The Food and Drug Administration has been busy in 2019 looking into the dietary supplement industry. In recent chain of events, the FDA has added the plant brassinosteroid 5-Alpha-Hydroxy-Laxogenin aka Laxogenin to their Dietary Supplement Ingredient Advisory List.
An ingredient placed on the Dietary Supplement Advisory List does not mean it is banned or illegal, but the FDA sees the ingredient as potentially unlawful. It also does not mean that the ingredient is harmful to consumers. Per the FDA, the Dietary Supplement Ingredient Advisory List is:
Inclusion on the Dietary Supplement Ingredient Advisory List does not necessarily indicate that the FDA has determined that the ingredient is unsafe; it means FDA is taking steps to further evaluate the ingredient.
Ingredients are added to the Dietary Supplement Ingredient Advisory List based on a preliminary evaluation by the FDA. This preliminary evaluation indicates that an ingredient may not lawfully be in dietary supplements for reasons including:
- the ingredient appears to be excluded from use in a dietary supplement;
- the ingredient does not appear to be a dietary ingredient and does not appear to be either an approved food additive or generally recognized as safe for use; and/or
- the ingredient appears to be subject to the requirement for pre-market notification, but the requirement has not been satisfied.
Laxogenin joins the list that also includes DMAA, Higenamine, Hordenine, N-Methyltyramine, Octopamine and Andarine.
What this means to supplement brands is they are advised to stop using the ingredient. Laxogenin is used in a lot of brands non-hormonal muscle building supplements. Laxogenin has been on the rise in sports nutritional supplements.
While the FDA looks into Laxogenin more, brands will still use and sell products containing the ingredient.
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Fitness Informant's POV
This one surprises me, a lot. Laxogenin is a plant-based steroid, or as we put it above, a plant brassinosteroid. To me, this sounds like it is naturally occuring in nature, which is what we look for in a lot of dietary supplements. There is nothing out there that says Laxogenin is harmful. The studies on Laxogenin show promise in regards to a non-hormonal muscle builder.
We've reviewed several products here that contain Laxogenin. It will be interesting to see ultimately what the FDA decides, but more-so interesting what brands decide to do. I think brands will continue to use the ingredient until the FDA decides to send out warning letters, if they do.
I understand the FDA wants to look further into this ingredient, but I do not feel there are any issues with it. I do not agree with this ingredient being on the FDA's Dietary Supplement Ingredient Advisory List.
