The FDA issued a consumer warning earlier this week urging consumers to stop using Las Vegas-based Extreme Products Group’s Tri-Methyl Xtreme following reports of serious liver injury. The product is stated to contain anabolic agents methyl-stenbolone, Max LMG (a non-methylated prohormone), and epistane.
The FDA is conducting an investigation to identify the product’s manufacturer following adverse event reports from consumers; one each from California, New Jersey and Utah. No reports of death have been from use of the product.
Steve Mister, president & CEO of the Council for Responsible Nutrition, has urged consumers to take seriously FDA’s consumer advisory urging people not to use the muscle growth product, Tri-Methyl Xtreme.
“According to the agency, Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids, not permitted to be sold in a dietary supplement, making it an adulterated product,” he said.
“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. In these cases, the full weight of the federal Food, Drug & Cosmetic Act permits FDA to issue recalls, seizures, injunctions and to seek civil or criminal enforcement.
“Additionally, the Drug Enforcement Administration 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.”
DASCA was signed into law at the end of 2014, and ensures anabolic steroids are not misrepresented as legitimate dietary supplements by broadening the definition and imposing tougher penalties on firms making and selling them.
The Act amends the Controlled Substances Act to add more than 25 new substances to current lists of defined anabolic steroids, and revises the process whereby new substances can be added in future. It also calls for DEA to address products that are “substantially similar” to anabolic steroids and that have been illegally marketed to promote muscle growth.
DASCA’s provisions include new DEA authority to place new anabolic steroids on the DEA Controlled Substance List and new criteria for placing additional anabolic steroids on the list going forward that will better enable DEA to identify and catalog new chemicals. DASCA will allow DEA to quickly crack down on criminals creating new anabolic substances that closely resemble red-flagged counterparts listed, but altered minimally with the intent of evading enforcement.
It also creates tougher penalties (up to $2.5m and up to 10 years in prison) for the manufacture, sale and/or distribution of substances that meet the definition.
‘The situation is not comparable with the NY AG’s actions’
“Unfortunately, critics of dietary supplement regulation will point to this matter to call for pre-market approval of dietary supplements, but that would not solve this problem,” said Mister. “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. But clearly, products like these create a problem—for consumers, and for responsible industry—and our association is continuing to seek ways to support FDA to get these products off the market. At the very least, more robust and more frequent inspections of manufacturers under the existing good manufacturing practices (GMPs) regulations is required.
“For those who relate this problem to the actions by the New York State Attorney General (NY AG) against four major retailers and herbal supplements, these situations are not comparable. The NY AG used a test that has been roundly criticized as being inappropriate for testing herbal extracts, making the foundation of his case without merit.
“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—which 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.
“Our association and its member companies are committed to providing consumers with safe dietary supplement options for their health, and we share the goal with FDA of taking dangerous supplements off the shelves—but we also believe these efforts should be based on sound science.”