NY Senator calls for BMPEA to be banned, but such a move would be ‘wasteful’, says NPA
Sen Schumer announced his request for a ban at a press conference held Sunday in response to a study from Dr Pieter Cohen of Harvard Medical School, which found BMPEA (a positional isomer of amphetamine) in varying quantities in 11 of 21 dietary supplements his team tested whose formulations were listed as being based on Acacia rigidula extracts.
Dr Cohen's paper follows an earlier study by FDA scientists published in the Journal of Pharmaceutical and Biomedical Analysis (Jan 2014, Vol. 88, pp. 457-466), which concluded: “Given the low natural abundance of PEA it the plant materials, it appears nearly impossible to achieve the amounts of [BM]PEA found in the dietary supplements by formulating them with plant material or extracts of A. rigidula. [BM]PEA, a positional isomer of AMP, was found in 9 of 21 dietary supplements analyzed at levels ranging from 963 to 60,500 micrograms per gram. We found no safety data on the biological effects of this isomer in humans.”
In his April 12 press conference, Sen Schumer demanded to know from FDA why this information had been swept under the rug for approximately two years.
“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,” he 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.”
‘A waste of the agency’s time and resources’
However, Dr Fabricant, executive director and CEO of the Natural Products Association, said 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.
“The proposed ban is not based in the reality of how food and drug law actually works,” he said. “The agency 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.
“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. 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.”
‘The roadmap is similar to DMAA’
Dr Fabricant told us that, while he may share Sen Schumer’s frustrations with the agency in terms of enforcement, the agency has the tools to deal with these kinds of situations.
“Is it a dietary ingredient? If it’s not then you cannot ban it. I think the roadmap is similar to DMAA. FDA’s own study shows that it doesn’t appear to occur in a plant and would therefore require an NDIN,” he said.
“If products are labeled to contain this ingredient then the agency can act on it now. If it’s not labeled then additional testing is needed to build the evidence.”
Self-policing
Various industry stakeholders have already moved in response to Dr Cohen’s study. The Vitamin Shoppe announced on April 8 that it would removes products containing BMPEA from its stores and website.
“BMPEA is a synthetic drug-like substance that should not be used in dietary supplements,” said the retailer. “We are concerned by the findings outlined in the study published in Drug Testing and Analysis, which state that some Acacia rigidula containing products may also contain BMPEA. If these findings are confirmed by the FDA, these products should not be sold as dietary supplements.
“[T]he Vitamin Shoppe continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe.”
The United Natural Products Alliance (UNPA) also announced an immediate 'no-sale' policy as a condition of membership. The Utah-based organization said that the results of Cohen’s study and an earlier FDA-funded study on the products makes it clear that formulators are spiking BMPEA into the products for added physiological effect.
Similar member actions could certainly be considered by NPA, said Dr Fabricant, via codes of ethics, but ultimately NPA is not the agency, and the agency needs to act on these kinds of issues.
