FDA Holds Historic Hearing on CBD to Shape the Future of the New Industry

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After Friday’s historic Food and Drug Administration hearing on the public health and safety concerns related to cannabidiol (CBD), a few things are clear: CBD products are showing up on shelves coast-to-coast, more research is needed, and everyone from regulators to CBD product manufacturers are desperate for the FDA to step up to the plate and make some sense of the mess that has become CBD in America.

The 2018 Farm Bill, signed into law in December, removed hemp from the Controlled Substances Act. This, by extension, legalized CBD, one of many cannabinoids found in found in both hemp and marijuana, as they are both of the genus Cannabis. And now the FDA, which for the first time approved a CBD-based cannabis plant extract as medicine last summer, available by prescription, must figure out what to do with this widely available compound that is the focus of the latest national wellness craze.

(For a deeper look at the FDA’s task, and the backstory, read this piece published in advance of the hearing.)

Friday’s hearing was just the beginning of a lengthy process during which the FDA must make a number of complex decisions before CBD rules are finalized. Still, the meeting brought together an unprecedented number and range of stakeholders to discuss whether and how CBD products could be safely sold and consumed.

Some regulators painted a chaotic scene related to CBD in their jurisdictions. The “very little consistency or uniformity” with CBD regulations is creating an “atmosphere where anything is allowed,” said Brenda Morris, with the Florida Department of Agriculture and Consumer Services. “CBD products in foods and cosmetics are being shipped in interstate commerce and is clearly within FDA’s regulatory authority,” Morris said.

Pam Miles, of the Virginia Department of Agriculture referenced the Carl’s Jr. 4/20 publicity stunt during which a CBD-sauced burger was sold in Colorado. “Recently a national quick-service restaurant chain served CBD-infused sandwiches as part of a promotion,” she said. “Across the United States, state and local regulators have been confronted with a huge onslaught of CBD,” she said.

Researchers called upon feds to remove roadblocks to studying CBD—and cannabis

Larry Walker, director of the National Center for Natural Products Research at Ole Miss, suggests national data collection, a national testing program, and a national adverse event program when it comes to CBD. “We need a lot more clinical research,” he said. (For context, Ole Miss remains the only federally-approved place to grow research-grade cannabis.)

Representing Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, the company behind the first FDA-approved CBD-based cannabis plant extract medicine, Epidiolex, Alice Mead called for a “comprehensive regulatory framework that first and foremost further encourages development of cannabis-derived medications for serious and life-threatening illnesses.” Moving forward, she added, U.S. federal policy should also ensure “that CBD consumer products can be safely used in a mass-market setting that lacks physician oversight,” as well as establish “a clear differentiation in dosing and concentration levels between FDA-approved medicines and consumer goods.”

With Epidiolex, said Mead, GW Pharmaceuticals has only begun to “scratch the surface.” Cannabis, she said, has “tremendous potential” to treat many more illnesses, and the British company is currently researching eight different disease areas.

“We’re leading the way, but” she warned, “without greater incentives, few companies will follow us down the FDA pathway.”

The approval of the FDA matters, said Mead, because this process is “the only way to answer important questions about a drug” and address safety considerations. For example, she noted, “no one knew CBD is potentially toxic to the liver until we conducted clinical and preclinical studies.” Through this research, GW Pharmaceuticals has found that the cannabinoid, even in small quantities, is not innocuous. Making her case against its wide usage, Mead said that, in addition to potential liver damage, the company has found that CBD “has powerful drug-drug interactions with other medications” and can cause “sleepiness, which can be a problem when driving.”

Before wrapping up, she warned that GW Pharmaceuticals “research shows that negative side effects from CBD begin to appear at one mg/kg of body weight, or about 70mg per day, for an average adult.”

Seventy milligrams is less than a quarter of a teaspoon.

Kevin Chapman, representing the American Epilepsy Society, was asked by the FDA panel if he knows of patients opting to buy and use CBD from unlicensed producers over Epidiolex.

“Yes, there are quite a few,” Chapman said, saying that Epidiolex is only approved for two rare and severe types of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Chapman also said the cost is a factor because Epidiolex can cost up to $30,000 a year, so for some, it’s cheaper just to go to a dispensary.

The FDA panel then asked Chapman about dosage of those unapproved CBD products. How do epilepsy patients figure it out?

“They are just sort of making it up as they go along,” Chapman said, highlighting an early theme that emerged from the hearing: what is a dose of CBD?

James Beck, chief scientific officer of the Parkinson’s Foundation, said that they need better access to cannabis as a study drug. Ninety-five percent of the neurologists surveyed by the foundation said their patients asked about medical cannabis. Parkinson’s disease has several side-effects, such as problems with sleep and mood disorders, that are not properly addressed by currently available medication, Beck said.

“Those in our community are seeking alternative ways in which to control the symptoms, and cannabis is not surprisingly one of those,” Beck said. However, he noted that cannabis, like any other drug, has side-effects, some which could actually be the same as the symptoms in Parkinson’s disease. Hence, the need for more research, Beck said.

And what about CBD for pets? Recent research suggests that CBD has potential anti-seizure effects for them. Ashley Morgan, with the American Veterinary Medical Association, said “we believe there is therapeutic potential in the development of cannabis-derived and cannabis-related compounds and we would like to see the potential realized.”

