We’re Watching the FDA’s Hearing on CBD So You Don’t Have ToLeafly StaffMay 31, 2019
On Friday, FDA Acting Commissioner Ned Sharpless kicked off the agency’s historic first-ever public hearing on CBD by noting that “we’ve seen an explosion of interest in products including CBD, [but] there is much we don’t know.”
There’s plenty we do know, however, and many of those facts were aired at the hearing, which Leafly’s editors covered live as it happened.
That’s a Wrap!
6:00 p.m. — Right on schedule, the FDA’s first-ever public hearing on CBD has concluded. Read on for a summary of what came up. We’ve also posted some of the day’s biggest takeaways in a separate article.
If today’s hearing inspires you to weigh in, don’t fret! There’s still time. You can submit written comments to the FDA until July 2. Comments can be submitted online or sent via mail to the following address:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Move Fast—Lives Are at Stake
5:43 p.m. — One of the day’s last speakers, Oklahoma-based CBD retailer Dana McMurchy, stressed the need for urgency as the FDA moves forward. The first indications that CBD could help treat severe seizure disorders, she noted, were published in the 1970s. But the first cannabis-derived drug didn’t receive FDA approval until more than a generation later.
“It took 45 years using the model we currently have,” McMurchy said.
Today, there are indications that CBD could help make a dent in the US overdose crisis, which has killed tens of thousands of Americans in recent years. “The number of deaths in the US exceed what we lost in World War II,” McMurchy said.
“I’m thrilled that Epidiolex got approved,” she said, but added that she doesn’t want to wait another 45 years for the next breakthrough.
There’s More Than One Way to ‘Standardize’
5:21 p.m. — Speakers seem to agree that there’s scant indication of what’s actually inside most CBD products today. But how to achieve more certainty is still a matter of debate.
James Werline is a pharmacist and the father of a daughter, Camila, with a seizure disorder. While his family had heard anecdotal evidence about CBD oils preventing seizures, Werline said his family didn’t trust the products that were on the unregulated market. “I wouldn’t know how to monitor for interactions … and who knows what would be in the bottle that we bought and gave her?” he said. “That is today’s world of unregulated and inadequately controlled CBD oil.”
Today Camila is on Epidiolex, the one FDA-approved CBD medication derived from cannabis. “I’m not testifying to promote the products,” he said, “but I have to share that Camila hasn’t had any seizures since she’s been on the medication.”
Werline said his travel expenses for the hearing were paid for by Greenwich Biosciences, a US subsidiary of GW Pharmaceuticals, which produces Epidiolex.
The majority of state-level product recalls issued have been for pesticides.
“What is in a bottle containing CBD that is purchased in a retail store or online?” Werline asked, urging that CBD products be subject to robust clinical trials. “Today, they’re flying blind. They don’t know what they’re taking.”
Patient advocates at Americans for Safe Access, however, say much of that certainty can be achieved through better testing and standards for existing nonprescription products. Heather Despres, director of the group’s patient focused certification program, noted that most states that have legalized some form of cannabis already have testing programs in place—and have successfully used those programs to get tainted products off the market.
Colorado, Oregon, California, and other adult-use states, for example, have seen product recalls of legal cannabis products as the result of failed tests. “The majority of recalls that have been issued have been for nonpermitted pesticides or exceeding the limits of nonpermitted pesticides,” Despres said. Meanwhile, no testing is currently required for unregulated CBD products.
Despres urged that CBD and other cannabinoids be subject to “validated analytical testing” and that operators and inspectors “have the education and training needed to safely perform the job they are required to do.”
Work With States, Not Against Them
4:39 p.m. – Sheri Orlowitz, the founding member of Artemis Holdings and a board member for the Marijuana Policy Project, said the “FDA looms large over all of the states” working to regulate cannabis and CBD products and urged the agency to craft regulation that takes into account those states schemes.
“The FDA should pave the cowpath,” she said. “We suggest that the FDA take note of the state markets and the state regulatory schemes as a starting point” for federal regulation.
In other words, while the FDA is relatively new to regulating cannabinoids, legal states are increasingly amassing experience. Rather than reinvent the wheel, the FDA could borrow from some of the best practices already established in legal jurisdictions.
