The paper was published yesterday in the journal Clinical Toxicology. It was written by a group headed by prominent industry critic Dr. Pieter Cohen, MD Harvard Medical School. John Travis, PhD, of NSF, also participated in the research.
The researchers searched for products marketed as sports nutrition supplements online that were advertised to contain deterenol or one of its synonyms (e.g., isopropylnorsynephrine and isopropyloctopamine) as an ingredient. This substance had briefly been marketed as a drug in nasal sprays in the 1940s and early 1950s but had not been on the market since.
According to NSF, deterenol is a potentially harmful ingredient that has been linked to adverse effects including nausea, vomiting, sweating, agitation, palpations, chest pain and even cardiac arrest, and is not approved for use in the United States. But deterenol wasn’t all that the researchers found.
“We’re urging clinicians to remain alert to the possibility that patients may be inadvertently exposed to experimental stimulants when consuming weight loss and sports supplements,” Dr Cohen said.
Products analyzed by two different labs
After purchasing 17 different supplements, the products were analyzed both by NSF and by the Netherland’s National Institute for Public Health and the Environment (RIVM). The Dutch lab analyzed the deterenol content while NSF looked for other stimulant ingredients.
The products were marketed under names such as N’Gorge NOS Extreme, Cannibal Ferox, Shredded-AF and Edge of Insanity. According to the label information, six were marketed as pre workouts, four were marketed as fat burners, three as weight loss products, one as a thermogenic and three had no indication on the label.
Rich brew of illegal ingredients
The results showed that eight other unapproved stimulant ingredients beyond deterenol were present: phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine.
A number of these ingredients have been the subject of specific enforcement actions on the part of the US Food and Drug Administration. DMAA was withdrawn from the market after being associated with several sudden deaths. But in 2016, FDA was said to be “following up” on reports that the ingredient was still widely available online. FDA ruled in 2015 that BMPEA was not a lawful dietary ingredient. And just this month, the Agency seized imports of the ingredient higenamine, because it was deemed to be a New Dietary Ingredient for which no notification has been filed.
“The risks of consuming these combinations of stimulants is unknown. The FDA should warn consumers about the presence of cocktails of experimental stimulants in weight loss and sports supplements and take immediate effective action to remove these stimulants from the market,” the authors concluded.
Industry groups say presence of illegal players not a surprise
Industry sources said Dr. Cohen was once again conflating illegal products with lawfully marketed dietary supplements. Also, no one contacted by NutraIngredients-USA was shocked that illegal products can be found for sale online.
“This report continues to tell an unfortunate but unsurprising truth about the internet: If researchers, like Dr. Pieter Cohen, specifically look online for products labeled to contain an illegal ingredient, they are not only likely to find them but other illegal ingredients as well,” said Steve Mister, president and CEO of the Council for Responsible Nutrition.
“The small collection of products identified in the March 23 report certainly does not represent the mainstream sports nutrition and weight management categories. The products identified in the analysis are not legal dietary supplements but illegal products that masquerade as supplements, hoping to evade detection,” he added.
“If they had provided this information directly to FDA and the Agency did nothing, that would be news. This is not news,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.
Loren Israelsen, president of the United Natural Products Alliance, said the continued presence of these kinds of ingredients in the market is indicative of what FDA is up against. If there are possibly as many as 80,000 different dietary supplements on the market, that’s a lot of moles to whack even if only a tiny proportion of those are SKUs knowingly sold with illegal ingredients.
“The hard part of enforcement for FDA is to keep in front of these kind of products to get them off the market. I think it’s great to have all these products mentioned by name so that action can be taken against these companies,” Israelsen said.
Source: Clinical Toxicology
Nine prohibited stimulants found in sports and weight loss supplements: deterenol, phenpromethamine (Vonedrine), oxilofrine, octodrine, beta-methylphenylethylamine (BMPEA), 1,3-dimethylamylamine (1,3-DMAA), 1,4-dimethylamylamine (1,4-DMAA), 1,3-dimethylbutylamine (1,3-DMBA) and higenamine
Authors: Cohen PA, et al.