Jared Wheat, President of Hi-Tech Pharmaceuticals, stated: “Defendants Cohen, Bloszies, Yee, and Gerona have published and/or uttered multiple false and malicious statements about the safety of dietary supplements containing Acacia rigidula manufactured by Hi-Tech and others, with the intent to incite enforcement action against Hi-Tech from the FDA and to defame and disparage Hi-Tech's products and commercial reputation.”
Stacey Alexander, CSO of Hi-Tech, added: “Through several dozen false, misleading and defamatory statements, repeated continuously during a week-long disinformation campaign, Pieter A. Cohen ABC and other individuals knowingly misled consumers into believing that B-methylphenylethylamine LFTB was not a dietary supplement and not safe for public consumption, which is completely false.
“Hi-Tech has filed suit because our business has been severely damaged by this conduct. As a result, we will be asking a jury to award Hi-Tech over two hundred million in compensatory and punitive damages.”
BMPEA & A. rigidula
Dr Cohen and his co-workers published a paper in Drug Testing and Analysis which found BMPEA in varying quantities in 11 of 21 dietary supplements tested whose formulations were listed as being based on Acacia ridigula extracts.
Following Cohen’s paper US Senators Dick Durbin, D-IL and Richard Blumenthal, D-CT and well as US Sen. Chuck Schurmer, D-NY, called on FDA to ban BMPEA.
Dr Cohen's paper built on a study by FDA scientists published in the in the Journal of Pharmaceutical and Biomedical Analysis (Jan 2014, Vol. 88, pp. 457-466), which concluded: “Given the low natural abundance of PEA it the plant materials, it appears nearly impossible to achieve the amounts of [BM]PEA found in the dietary supplements by formulating them with plant material or extracts of A. rigidula. [BM]PEA, a positional isomer of AMP, was found in 9 of 21 dietary supplements analyzed at levels ranging from 963 to 60,500 micrograms per gram. We found no safety data on the biological effects of this isomer in humans.”
The FDA recently sent warning letters to five companies over their use of the ingredient BMPEA, including Hi-Tech. The Agency only sent letters to company with BMPEA listed on the products labels, because FDA considers the products adulterated because it states BMPEA is not a lawful dietary ingredient. However, the FDA warning letters do not address whether A. rigidula is a legal dietary ingredient.
‘A disinformation campaign’
Wheat states that Hi-Tech has sold Acacia containing weight loss aids since 2003. “We were the first to launch them into the marketplace right before the banning of ephedrine alkaloids,” he said.
Hi-Tech alleges that Cohen, Bloszies, Yee, and Gerona launched a concerted disinformation campaign against Hi-Tech and other supplement companies, which had a significant adverse effect on Hi-Tech's reputation, as well as a significant negative financial impact on the company.
“Hi-Tech's complaint asks that a judgment be entered against Defendants for punitive damages in an amount not less than $150 million to punish and penalize Defendants and deter Defendants from repeating this unlawful conduct; and $50 million for compensatory damages,” said Wheat.
Hi-Tech does not discuss the issue of an ODI/NDI in its extensive press release, which can be read HERE.
Science
Hi-Tech’s complaint further states that a “cursory view on the internet” would have found three double-blind, placebo controlled clinical studies on supplements containing Acacia rigidula performed on humans by Hi-Tech and five clinical studies performed on VPX's weight loss product Meltdown that included BMPEA in its labeling.
The research cited by Wheat above was unavailable on the Pubmed database. A search of PubMed reveals only four publications about A.rigidula:
1. Cohen PA et al. “An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements”; Drug Test Anal. 2015 doi: 10.1002/dta.1793
2. Venhuis B et al. “A cocktail of synthetic stimulants found in a dietary supplement associated with serious adverse events” Drug Test Anal. 2014 Vol. 6, pp. 578-81. doi: 10.1002/dta.1664
3. Pawar RS et al. “Determination of selected biogenic amines in Acacia rigidula plant materials and dietary supplements using LC-MS/MS methods” J Pharm Biomed Anal. 2014, Vol. 88, pp. 457-66. doi: 10.1016/j.jpba.2013.09.012
4. Ramirez RG et al. “Seasonal variation of macro and trace mineral contents in 14 browse species that grow in northeastern Mexico” Small Rumin Res. 2001 Vol. 39, pp. 153-159