The FDA panel asked Morgan if veterinarians are currently recommending medical cannabis.

“No,” Morgan said quickly. “Well. Not legally,” said said, which was met with laughter from those attending the meeting.

William Bookout with the National Animal Supplement Council said there are currently 149 hemp derived animal supplements in the marketplace, and “they have been on the market for over 10 years,” he said.  

Erin Bubb, of the Association of American Feed Control Officials, talked about the use of hemp products in the animal feed market. Bubb was asked by the panel, “To what extent are you seeing the use of CBD in the feed of food producing animals?”

Bubb responded, “There is talk about it. There is interest. They would like to do it.”

No one knew CBD is potentially toxic to the liver until we conducted clinical and preclinical studies.

Alice Mead, Greenwich Biosciences

The conversation also turned to hurdles with studying cannabis more broadly, beyond just CBD.

Health professionals from across the country weighed in, the bulk of whom called upon the agency and other federal regulators to update its stance on cannabis so that they can conduct research.

During her presentation, Sue Sisley, head of the Scottsdale Research Institute in Arizona, pointed to a study she and her colleagues recently completed, which examines four varieties of cannabis for military veterans with PTSD. The study, Sisley underscored, took her team ten years to complete, largely as a result of “all of the regulatory hurdles” and “excessive layers of government red tape.”

In 2016, she said, it seemed as though one of those obstacles would finally be eliminated. That year, it was announced that the DEA would license more cannabis growers for research. However, to date, that has not happened–even though the DEA received “over a dozen bipartisan letters” from members of Congress asking it to take action.

“The next clinical trial at our laboratory,” Sisley added,  “will be looking at smoked cannabis flower compared to fentanyl for late-stage cancer patients.” However, the FDA requires that drugs used in Phase III trials must be the drugs that will be made available to the public. And currently, cannabis supplied by the National Institute on Drug Abuse “is not authorized to be available for sale as a prescription FDA-approved medicine.” As a result, there is “no way to put flower through the entire FDA process,” unless Sisley and her colleagues use flower from a foreign manufacturer.

“Our big push here today is to urge you to help us work with the DEA,” said Sisley, “to urge them to make good on their pledge to the public and license other growers for research.”

In that same vein, Elise Weerts, a researcher at the Johns Hopkins School of Medicine, said that the FDA needs to accelerate its Investigational New Drug (IND) program, a process through which a pharmaceutical company obtains permission to conduct human clinical trials, as well as to ship an experimental drug across state lines.

When asked what the 2018 Farm Bill has done to advance medical research, Weerts stated plainly: “It has no impact.”

When asked to elaborate, Weerts added: “So, I have a DEA Schedule I license to study cannabinoids. My twenty-one-year-old son can walk into a store and buy it, and I cannot. That’s really it in a nutshell. I cannot purchase, store, or test that product. It is illegal for me to do so. Because I’m following the regulations of the DEA. And I’m following the regulations of the FDA, which [stipulate that] anything I test has to go through an IND and meet all those requirements.”

“It’s a very circular process,” she said. “It can take months and months.”

“No need to reinvent the wheel”

Some speakers argued that there are regulations already in place for the FDA to use while crafting rules for CBD. “There is no need to reinvent the wheel,” said Garrett Graff, an attorney with Hoban Law Group. Speaking about hemp products in particular, he said that existing FDA mechanisms on product classifications, testing, and labeling are all applicable.

“Labeling conventions for foods, supplements, cosmetics, and other product types already regulated by the FDA are sensible, and provide an appropriate way to disseminate information to consumers,” said Graff. He added that there are companies that have been testing food additives, dietary ingredients, and finished products for decades and have the knowledge to test hemp products for potency, contamination, and heavy metals.

As for hemp product manufacturers, Graff said there should not be required to adhere to any different standards. “Solvent-based manufacturing is not new. Plant-based products are not new,” Graff said, “There is no need to specifically regulate hemp akin to how vapes or tobacco have been regulated by FDA in one-off ways in the past.”

Graff also urged the FDA panel to take this opportunity to draft regulations that would be applicable to not just CBD, but cannabinoid compounds in general. “There are over a hundred cannabinoid compounds within cannabis,” Graff said, “So these are issues we have to replicate time and time again, or we can take this opportunity to handle that for all the different cannabinoids now.”

Sheri Orlowitz with the Marijuana Policy Project, a group that has helped pass many of the medical and adult use cannabis laws in the US over the decades, cautioned against creating an “unduly restrictive” regulatory framework as it could once again lead to illegal cannabis markets.

“No more back alley sales. The retailer needs to have confidence in what they’re selling and the consumer needs to have confidence in what they’re buying.”

She recommended the FDA look to states while crafting regulations. “We need and we welcome the FDA regulation,” Orlowitz said, “We suggest that the FDA take note of state markets and state regulations as a starting point.”

Shawn Hauser, Vicente Sederberg LLC, representing the Cannabis Trade Federation, echoed Orlowitz’ view.

“Cannabis products can be safely regulated under the existing work and where products are intended for non-medicinal purposes, it’s appropriate to regulate them as such,” Hauser said, “Years of data from the state regulatory regimes are very important source of data for the agency to consider, in determining the appropriate regulatory pathway here.”

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