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July 13, 2022 By: Asa Waldstein

Company Cited For Selling Selective Androgen Receptor Modulators (SARMs)

Takeaway -

The FDA regulates based on intended use

The FDA sent a warning letter to a company distributing Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids.

This is an excellent example that the FDA regulates based on the intended use. The company apparently was marketing this product for ingestible use but labeling as follows.

From warning letter: “Despite statements on your product labels marketing your SARMs products for “RESEARCH ONLY” and “Not for Human Consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.”

What is mind-blowing about this warning is that a company executive was sentenced to a year in prison last year for selling the same type of products! Here is the article by Steven Myers about this.

Read the full warning letter here

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices