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FDA Criminal Office Said to Be Examining Drug Ostarine in Dietary Supplements

Citing drug trials, FDA has taken the position in at least one warning letter that Ostarine doesn't qualify as a dietary supplement.

FDA’s Office of Criminal Investigations (OCI) has been reportedly looking into complaints that marketers of sports supplements have sold Ostarine in their products, a substance that a biopharmaceutical company has been studying in clinical drug trials for nearly a decade.

Government probes into Ostarine reflect FDA’s continuing efforts to crack down on marketers of “dietary supplements" that are tainted with pharmaceutical drugs and other illegal substances.

So-called SARMs, or selective androgen receptor modulators, which include Ostarine, have been under development by pharmaceutical companies. Memphis, Tennessee-based GTx, Inc. has been developing SARMs to treat serious diseases including breast cancer, a form of muscular dystrophy and urinary incontinence.

Ostarine is the brand name for the compound enobosarm, and the drug has been tested by GTx in roughly 24 clinical studies involving more than 1,500 subjects in the United States and abroad, said Mary Ann (Mayzie) Johnston, GTx’s vice president of clinical development, in an emailed statement.

FDA has taken the position in at least one warning letter that Ostarine (also known as MK-2866) doesn’t qualify as a dietary supplement. Generally under federal law, dietary supplements cannot include an article that is authorized for an investigation as a new drug and is the subject of substantial clinical investigations that have been publicized.

FDA cited GTx’s clinical investigations dating back to 2007 to treat cancer cachexia or muscle wasting. While the studies to treat cancer patients for muscle wasting were completed in 2013 and did not meet criteria to obtain FDA approval, GTx subsequently has done studies of enobosarm to treat breast cancer and stress urinary incontinence, Johnston noted.

“Depending on the indication for which approval is sought from FDA, and assuming the drug is determined to be safe and effective for the indication, it could take a few to several more years to gain regulatory approval," she said.

Meanwhile, marketers of sports supplements have been accused of selling Ostarine in their products.

“GTx became aware that some companies, primarily through the internet, were offering for sale [an] active pharmaceutical ingredient represented to be enobosarm and dietary supplements purportedly containing enobosarm, all in violation of GTx’s patent and trademark rights and in violation of the Federal, Food, Drug, and Cosmetic Act [FDCA]," said Robert J. Wills, Ph.D., executive chairman of GTx’s board of directors, in an emailed statement.

Wills indicated that after GTx retained outside legal counsel and internet investigators to help identify the wrongdoers, GTx sent cease-and-desist letters to a number of companies as part of a “comprehensive strategy for targeting the illegal conduct." A number of the recipients of the letters agreed to stop selling Ostarine, he noted.

“In addition, GTx has communicated its concerns directly to the U.S. Food and Drug Administration and is engaged with FDA through various channels, including the Office of Criminal Investigations," Wills said.

Nutrition Distribution, LLC, an Arizona-based sports nutrition company that has accused competitors in lawsuits of selling drugs including Ostarine, said it also has been contacted by FDA’s OCI.

FDA didn’t respond Thursday to a request for comment.

As the men’s magazine Maxim noted in a 2015 article, SARMs have been sold online for “research purposes" when in fact bodybuilders have been using them as an alternative to steroids. The federal government has brought criminal charges against individuals who sold drugs including Ostarine but claimed that they were intended for research.

“SARMs have been available online as ‘research chemicals’ for many years, but it is only fairly recently that FDA’s Office of Criminal Investigations … has initiated prosecutions against online companies fraudulently selling SARMs as research chemicals," said Rick Collins, an expert on sports supplements and partner with the New York-based law firm Collins Gann McCloskey & Barry PLLC, who discussed SARMs during a recent Healthy INSIDER Podcast. “I think FDA is just starting to grapple with what to do about the same compounds sold now not as research chemicals, but as dietary supplements."

As was the case with individuals who were prosecuted for selling active ingredients in prescription drugs under the pretext of research, it’s conceivable that marketers of “dietary supplements" containing SARMs who are targeted by FDA will be charged with a felony under the FDCA: namely introducing misbranded drugs into interstate commerce with the intent to defraud and mislead.

“The element of intent to defraud could be a key point contested by the defense, as well as whether principals within the company, as opposed to the company itself, should be charged with any criminal conduct," Collins said in an emailed statement. “These cases may also present complicated issues under the U.S. Sentencing Guidelines."

Pending Appeal in Ninth Circuit

The government is not the only threat to companies that have purportedly marketed SARMs in dietary supplements. At least one sports nutrition company is pressing ahead with litigation against a rival who was accused of selling Ostarine. Last month, a federal judge in California dismissed a lawsuit filed by Nutrition Distribution, LLC against IronMag Labs, LLC. Nutrition Distribution has filed a notice of appeal with the U.S. Court of Appeals for the Ninth Circuit.

In seeking relief under the federal Lanham Act, the lawsuit alleged IronMag Labs falsely advertised as safe its dietary supplements because the products OSTA RX and Super DMZ 4.0 contained a new drug, namely Ostarine. On April 6, U.S. District Judge Manuel Real dismissed the complaint, finding FDA hadn’t made a final determination on whether Ostarine is a new drug.

“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 DMX 4.0 are or contain a new or prescription drug that may not be sold or included in a dietary supplement," the judge wrote in his order. “Such an expedition requires expertise and uniformity in administration, not practicable through the courts."

IronMag Labs CEO Robert DiMaggio said he was pleased with the court decision and prepared to contest Nutrition Distribution’s appeal. “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," he said in a statement to PricePlow, a price comparison shopping site for nutritional supplements that reported the court dismissal on its blog.

IronMag Labs stopped selling Ostarine several months ago, DiMaggio told INSIDER Thursday in an email.

Before Real’s ruling, Nutrition Distribution argued in court papers that the outcome of its claims for false advertising “are independent of interpretation of the FDCA."

“The U.S. Supreme Court has recently recognized the importance of Lanham Act cases like this one to supplement the efforts of the FDA in enforcing the FDCA, noting that the Lanham Act and FDCA ‘complement each other’ in a ‘fundamental respect,’" Robert Tauler, a lawyer in Los Angeles representing Nutrition Distribution, wrote in March 14, 2016 court papers opposing IronMag Labs’ request to dismiss the lawsuit.

Tauler, who noted his client has 16 lawsuits pending against other companies, said he was confident the Ninth Circuit would reverse Real’s dismissal of the case.

“In the meantime, we will continue to pursue other companies that break the law whether those complaints reference the FDA or pursue Lanham Act claims or whether we proceed under different laws similarly enacted to protect against illegal activity in the marketplace," said Tauler, a founding partner with the law firm Tauler Smith LLP, in an emailed statement.

 

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