05.01.15
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 that hasn’t been tested for safety in humans.
BMPEA—or the amphetamine isomer beta-methylphenylethylamine—was previously found in dietary supplements in 2013, but FDA did not 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-quadruple time-of-flight mass spectrometry. Claims for the products inluded benefits for weight loss, cognition and 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.
Pieter Cohen, MD, lead author of the study and assistant professor at Harvard Medical School, along with co-authors, urged FDA to warn the public about the dangers of BMPEA immediately and formally ban its use in dietary supplements.
Specialty retailer The Vitamin Shoppe issued a statement that it was immediately removing all Acacia rigidula containing products from its stores and website, due to the concern that some of them may contain BMPEA.
U.S. Senator Charles Schumer urged FDA to ban dietary supplements that contain BMPEA. “The FDA has all the proof it needs to exercise their authority and take these dietary and workout pills off store shelves, but consumers still know none of the risks,” Senator Schumer said. “The FDA’s report showing that widely used dietary supplements contain a hidden, hazardous chemical is jaw dropping. The FDA should ban these tainted supplements immediately and make sure the companies involved are held accountable.”
Instead of banning products, Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), said FDA has several stronger and quicker tools it can rely on to go after products that it feels pose a threat to consumers, including mandatory recall authority and administrative detention. NPA “strongly believes that banning products containing BMPEA is an unrealistic way for the FDA to remove them from store shelves, and is a waste of the agency’s time and resources.”
“What’s more, the FDA has the necessary expertise on staff to determine whether BMPEA is dangerous, and if and how it should be removed from the marketplace,” Dr. Fabricant continued. “While many have questioned whether BMPEA is a legitimate dietary ingredient, that decision is ultimately up to the FDA, and the agency can use its power to take action against companies that have not filed New Dietary Ingredient notifications. The FDA has always had full regulatory authority over dietary supplements, and protecting public health is at the forefront of its mission. NPA supports FDA exercising its full regulatory authority under the law if it finds valid safety concerns with certain products.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said the association shares concerns about BMPEA, which “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 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.”
The United Natural Products Alliance (UNPA) responded to the study by adopting a “no-sale” policy for BMPEA as a condition of membership for current and prospective members.
UNPA said it is clear that BMPEA is a synthetic ingredient that is added or “spiked” into weight loss, sports nutrition and cognitive function products that list Acacia rigidula as an ingredient. The synthetic nature of the ingredient and its presence in products labeled as dietary supplements makes them adulterated drugs under federal law.
“Having become aware of these two studies identifying BMPEA in these products and understanding that the products do not contain the naturally occurring form of Acacia rigidula, prompt action was warranted,” said Loren Israelsen, UNPA president. “As we have done before with no-sale policies for ephedra, DMAA and kratom (Mitragyna speciosa), we’re committed to moving quickly to define the boundaries of responsible practices within the industry.”
BMPEA—or the amphetamine isomer beta-methylphenylethylamine—was previously found in dietary supplements in 2013, but FDA did not 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-quadruple time-of-flight mass spectrometry. Claims for the products inluded benefits for weight loss, cognition and 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.
Pieter Cohen, MD, lead author of the study and assistant professor at Harvard Medical School, along with co-authors, urged FDA to warn the public about the dangers of BMPEA immediately and formally ban its use in dietary supplements.
Specialty retailer The Vitamin Shoppe issued a statement that it was immediately removing all Acacia rigidula containing products from its stores and website, due to the concern that some of them may contain BMPEA.
U.S. Senator Charles Schumer urged FDA to ban dietary supplements that contain BMPEA. “The FDA has all the proof it needs to exercise their authority and take these dietary and workout pills off store shelves, but consumers still know none of the risks,” Senator Schumer said. “The FDA’s report showing that widely used dietary supplements contain a hidden, hazardous chemical is jaw dropping. The FDA should ban these tainted supplements immediately and make sure the companies involved are held accountable.”
Instead of banning products, Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), said FDA has several stronger and quicker tools it can rely on to go after products that it feels pose a threat to consumers, including mandatory recall authority and administrative detention. NPA “strongly believes that banning products containing BMPEA is an unrealistic way for the FDA to remove them from store shelves, and is a waste of the agency’s time and resources.”
“What’s more, the FDA has the necessary expertise on staff to determine whether BMPEA is dangerous, and if and how it should be removed from the marketplace,” Dr. Fabricant continued. “While many have questioned whether BMPEA is a legitimate dietary ingredient, that decision is ultimately up to the FDA, and the agency can use its power to take action against companies that have not filed New Dietary Ingredient notifications. The FDA has always had full regulatory authority over dietary supplements, and protecting public health is at the forefront of its mission. NPA supports FDA exercising its full regulatory authority under the law if it finds valid safety concerns with certain products.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) said the association shares concerns about BMPEA, which “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 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.”
The United Natural Products Alliance (UNPA) responded to the study by adopting a “no-sale” policy for BMPEA as a condition of membership for current and prospective members.
UNPA said it is clear that BMPEA is a synthetic ingredient that is added or “spiked” into weight loss, sports nutrition and cognitive function products that list Acacia rigidula as an ingredient. The synthetic nature of the ingredient and its presence in products labeled as dietary supplements makes them adulterated drugs under federal law.
“Having become aware of these two studies identifying BMPEA in these products and understanding that the products do not contain the naturally occurring form of Acacia rigidula, prompt action was warranted,” said Loren Israelsen, UNPA president. “As we have done before with no-sale policies for ephedra, DMAA and kratom (Mitragyna speciosa), we’re committed to moving quickly to define the boundaries of responsible practices within the industry.”
