Food and Drug Administration

Study finds oxilofrine in dietary supplements

Pharmaceutical levels — or higher — of the stimulant oxilofrine were found in more than half of the dietary supplements tested in a recently published study. The FDA has contacted seven companies about misusing the substance.

A recently published study by perennial supplements critic Pieter Cohen, “Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA,” found oxilofrine in 14 of 27 supplement brands listing methylsynephrine as an ingredient.

The report, published online in Drug Testing and Analysis, said the supplements contained oxilofrine doses as high as 75 mg per serving. To stimulate the heart and increase blood pressure, the stimulant is prescribed in dosages of 16 to 40 mg, according to the study.

In response to the study, the Council for Responsible Nutrition President and CEO Steve Mister said in a statement: “The findings of Dr. Pieter Cohen’s latest study are particularly troubling to responsible marketers of dietary supplements because they demonstrate once again that rogue companies will ignore the laws designed to protect consumers. Oxilofrine is not a legitimate dietary ingredient, and its marketers have not complied with the legal requirements for bringing a new dietary ingredient to market so it cannot legally be sold in dietary supplements.”

He continued, “We urge FDA to use all the resources at its disposal to take action to sanction these companies — and others — to remove the products from the marketplace. We urge consumers to follow FDA’s advice and not use any products marketed as supplements that contain methylsynephrine, oxilofrine, or p-hydroxyephedrine.”

According to the Food and Drug Adminstration, methylsynephrine is not a dietary ingredient as defined by the federal Food, Drug and Cosmetic Act. Any dietary supplement that declares methylsynephrine — also known as oxilofrine or p-hydroxyephedrine — as a dietary ingredient is misbranded. In March, the FDA warned seven companies about marketing dietary supplements that list methylsynephrine as a dietary ingredient:

  • NutraClipse Inc. of Wilson, North Carolina, regarding Thermobombs. The FDA said the product also listed as a dietary ingredient AMP Citrate, also known as DMBA, which would be a new dietary ingredient. Because the agency did not find evidence that the ingredient would be safe, the FDA declared that Thermobombs is an adulterated product.
  • Swagger Supps of Carrollton, Texas, for Miami Lean.
  • Total Body Nutrition LLC of Bethpage, New York, regarding Ephedra Free Tummy Tuck and Ephedra Free Shredder.
  • Xcel Sports Nutrition LLC of Lubbock, Texas, for Leaner You.
  • M4 Nutrition Companies LLC of Dallas, Texas, regarding iBurn2. The FDA wrote that the product also lists picamilon, also known as nicotinoyl-GABA, as a dietary ingredient. Picamilon has not been approved as a food additive or authorized to be used in dietary supplements.
  • Line One Nutrition Inc. of Austin, Texas, for Fat Burning Lean Pills. The product also lists methylhexanamine, or DMAA, as a dietary ingredient. The FDA says methylhexanamine is an unsafe food additive; consequently, Fat Burning Lean Pills is an adulterated product.
  • Chaotic Labz of Atkins, Arkansas, regarding Malice.

Mister said, “When rogue companies use the supplement space to peddle illegal products, like we have in this situation, the legitimate companies have their reputations damaged and — worst of all — consumers are put at risk. In addition to implementing self-regulatory initiatives, we are part of a coalition that lobbies for FDA to receive additional resources in order to fully enforce the law. We are committed to doing what we can to help to support both the agency’s and industry’s efforts to protect consumers.”

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