A2Z Industries, LLC – FDA Warning Letter, Apr 22, 2014
On February 9, 2015, the FDA issued a Warning Letter to A2Z Industries, LLC, following an inspection from April 17-22, 2014, and a website review in March 2014. The letter identified significant violations regarding several products.
Halo V, EPI 2A3A, and Protex were deemed unapproved new drugs and misbranded. Halo V and EPI 2A3A, marketed for "Rapid Muscle Growth" and "lean muscle mass gains," contain synthetic steroids (2a, 3a-epithio-17a-methyletioallocholanol and 4-chloro-17a-methyl-androst-1, 4-diene-3, 17b-diol), which are not dietary ingredients. Protex, with claims related to improving "blood pressure, cholesterol," is intended for disease treatment. These products are considered "new drugs" lacking FDA-approved New Drug Applications (NDAs) and are misbranded because they lack adequate directions for use, being prescription drugs requiring professional supervision.
Additionally, Post Cycle 3X and Blockade on Cycle Defense were cited as misbranded dietary supplements. Blockade lacks a domestic address/phone number for adverse event reporting. Post Cycle 3X and Blockade on Cycle Defense fail to identify the plant part for botanical ingredients. Blockade on Cycle Defense and Protex
ID · a896ce6f-c4aa-4e44-905d-35cf5e0dd34f
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