Ostarine®, Dietary Supplements and the Law

in Articles

Q: Can Ostarine be legally sold as a dietary supplement ingredient?

A: I’ve been asked this question so frequently that I’m compelled to give an answer! Some people even ask whether it’s covered by the new Designer Anabolic Steroid Control Act (DASCA). So let’s hash out the details.

Ostarine®, a.k.a. MK-2866 and GTx-024, is the registered trademark name for enobosarm, an investigational Selective Androgen Receptor Modulator (SARM). It’s currently being investigated by the pharmaceutical company GTx for use in women with certain types of breast cancer.[i] Dr. Doug Kalman, a clinical researcher with Miami Research Associates who has been a consultant to GTx on their SARM program, notes that Ostarine® has also been studied for its potential to treat cancer-induced muscle wasting. Although it is not an anabolic steroid and is not within the scope of the DASCA, it selectively binds to the androgen receptor in skeletal muscle and bone – offering the potential for lean muscle growth with a much lesser risk for the possible undesirable side effects of anabolic steroids. Indeed, one cancer wasting study concluded that the “use of enobosarm might lead to improvements in lean body mass, without the toxic effects associated with androgens and progestational agents.”[ii]

Even though the safety and efficacy of Ostarine® is still under investigation and it has yet to be approved as a drug by FDA, it’s not surprising that enobosarm is of interest to those looking to build muscle or improve athletic performance. Recognizing the performance-enhancing potential of SARMs as a class, the World Anti-Doping Agency banned them (including “andarine and ostarine”) in January 2008.[iii] Oliver Catlin, President and Co-founder of the Banned Substance Control Group (BSCG.org), noted that current testing methods will detect enobosarm and other SARMs in sports doping tests and that the period of detection continues to improve as researchers find more long-term metabolites. Indeed, Russian cyclist Nikita Novikov was provisionally suspended in June 2013 due to a positive A-sample result for enobosarm.

How are U.S. athletes getting enobosarm? Raw powders are ordered and imported (sometimes mislabeled as amino acids) from chemical suppliers in China. In some cases, the powder is then sold online as a “research chemical.” From a legal perspective, although chemical supply companies sell all sorts of active pharmaceutical ingredients, folks marketing SARMs to bodybuilders under the fraudulent guise of “research chemicals” risk federal prosecution.[iv] From a consumer safety perspective, Dr. Kalman warns that “what’s sold on the research chemical market might not match the exact chemical structure of the investigational drug described in the GTx patents as no publication reveals its exact configuration.”

The same concerns expressed about enobosarm in the research chemical market apply in the dietary supplement market. From a legal perspective, the definition of what is a permissible “dietary ingredient” is set forth in Title 21 of the U.S. Code, § 321(ff). Would enobosarm fit in among the vitamins, minerals, herbs or other botanicals, or amino acids permitted by the statute? Nope. Or could it possibly be viewed as “a dietary substance for use by man to supplement the diet by increasing the total dietary intake”? Not reasonably. And even if it did, unless it was marketed as a dietary ingredient before it was investigated as a new drug by GTx, it wouldn’t be legal as a supplement. That’s because “an article authorized for investigation as a new drug … for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public” can’t thereafter be marketed as a dietary ingredient.[v]

Oliver Catlin agrees, saying, “Ostarine® is clearly an investigational drug. I see no way that it would meet the criteria to be considered a dietary supplement.” That’s likely how FDA would see it as well. A member of FDA’s Office of Criminal Investigations recently told me that while he can’t yet speak on behalf of the agency, he personally views dietary supplements containing Ostarine® as illegal, misbranded and unapproved drugs, not supplements. Whether he will be authorized to direct agency resources toward investigating and prosecuting these cases remains to be seen.

Meanwhile, anyone in the supplement industry with questions as to the legality of any of their product ingredients should feel free to contact me. Avoiding legal trouble is more cost-effective and a lot less stressful than trying to get out of it. I’m here to help anyone who needs it at 516-294-0300.

[i] www.gtxinc.com/Pipeline/OstarineMK2866.aspx

[ii] www.ncbi.nlm.nih.gov/pubmed/23499390

[iii] See http://list.wada-ama.org/list/s1-anabolic-agents

[iv] See www.steroidlaw.com/2013/12/melanotan-ii-other-peptides-and-the-law-of-research-purposes-only-chemicals

[v] 21 U.S.C. § 321(g)(3)(B)(ii)