FDA WARNING_LETTER - JW Nutritional LLC Dallas - June 06, 2014

The FDA inspected JW Nutritional LLC from May 20 to June 6, 2014, revealing multiple violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). This caused their Vanish V2 Domestic, Mr. Hyde Fruit Punch, and Garcinia Cambogia dietary supplements to be adulterated under 21 U.S.C. § 342(g)(1).

Additionally, a March 2015 review of www.transformsupplements.net showed claims for Forged Joint Repair, Forged Liver Support, and Forged Methyl EAA that establish them as unapproved new drugs under 21 U.S.C. § 321(g)(1)(B) and § 321(p), due to intended use for disease treatment, cure, mitigation, or prevention. These products are also misbranded under 21 U.S.C. § 352(f)(1) as they lack adequate directions for layperson use, particularly Forged Joint Repair and Forged Methyl EAA, which address conditions not amenable to self-diagnosis or treatment. Introducing these unapproved new drugs and misbranded drugs into interstate commerce violates 21 U.S.C. § 331(d) and § 331(a).

Specific CGMP violations for dietary supplements included: 1.