Jared Wheat, President of Hi-Tech Pharmaceuticals, stated: 'Hi-Tech Pharmaceuticals, a leading global manufacturer of dietary supplements and OTC Pharmaceuticals, has 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 owing 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 labelled 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 scrutinised 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 26 November 2013 by Natural Products Insider about Acacia rigidula, also known as blackbrush, which is native to Texas. In an interview, Beverly Clement, PhD, 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.'
'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.
'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 organisations maligning acacia just so they can commercialise 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.:
http://origin-qps.onstreammedia.com/origin/multivu_archive/ENR/Acacia-Fastin-XR-study.pdf.
http://origin-qps.onstreammedia.com/origin/multivu_archive/ENR/TheAcutePhysiologicalEffectsofAcaciaRigidula.pdf.
