SARMs on the Ropes: FDA Finally Issues Warning Letters

FDA SARMs

The FDA is on the prowl again, this time they’re officially going after three companies who have sold SARMs into the sports nutrition market.

Don’t look now meatheads, but SARMs are officially under fire from the FDA – only two years after we predicted it’d happen!

It’s been a particularly tumultuous few weeks for the supplement industry. Recently we’ve seen Hi-Tech Pharmaceuticals raided, Jared Wheat arrested, and DMAA / Prohormones seized. Riding high on these “victories”, the U.S. Food and Drug Administration (FDA) has issued a warning letter the three companies for illegally selling supplements containing SARMs, but this only actually makes sense from a “supplement industry” point of view.

The three companies issued warning letters are:

  • Infantry Labs
  • IronMag Labs
  • Panther Sports Nutrition

The FDA states it has “significant safety concerns” over several of the products marketed as dietary supplements yet they contain selective androgen receptor modulators (SARMs). The FDA contends these products can result in “Life threatening reactions, including liver toxicity” and “also have the potential to increase the risk of heart attack and stroke.”[1,2,3]

SARMs contained in the questionable supplements listed in the warning letters were:

IronMag Labs Logo

IronMag Labs was one of three companies recently issued a warning letter by the FDA.

  • Ostarine (or MK 2866)

    ((2S)-3-(4-cyanophenoxy)-N-{4-cyano-3-(trifluoromethyl)phenyl]-2-hydroxy-2-methylpropanamide

  • LGD-4033

    4-((R)-2-((R)-2,2,2-trifluoro-1-hydroxyethyl) pyrrolidin-1-yl)-2-trifluoroMethyl) benzonitrile

Citing section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], the FDA states that the SARMs are in fact “prescription drugs” due to their toxicity or possibility for inducing harmful effects with their use.

The compounds have also never been found in nature, which makes them ineligible to be marketed as supplements. But some of the operated in the very gray area of “research chemicals”, and were “not for human consumption”, although some companies definitely did sell them as supplements earlier on in 2015.

Don’t Mess with DASCA

And even if these didn’t qualify as prescription drugs, the FDA could also enlist the DEA in making them DASCA-scheduled anabolics, bringing even more heat.

Point being, given the recent Hi-Tech Pharma raid on the andro’s, right now is a horrible time to be making anything unnaturally anabolic… which of course means some young cockslinger who’s willing to risk jailtime will likely come out of the shadows and take on the new hole in the market.

Brands Speak Out!

We contacted each of the brands that were issued warning letters and received nearly immediate responses:

”We were a little surprised that the FDA sent us a warning letter when a Google search would have shown Super DMZ 4.0 is not on our website nor is it available at any online retailers. Super DMZ 4.0 was a ‘one-run’ product that we discontinued over two years ago, it was replaced with version 5.0 which does not contain any SARMS.

IronMag Labs has not used a SARM in any of our products since 2015, and all of our ingredients and compounds currently used comply with all DSHEA regulations.” — IronMag Labs HQ

One of the other two brands anonymously stated,

”They should probably do a little better research. Nowhere has the bottle ever said ‘dietary supplement’ and those products have been pulled off the shelves for months.”

The FDA states that each company has 15 days to respond to the warning letters with a specific plan to correct the violation and steps to prevent future violations like this from happening down the road. More than likely, these warning letters will be ignored as the brands in question no longer produce/sell these products through their websites.

More Bad News for SARM companies…

This also seems to be game over for those that were fighting Nutrition Distribution in court over the anti-competitive laws. With an FDA warning on their side, we’d think that Nutrition Distribution is almost guaranteed to get a settlement or a court victory, and may be able to re-open any cases they lost.

What are SARMs?

Ostarine Structure

Say hello to Ostarine (MK-2866) one of the most well known and widely used / distributed SARMs.

SARMs are are research drugs that are chemically similar to anabolic steroids. These chemicals have not been approved for medical use, hence their classification as a “research chemical.” SARMs work by selectively targeting certain tissues in the body, like your muscles, and tell the cells in those tissues to grow.

Anabolic steroids, on the other hand, are more of an “all out assault” that tells impacts all kinds of tissues, including the brain, liver, prostate, and muscles.  SARMs are “supposed” to come with fewer side effects due to their more targeted selection of tissues and not the truckload of systemic side effects that can result as a consequence of steroid use. A more apt comparison is that SARMs are like precisely guided strike missiles, while steroids are more like an atomic bomb circa 1945.

Still, SARMs remain a very much untested and proven collection of compounds, but that hasn’t stopped several supplement companies from willingly selling them as OTC supplements.

The FDA is slow, but strong

Turtle Swimming

Slow and steady seems to be the FDA’s gameplan for relentlessly going after the supplement industry.

It seems the FDA might be a bit backlogged with their endless litigation against Hi-Tech Pharmaceuticals (while, of course, approving deadly suicide-inducing “antidepressants” and creating a national opiate epidemic). Considering these products haven’t been in production for over 2 years in some cases, the FDA is proving that doing the crime will eventually catch up to you – but you may be able to make millions in the process.

SARMs are either intellectual property owned by pharmaceutical companies, or unscheduled research chemicals and the long-term use and safety of them is certainly ambiguous, but having a federal agency be this far behind the times with warning letters is an incredibly poor showing on their part.

Right now’s a terrible time to be making or selling SARMs, but there’s about to be a massive hole in the market. So who’s going to enter the ring, and is it worth flirting with DASCA over?

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References

  1. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582685.htm
  2. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582464.htm
  3. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm581630.htm
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