Liver Transplant Prompts FDA to Warn Consumers About Dietary Supplement Containing Steroids

The United States Food and Drug Administration (FDA) has released a letter warning consumers to avoid buying or using a product called “Mass Destruction”, The announcement was made after a man who used the product suffered complete liver failure. He was later the recipient of a liver transplant. Mass Destruction contains two different synthetic steroid ingredients listed on the label as 17a-methyl-1,4-androstadiene-3,17diol (M1,4ADD) and 18-methylestr-4-en-3 one-17beta-ol (18-NANO).

The North Carolina Department of Health and Human Services alerted the FDA to a case of serious injury associated with the consumption of Mass Destruction by a 28-year old man. The man had reportedly been healthy prior to using Mass Destruction. Liver failure resulted after using the product for several weeks. 

The North Carolina-based Blunt Force Nutrition was the distributor of Mass Destruction. The contract manufacturer who produced Mass Destruction has not been publicly identified. Mass Destruction was sold in both local retail stores and on internet ecommerce websites.

In a press announcement dated December 23, 2013, Howard Scklamber, the director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, asserted the FDA's commitment to protecting consumers from supplements containing steroids.

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Sklamberg. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”

The news media often erroneously states that the dietary supplement industry is (entirely) unregulated. This is not true. The Dietary Supplement Health and Education Act (DSHEA) provides a robust legal framework for regulating the industry. The main problem has been a lack of enforcement by the FDA.

Synthetic (anabolic) steroids have been sold as dietary supplements in the United States for many years. Contrary to most mainstream media characterizations, the steroidal ingredients, in most cases, are not secretly masquerading as dietary supplements nor are the products “spiked” with hidden ingredients. The synthetic steroids are openly listed as the ingredient(s) on the label.

While a few steroidal ingredients have been compliant with DSHEA, most of the steroids commercially sold as dietary supplements have not. This has not stopped sports supplement companies from selling them.

Sports supplement makers almost inevitably refer to Julius Vida's “Androgens and Anabolic Agents” when looking for new prohormone products. The classic textbook identifies thousands of steroid candidates that had been researched by pharmaceutical companies but later abandoned. The steroids were never commercially introduced. The steroids were essentially forgotten until they saw new life as “prohormones” and “dietary supplements”.

The steroidal ingredients introduced by supplement makers were not legally defined as “anabolic steroids”; they were not included on the Controlled Substances list. The fact that they were not controlled substances did not necessarily make them legal to sell. DSHEA contains several other criteria that prevent most synthetic steroids from being DSHEA-compliant.

Unfortunately, the FDA has grossly failed to enforce DSHEA when it comes to steroids.

Source:

FDA. (December 23, 2013). FDA warns consumers not to use muscle growth product. Retrieved from //www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm379711.htm