Amid the escalating demand for CBD in the United States, many companies are selling “hemp extracts,” a strategy based on regulatory and scientific considerations. Marketers of hemp extracts must distinguish their products from the compound (CBD) under investigation by GW Pharmaceuticals plc, which announced Thursday that an FDA committee unanimously recommended supporting approval of its new drug application for Epidiolex.
Editor’s note: This is the seventh in a series of articles examining regulatory hurdles facing cannabidiol (CBD) producers and marketers in the dietary supplement industry, and ongoing efforts to comply with federal regulations. Click the following link for the sixth article in the series.
With a license to grow, distribute and sell marijuana in Canada, Emerald Health Sciences explored expansion into the U.S. nutraceuticals market with cannabidiol (CBD).
Ultimately, the public company decided not to sell CBD in U.S. natural products after meeting with two law firms specializing in cannabis law.
“They gave us two bits of advice, and the advice from both firms was identical,” said Jade Beutler, CEO of Emerald Health Bioceuticals, a San Diego-based subsidiary of Emerald Health Sciences. “Number one, don’t do it. And number two, if you do it, don’t say you’re doing it. And interestingly, you’ll see the CBD companies now shifting from CBD to what they’ll call a whole hemp extract or something of that nature.”
During an interview at Expo West in Anaheim, California, Beutler described the shift of existing CBD companies as a “duck, dodge and deflect strategy as the FDA and DEA continue to put the squeeze on.”
Amid the escalating demand for CBD in the United States, many companies are selling “hemp extracts,” a strategy based on regulatory and scientific considerations. Marketers of hemp extracts must distinguish their products from the compound (CBD) under investigation by GW Pharmaceuticals plc to treat rare forms of epilepsy because FDA has essentially concluded GW’s drug trials exclude CBD from the definition of a dietary supplement.
Epidiolex, if approved by FDA, could hit the U.S. market in the fourth quarter of 2018, according to some Wall Street analysts. GW on April 19 said an FDA advisory committee unanimously recommended supporting the approval of its new drug application for Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older.
Some regulatory lawyers have speculated FDA will crack down on U.S. marketers of CBD after Epidiolex is approved, perhaps leading to a confrontation in federal court.
FDA has concluded CBD is excluded from the definition of a dietary supplement under the Federal Food, Drug & Cosmetic Act (FDCA) because it has been authorized for investigation as a new drug and is the subject of substantial clinical investigations that have been made public.
Hemp industry professionals suggested whole plant hemp extracts are not only distinguishable from the compound under investigation by GW Pharmaceuticals—and consequently not subject to the clause in federal law that excludes drugs from being sold in supplements—but they offer greater health benefits than CBD as an isolate.
Drug companies like GW will be “using single molecule compounds of cannabis to create a pharmacological drug for a specific ailment or injury or syndrome,” said Tim Gordon, president of the Colorado chapter of the Hemp Industries Association (HIA).
Gordon also is president of Functional Remedies, a Boulder, Colorado-based marketer of CBD hemp oil. “In our products, we don’t call out the amount of CBD,” he said. “We call out the amount of phytocannabinoids.”
In a 2017 interview, Ashley Grace, then chief marketing officer of Denver-based CW Hemp, cited research in Israel describing the “entourage effect.”
The idea is a plant’s various compounds “work synergistically together to deliver an outcome as nature has created them,” explained Grace, who no longer is employed with CW Hemp, “and that’s always going to outperform any Western medicine-derived specific compound that we may take out of nature and try to apply …. as a drug.”
The market for CBD—and hemp extracts—has grown precipitously over the last five years since CNN’s Sanjay Gupta profiled Charlotte Figi, a Colorado girl diagnosed with a severe form of epilepsy: Dravet syndrome, one of the medical conditions GW’s Epidiolex has been developed to treat.
Charlotte’s mom decided to try medical marijuana for her then 5-year-old daughter, CNN reported in 2013, after the child’s medical condition deteriorated to the point that she suffered hundreds of seizures a week and could not eat, talk or walk.
Ultimately, the family started using a strain of medical marijuana high in CBD and low in tetrahydrocannabinol (THC)—the psychoactive compound in marijuana—from dispensary owners known as the Stanley brothers. The seven brothers from Colorado founded CW Hemp, and in 2012 developed the genetics for Charlotte’s Web.
Louisville, Colorado-based Bluebird Botanicals entered the CBD market in late 2013, the same year CNN reported Charlotte Figi was “thriving” thanks to the Stanley brothers’ CBD. According to Bluebird’s Chief Brand Officer Michael Harinen, the company began using CBD prominently on its label and standardized its products for CBD content.
The reason: CBD was what consumers were looking for.
In 2015, FDA declared in a Q&A (last updated in August 2017) that CBD could not be sold in dietary supplements. Its statement, reiterated in 2016 and 2017 warning letters, contributed to the shift in recent years to sales of hemp extracts.
Bluebird, Harinen said, began to produce hemp extracts that were standardized for total cannabinoid content rather than just CBD.
From a marketing standpoint, he acknowledged the challenges of not highlighting the CBD content in Bluebird’s products. On the other hand, he said Bluebird seized the moment to educate customers about the benefits of a whole plant hemp extract.
According to Bluebird’s website, its “Classic Hemp CBD Oil” contains more than 80 different phytocannabinoids. Other substances naturally present in Bluebird’s hemp extracts include amino acids, carbohydrates, vitamins and fatty acids, the company says.