New Jersey-based Vitamin Shoppe Inc. has reached an agreement with Oregon and Vermont’s attorney generals on prohibiting the sale of BMPEA-containing supplements, just weeks after Food and Drug Administration (FDA) demanded that a handful of supplement companies cease distribution of products that contain BMPEA. The retailer also pulled all products with Acacia rigidula, unless testing confirms that the supplements do not contain BMPEA.
Physician Pieter Cohen of Harvard Medical School identified BMPEA as an amphetamine-like substance that was being sold in a number of weight-loss and sports supplements.
“This is a very important step that goes beyond the steps the FDA has taken to date,” said Cohen. “I hope that the FDA moves to make this their policy as well since there is no legitimate role for Acacia rigidula in supplements, and Acacia rigidula has been used as code for synthetic stimulants.”
NPA CEO and Executive Director, Daniel Fabricant, PhD, former director of Division of Dietary Supplement Programs at the FDA, noted that in the case of BMPEA, the health effects of this compound are unknown at present. “This directly contradicts the claim that BMPEA acts like an amphetamine, the health effects of which are widely known and characterized. While BMPEA may interact with the same receptor targets as amphetamine, it won’t have the same potency or side effects of amphetamine,” he said.
FDA stated in the warning letters that products declaring BMPEA as a dietary ingredient are “misbranded” because the substance doesn’t meet the definition of a dietary ingredient under the Federal Food, Drug & Cosmetic Act (FD&C).
“NPA supports the agency using all of its resources to protect consumers when it finds an issue with a misbranded or adulterated product in the marketplace,” Fabricant said. “The ongoing discussions surrounding BMPEA and whether it is found in nature will undoubtedly continue, but the agency has clearly taken a stance on how it fits under 201(ff) of the Federal Food, Drug and Cosmetic Act and demonstrated its ability to protect public health with its authorities and tools.”
Georgia-based Hi-Tech Pharmaceuticals Inc., a supplement manufacturer whose Acacia rigidula products were tested as part of Cohen’s research and found to contain BMPEA, said the supplements are safe.
“Hi-Tech has sold over 1 billion doses since 2003 of Acacia rigidula and its alkaloids—including BMPEA—and have conducted numerous studies of these alkaloids and believe them to be safe and effective when used as directed,” said Jared Wheat, president of Hi-Tech.