inc - November 03, 2009

On October 30 and November 3, 2009, the FDA inspected Amerilab Technologies, Inc. and reviewed its website, www.drinkinmate.com, regarding the product Drinkin' Mate. The inspection and website review revealed that Drinkin' Mate 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)]. Therapeutic claims, including numerous personal testimonials on the website, establish the product's intent for the cure, mitigation, treatment, or prevention of disease, violating the Act.

The product is deemed 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 labeled or promoted uses. New drugs require prior FDA approval under section 505(a) of the Act [21 U.S.C. § 355(a)], which Drinkin' Mate lacks.

Furthermore, even if not a new drug, Drinkin' Mate is misbranded as a dietary supplement. Violations include: * **Section 403(q)(5)(F)(i) of the Act [21 U.S.C. §