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FDA takes action against BMPEA & DMBA, declaring they are not dietary ingredients.

BMPEA does not meet the statutory definition of a dietary ingredient, according to the U.S. FDA, which issued Warning Letters to five companies in April. A total of eight products from the companies (Hi-Tech Pharmaceuticals, Tribravus Enterprises, Train Naked Labs, Better Body Sports and Human Evolution Supplements) listed the stimulant as a dietary ingredient on labeling. Two of the companies further identified the source of BMPEA as the botanical Acacia rigidula.

FDA declared: "The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement."

Additionally, relating to the two companies that identified Acacia rigidula as the source of BMPEA, research conducted by the FDA in 2013 established that BMPEA is not a constituent or extract of Acacia rigidula. FDA considers these products to be misbranded for this reason, as well.

Under existing law, including the Dietary Supplement Health and Education Act (DSHEA), FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).

A recent case report published in The Annals of Internal Medicine also connected BMPEA with exercise-induced stroke.

Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), commended FDA's recent actions. "The FDA has both the authorities and tools in place to take action against firms that it believes have infringed on laws that protect against misbranding or adulteration. 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."

In the case of BMPEA, the clinical report described the health effects of the compound to be unknown at present. "This directly contradicts the claim that BMPEA acts like an amphetamine, the health effects of which are widely known and characterized, "Dr. Fabricant noted." While BMPEA may interact with the same receptor targets as amphetamine, it won't have the same potency or side effects of amphetamine.

"Nevertheless, the agency has taken the necessary steps to shield consumers against products that it has found to contain an illegal, adulterated dietary ingredient," Dr. Fabricant continued. "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."

FDA also recently issued Warning Letters to 14 companies regarding a total of 17 products that contain DMBA, claiming the products are adulterated under the law because DMBA is not a dietary ingredient.

"We applaud FDA efforts to remove harmful ingredients such as DMBA from dietary supplements," said John Travis, NSF International's senior research scientist and dietary supplement testing expert. "Our research last October found DMBA in 12 dietary supplements, which was concerning as DMBA is chemically similar to other harmful stimulants that have been banned by regulatory agencies in the U.S., U.K., The Netherlands, Brazil and elsewhere because DMBA can harm human health."

DMBA has been attributed to negative health events such as strokes, heart failure and sudden death, Mr. Travis said. "We are seeing a pattern that has continued with new stimulants such as DEPEA and BMPEA cropping up under the deceptive guise of botanical extracts. This is why retailers and consumers look for dietary supplements that have been tested and certified by a third party such as NSF International, because it provides assurance that the product label is accurate and free of harmful contaminants and adulterants like DMBA. It is also why the number of certified supplements has doubled in the last year as responsible companies demonstrate the safety and quality of their products."
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Title Annotation:Top of the News
Publication:Nutraceuticals World
Geographic Code:1USA
Date:Jun 1, 2015
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