The Hollywood, FL-based company’s MaCoca branded blend is already used in MB’s own brand of supplements – the Slimple range – but not in other products yet, Richard Gelso from MB Innovations, LLC, told NutraIngredients-USA.
According to MB Innovations, the MaCoca blend contains eight ingredients: Maca Root, citrus bioflavonoids, glycomacropeptide (GMP), guggul (gum extract), green tea, Lotus Leaf extract, annatto leaf powder and the key ingredient, decocainized coca leaf extract.
A report by the Natural Standard Research Collaboration commissioned by MB Innovations and authored by Catherine Ulbricht, PharmD, MBA, concluded that the MaCoca brand may; help reduce/slow fat absorption, help maintain a healthy body weight, help regulate food intake, help you feel full, help regulate blood sugar and help reduce/slow energy absorption and stimulate metabolism.
The company is continuing to develop the needed scientific basis for the appetite-related claim, said Gelso.
According to MB Innovations, the MaCoca ingredient does not have any negative side effects such as the jitters or crashing, and is also a rich source of vitamins, minerals, and flavonoids.
“The material comes from a very reliable source in South America,” confirmed Gelso. “The particular source for our supply is a trade secret.”
While coca leaves are illegal in the US and many other countries, special accommodation is made for "decocainized" coca leaf, said the company.
Gelso obtained legal advice from well-known attorney Jim Prochnow of Greenberg Traurig, LLP, for the use of decocainized coca leaf extracts in dietary supplements.
“Among other things, I have advised Mr Gelso that the U.S. Controlled Substances Act, in Section 812 (c), Schedule (a)(4) excepts such leaves from the reach or application of that Act,” said Prochnow in an email to NutraIngredients-USA.
The coca-derived ingredients/products do not require special authorization from USDA and/or FDA, he said, and there are no limitations on claims (except no drug-like claims) and no special labeling is required.
“A product that contains this ingredient can be sold either as a conventional food, such as a beverage, or as a dietary supplement. Please note that 21 CFR 182.20 provides that Coca (decocainized) has GRAS status for its intended use,” added Prochnow.
Denver-based Prochnow added that, in his judgment, one of the most significant challenges from a legal standpoint was establishing the specifications of identity, strength, composition and purity for these special kind of coca leaves.
“Although manufacturers of dietary ingredients or other components of them, whether those manufacturers are foreign or domestic, are not subject to the GMPs for dietary supplements, supplement ingredients or components are subject to the GMPs,” he added.
Indeed, MaCoca was tested by Flora Research Laboratories, an FDA and DEA registered & inspected laboratory in Southern Oregon. The lab’s director, James Neal-Kababick, confirmed to NutraIngredients-USA: “We tested a sample for MB Innovations of the decocainized coca and the sample did meet the requirements for decocainization based on our understanding of the regulations.”