On April 7, 2015, Dr Pieter 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.
On April 8, 2015, Vitamin Shoppe announced it would proactively remove all A. rigidula-containing products from its stores and website. This announcement came before notices were received from Oregon or Vermont, said the company.
FDA’s response took two weeks, with the agency sending warning letters dated April 22 to five companies over their use of the ingredient BMPEA. The Agency only sent letters to company with BMPEA listed on the products labels: FDA considers the products are adulterated because BMPEA is not a lawful dietary ingredient. However, the FDA warning letters did not address whether A. rigidula is a legal dietary ingredient.
Vitamin Shoppe has now announced that it has entered into an Assurance of Voluntary Compliance (AVC) with the Oregon AG and an Assurance of Discontinuance (AOD) with the Vermont AG.
As part of both the AVC and AOD, Vitamin Shoppe, Inc. has agreed to the following:
The Company will not sell products that contain BMPEA
The Company will also not sell products containing the botanical A. rigidula, which are at risk for containing BMPEA, unless adequate testing has been done to determine the product does not contain BMPEA
“The health and safety of Vitamin Shoppe customers is the company's number one priority, and the company removed these products out of an abundance of caution,” said the company in a statement. “Vitamin Shoppe, Inc. continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe.”
Lawsuit
While Vitamin Shoppe has been quick to distance itself from the ingredient, one manufacturer of products containing BMPEA and A. rigidula is putting up a fight: Earlier this week, BMPEA proponent Hi-Tech Pharmaceuticals, Inc, announced it has filed a suit against four researchers, including Dr Pieter Cohen, alleging their Drug Testing and Analysis paper is defamatory. The Georgia-based company claimed in an extensive press release, which can be read HERE, that it is seeking $50 million in compensatory damages and $150 million in punitive damages for libel and slander.
In its complaint, the company claims that a “cursory view on the internet” would have found three double-blind, placebo controlled clinical studies on supplements containing A. 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. However, the research cited by the company is unavailable on the Pubmed database (accessed May 7, 2015).
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