The supplement, manufactured by New York-based Driven Sports, Inc., is a rising star in the pre-workout supplement segment, and has steadily grown in popularity since its release last November to quickly became the company’s best selling product, according to Matt Cahill, VP of operations for Driven Sports.
“We are not sold in GNC or Vitamin Shoppe yet, so there is still a lot of growth potential,” Cahill told NutraIngredients-USA.com.
However, such growth may be stymied by the class action dated March 16, 2012, which alleges that the product contains amphetamines, that the product is manufactured in facilities that are not cGMP compliant, and that the products contains new dietary ingredients that have not been the subject of a NDI notification: Dendrobex (Dendrobium Extract, Stem - orchid) nor Citramine (Citrus Reticulata Extract, Fruit).
Cahill could not comment on the class action, given that the litigation is ongoing. However, he was adamant that Craze does not contain amphetamines, and that neither Dendrobex nor Citramine are drugs, nor do they require a new dietary ingredient notification (NDIN).
So both ingredients were on the market prior to 1994? “That’s our belief,” he said.
Please click here for a full copy of the class action and its allegations.
‘Grandfathered’?
According to American Herbal Products Association (AHPA) composite list of old dietary ingredients (ODIs), both Dendrobium nobile Lindl. and Dendrobium officinale are old dietary ingredients.
However, the real question is whether or not all of the individual compounds listed in the “Dendrobex Complex” are in fact found in Dendrobium.
Unfolding science
James Neal-Kababick, director of Flora Research Laboratories, told NutraIngredients-USA that much of the work that his lab is doing on dendrobium is “literally unfolding now and it has involved no less than six instrumental techniques and there is much more to do”.
Despite his extensive research and use of numerous analytical techniques, Kababick said he is yet to find that phenylethylamines are native to dendrobium. He could not comment specifically on Craze, but he did say that he is testing several dendrobium extract materials and cut/dried stem pieces.
Speaking on the wider issue of dendrobium, and not specifically about Craze, he said that his company routinely sees samples that are authentic by HPTLC (high performance thin layer chromatography). “That is, the phytochemicals extracted and profiled match up to authentic dendrobium reference materials. The same goes for many citrus extracts.
“However, dendrobium extracts can contain other compounds like beta-phenethylamines. As with steroids and PDE-5 inhibitors, there are almost an unlimited number of analogues that can be created to elude detection.”