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CBD Oil 2019

FDA officials ponder definitions of ‘hemp extracts,’ ‘THC-free’ at CBD hearing

A public hearing hosted by FDA highlighted the complexities of key terms whose meanings have neither been clearly defined by the hemp industry nor the federal government.

Full-spectrum hemp extracts, the argument goes, are distinct from the compound studied by GW Pharmaceuticals—CBD—and consequently not barred from being marketed in dietary supplements in the United States.

But a recent public hearing highlighted the complexities of key terms whose meanings have neither been clearly defined by the hemp industry nor the federal government.

In June 2018, FDA approved Epidiolex, a CBD drug manufactured by GW Pharmaceuticals to treat seizures associated with two severe forms of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome, in patients at least two years old.

A long-held and controversial position taken by FDA—that CBD cannot be marketed in dietary supplements or added to conventional food—is tied to GW’s clinical research into Epidiolex and another drug, Sativex.

The hemp industry has lobbied FDA officials and Congress to expressly authorize CBD-containing hemp extracts in dietary supplements and maintained such products are distinguishable from Epidiolex.

“Hemp extract does not resemble the drug Epidiolex to which it is being compared to,” said Karen Howard, executive director and CEO of Organic & Natural Health Association, during a May 31 public hearing hosted by FDA at its headquarters in Silver Spring, Maryland. “For us, the issue is whether hemp extracts are equivalent to the drug, and it is not.”

An FDA official expressed interest in what Howard meant by “hemp extract.” Representatives of the agency asked similar questions several times during an all-day hearing aimed to gather information about cannabis-derived compounds.

“Well, we do mean CBD,” Howard responded, but she added “hemp extract, hemp CBDs and all of the derivatives from the hemp plant are simply not related to the product that it's being compared to, which is the pharmaceutical.”

Rod Kight, an attorney in Asheville, North Carolina, told FDA officials “hemp extract contains dozens of compounds and is not the same moiety as” Epidiolex.

“For supplements, FDA has been clear that highly purified and isolated CBD can't be added to food or dietary supplements,” said Duffy MacKay, senior vice president of scientific and regulatory affairs with CV Sciences, during the public hearing. “However, scientific and legal experts agree that a hemp extract containing a full array of cannabinoids and other plant constituents is a significantly different article than a highly purified CBD. Each has a unique identity and a unique biological activity.”

Josh Epstein is CEO of Socati, a Woodburn, Oregon-based producer of “THC-free full-spectrum hemp extract,” according to the company’s website. During the FDA hearing, Epstein highlighted a lack of a standard definition on what constitutes THC-free, and he mentioned “full” and “broad” spectrum extracts.

An FDA official asked whether the latter terms were interchangeable or distinct. Epstein suggested full- and broad-spectrum extracts both incorporate other cannabinoids beyond CBD. However, THC—the psychoactive compound found in high quantities in marijuana—is removed in broad-spectrum extracts, while full spectrum includes “residual amounts” of THC, he said.

Asked about the types of levels of CBD in an extract, Epstein said the amount depends largely on the “starting materials,” but he cited a range of 70 to 90%.

“You can understand the challenge in creating a standard around something that varies like that,” an FDA official said.

“Absolutely,” Epstein responded.

Brandon Beatty is CEO of Bluebird Botanicals in Louisville, Colorado. Asked in an interview what “full spectrum” means to him, he described extracts that contain many constituents beyond CBD and the other cannabinoids, including such things as amino acids, flavonoids, terpenes and trace minerals.

However, he cautioned, “I don’t think there’s any extract out there that could have all the same materials as the full plant. I think if you were eating the raw plant, that you can’t get that exact same composition and effect through any extract.”

Dana McMurchy, a board member of Oklahomans for Health, a social welfare organization, also suggested full-spectrum hemp oil is distinguishable from CBD alone.

“It's cannabidiol, terpenes, flavonoids, fatty acids, vitamins and minerals,” she said during the FDA hearing.

But the type of extraction method affects the finished product, noted Jared Stanley, vice president of cultivation with Charlotte’s Web. Alcohol and CO2, he noted in an interview, are the leading hemp extraction methods.

“While CO2 has many of the compounds, it’s not as thick of an oil as alcohol,” Stanley said, explaining alcohol extracted products contain “far more compounds of the whole plant” than CO2 extracted products.

However, “we use ‘full spectrum’ for both,” he added.

Commenting on CBD that has been isolated, Stanley said, “We know that’s not full spectrum.”

Garrett Graff, managing attorney in Denver at Hoban Law Group, suggested the cannabis plant contains more than 100 cannabinoids.

During the FDA hearing, Graff described full spectrum as “a full representative profile of the entire cannabis plant, and the compounds and cannabinoids” within it. He characterized broad spectrum as “a broad, but not yet full representative profile.”

“We're struggling with definitions about CBD extract, broad, full spectrum, things like we've talked about earlier today,” Brian Malkin, a food and drug attorney in New York with the law firm Arent Fox, said during the FDA hearing. “What is hemp extract? Is it from the hemp seed or from the plant? That's not clear all the time. What does ‘THC-free’ mean?”

FDA will likely have to answer these difficult questions if it decides to expressly authorize the sale of CBD-containing “hemp extracts” in dietary supplements. Appropriate FDA oversight of cannabis-derived products includes, among other things, “the need for consistent terminology,” two FDA officials, who co-chair a CBD working group, suggested in a recent article on the agency’s website.

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