The stimulant oxilofrine is considered dangerous and banned by the World Anti-Doping Agency, Major League Baseball, National Football League and other sports organizations.
Yet a global public health organization says the ephedrine-like substance is found in 14 over-the-counter dietary supplements sold by popular retail stores in the United States. It is the fourth time in three years that NSF International research team has found unapproved stimulants disguised in supplements as botanical ingredients.
After NSF International raised the alarm about unapproved pharmaceutical stimulant, the U.S. Food and Drug Administration (FDA) on April 4 sent warning letters to seven companies with formal notice that products containing oxilofrine that do not list it on the label are misbranded.
The dietary ingredient has been studied in animals and humans. It has been found to cause effects on the heart similar to ephedrine, which was banned by FDA in 2004 for its serious side effects.
Replacement stimulants since then have included DEPEA, DMAA, and DMBA. Oxilofrine is apparently only the latest to be found in dietary supplements.
Reactions to oxilofrine have included nausea and vomiting, tachycardia, chest pain and cardiac arrest. On the label, oxilofrine is often listed as “methylsynephrine” or “extract of Acacia.”
If taken according to label directions, some of the supplement products result in a person consuming 250 mg daily, or about double the approved level for adults. Adolescents could be putting themselves at especially great risk by consuming that amount of oxilofrine. NSF International quoted a Harvard Medical School researcher in its report.
“Adolescents who use these products might be placing themselves at risk of serious harm. The larger-than-adult doses we found might overstimulate their smaller, growing bodies,” said Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has conducted extensive research on supplements.
“In countries where oxilofrine is prescribed by doctors the usual amount of the drug for adolescents is 24 mg or less. We found amounts in supplements of oxilofrine more than three times higher than the usual pediatric dose. Combined with physical activity and other stimulants commonly found in supplements, the consequences could be catastrophic.”
Products named by NSF International, along with the name of the manufacture, label dosage and “health claims” were:
- Hyper Drive 3.0 by ALR Industries, 250 mg — “Hardcore diet and energy aid”
- Ephedra Free Shredder by TBN Body Nutrition, 220 mg — “A killer ABS formula”
- Fastin by Hi-Tech Pharmaceuticals, 190 mg — “Pharmaceutical-grade weight loss aid for optimal diet and energy”
- Lean Pills by Line One Nutrition, 98 mg — “Fat burning”
- Ephedra Free Tummy Tuck by TBN Total Body Nutrition, 44 mg — “A killer ABS formula”
- Methyl Drive 2.0 by ANS, 35 mg — “Powerful thermogenic rush”
- Drop Factor by MTS Nutrition, 33 mg — “Thermogenic powerhouse”
- Exile by American Muscel Sports Nutrition Co., 25 mg — “Euphoric weight loss”
- China White 25 Ephedra by Cloma Pharma Laboratories, 23 mg — “Energy, thermogenesis, alertness, fat burning”
- Phenadrine by APS, 11 mg — “World strongest diet and energy diet”
- Hypercor by Kat-a-lyst Nutraceuticals, 1.2 mg — “Metabolic formula”
- MethylDrene 25 Ephedra Elite Stack by Cloma Pharma Laboratories, .05 mg — “Super intense-hardcore version”
- Miami Lean by Skyline Nutrition, 02 mg — “Far burner”
- Eliminator X by Rok Hard Body Sport Nutrition, .0003 mg — “Maximum strength formula”
Any of these products might be found wherever dietary and muscle supplements are sold at retail outlets throughout the United States.
“Products certified to the stringent NSF Certified for Sport program include additional steps to screen supplements for more than 230 athletic banned substances, which is why the program is used by the NFL, NHL, MLB, PGA, LPGA, the Canadian Centre for Ethics in Sport (CCES) and the New York City Police Department,” according to a NSF news release about its oxilofrine findings.
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