FDA Sends a 1-Andro Warning Letter… Into a Black Hole

1-Andro Warning Letter

The FDA’s Cincinnati District sent the first warning letter over 1-Andro. Is something brewing for 2017?

On September 27, 2016, the FDA’s Cincinnati District Director, Steven B. Barber, sent a warning letter to Proprietary Wellness LLC over the products pBOLD and LG Sciences 1-ANDRO.[1]

This news escaped most people in the industry, mainly because Proprietary Wellness LLC is no longer in business! This was the parent company of LG Sciences, but was formally closed when Hi-Tech Pharmaceuticals acquired LG Sciences and the rights to their DHEA patents which are utilized in these products.

However, it’s worth knowing because it could be a sign of future battles to come over prohormones such as 1-Andro and other legal prohormones on the market.

Key sections of the letter

Most of the letter is less relevant, since it is due to labels that have long since been redesigned, but a key part of the warning letter that prohormone users should take note of is in the first bullet point:

Finally, 3b-hydroxy-androst-1-ene-17-one and 17beta-[1-ketoethyl]-androsta-1,4-diene-3-one,17a-ol are not concentrates, metabolites, constituents, extracts, or combination of vitamins; minerals; herbs or other botanicals; amino acids; or dietary substances for use by man to supplement the diet by increasing the total dietary intake.

— FDA Warning Letter[1]

(emphasis ours)

Once again, it looks like the vague FDA DSHEA regulations come back to haunt everyone involved. 1-DHEA is a metabolite of DHEA, and 1-DHEA is found in nature. Time and again, we encounter the debate as to whether “Found in Nature, Synthesized in a Clean Lab” is DSHEA compliant — an argument which the FDA’s new NDI Draft Guidelines still don’t fully clarify.

Reaching Hi-Tech for Comment

We contacted Hi-Tech Pharmaceuticals, and founder and CEO Jared Wheat was happy to leave a comment:

Hi-Tech has one of the nation’s foremost experts in the dietary supplement field write a legal opinion of the legality of 1-DHEA as being both a lawful dietary supplement and legal under DASCA. As always Hi-Tech continues to fight to bring the most powerful compounds available to the industry, as well as, ensure the are legal to be sold. We have seen great results with 1-DHEA and expect the results to continue to come in as more people try this amazing compound.

— Jared Wheat, Hi-Tech Pharmaceuticals

Hi-Tech attached the following document to be shared from their legal counsel:

Also worth noting is that the labels of the products at hand were redesigned far prior to the creation of this letter.

What will happen next?

The next question is whether the FDA will send additional warning letters to Hi-Tech Pharmaceuticals themselves. We feel that this is unlikely to happen, given that Hi-Tech is apt to sue the FDA like they did with DMAA. Note that the FDA never even sent Hi-Tech a warning letter over DMAA, and we’re not sure how much legal power Cincinnati district director even has.

This puts us in a little bit of a stand-off, with consumers waiting to see what to do next.

Should prohormone users stock up?

At this point, we don’t believe stocking up is necessary. There are plenty of 1-Androsterone products available from several brands and that shouldn’t change anytime soon. The ultra-paranoid who enjoy the gains may still wish to buy a bottle, but it seems unnecessary to panic at the end of 2016.

Stay tuned to PricePlow though, since that attitude may change if additional action’s taken in the near future.

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References

  1. Barber, Steven B; US Food and Drug Administration; “Proprietary Wellness LLC 9/27/16”; September 27, 2016; http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525961.htm
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