“We suggest that the FDA work hand-in-hand with the states,” Orlowitz said, “and not against the states.”
Like a number of other speakers today, Orlowitz’s comments went much further than CBD, referencing the growing number of states that have legalized full-THC cannabis for adult use. It’s a sign that at least some speakers see this hearing as a discussion about not only CBD but about how the FDA might approach regulation of other cannabinoid products going forward.
Move Forward, but Don’t Take Away What Works
4:14 p.m. — If there’s one group that’s experienced the life-changing potential of CBD, it’s the epilepsy community. CBD oil and CBD-based pharmaceuticals have been demonstrated to drastically reduce the frequency and intensity in certain types of epileptic seizures.
“As much as I am afraid of what we have now, as a member of my community, I am more afraid of losing it.”Jacqueline French, Epilepsy Foundation
Jacqueline French, a professor of neurology at NYU and the chief scientific officer for the Epilepsy Foundation, said that as much as standardization and safety are key for the epilepsy community, so too is preserving access to affordable CBD products.
“We in the epilepsy community know that cbd is a drug and is a life-changing drug,” French said. And while concerns around production standards and labeling are worrisome, so too is the thought of regulation that would take botanical CBD products off store shelves.
With more than a thousand forms of epilepsy, French said, the FDA approval process can actually be an obstacle to accessing potentially beneficial treatments such as botanical CBD oils.
“As much as I am afraid of what we have now,” she said, “as a member of my community, I am more afraid of losing it.”
We’re Entering the Home Stretch
3:58 p.m. — Today’s final group of speakers is the “other” category: concerned citizens or other stakeholders with an interest in how CBD is regulated. Speakers so far have included a mother who moved her family from Colorado to Texas over concerns about legal cannabis, a member of the Parkinson’s Foundation who spoke about the need for further research, and a representative of a testing laboratory who shared this graphic for how the FDA might proceed:
The point of that graphic? To show that despite the host of complications that surround CBD regulation, the basic path forward has broad consensus—and isn’t all too different than what the FDA does every day.
That argument was echoed by Daniel Fabricant of the National Products Association, who said that reportedly 1,500 CBD products have come onto the market in the past three years. Fabricant challenged an earlier speaker’s claims that CBD brings the FDA into “uncharted territory.”
One example? Caffeine. “You see standards for products with caffeine,” Fabricant noted. “You saw levels for pregnancy, for children, things like that.”
We’re on Break
3:20 p.m. — The hearing is on a 15-minute break. That sound you hear? That’s the sound of Leafly editors simultaneously refilling their buckets of coffee.
Who Gets to Participate in a Regulated CBD Market?
3:01 p.m. — Should CBD companies that rush products to market be allowed to share in the CBD boom? Aaron Secrist, VP of regulatory affairs for NOW Health Group, isn’t so sure.
Secrist said that the unregulated nature of CBD has created incentives for less reputable companies than his to sell products of questionable safety and quality. He called on federal regulators either to enforce current statutes that have prevented mainstream companies from getting into the CBD business or to “allow hemp-derived products such as CBD to be recognized as legal dietary ingredients.”
In the meantime, Secrist said, the FDA should consider at least temporarily barring companies that are currently pushing the limits from participating in a future regulated marketplace.
Legal Gray Area Rewards Shady CBD Sellers
3:00 p.m.—The lack of FDA and state-level approvals for making CBD products hurts consumers by keeping out the most law-abiding manufacturers, the FDA learned today.
Maryland Packaging Ltd. CEO Marwan Moheyeldien told the FDA today that fully licensed businesses like himself can’t touch CBD, while underground actors serve customers. He asked for provisional permits for compliant companies such as himself.
“If we receive a letter telling us we can’t operate under any circumstance, we expect you to do that every other manufacturer,” he said. “All we’re asking for is a level playing field.”
If the FDA over-regulates CBD, “all the FDA is going to do is drive those manufacturers underground to the black market. You can’t control the product on the shelf. As long as people want it people are going to manufacture it,” he said.
“We want regulations and we welcome it so please find a path for us.”
The next speaker, Stephen Muller, from Colorado’s Mile High Labs, piled on, noting that “this thing is taking off, regardless of existing regulations.”
Muller advised the FDA to regulate CBD like dietary supplements.
