Durbin, Blumenthal call on FDA to investigate supplement makers in growing debate over amphetamine substance

Two lawmakers called on FDA today to investigate manufacturers of dietary supplements containing an amphetamine-like substance known as BMPEA and take swift regulatory action.

“While the direct effects of BMPEA in the human body are not known, FDA should not wait for tragedy to strike before taking action to warn consumers and to remove this mislabeled product," Sens. Dick Durbin (D-Illinois) and Richard Blumenthal (D-Connecticut) wrote in a letter addressed to Stephen Ostroff, M.D., FDA's acting commissioner. 

FDA is facing growing pressure from lawmakers on Capitol Hill to remove BMPEA-containing supplements from the market after research led by Pieter Cohen of Harvard Medical School revealed a number of weight-loss and sports products contained the amphetamine-like substance.

“For too long, dietary supplement manufacturers have either failed to list BMPEA on product labels or have listed the stimulant as a ‘natural botanical,’ which the Food and Drug Administration’s own scientists have disproved," Durbin and Blumenthal declared in the letter.

“In their own 2013 study published in Journal of Pharmaceutical and Biomedical Analysis, FDA scientists concluded that it is nearly impossible for the amounts of BMPEA present in dietary supplements to be derived from A. rigidula plant extracts," the senators continued. “Thus, BMPEA cannot be considered synonymous with A. rigidula, and dietary supplement manufacturers that list A. rigidula, but not BMPEA, on their product label are in violation of the Dietary Supplement Health and Education Act of 1994."

The letter was addressed to FDA just two days after Sen. Charles Schumer (D-New York) called on the agency to ban supplements that contain BMPEA. Citing medical professionals, he said the amphetamine-like substance could increase blood pressure and cause other complications such as stroke.

“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," Schumer said in a statement in an April 12 press release.

Daniel Fabricant, Ph.D., a former director of FDA’s division of Dietary Supplement Programs who presently heads up the Natural Products Association (NPA), said an FDA ban would constitute “a waste of the agency’s time and resources.

“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," Fabricant said in a statement, referencing FDA’s expanded powers under the 4-year-old Food Safety Modernization Act (FSMA).

The agency said last week it had not identified “a specific safety concern" in connection with BMPEA.

FDA spokeswoman Siobhan DeLancey said Tuesday the agency “faces a high burden [under current law] before it can take enforcement action relating to the manufacture or distribution of a product marketed as a dietary supplement."

“That said, we recognize that more can and should be done," DeLancey continued in an emailed statement. “The FDA takes seriously recent reports about the dangers of dietary supplements containing BMPEA (also known as beta-methylphenylethylamine), a substance that is related to amphetamines. While the agency evaluates the available information on BMPEA, the FDA continues to encourage individuals to consult with a health care provider before taking supplements. In addition, FDA encourages anyone who believes that have suffered an adverse event related to taking a dietary supplement to report it to Medwatch."

The research led by Cohen and published in the journal Drug Testing and Analysis said the safety of BMPEA hasn’t been studied in humans. But the authors cited research in the early 20^th century that found the amphetamine-like substance increased blood pressure and heart rates in cats and dogs.

FDA’s northern counterpart, Health Canada, identified a bodybuilding product last year that contained BMPEA and another amphetamine-like substance. In an advisory published in December 2014, the agency said the product known as Jetfuel Superburn was recalled and characterized the “amphetamine-like drug substances" as posing “serious health risks."

In response to growing concerns over BMPEA, some retailers including Vitamin Shoppe have stopped selling supplements that contain the substance. Vitamin Shoppe said it was concerned about Cohen’s findings.

“The Vitamin Shoppe decided to remove these products because the safety of these products is now in question and may not be in compliance with FDA regulations," the specialty retailer said in a statement. “In addition, the Vitamin Shoppe continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe."

Hi-Tech Pharmaceuticals, whose products were found to contain BMPEA, claims Cohen’s study is flawed and refuted accusations that such supplements are contaminated. Jared Wheat, president and CEO of the supplement manufacturer, characterized the substance in an emailed statement last week as a “naturally occurring alkaloid."

"The 2013 study carried out by FDA scientists scrutinized the testing done and methods used by Texas A&M researchers in studies on Acacia rigidula performed in 1997 and 1998 (https://www.erowid.org/archive/rhodium/pdf/acacia.rigidula.pdf), but what Cohen and his peers did not include was the studies performed by Texas A&M finding various methylated Phenylethylamine alkaloids in Acacia Rigidula," Wheat said in a separate statement in an April 9 press release.

But the research published last week claimed “the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas."

Last week, the United Natural Products Alliance (UNPA) announced adopting a “no-sale" policy for BMPEA supplements as a condition of membership for current and prospective members. The Utah-based trade association referenced an FDA study and Cohen’s research, which both found the presence of BMPEA in a number of supplements.

“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," UNPA president Loren Israelsen said in a statement. “As we have done before with no-sale policies for ephedra, DMAA and kratom (Mitragyna speciosa), we’re committed to moving quickly to define the boundaries of responsible practices within the industry."