CBD brand includes melatonin in sleep product
The brand, called GoGreen Hemp, is the brainchild of NYU grad Romas Marcinkevicius. Like many other product developers in the space, he came to CBD through personal experience. He was at one time a player on the university’s basketball team, but a catastrophic ankle injury ended his career and landed him on the long list of Americans using prescription pain killers.
“I had surgery and a bunch of screws placed in my ankle,” Marcinkevicius told NutraIngredients-USA. “I was trying to get off opiods and I found a CBD salve I was using helped.”
Marcinkevicius earned a business degree at NYU and spent several years in the vaping industry before launching GoGreen Hemp and moving into dietary supplement delivery forms.
Relaxation property fits with melatonin
CBD, or cannabidiol, is a non narcotic fraction of Cannabis sativa. Marcinkevicius sources his company’s CBD from Colorado, where the industrial hemp raw material is grown and the CBD oil is extracted. Industrial hemp is defined by law as having less than 0.3% THC content by weight. THC, or tetrahydrocannabinol, is the narcotic portion of the plant, and sourcing CBD from industrial hemp stock assures a finished product that steers clear of regulatory pitfalls, Marcinkevicius said.
CBD has been researched for a variety of health indications, and FDA just last week approved a drug to treat childhood epilepsy that was developed by English company GW Pharmaceuticals.
In addition to its anti seizure properties, CBD has also been used in products aimed at pain relief and mood support. It’s the ingredient’s purported relaxation benefits that made it a natural to pair with proven sleep support ingredient melatonin, Marcinkevicius said.
Regulatory future of CBD
CBD has had a troubled history as an ingredient. As far as the letter of current FDA policy is concerned, it is not a legal dietary ingredient for use in supplements. The agency has based this conclusion on the IND that was originally filed by GW Pharmaceuticals in its drug development program. According to FDA, to date no company or individual has come forward with evidence showing that CBD was on the market prior to that drug filing.
But the agency appears to be fully aware that even so hundreds of CBD-containing products are being sold under a variety of product categories including being marketed as dietary supplements. The agency appears to be taking a risk-based approach with CBD products as it has with others. While some companies marketing CBD products have received warning letters, the actions were predicated on the claims the companies were making, not on the use of CBD per se. There has been no blanket effort to quickly remove CBD containing products from the market over health concerns as happened with the sports product ingredient DMAA, for instance.
Marcinkevicius said he thinks the experience of the vaping industry could serve as an indication of what might eventually happen with CBD products.
“Just like with e cigarettes and e juices, I think FDA will take a similar approach and they will come up with some enforcement specific to these products eventually,” he said.
“In the meantime, we are very careful about what we say on our marketing. The claims we make are very vague and general,” Marcinkevicius said.
