Hi-Tech Responds to "Bullying Tactics" Issued by FDA on Acacia Rigidula

NORCROSS, Ga., April 24, 2015 /PRNewswire/ -- Hi-Tech Pharmaceuticals refutes the results from FDA '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. The FDA is resting its very, very shaky position on a false premise, or misguided hope, that Methylphenylethylamine is not found in Acacia. In fact, these studies are contradicted by multiple other studies and cannot be relied on because of the deficiencies and inconsistencies discussed below. In addition, the study does not provide all of the information necessary to demonstrate proper authentication. These omissions raise questions about the identity and quality of the plant materials tested. For example, the study did not provide a description of the geography and habitat where the plant materials were collected nor any organoleptic characteristics of the plant material (e.g., smell, taste, touch, color); and representative images (e.g., digital pictures or sketches) of the plant in its growing habitat and as a post-harvest mounted specimen.  

Hi-Tech Pharmaceuticals was forced to sue the FDA November 5th, 2013 in Federal Court because the agency bypassed standard rule-making procedures in favor of a bullying campaign to try to force companies to destroy their products containing DMAA.  Now the agency has engaged in the exact same tactics with Acacia it resorted to with DMAA, that is now the center of an 18 month battle between Hi-Tech and FDA. 

Hi-Tech also believes the FDA is responding from pressure from outside sources like New York Senator Chuck Schumer and Dr. Cohen from Harvard. 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.The position of the FDA flies in the face of analytical testing and research done over the past 60 years on acacia species. Unprecedented findings of this nature usually require a more in depth scientific study and additional scientific tools to confirm the accuracy of the findings.  The FDA has provided no such follow-up studies.

Hi-Tech has invested heavily in clinical and analytical research on Acacia rigidula and Methylphenylethylamine. We will be making a substantive submission to FDA providing the most up to date information regarding the safety and legality of Acacia and its alkaloids. This will include multiple peer-reviewed, published clinical and analytical studies. We believe if the FDA is objective to our overwhelming evidence as to the occurrence of these phenylethylamine alkaloids in Acacia they will back off their current stance.

"Texas A&M was the pioneer in the exhaustive research on Acacia species. I believe that nobody at FDA 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 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 did not respect the concerns voiced about the degradation of alkaloid content by Clement," said Jared Wheat, President of Hi-Tech Pharmaceuticals. "Hi-Tech Pharmaceuticals has sold more than a billion doses of Acacia rigidula since 2003," Wheat continued.  The company has conducted three clinical studies on the effects of Acacia rigidula, Wheat said, and none have found any serious adverse events, "other than possibly a jitter or shake which is common amongst stimulants."  

Other studies the FDA failed to consider when their abnormal results came back were from the following: Camp & Lyman 1956 was the first peer-reviewed publication that reported the presence of 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 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. Methylphenethylamine increased in the leaves on regrowth following aeration and did so more on leaves from juveniles stems than on mature stems.

However, despite the large variance in the total reported concentration of phenylethylamine — including methylphenylethylamine —  in the findings of these studies, the  FDA did not question the possibility of degradation of alkaloids in their sample, which is a very common occurrence. Finally, FDA's study do not credibly refute the dozens of studies reporting that methylphenylethylamine does occur in Acaia rigidula.  In conclusion, Hi-Tech disagrees with FDA's contention that methylphenylethylamine is not a dietary ingredient under section 201(ff)(1) of the Act. The totality of the scientific evidence discussed above demonstrates the presence of methylphenylethylamine in various Acacia species.

Wheat continued, "I also feel this is a joint effort by big pharma and institutions to rid the marketplace of acacia as they did with ephedrine in 2006." Why do a study on ephedrine if it is so unsafe? asks Wheat.  In a study years after the banning of ephedrine alkaloids by the FDA, the pharmaceutical giant Glaxo performed a study and confirmed that ephedrine is a reliable thermogenic compound against which comparison of novel thermogenic agents may be made after both acute and chronic administration (http://www.hindawi.com/journals/jobe/2011/210484/). The study found highly precise methods are paramount for detecting subtle differences in energy expenditure when evaluating the thermogenic properties of drugs that are being evaluated for the treatment of obesity. Our data confirms that modest drug effects, where present, can be detected by whole-body indirect calorimetry, and this technique should be considered when planning small experimental medicine studies to evaluate manipulations of energy balance. We have assessed ephedrine's merits as a comparator compound in the evaluation of novel thermogenic agents.

Thermo-Rx® brand Acacia Rigidula Extract used by Hi-Tech is a quantum leap in the field of weight loss backed by a clinical study on the ingredient itself and 3 studies with Acacia in combination with other ingredients. The results seen with Thermo-Rx® brand Acacia Rigidula Extract were compared by Hi-Tech Researchers to previous studies on Ephedrine —  the Gold Standard for OTC diet aids. The findings were amazing as Thermo-Rx® brand Acacia Rigidula Extract was found to be over 20% stronger than 30mg Ephedrine and 82% stronger than 10mg Ephedrine. The findings of the present study indicate that the increase in resting metabolic rate exhibited with 250 mg Acacia Rigidula (12+%) are comparable to the findings of previous studies which reported that 10 to 30 mg ephedrine increased energy expenditure by 6.6% to 10%.

Hi-Tech is determined to force FDA to follow the law and stop its "Bullying Tactics". If FDA is allowed to run amok and continue to "Bully" ingredients that they do not like off the market, then the dietary supplement industry will cease to be able to give consumers ingredients they desire, such as DMAA and Acacia, that have been proven safe and effective.

"Hi-Tech Pharmaceuticals fought the outlawing of ephedrine alkaloids and will not sit idly by while researchers and a biased media try to destroy 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.