Durbin, Blumenthal urge FDA to take action against BMPEA

By Hank Schultz contact

- Last updated on GMT

Durbin, Blumenthal urge FDA to take action against BMPEA

Related tags: Dietary supplement, Food and drug administration

US Senators Dick Durbin and Richard Blumenthal sent a letter yesterday to the Food and Drug Administration asking the agency to take action against products containing the synthetic stimulant ingredient known as BMPEA, products which the pair called both “mislabeled and deceptive” and “potentially dangerous.”

The ingredient is at the center of a developing controversy, which was rekindled last week with the release of a study from a team headed by prominent dietary supplement industry critic Dr Pieter Cohen​ of Harvard Medical School. That study, published in the journal Drug Testing and Analysis​ and building on earlier work done by FDA’s own scientists in 2013, found that BMPEA was present in 11 of 21 products in the weight loss and sports categories that listed Acacia rigidula, ​a shrub native to Texas and Mexico,as the primary herbal ingredient on the label.  

BMPEA, or beta-methylphenethylamine, is a positional isomer of amphetamine, and the senators’ letter noted that the earlier FDA study stated that if the chemical can be found in A. rigidula ​extracts at all it is present in such tiny quantities that the dosages found in the products must almost certainly have come from a synthesized form added after the fact. Cohen’s team came to the same conclusion, finding a top dosage of 94 mg, whereas the earlier FDA study found BMPEA present in 9 of 21 products studied in dosages ranging up to 146 mg. Products listing A. rigidula ​but not BMPEA on the label are misbranded under DSHEA, the letter points out.

BMPEA has never been studied in humans, at least so far as anyone can tell, so safety information is lacking. The ingredient is a central nervous system stimulant, and can be expected to have a range of side effects including increased heart rate, blood pressure and the risk of cardiovascular complications including increase risk of stroke.

“While the direct effects of BMPEA in the human body are not known, FDA should not wait for tragedy to strike to take action to warn consumers and to remove this mislabeled product,” ​they wrote.

NDI status

The letter also delves into the regulatory status of A. rigidula​ itself. The botanical does not appear to have been used much, if at all, prior to the beginning of this decade, so it seems an unlikely candidate for Old Dietary Ingredient status.  And FDA, when queried recently on the matter, responded that no NDI notification is on file for either Acacia rigidula​ or the alternative (and according to at least one botanist, more correct) name of Vachellia rigidula (Benth.) Seigler & Ebinger.​  FDA said at the time that it has not yet determined the NDI/ODI status of the ingredient.

Durbin (D-IL) and Blumenthal (D-CN) are seeking clarification on this and other points, listing specific requests to be contained in a response including why FDA might or might not believe that an NDI notification is needed for either Acacia rigidula​ or BMPEA or if the agency has in fact received such notifications.  The senators also want to know when FDA first knew that products labeled as  A. rigidula​ might contain BMPEA.

Other specific requests what kind of communication FDA has with the manufacturers of the products it studied in 2013 and what kind of followup it did with those companies whose products were found to contain BMPEA.  The letter also seeks clarification on how many adverse event reports the agency may have received on BMPEA and whether it has put out any warnings to consumers on the ingredient.

Finally, Durbin and Blumenthal are seeking a definitive declaration of how many staff the agency has devoted to the regulation of dietary supplements.  The senators wrote they “hope this gives your agency an opportunity to reevaluate internal procedures to ensure there is robust oversight of dietary supplements.”

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2 comments

Disingenous Reporting

Posted by Arvilla,

Oh my, just as our local station did the other night (NPR affiliate) with their sloppy (if not overtly manipulative) reporting, now we see it here by way the repeated concern is so ambivalently worded to make it more likely to leave many (if not most) readers with a negative impression that ALL dietary supplements should be under a more discerning spotlight. Put another way, while I agree the latest finding about BMPEA is valid for further investigation, what reporters are failing to do to be in their journalistic integrity is to 'narrow the focus' to (only) fitness, sports, or weight loss supplements; or not fail to provide such finite distinction so readers won't speculate that such latest issue is related to ALL dietary supplements.

Even with the last sentence, it would be more accurate (honest) for the Senator's intention to focus on and close with, "...hope this gives your agency an opportunity to reevaluate internal procedures to ensure there is robust oversight of CERTAIN dietary supplements."

Again, when the latest finding is not about all dietary supplements on the market, a properly defined distinction must be made, albeit, if it's the TRUTH one is after in this matter.

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What did they know and when did they know it?

Posted by Jeff Nedelman,

The late US Senator Howard Baker (R-TN) coined the phrase during Watergate scandal, butthe former US Senator from TN Fred Thompson, who was the Committee's Counsel, is credited with writing it.

Would be interested to find out what Fabricant knew and when did he know it and did he recuse himself from FDA deliberations. It is sort of the elephant in the room question.

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