FDA WARNING_LETTER - Performance Nutrition Formulators LLC dba VMI Sports - October 27, 2017

On October 10-27, 2017, the FDA inspected Performance Nutrition Formulators LLC d.b.a. VMI Sports, finding significant violations of dietary supplement CGMP regulations (21 CFR Part 111), rendering products adulterated.

The product "Arimistane" was deemed an unapproved new drug and a misbranded prescription drug. Its ingredient, Androsta-3,5-Diene-7,17-Dione, is an aromatase inhibitor, not a dietary ingredient, and the product's claims (e.g., "vastly improves muscle energy, strength, mood & libido") indicate drug intent. It is not generally recognized as safe and effective, lacking an FDA-approved New Drug Application (NDA). Adverse effects of aromatase inhibitors include bone, reproductive, and organ issues.

Additionally, website claims for "Cycle Guard" (e.g., "Combat the proliferation of free radicals and oxidative stress," "treating alcoholic liver cirrhosis") and "Vasogen" (e.g., "potent vasodilator," "reduces blood pressure") establish them as unapproved new drugs and misbranded drugs due to therapeutic claims and lack of adequate directions for use.

CGMP violations include failure to establish and follow written procedures for quality control operations (21 CFR 111.103), including material review and disposition, and lack of documentation for quality control release of products (21 CFR