April 22, 2015
FDA recently warned consumers not to use a bodybuilding product called Tri-Methyl Xtreme that is marketed as a dietary supplement illegally and claims to contain anabolic steroids. This advisory was in response to three adverse event reports (AERs) the agency received from consumers who had taken the product in California, New Jersey and Utah. The distributor of the product is Las Vegas-based Extreme Performance Group, but FDA is trying to figure out who manufactures this product, which is sold online and in some retail stores and gyms.
“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers," said Charles Lee, M.D., a senior medical advisor in the Office of Compliance at FDA’s Center for Drug Evaluation and Research (CDER), in the consumer advisory posted on FDA’s website. “Anabolic steroids may have a range of serious adverse effects on many organ systems, and the damage may be irreversible."
FDA reminded consumers use of anabolic steroids and steroid-like substances is known to contribute to liver injury and can have a negative effect on hormone levels, breast size, testicles, fertility, cholesterol levels, risk of heart attack and stroke, and childhood growth. The agency urged any consumers who suspect any ill effects from taking Tri-Methyl Xtreme or similar products to consult a health care professional. It noted signs for consumers to watch out for include unexplained fatigue, abdominal or back pain, discolored urine or any other unexplained changes in their health. Adverse events can be reported via FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
I asked FDA to provide more information on the AERs associated with Tri-Methyl Xtreme, but the agency did not provide additional details. FDA also did not reveal which ingredient triggered the advisory. The product is advertised as containing the prohormones methylstenbolone, LMG (13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one) and epistane.
I discovered several other EPG muscle growth products contain anabolic and androgenic substances, including:
Ostarine, a SARM (selective androgen receptor modulator) that has been studied as an IND (investigational new drug) by GTx Inc.
DMZ (Dymethazine or 17beta-hydroxy 2alpha,17, beta-dimethyl 5alpha, -androstan3-on azine).
Trenavar (prohormone to the injectable steroid trenbolone).
The problem with these compounds could be tied to one or all of: the definition of “dietary ingredient" per DSHEA (Dietary Supplement Health and Education Act), the prohibition of designer anabolic and androgenic compounds per the recently passed Designer Anabolic Steroid Control Act (DASCA, full text here) and new dietary ingredient (NDI) notification requirements.
FDA told me there are currently no NDI notifications posted with regard to ostarine. However, the agency reminded the Federal Food, Drug and Cosmetic Act (FDCA), section 201(ff)(3)(B) mandates, “If a substance has been authorized as an investigational new drug (IND) for which substantial clinical investigations have been instituted and made public, and the substance was not marketed as a dietary supplement prior to the IND authorization, the substance would be excluded from the dietary supplement definition."
Establishing the agency’s view of ostarine in dietary supplements, a recent warning letter from FDA to Biogenix USA advised the company’s male enhancement product is adulterated with several pharmaceuticals including ostarine.
“Under the law, FDA can remove products marketed as dietary supplements as being adulterated if they contain new dietary ingredients without having been properly notified to the agency as being safe, or if they present an unreasonable or serious risk of injury to consumers, or if they pose an imminent health hazard," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), who noted the full weight of the federal FDCA permits FDA to issue recalls, seizures, injunctions and to seek civil or criminal enforcement. “Additionally, the Drug Enforcement Administration (DEA) can take a product containing an anabolic steroid off the market by declaring it a controlled substance, under the Anabolic Steroid Control Act, a law the supplement industry helped pass in 2004, and further expanded last year by the Designer Anabolic Steroid Control Act, also passed with the supplement industry’s strong support."
CRN urged consumers to take the FDA advisory seriously and highlighted the fact such products are not permitted to be sold as dietary supplements.
The products appear to be distributed and marketed by both Extreme Products (aka Extreme Performance Group/EPG) and Brand New Energy Sports Distribution. All these entities appear to be owned and run by a husband and wife team out of their home in Las Vegas. I reached out to Darren Housholder, co-owner of EPG and related companies, but calls were not returned by the time I posted this blog.
I easily found several products with similar steroid or prohormone ingredients for sale at a number of bodybuilding retail websites. Why are these products still on the market? There is a consumer advisory but no warning letter sent to EPG? These products are sold out in the open, retailers proudly tout the prohormone and steroidal ingredients. There also are numerous violative claims made in the marketing and advertising of these products. Such adulterated, mislabeled and illegally marketed products masquerading as sports supplements hurt the reputation of the responsible dietary supplement industry and give fodder to industry critics looking to increase supplement regulations.
In anticipation of calls from industry critics for additional dietary supplement regulations, Mister declared existing law sufficient and pointed out pre-market approval would not solve the problem of adulteration. “Companies intentionally marketing illegal products could potentially pass a pre-market approval process with an ‘all herbal’ formula, and then spike the product during manufacturing prior to bringing it to market," he explained. However, he acknowledged such cases of adulteration are problematic and assured CRN continues to explore ways to support FDA’s removal of these products market. “At the very least, more robust and more frequent inspections of manufacturers under the existing good manufacturing practices (GMPs) regulations is required."
Mister was also quick to differentiate this situation from that of the NY Attorney General’s investigation of herbal supplements, which featured a widely criticized testing method considered inappropriate for herbal extracts. “Further in the NY AG’s settlement with one of the retailers, the agreement indicates that those products in question were (at the time they were removed)—and still are—safe, pure, properly labeled and in full compliance with all regulatory requirements," he said, noting it begs the question: why did the NY AG demand they be removed in the first place? “By contrast, the matter of intentionally spiking products with illegal anabolic steroids does deserve attention by law enforcement."
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