ConsumerLab.com uses JavaScript to provide the best possible experience for our content, but your browser has it disabled. Learn how to enable it here.

About ConsumerLab.com

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:

Twenty-one Sexual Enhancement Products Recalled

Twelve Sexual Enhancement Supplements Found to Contain Prescription Drug

Sexual Enhancement Supplement Contains Undeclared Drugs Fourteen Enhancement Supplements Found to Contain Undeclared Drugs

Imported Supplements Can Be Dangerous, FDA Warns

"Herbal Viagra" Taken by Lamar Odom Was a Known Problem

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