GW Pharma: We Found Side Effects, Interactions
2:42 p.m. — One of the biggest players in the CBD world, the British company GW Pharmaceuticals, finally appears, repped by company official Alice Mead.
GW Pharma developed Epidiolex, the world’s first FDA-approved CBD drug. Mead urged the FDA officials to create a “strong regulatory framework” that will serve patients facing “serious and life-threatening illnesses.” She also would like to see clear differentiation in dosing and concentration levels between FDA-approved medicines like Epidiolex, and consumer goods.
On a day when real data is rare and precious, Mead offered insight from GW’s clinical trials of Epidiolex, which is largely CBD. “No one knew CBD is potentially toxic to the liver until we entered clinical studies,” she says. (For context, NSAIDs like Advil are also potentially toxic to the liver.) “We also know CBD has powerful drug-drug interactions,” as with a common blood thinner. CBD-rich extracts can also cause minor effects such as drowsiness.
“Our research shows that negative side effects can begin with doses … as little as about 70 mg per day in an average adult.” Again, for context, many CBD oil bottles contain 300mg of CBD, and each dropper doses about 7mg.
Meanwhile, one of the reasons patients are buying untested CBD products is the high cost of GW’s Epidiolex, as mentioned by a previous speaker.
There was an audible gasp in the room when Kevin Chapman of @AmEpilepsySoc told the #FDA that patients with #epilepsy were going to dispensaries to purchase CBD and in terms of dosing, “making it up as they go along,” because access to Epidiolex is expensive and restricted.
— Chloe Aiello (@chlobo_ilo) May 31, 2019
‘Quality Is Really the Issue Here’
2:35 p.m. — CBD products seem to be everywhere these days, but hardly anyone can be certain what they’re getting. That was the thrust of testimony from Dr. Rosemary Mazanet, chief scientific officer for multistate medical cannabis operator Columbia Care.
Mazanet pulled up studies showing that as recently as 2017, the bulk of CBD products tested—69%, according to one study—were mislabeled. “I’m telling you something you’ve heard all day,” she acknowledged, but “quality is really the issue here.”
In another study, out of California, two CBD products were found to contain no CBD whatsoever. “There are people that rely on these medicines,” she said. “If I were a parent of a child that had a seizure disorder … and I was buying CBD, this would make me sick.”
Like many other speakers, Mazanet called for standardization in production practices and labeling. “We are overtaking more than a dozen trials in US and Europe,” she said. To ensure the results are usable, “we believe very strongly that you have to have the same product, you have to have the same variables.”
“We’re not big fans, as you might imagine, of flower,” she added.
What to make of the fact that so many existing CBD products have been flagged for being mislabeled? “What that shows is just that people are lazy,” Mazanet said. People are extracting pretty much whatever they can from whatever cannabis or hemp products are available, she said, and “until somebody tells them that they can’t do that, they will continue to do it.”
CBD Cut Pain by 50% in New Michigan Trials
2:30 p.m.—CBD taken under the tongue treated PTSD, opioid dependence, insomnia, anxiety, and pain in six small human trials, Dr. Deb Kimless told the FDA today.
The 25 year-veteran doctor and board certified anesthesiologist works with Pure Green, a licensed Michigan medical cannabis producer.
She called CBD a “safe and effective treatment option for my patients.”
In contrast to critics’ claims that we know nothing, Dr. Kimless said “data does exist to help the FDA gain insight into the safety and efficacy of sublingual CBD.”
For pain, CBD caused sensations of pain to drop by an average of 50% within eight minutes and the effect lasted four to six hours.
Pure Green tracked the administration of 500,000 doses, with only two rare side effects: drowsiness and ‘an overwhelming sense of well-being.’
That gave the FDA pause. They asked Kimless to explain what, ‘an overwhelming sense of well-being’ was and how they defined it.
Kimless stated what patient reports said: People reported feeling that things would be OK.
Synthetic CBD? Lower THC Limits? Oh My!
2:11 p.m. — Noramco, a Delaware-based corporation, has spent years manufacturing synthetic cannabinoids—for example dronabinol, a synthesized THC suspended in sesame oil. Bill Grubb, the company’s VP of business development, said synthesized CBD could offer significant benefits over plant-derived forms.
