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Unapproved Ephedrine-like Stimulant Found in Dietary Supplements

Phase 2

NSFResearchers from global public health organization NSF International, Harvard Medical School, the National Center for Natural Products Research (NCNPR) at the University of Mississippi and the National Institute for Public Health and the Environment in the Netherlands (RIVM) have found the unapproved pharmaceutical stimulant oxilofrine in 14 over-the-counter dietary supplement products. Their research on oxilofrine was published in Drug Testing and Analysis.

The U.S. Food and Drug Administration (FDA) took action on April 4, 2016 to remove oxilofrine from the marketplace, issuing warning letters to seven companies that list the compound on their product labels. According to the FDA, oxilofrine is an illegal dietary ingredient, which means products containing oxilofrine are considered misbranded under the law.

Oxilofrine has been studied in animals and humans and found to cause effects on the heart similar to ephedrine, a compound banned by the (FDA) in 2004 due to serious side effects. Since then, scientists at NSF International have discovered several unapproved and potentially dangerous replacement stimulants such as DEPEA, DMAA, DMBA and now oxilofrine in dietary supplements.

According to the research, 26 adverse events have been reported in the Netherlands linked to supplements containing oxilofrine.  These supplements led to nausea and vomiting, tachycardia, chest pain and cardiac arrest. Additionally, oxilofrine is often disguised on labels as “methylsynephrine” or “extract of Acacia rigidula.”

Following the instructions on the product label, consumers could ingest much more than prescription levels of oxilofrine—up to 250 mg of the compound in a day. This dosage is twice the typical adult dosage prescribed by physicians in other countries where the drug is approved for use during anesthesia and for treating a variety of medical conditions.  Several professional athletes also have been disqualified from sport due to testing positive for oxilofrine, which is banned by the World Anti-Doping Agency (WADA) and most major sports organizations including Major League Baseball (MLB) and the National Football League (NFL).

“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.”

This is the fourth time in three years that the research team has found unapproved stimulants disguised in supplements as botanical ingredients. “This compound was found in 14 supplements which are used as either dieting aides or pre-workout supplements,” said John Travis, NSF International research scientist. “As a public health organization we want to warn consumers about these compounds that may harm instead of improve their health.”

Consumers should avoid the following products that contain oxilofrine.

  • HyperDrive 3.0 (ALR Industries)
  • Ephedra Free Shredder (TBN Total Body Nitrition)
  • Fastin (Hi_Tech Pharmaceuticals)
  • Lean Pills (Line One Nutrition)
  • Ephedra Free Tummy Tuck (TBN Total Body Nutrition)
  • Methyl Drive 2.0 (ANS)
  • Drop Factor (MTS Nutrition)
  • Exile (AmericanMuscle Sports Nutrition Company)
  • China White 25 Ephedra (Cloma Pharma Laboratories)
  • Phenadrine (APS)
  • Hypercor (Kat-a-lyst Nutraceuticals)
  • MethylDrene 25 Ephedra Elite Stack (Cloma Pharma Laboratories)
  • Maimi Lean (Skyline Nutrition)
  • Eliminator X (Rok Hard Body Sports Nutrition)

For more information, visit www.nsf.org, or call (734) 545-2023.