BMPEA In Supplements Spells Trouble To Researchers; FDA Has Different Idea

Researchers say beta-methylphenylethylamine – BMPEA – is a synthetic stimulant and they found it in 11 of 21 supplement products labeled as containing “Acacia rigidula.” FDA also has looked at BMPEA in supplements and says there is not “a specific safety concern at this time.”

The alphabet soup of suspect ingredients found in products marketed as dietary supplements grows as researchers and industry groups recommend FDA enforcement on BMPEA, while the agency says available information does not point to a safety concern.

Researchers including Pieter Cohen, an outspoken advocate for improving FDA’s regulation of the supplement industry in order to keep potentially unsafe products off the market, report in a study published April 7 that they found the synthetic stimulant beta-methylphenylethylamine in 11 of 21 supplement products they tested that were labeled as containing “Acacia rigidula” (see box next page).

Some marketers have claimed BMPEA is an extract from Acacia rigidula, a shrub plant native to Texas.

Cohen, of Harvard Medical School Department of Medicine, and his colleagues note that FDA also found BMPEA in Acacia rigidula-labeled products in research published in 2013.

“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,” according to the study Cohen and his colleagues published in the Drug Testing and Analysis journal.

There is a reason for that, FDA’s Center for Food Safety and Applied Nutrition told “The Tan Sheet.”

The agency’s 2013 Acacia rigidula supplements study, published in the Journal of Pharmaceutical and Biomedical Analysis, was part of its “overall work on detecting and removing adulterated supplements from the market, and ensuring that products are labeled in a manner that is truthful and not misleading,” a CFSAN spokeswoman said.

“While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers,” she added.

Stakeholders Wait For Action

The authors of the latest research are not alone in suggesting FDA order BMPEA-containing products off the market, and one of the manufacturers named in the Drug Testing and Analysis study stopped distributing the allegedly adulterated products.

“FDA has ample authority to act on this and they should take action,” said Andrea Wong, the Council for Responsible Nutrition’s VP for scientific and regulatory affairs.

Wong added that information in FDA’s own study of Acacia rigidula-labeled products shows that removing BMPEA from the market is appropriate. The ingredient “has no place being in dietary supplements,” she said.

The United Natural Products Alliance on April 9 adopted a "no-sale" policy for BMPEA in dietary supplements as a condition of membership for prospective and all current UNPA members.

“Having become aware of these two studies identifying BMPEA in these products and understanding that the products do not contain the naturally occurring form of Acacia rigidula, prompt action was warranted,” said UNPA President Loren Israelsen.

In their study, CFSAN Office of Regulatory Science researchers said Acacia rigidula almost certainly is not the source of BMPEA and similar phenylethylamine – PEA – substances found in the products tested.

“Given the low natural abundance of PEA in the plant materials, it appears nearly impossible to achieve the amounts of PEA found in the dietary supplements by formulating them with plant material or extracts” of Acacia rigidula, said the CFSAN researchers led by Rahul Pawar.

Natural Products Association Executive Director and CEO Daniel Fabricant also expects FDA action on BMPEA but notes enforcement can be a lengthy process.

Warning letters or other enforcement would be supported by testing of certain products that FDA’s Office of Regulatory Affairs conducts with chain-of-custody documentation. The agency, however, could publish announcements cautioning consumers about ingredients independent of warnings or investigations.

“How they pull the products for their research is very different” from an investigation, Fabricant said. “Companies are entitled to due process.”

While CFSAN’s researchers concluded BMPEA likely is not a botanical substance, FDA’s regulatory policy is not in agreement, but soon should be, he added. “If it is a legitimate ingredient, there’s no reason why someone wouldn’t go through the” new dietary ingredient notification process.

Fabricant pointed out that while the latest research notes the stimulant dimethylamylamine also was found in supplements and led to FDA enforcement, DMAA adulteration was more prevalent in the market and adverse event report information identified a problem on which the agency acted (Also see "FDA Ushers Out Known DMAA, Closes Dietary Ingredient Door" - Pink Sheet, 22 Apr, 2013.).

