BMPEA: Did the FDA Get it Right or Just Respond to the Press?

On April 22, the FDA sent warning letters to Hi-Tech Pharmaceuticals, Inc., Better Body Sports, LLC, Train Naked Labs, LLC, Human Evolutions Supplements, Inc., and Tribavus Enterprises, LLC asking them to cease distribution of their supplements containing BMPEA whose numerous alternate names include βMePEA, R-beta-methylphenethylamine, R-beta-methylphenethylamine HCl, and Beta-methylphenethylamine.

The FDA contends that BMPEA does not meet the statutory definition of a dietary ingredient under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)].  The FDA has taken the position that BMPEA is not found in Acacia rigidula based upon research conducted by the FDA in 2013.

The warning letters came after Pieter Cohen, a self-professed “dietary supplement expert” and assistant professor at Harvard Medical School, was quoted in many publications that the FDA had “completely dropped the ball.” Dr. Cohen wrote a paper earlier in April 2015 that was published in Drug Testing and Analysis on BMPEA, which concluded that “BMPEA remained known only as a research chemical until early 2013 when the FDA identified BMPEA in multiple supplements labeled as 'Acacia rigidula', even though the stimulant has never been identified or extracted from Acacia rigidula, a shrub native to Texas.”   

 Dr. Cohen’s paper and interviews gained the interest of CBS News, The New York Times, NBC, and Forbes. 

Critics have stated that BMPEA is an amphetamine-like substance. However, there appears to be no proof that BMPEA is unsafe. On the contrary, one of the recipients of the warning letter, and probably the largest reseller of products containing BMPEA, Hi-Tech Pharmaceuticals, Inc., said that it has “sold over 1 billion doses since 2003 of Acacia rigidula and its alkaloids—including BMPEA—and have conducted numerous studies of these alkaloids and believe them to be safe and effective when used as directed.” 

Even better, Hi-Tech included a raft of studies that appear to negate Morgan’s nay-saying. “There is a wealth of science on Acacia species and their phenylethylamine alkaloids dating back to White, E.P., 1954,” the company said in its statement.

Here it is! What’s listed below is taken from the company’s release: read it here. I’ve included abstracts where I could find them.

"The occurrence of N-methyl-beta-phenylethylamine in Acacia prominens A. Cunn." New Zealand J. Sci. & Tech. 35B:451-455. Camp & Lyman, 1956, was the first peer-reviewed publication that reported the presence of beta-Methylphenethylamine in Acacia berlandieri at 0.54% by dry weight.

--Camp & Moore, 1960, published a synthesis for methylphenethylamine and a quantitative assay. They also looked at potential seasonal fluctuations in the total amine content of Acacia berlandieri (using leaves collected during 1958) and the quantities were as follows: May 0.66%, June 0.46%, July 0.42%, August 0.46%, September 0.28%, and October 0.46%.

--Camp, et al., 1964, reported beta-Methyl-phenethylamine in Acacia berlandieri.

--Camp & Norvell, 1966, evaluated a number of additional Acacia species, including Acacia rigidula. They reported Acacia rigidula to contain 0.025% total alkaloid by dry weight and identified beta-Methylphenethylamine.

(And, yes, Camp’s studies are listed on PubMed. Search “Camp BJ.”)

--Fitzgerald, 1964 (Australia), reported Acacia adunca and Acacia kettlewelliae beta-Methylphenethylamine 2.4% in leaves; 3,2 % alkaloids in aeriel parts (stems, leaves, flowers); about 70% was beta-Methylphenethylamine.

--Pemberton, et al., 1993, was an account of an isolation approach for assaying Acacia berlandieri. Using plants collected in Zavala County, they reported Tyramine, beta-Methylphenethylamine, and others. (Abstract: http://1.usa.gov/1QM9uf5)

--Forbes, et al., 1995, studied alkaloid levels over a period of months and attempted to correlate the levels of beta-Methylphenethylamine with factors such as date of harvest, age of growth, and rainfall.

--Windels et al., 2003, evaluated the amine concentration in regrowth resulting from a practice known as aeration in which the aboveground parts of the plant are damaged with large mechanical rollers. beta-Methylphenethylamine increased in the leaves on regrowth following aeration—and did so more on leaves from juveniles stems than on mature stems. (Abstract: http://1.usa.gov/1IugdjZ)

--Oh, and Hi-Tech has performed two studies on Acacia rigidula, which you can read in the company's statement. 

Was the FDA’s issuance of the warning letters regarding BMPEA a hasty reaction to the publicity? Let me know what you think.