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Posted May 29, 2018

FDA Warns Seller of "Aromatase Inhibitor" Supplement

On May 18, 2018, the FDA issued a warning letter to Performance Nutrition Formulators LLC d.b.a. VMI Sports because its product Arimistane contains Androsta-3,5-Diene-7,17-Dione, an ingredient that the FDA considers to be a new drug and not a dietary supplement ingredient.

Arimistane is promoted with statements on the label such as "Arimistane is a revolutionary Aromatase Inhibitor (AI) that effectively manages estrogen, and thus potentially vastly improves muscle energy, strength, mood & libido!" and "FIGHTING THE UPHILL BATTLE AGAINST THE AROMATASE ENZYME." The FDA stated in it's warning that Androsta-3,5-Diene-7,17-Dione is "not generally recognized as safe and effective for its labeled uses." In addition, it stated that Androsta-3,5-Diene-7,17-Dione can be considered a prescription drug due to its "because of its toxicity or other potentiality for harmful effect." 

Aromatase inhibitor drugs can inhibit conversion of androgen hormones into estrogen. The agency warned that adverse events associated with aromatase inhibitor drugs include decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.

In addition, the FDA stated that VMI Sports made statements about other supplements it sells, including Cycle Guard and Vasogen, to be drug claims, and that some of its supplements were found to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements. These violations included failure to establish and follow written procedures for the responsibilities of quality control operations.

See Related Warnings:

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To read the FDA's warning, use the link below.