NuLeaf bills itself as “a leading provider of CBD wellness products and dietary supplements derived from a full spectrum, whole plant hemp extract.” But the precise positioning of the products is still a work in progress, said Jessica Parsley, NuLeaf’s vice president of sales.
“We are going to be changing the label,” Parsley told NutraIngredients-USA. “We do have ‘dietary supplement’ on there at this point, but we are getting a new draft label to a consultant this week.”
Anomalies of using CBD in wellness products
Parsley said the brand is working with the management of the Natural Products Expo West trade show on the label project. The show has a compliance program that aims at preventing language that does not comply with FDA guidelines from appearing on labels and promotion materials. Parsley said NuLeaf hopes to be able to exhibit at the show at its next installment in March, 2018.
Parsley said the precise language to be used on the label—where, and even whether, to say 'CBD,' for example—complicates the labeling question. NuLeaf makes no claims about the health properties of CBD, Parsley said, though it does have links on its website to research on teh substance’s health effects. NuLeaf is hardly alone in its confusion; all of the developers of CBD products are dancing around the position of the Food and Drug Administration and other regulatory agencies on the issue.
CBD stands for cannabidiol, one of the non narcotic fractions that can be extracted from Cannabis sativa. CBD has been studied for various health properties including pain relief and as an antispasmodic. The whole plant, not just THC, the narcotic fraction, is still on the schedule 1 list of controlled substances maintained by the Drug Enforcement Administration, which is a huge hurdle in the marketplace. This has stunted the growth of banking services for the industry, for example. And in 2015 FDA said it did not think CBD was a legal dietary ingredient, and it reaffirmed that position last year. The agency based this ruling not on safety considerations per se, but on the existence of an Investigational New Drug application filed by English company GW Pharmaceuticals to cover its development of the molecule as a drug to treat certain forms of intractable childhood epilepsy. Opponents of this stance maintain that those IND applications should apply to those specific uses only, and should serve as a stricture against the marketing of CBD for other health end points.
Even with all of these regulatory pitfalls, the cannabis industry has shown spectacular growth, aided by the many states in which it is either fully legal by state law or is approved in a ‘medical marijuana’ setting. Colorado is one of these states, which has made NuLeaf’s business development possible.
Cultivar optimized for flower production
The company grows its raw material in concert with a farmer in southern Colorado near the city of Pueblo, on that state’s eastern plains. NuLeaf’s plants are grown out of doors, after being started in a greenhouse. Parsley said because the goal of the project from the outset was to extract CBD, the plants more closely resemble medical or recreational marijuana plants in that they are shorter and have abundant flowering parts. The critical difference is that the cultivars the company uses have been developed to come in under the legal limit for THC, which is 0.3%. Some other raw material grown as industrial hemp is also used for other purposes, such as for fiber, and the plants are tall, with long, thick stalks. It’s possible to use this for CBD products too, Parsley said, but requires a great deal of raw material to be extracted to get a small amount of CBD.
“The hemp that is grown in Colorado is different from typical industrial hemp because it is grown for the flower. We do do a full plant extract, but the flower is going to produce the highest amount of CBD,”she said.
“We have partnerships with the growers and with an extractor,” Parsley said.“We do the formulation and bottling ourselves, and we use an organic hemp seed oil as a carrier for the CBD extract.”
Specialty retail focus
Parsley said the company already has partnership with individual health care providers in addition to its online sales distribution. But the goal is to penetrate the specialty retail channel.
“We are operating under the 2014 Farm Bill that separates hemp from marijuana at that 0.3% THC threshold. The larger chains still aren’t taking on CBD because of the whole issue with the FDA. The natural grocery channel is really our next focus,” Parsley said.