04.08.15
A study published in the journal Drug Testing and Analysis examined supplements supposedly containing Acacia rigidula, a shrub native to Texas, and instead found traces of BMPEA, a synthetic amphetamine-like chemical never before tested on humans.
BMPEA—or the amphetamine isomer beta-methylphenylethylamine—was previously found in dietary supplements in 2013, but the Food and Drug Administration failed to order its removal from the market. The new study conducted by Harvard Medical School scientists aimed to determine whether BMPEA was still present in the supply chain over a year later.
Twenty-one products claiming to contain Acacia rigidula were tested using liquid chromatography-quadrupole time-of-flight mass spectrometry. Claims for the products ranged from benefits for weight loss to cognition to sports nutrition. More than half of the products were found to contain BMPEA, including: JetFuel Superburn, JetFuel T-300, MX-LS7, Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.
While the effects of BMPEA on human health are unknown, it was found to increase blood pressure and heart rate in dogs and cats during testing in the 1930s and 1940s. The substance is among the ingredients barred by the World Anti-Doping Association.
The study’s authors urged FDA to immediately warn the public about the dangers of BMPEA and formally ban its use in dietary supplements.
The Council for Responsible Nutrition (CRN), Washington, D.C., responded to these findings by echoing the study’s sentiments.
Steve Mister, president & CEO of CRN stated, “We share the concerns of Dr. Pieter Cohen and his study co-authors regarding BMPEA, an amphetamine isomer stimulant that should not be used in dietary supplement products because it is a synthetic drug-like substance, not a dietary ingredient.”
He added, “FDA first raised the issue of Acacia rigidula supplements adulterated with BMPEA in an article published by the agency in 2014 in the Journal of Pharmaceutical and Biomedical Analysis, noting that the amine compound is not found in the Acacia rigidula plant. Given FDA’s earlier findings combined with this new study by Dr. Cohen, we urge FDA to take immediate enforcement action against these adulterated products containing BMPEA and the companies illegally spiking these products with this synthetic drug. BMPEA does not appear to be a legitimate dietary ingredient, and therefore, its inclusion in a product labeled as a dietary supplement makes the product adulterated under the Dietary Supplement Health & Education Act (DSHEA).”
Mr. Mister encouraged the agency to recall products containing this illegal drug for potential safety concerns. In addition, he also noted that FDA could declare products with BMPEA as misbranded because it was not listed on the labels, or proclaim the products are adulterated. “These legal options come with the ability for FDA to seek injunctive relief to remove the products from the market, as well as a range of civil and criminal penalties for those who intentionally introduce these products to consumers,” he said. “FDA has the tools it needs under the law to take action before there are serious health consequences, and CRN is asking the agency to do just that.”
BMPEA—or the amphetamine isomer beta-methylphenylethylamine—was previously found in dietary supplements in 2013, but the Food and Drug Administration failed to order its removal from the market. The new study conducted by Harvard Medical School scientists aimed to determine whether BMPEA was still present in the supply chain over a year later.
Twenty-one products claiming to contain Acacia rigidula were tested using liquid chromatography-quadrupole time-of-flight mass spectrometry. Claims for the products ranged from benefits for weight loss to cognition to sports nutrition. More than half of the products were found to contain BMPEA, including: JetFuel Superburn, JetFuel T-300, MX-LS7, Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion.
While the effects of BMPEA on human health are unknown, it was found to increase blood pressure and heart rate in dogs and cats during testing in the 1930s and 1940s. The substance is among the ingredients barred by the World Anti-Doping Association.
The study’s authors urged FDA to immediately warn the public about the dangers of BMPEA and formally ban its use in dietary supplements.
The Council for Responsible Nutrition (CRN), Washington, D.C., responded to these findings by echoing the study’s sentiments.
Steve Mister, president & CEO of CRN stated, “We share the concerns of Dr. Pieter Cohen and his study co-authors regarding BMPEA, an amphetamine isomer stimulant that should not be used in dietary supplement products because it is a synthetic drug-like substance, not a dietary ingredient.”
He added, “FDA first raised the issue of Acacia rigidula supplements adulterated with BMPEA in an article published by the agency in 2014 in the Journal of Pharmaceutical and Biomedical Analysis, noting that the amine compound is not found in the Acacia rigidula plant. Given FDA’s earlier findings combined with this new study by Dr. Cohen, we urge FDA to take immediate enforcement action against these adulterated products containing BMPEA and the companies illegally spiking these products with this synthetic drug. BMPEA does not appear to be a legitimate dietary ingredient, and therefore, its inclusion in a product labeled as a dietary supplement makes the product adulterated under the Dietary Supplement Health & Education Act (DSHEA).”
Mr. Mister encouraged the agency to recall products containing this illegal drug for potential safety concerns. In addition, he also noted that FDA could declare products with BMPEA as misbranded because it was not listed on the labels, or proclaim the products are adulterated. “These legal options come with the ability for FDA to seek injunctive relief to remove the products from the market, as well as a range of civil and criminal penalties for those who intentionally introduce these products to consumers,” he said. “FDA has the tools it needs under the law to take action before there are serious health consequences, and CRN is asking the agency to do just that.”
