Acacia rigidula is a bushy plant native to Texas. Proponents of the extract of the leaves of the plant have put it forward as an effective thermogenic ingredient that offers a legal alternative to ephedra, which has long been banned. But Cohen’s team concluded in a Short Communication paper released today by the journal Drug Testing and Analysis, that in more than half of the cases, the products contained something else, namely beta-methylphenethylamine (BMPEA), a synthetic positional isomer of amphetamine first synthesized in the 1930s that has never been tested for safety in humans. BMPEA is classified as a banned substance by the World Anti-Doping Agency.
The researchers noted that FDA had identified the presence of BMPEA in 43% of Acacia ridigula products purchased in 2012 (five of those products also appeared in the most recent study, but the researchers said FDA was not at liberty to say exactly which ones). Despite the fact that no human safety data on the compound is known to exist, the researchers noted, “More than two years after the FDA’s discovery, the FDA has yet to warn consumers about the presence of the amphetamine isomer in supplements.”
The research paper notes that Acacia rigidula is not approved for sale in the European Union until more safety data becomes available. And despite what certain marketers claim, the researchers concluded that the claims of botanical origin for this ingredient are a pure smoke screen.“Despite the marketing of BMPEA as an extract of Acacia rigidula, there is no scientific evidence that BMPEA has ever been extracted from Acacia rigidula or any other plant.Instead, the dosages of BMPEA in supplements strongly suggest that the amphetamine isomer is synthetically produced and placed in the supplement to lead to physiologic effects,” they wrote.
Cohen: Clear cut case
“This is really about the FDA and why the FDA is not enforcing the law,” Cohen, who is an assistant professor at the Harvard School of Medicine, told NutraIngredients-USA. “This is a great example of how the FDA could so easily move now and not wait like it did with DMAA, not wait until strokes and heart attacks become front page news.
“The plant itself is not a legitimate dietary ingredient. Why hasn’t the FDA moved against it and not even worried about the origin of the BMPEA? And this is a case unlike DMAA and DMBA which had a bunch of cover in the form of obscure articles saying these substances were found in plants. Here we don’t have a single article that says DMPEA can be found in plants, and the FDA already knows all of this. They already done all of the hard work,” Cohen said.
Need for NDI notification
Daniel Fabricant, PhD, CEO of the Natural Products Association, said that while the botanical’s status in Europe might be of interest, the real issue is its regulatory status here. And in that case, he thinks there is a good case to be made for the need for a New Dietary Ingredient notification for Acacia rigidula.
“The bottom line is, and here is where we agree with (Cohen’s team), if there is a problem, the agency has all the tools to deal with it and we want them to do so. There is a procedure in this country for dealing with new ingredients and this one didn’t go through that gate,” Fabricant said.
“I have no evidence that Acacia rigidula is an Old Dietary Ingredient so my presumption is that someone should have filed a NDI notification, which would have given FDA the opportunity to ask questions about the ingredient’s safety and object if it felt necessary. Why FDA has not moved against these companies is an internal FDA matter,” said Mark Blumenthal, founder and executive director of the American Botanical Council.
"Given FDA’s earlier findings combined with this new study, CRN is urging FDA to take immediate enforcement action and use the ample tools available to them to remove the products from the market, as well as administer civil and criminal penalties for those who intentionally introduce these products to consumers," said Steve Mister, president and CEO of the Council for Responsible Nutrition.
Cohen’s research team purchased 21 supplements online from a variety of manufacturers between January and April of 2014 and analyzed them against a BMPEA reference standard purchased from the company Sigma. Eleven of the 21 supplements (or 52%) contained BMPEA, leading the researchers to remark that the inclusion of BMPEA in products in the marketplace seems to be going up. The delivered doses of the stimulant (based on maximum recommended product intake on the label) ranging from 3 mg on the low end of those products that contained BMPEA up to 94 mg. While the inclusion rate of BMPEA seems to have gone up a bit, dosages seem to have declined; in the 2012 product sample the maximum dosage FDA found was 146 mg.
Of the 11 supplements tested by Cohen’s team found to contain BMPEA, six were brands manufactured by Hi-Tech Pharmaceuticals, a Georgia-based company that has had at least a decade of run-ins with regulators. In 2008, the Federal Trade Commission secured a permanent injunction against Hi-Tech and its CEO Jared Wheat on a case that began in 2004. The injunction prohibited the company from advertising weight-loss products with certain claims unless those claims were substantiated by competent and reliable scientific evidence. In 2013 FDA seized more than $2 million worth of what it called “adulterated dietary supplements” from Hi-Tech’s Norcross, GA facility that it said contained the banned stimulant ingredient DMAA. Hi-Tech took the unusual move at that time of suing FDA over what it termed as a “bullying campaign”.
Later in 2013, Wheat and the company were found in contempt of the FTC order because they continued to market products with claims lacking sufficient evidence. In May of last year the company was also ordered to pay a $40 million in compensatory damages (the amount of the sales of the offending products). In September of last year, according to attorney Riëtte van Laack writing in the FDA Law Blog, Wheat was ordered to report for a prison term on the contempt charge in the FTC case. Requests for comment from Hi-Tech went unanswered, so it is unknown whether Wheat served time behind bars and if so, how much.
According to CNBC, this is not Wheat’s first encounter with law enforcement. According the news organization, 20 years ago Wheat was convicted of running a massive marijuana smuggling operation in the South.
Wheat’s trajectory in the business characterizes what many industry insiders say about such cases: These are not members of the responsible dietary supplement community. They are, instead, criminals trying to disguise the marketing of illegal drugs under that guise of legitimate dietary supplements. But in the current troubled atmosphere created by NYAG Eric Schniederman’s investigation of the dietary supplements industry these arguments don’t carry as much weight as they did at one time, Fabricant said.
“Considering everything else that is going on right now someone will push this into the ‘unregulated industry’ box. We have kind of a perception problem right now and when that is true you are only as good as your weakest link and I think that’s something that everyone in industry needs to be aware of,” Fabricant said.
Source: Drug Testing and Analysis
Published online ahead of print, doi: 10.1002/dta.1793
“An amphetamine isomer whose efficacy and safety in humans has never been studied, β- methylphenylethylamine (BMPEA), is found in multiple dietary supplements.”
Authors: P.A. Cohen, C. Bloszies, C. Yee, R. Gerona