Mezotrace Corporation – FDA Warning Letter, Aug 20, 2013

The FDA inspected Mezotrace Corporation in Winnemucca, Nevada, on August 19-20, 2013, finding serious violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Mezotrace holds and distributes dietary supplements manufactured by contract manufacturers, supplying the main raw ingredient.

The inspection revealed that Mezotrace's products (Mezotrace Calcium/Magnesium Natural Minerals & Trace Elements, with Vitamin D, and Powdered Minerals) are adulterated under 21 U.S.C. § 342(g)(1) due to non-compliance with CGMP. Additionally, FDA review of product labeling and the website (www.mezotrace.com) in October 2013 and June 2014 determined that Mezotrace products are promoted with therapeutic claims, causing them to be unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and misbranded under 21 U.S.C. § 352(f)(1) for lacking adequate directions for use. Examples of drug claims include relief from arthritic conditions, bursitis, bone spurs, and aid in healing bone/joint injuries.

Specific CGMP violations include: 1. Failure to implement quality control operations for holding dietary supplements (21 CFR 11