BMPEA use in products and by consumers, though, is far less common and AER information apparently has not linked the ingredient to a safety problem, he said.

Manufacturer GAT WHP on April 10 suspended distribution and sales of its JetFuel Superburn and T-300 products “due to potential safety concerns. The Monroe, Conn., firm said it hired a third party to evaluate the safety profile of those and other GAT products, but points out “there have been no reports of serious adverse events in the U.S. regarding the use of these products as formulated.”

Nutritional products retailer [Vitamin Shoppe Inc.] on April 9 said it is “immediately removing all acacia rigidula containing products, due to the concern that some of them may contain BMPEA,” which “is a synthetic drug-like substance that should not be used in dietary supplements.”

However, another firm named in the study, Hi-Tech Pharmaceuticals Inc., contests the findings and said it has marketed products with Acacia rigidula-derived ingredients since 2013. The Norcross, Ga., firm which also questioned CFSAN’s study of the ingredient, said the latest findings were “not the product of reliable scientific principles and methods and therefore do not form a reliable basis for allegations of adulteration, or selling a contaminated product."

BMPEA Use Growing?

Cohen and his colleagues explain, though, that other regulators do not agree with FDA and that use of the ingredient appears to be growing.

The European Union’s Food Standards Agency says Acacia rigidula was not previously consumed as a food and is not permitted to be sold until there is additional evidence of safety, and in December 2014 Health Canada found BMPEA in a supplement and ordered it recalled.

Without scientific evidence that BMPEA is extracted from Acacia rigidula “or any other plant,” the study says, “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.”

According to the study, 16 of the tested products were marketed for weight loss, three to boost athletic performance and one to enhance cognitive function. In addition to being labeled as containing Acacia rigidula, the products tested were available online in the U.S. between January and April 2014.

Labels for three products – all marketed by Hi-Tech Pharmaceuticals – listed as ingredients both Acacia rigidula and a substance with a name similar to BMPEA – “R-Beta-Methylphenylethylamine” to imply “that BMPEA had been extracted from the plant.”

In addition to rejecting the study findings, Hi-Tech Pharmaceuticals on April 6 announced that its Thermo-Rx supplement contains Acacia rigidula extract. Thermo-Rx was not among the products tested in the recent study. The firm also contested FDA’s enforcement to rid the market of DMAA-containing supplement products (Also see "Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”" - Pink Sheet, 25 Nov, 2013.).

The researchers noted FDA’s 2013 study found BMPEA in 42.9% of products tested and their study found it in 52.4%. “Whether this represents a true increase in the prevalence of BMPEA or is due to differences in sampling methods or other factors is not known. Regardless, the continued presence of BMPEA in mainstream supplements continues to expose consumers to potential risks,” the say.

And with no known human trials of BMPEA’s safety or efficacy, its “effects on human health are entirely unknown,” the researchers add.

In a previous Drug Testing and Analysis journal study, Cohen and other researchers in October 2014 urged manufacturers to recall products containing the stimulant dimethylebutylamine – DMBA – and suggested FDA warn consumers about DMBA, determine whether the ingredient is appropriate for use in supplements and, if it is found to be unsafe, enforce against firms that continue marketing violative products (Also see "Recall DMAA Analog While FDA Evaluates Safety – CRN, Researchers" - Pink Sheet, 9 Oct, 2014.).

BMPEA Positive Products

Below are the 11 products labeled as supplements, listed with their marketers and divided by usage, found to contain BMPEA in a study in the Drug Testing and Analysis journal. Hi-Tech Pharmaceutical Inc.’s three products included on their labels both Acacia rigidula and a substance with a name similar to BMPEA.

Weight Loss Products

• Aro Black Series Burn / Vitacost.com Inc. (acquired by Kroger Co. in July 2014)
• Dexaphine XR / Tribravus Enterprises LLC, dba iForce Nutrition
• MX-LS7 / iSatori Inc.
• Black Widow, Fastin XR, Lipodrene Hardcore, Lipodrene Xtreme, Stinerex-ES and Yellow Scorpion / Hi-Tech Pharmaceuticals

Sports Supplements

• JetFuel Supplement, JetFuel T-300 / GAT WHP