UPDATED on April 6, 2016:
United States District Judge Manuel L. Real has ruled on the Nutrition Distribution vs. IronMagLabs SARMs case, granting IronMagLabs’ motion to dismiss the case.
The PDF is below, followed by commentary from both companies:
The long and short of it is that the FDA has never made an official ruling on SARMs or Ostarine, and until they do so, the judge cannot agree that it is truly “illegal”. “Not legal” is not the same as “illegal”.
Both parties were able to be reached for comment. Starting with Robert DiMaggio, CEO of IronMag Labs:
“We are very happy with the federal district judge’s decision to dismiss this lawsuit with prejudice; and we are more than ready to fight Nutrition Distribution’s appeal if they choose to take that route.
As I said when this lawsuit was first filed last year we will continue to fight them, and I hope that every other company that has a pending lawsuit against them does the same thing.”
-Robert DiMaggio, CEO of IronMag Labs, LLC
Nutrition Distribution’s Michael Keplinger stated that this is not yet over though:
“We are disappointed that Judge Real got this wrong, however, we are confident that our appeal before the 9th Circuit will be successful and his ruling will be overturned.
The real upside for us is that Judge Real’s Order gave us the green light to enforce IronMag’s false advertising with the FDA directly. After the ruling on this case was issued we were immediately contacted by the FDA OCI office to setup a meeting that will take place in three weeks. Since the FDA has punitive authority far exceeding that of a civil lawsuit, we are very confident that IronMag Labs will be brought to justice very soon and likely before our appeal is even heard.”
— Michael Keplinger, Managing Partner, Nutrition Distribution
So there’s seemingly more to come, and we’ll update this post when we know more.
The key point from the judge is that Without a final determination or any clear statement by the FDA on this issue, the Court or a jury, would have to apply the FDCA definitions to the substances at issue to determine whether OSTA RX and Super DMZ 4.0 are or contain a new or prescription drug that may not be sold or included in a dietary supplement.
Basically, the judge seems to be saying that only the FDA can definitively rule on such a gray area compound — not the courts, so until the FDA says anything, the case is dismissed.
A controversial judge?
We Googled the judge and found some interesting stuff, to say the least. Judge Manuel L. Real has his own Wikipedia page, which includes allegations of questionable practices. Judge Real also has a review page on The Robing Room (a review site for judges that lawyers use!) that is less than flattering, but note that the reviews are coming from lawyers, so you can’t know who to trust.
Regardless, the judge is the judge and this case is dismissed until further notice.
BREAKING NEWS: The first lawsuit regarding the ongoing SARMs controversy in the supplement industry has surfaced:
Nutrition Distribution LLC has filed suit against IronMagLabs over their sale of SARMs.
The complaint has been filed in California with the following allegations:
- False Advertising (per the Lanham Act § 43 (a)(1)(B))
- Unfair Competition in California (California Business and Professions Code Section 17200)
- California Unfair Competition (Business and Professions Code Section 17500)
The initial complaint is now publicly available, PricePlow’s social media follower can get it below:
The Lawsuit Summary
- IronMagLabs is being sued over the use of the SARM Ostarine in two of their products, Osta RX and Super DMZ 4.0.
- The complaint alleges that the defendants (IronMagLabs) have misbranded Osta RX and Super DMZ as “dietary supplements”.
- The complaint discusses that Ostarine is “currently under investigation as a new pharmaceutical drug” and not recognized as safe and effective.
- The complaint mentions that Osta RX is falsely marketed and advertised as natural, although it is a synthetic substance, and later invokes the FDA’s DSHEA Act of 1994, stating that Osta-RX and Ostarine “Are not vitamins, minerals, herbs, botanicals, or amino acids. Thus, OSTA RX cannot be legally sold as a “dietary supplement” and its inclusion in such product deems it adulterated”.
- The plaintiff, Nutrition Distribution, is also known as Athletic Xtreme. They use their testosterone-boosting supplement, Advanced PCT, as an example of a product that directly competes with Osta RX. “Users of OSTA RX have little incentive to use a natural product like Advanced PCT until they are hurt or the product is taken off the shelves.
- Potential medical side effects are discussed, alleging that IronMagLabs claims “side effects are basically non-existent.”
- They are suing for the following:
- Preliminary and permanent injunctive relief – IronMagLabs may no longer produce, license, market, or sell Ostar RX or any other SARM such as Ostarine.
- An award for damages to be decided at trial
- An award of any and all of IronMagLabs’ profits from these products, as well as ill-gotten gains, treble damages, and punitive damages
- Costs and attorney’s fees any other relief the court deems appropriate.
IronMagLabs Official Response: “Frivolous”, “Will fight them til the end”
We contacted IronMagLabs for comment, and their owner and CEO, Robert Dimaggio, immediately responded with the following statement:
We feel this is a frivolous lawsuit with baseless claims and we will fight them til the end. We are getting together with several other supplement companies that are also being sued by Nutrition Distribution on the same grounds.
Thank you, — Robert DiMaggio, CEO/Founder, IronMagLabs
Nutrition Distribution Speaks out in an interview
From an interview on Natural Products Insider:
“Companies, like Nutrition Distribution, cannot compete in the marketplace when so many competitors sell products with ingredients that the FDA categorizes as unapproved or prescription drugs such as SARMs,” said Michael Keplinger, vice president of Nutrition Distribution, in an emailed statement. “Our main goal is to get products that contain these types of ingredients off of the market.”
That article is also quick to point out that Athletic Xtreme once operated as Anabolic Resources / Anabolic Xtreme, and was fined $500,000 and $100,000 for having adulterated supplements in 2011. Keplinger stated that they took responsibility for their actions and fixed their issues, but clearly do not seem happy that few other companies have done the same, making for an unfair playing field.
This is surely going to cause an uproar from both sides, and the comments are open.
One extremely interesting thing is that this is one of the first times one supplement company has sued another for Unfair Competition per the Lanham Act, at least to our knowledge.
POM Wonderful vs. Coca-Cola Rears its Head?
Earlier this year, we suggested that a case like this type of lawsuit could be a possibility, as it was opened up in the US Supreme Court’s decision to allow POM Wonderful to sue competitor Coca-Cola over Coke’s “Pomegranate Blueberry Flavored Blend” (which contained only 0.3% pomegranate juice).
GTx Not Involved?
Another interesting thing to note is that GTx Inc. is actually the patent-holder for Ostarine! We are not sure if they are involved in any way, but surely they must know what’s going on at this point. They may be preparing their own litigation.