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Illegal Ingredient, 5-Alpha-Hydroxy-Laxogenin, Appearing in More Supplements

UPDATED: May 25, 2022

Reflecting a past and current trend of ingredients being added illegally to dietary supplements, athletes and others subject to anti-doping rules are advised that the Food and Drug Administration (FDA) has confirmed through several recent warning letters that the ingredient 5-Alpha-Hydroxy-Laxogenin is not a lawful dietary ingredient. The purpose of this list is to warn consumers about ingredients that appear to be unlawfully included and marketed in dietary supplements.

 

What is 5-Alpha-Hydroxy-Laxogenin?

5-Alpha-Hydroxy-Laxogenin is often marketed in dietary supplements as a plant-based anabolic agent. However, this is false advertising. While it is related to the plant steroid laxogenin, there are no reports of the 5-Alpha-Hydroxy-Laxogenin derivative being detected in or isolated from any natural source.

5-Alpha-Hydroxy-Laxogenin has been on USADA’s radar for some time because it’s frequently listed on labels of products that also happen to be contaminated or spiked with performance-enhancing drugs (PEDs). On the Supplement Connect High Risk List, for example, of the products that list laxogenin on the label, about half of them also list a prohibited substance on the label, while the other half tested positive for an undeclared (unlisted) stimulant, anabolic steroid,or Selective Androgen Receptor Modulator (SARM).

On supplement labels, 5-Alpha-Hydroxy-Laxogenin could be listed in a variety of ways, including 5-laxogenin, 5-alpha-laxogenin, or by the chemical name. It is possible that some companies are using the term “laxogenin” as code for a hidden (undeclared) PED.  

Is 5-Alpha-Hydroxy-Laxogenin prohibited in sport?

Currently 5-Alpha-Hydroxy-Laxogenin is not prohibited because it doesn’t meet at least two of the three World Anti-Doping Code criteria for inclusion. There is unclear evidence showing that it has performance-enhancing effects in humans. However, if new data or information becomes available that shows 5-Alpha-Hydroxy-Laxogenin enhances performance, the World Anti-Doping Agency may change the status of this ingredient immediately.

Can 5-Alpha-Hydroxy-Laxogenin legally be sold in dietary supplements?

No. The FDA has recently clarified in several warning letters (linked above) to dietary supplement manufacturers that laxogenin is not a legitimate dietary ingredient. 

Are there health effects associated with 5-Alpha-Hydroxy-Laxogenin?

The safety of 5-Alpha-Hydroxy-Laxogenin is unclear because the ingredient hasn’t been tested in humans. However, there are two more good reasons to avoid this ingredient:

  1. It might indicate the presence of an undeclared PED in a product.
  2. The FDA considers it unlawful in dietary supplements.

More questions?

For questions about specific products, substances, and methods, contact USADA’s Drug Reference Line at drugreference@usada.org or call (719) 785-2000, option 2.

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