Hi-Tech Pharmaceuticals Refutes Harvard Researcher's Claims in Full and Robust Response on Acacia Rigidula

NORCROSS, Ga., April 9, 2015 /PRNewswire/ -- Jared Wheat, President of Hi-Tech Pharmaceuticals (https://www.hitechpharma.com/index.htm), stated, "Hi-Tech Pharmaceuticals, a leading global manufacturer of dietary supplements and OTC Pharmaceuticals, today announced that it refuted the claims made by the Harvard led study by Pieter Cohen, the lead researcher and an assistant professor at Harvard Medical School in his Drug Testing and Analysis paper  with full and robust responses to every point raised in the article, including original test results by FDA and the results of retesting that was performed by Harvard on the product lots cited in the paper. Unlike the DNA barcoding test used by the Attorney General's office, the industry-standard tests are able to identify ingredients that are stripped of their DNA in the manufacturing process. Because DNA barcoding is limited to measuring DNA, it is unable to identify all of the ingredients in approved supplements, making its results incomplete and unreliable. Here the original analysis done in 2013 was flawed due to not understanding the degradation of alkaloids if not stored in the correct atmosphere."

In Hi-Tech's response to Dr. Cohen and the group at Harvard, Wheat addressed the falsity of Dr. Cohen and his colleagues' statement 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." Hi-Tech responded by showing where they began selling Acacia not in 2013 — but 10 years earlier in 2003. Hi-Tech also cited the analysis done by Rahul Pawar, et.al. regarding lack of validity of the Acacia alkaloid based testing (http://www.ncbi.nlm.nih.gov/pubmed/24176750). Wheat said, "In Hi-Tech's chemists and overseas factories expert opinion, the allegations in the Harvard Research paper regarding the results of the 2013 testing for beta-methylphenethylamine in acacia -based products was 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 as identified in the Harvard paper."

"What most concerns me was that Mr. Cohen stated that Acacia rigidula was released in 2013 when Hi-Tech has sold Acacia containing weight loss aids since 2003 and VPX since 2007. We were the first to launch them into the marketplace right before the banning of ephedrine alkaloids. Any due diligence would have come up with these facts along with VPX's original weight loss product Meltdown®, which underwent five peer-reviewed University Clinical Trials at the University of Memphis. One of the compounds in that formulation was beta-methylphenethylamine," stated Wheat.

"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," said Wheat.

The studies mentioned above by Texas A&M was reported on November 26, 2013 by Natural Products Insider about acacia rigidula, also known as blackbrush, which is native to Texas. In an interview Beverly Clement, Ph.D., the lead scientist on this study, was a synthetic organic (natural products) chemist working at Texas A&M on research in toxicology spoke about what prompted the study of Acacia rigidula amine constituents and framed her team's findings.  "Texas A&M was the pioneer in the research on Acacia species. I believe that nobody at FDA or Harvard tried to replicate the work of Clement, rather than apparently rejecting the precautions taken to prevent degradation as being unnecessary. I would suggest that, thus far, no one in the scientific community can legitimately claim that anyone attempted to replicate what was reported in Clement et al. 1997 and 1998. For the most part, Clement began by extracting fresh (1997) and fresh and still frozen (1998) plant materials, whereas Pawar et al 2014 freeze-dried their fresh plant samples. (Clement had used freeze drying of fresh frozen leaves for quantification of beta-methylphenethylamine.) Pawar also omitted the use of argon which Clement presented as important to prevent degradation of alkaloids. However, Pawar's interest was not an academic one trying to reproduce Clement's results but rather was focused on establishing what compounds were in the diet products they also tested and whether those contents came from this plant. However, The FDA and now Harvard did not respect the concerns voiced about the degradation of alkaloid content by Clement," said Wheat.

There is a wealth of science on acacia species and their phenylethylamine alkaloids dating back to White, E.P. 1954. "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. Other non Texas species have also been found to contain beta-Methyl-phenethylamine —Fitzgerald 1964 (Australia) 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. 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 above ground 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.

"Hi-Tech Pharmaceuticals refutes the results from Harvard's researchers' paper, that such was not the product of reliable scientific principles and methods and therefore does not form a reliable basis for allegations of adulteration. We also will respond to other organizations maligning acacia just so they can commercialize it into a prescription drug and ban it from the dietary supplement industry as they did with ephedrine alkaloids," concluded Wheat. 

Clinical Studies on Acacia Rigidula Extract Conducted by or on behalf of Hi-Tech Pharmaceuticals, Inc: 

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