FDA WARNING_LETTER - V-SAB Medical Labs, Inc. - June 20, 2012

The FDA issued a Warning Letter to V-SAB Medical Labs, Inc., following an inspection from May 22 to June 20, 2012, concerning the manufacture, marketing, and distribution of topically administered products: Trans-D Tropin, TD-DMPS, and Progesterone-3/.3.

The FDA determined these products are unapproved 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 intended uses, as evidenced by promotional claims on websites (www.drbuttar.com, www.TransD.com, www.balancenutraceutical.com), YouTube videos, and radio appearances. Examples of claims include treating chronic pain, blood sugar abnormalities, depression, and heavy metal detoxification. The products are also misbranded under section 502(f)(1) [21 U.S.C. §352(f)(1)] for lacking adequate directions for use, as they are prescription drugs without approved applications.

Furthermore, the inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, causing the products to be adulterated under section 501(a)(2)(B) [21 U.S.C. §351(a)(2)(B)]. Specific CGMP violations, many of which were repeat