There are “significant advantages to synthetic production,” Grubb said, such as no heavy metals from the soil, no residual pesticides, no environmental influences, and no impurities from the plant to remove. He said he was not aware of any downsides of synthetic production, though patients have reported more side effects from dronabinol than from plant-based medical marijuana.
Grubb also called for the THC limit on hemp-derived products to be reduced to 0.1%, down from the current level of 0.3%. Their synthetic product, he said, is “around 10 parts per million.”
Isolate vs. Full Spectrum vs. Broad Spectrum
2:08 p.m.—Another theme today: The CBD industry’s evolving and confusing terminology. Josh Epstein from the CBD manufacturer Socati addresses it head-on: The FDA should require companies to be certified through third-party validation, he says. But right now there’s not even agreement on terms.
“How can you validate that a product is THC-free, or full spectrum, broad spectrum, or isolate? There’s no agreed-upon standard. The FDA should establish this standard.”
This is extremely clear and helpful testimony, and the FDA officials seem to recognize that. Several ask Epstein to follow up and tell them what those terms do mean, at least to him.
Epstein says: Isolate is pure CBD without any other component. Full spectrum CBD contains a suite of other cannabinoids and terpenes, including residual amounts of THC. Broad spectrum CBD is full spectrum CBD minus the residual THC.
“You can imagine the challenge in creating a standard in a product that varies like that,” one FDA official said. “If you have ideas, it’d be useful for you to submit them to the docket.”
US Labs Struggle to Test CBD
2:00 p.m.—It’s clear Americans need pure supplies of CBD extracts, but a key part of the supply chain—the labs—isn’t working, the FDA learned today.
America’s analytical labs are usually not licensed to handle CBD, a schedule 1 drug. The ones that do test for CBD in medical and adult use states each can use their own methods, leading to variance in results. There is no federal lab standard for testing CBD, like for example the EPA’s standard methods for water pollution testing.
Justin Blehar from CBD oilmaker Genco Pura pointed out the industry’s needs for better testing during testimony after lunch. He advocated a light regulatory approach that favors international standards like the “ISO 9000” standard.
The next speaker—from Full Spectrum Omega, a Los Angeles CBD company—also called for streamlining rules around CBD testing. His company can’t legally get his proprietary products to federal labs on the east coast. America businesses are getting beaten by companies in Canada, where federal legalization has enabled stronger lab standards and more effective cannabinoid medicines, he said.
The speaker added to calls from Dr. Sue Sisley for better supplies of research cannabis in the US. Federal supplies from one farm Mississippi do not reflect the real world. He said researchers and innovators like myself are, “handicapped by using sub-standard product to try to prove a point.”
We Need Alternatives to NIDA Ditch Weed, Researcher Says
1:44 p.m. — Dr. Sue Sisley, an internal medicine physician who leads the Arizona-based Scottdale Research Institute, has led some of the country’s key clinical trials into smoked or vaporized cannabis flower in an effort to put cannabis flower itself through the FDA approval process.
“In this excessive exuberance to make sure that cannabis is standardized, we lose the efficacy of the flower.”
But under current federal protocols, Sisley said, that process proceeds at a snail’s pace. An ongoing trial into using cannabis flower to treat PTSD in military veterans, for example, has stretched on for nearly a decade. “You’ll see why this study took 10 years,” Sisley said, pulling up a slide of the country’s convoluted cannabis research and approvals process.
One big obstacle is actually sourcing cannabis flower. Sisley has in the past used cannabis from the National Institute on Drug Abuse, but the quality of research-grade cannabis at times made progress nearly impossible.
“We sent this to Schedule I–licensed laboratories in the US,” Sisley said, showing a slide of NIDA-provided cannabis that resembled dry dill weed. “They all showed excessively high levels of mold in all the batches”—levels that would’ve failed microbial testing standards in most states’ legal cannabis markets.
While changes in recent years have aimed to open the door to more domestic cannabis production for research purposes, “the DEA has not processed any of these applications,” Sisley said. “The point is that researchers need access to options.”
Sisley also urged product standards—but within a paradigm that recognizes the botanical nature of the plant. She said standard cannabis should be only the “flowering tops of plants” that should be free from pesticides, heavy metals, and microbials. Importantly, she said, botanical products should “not be so overprocessed that it no longer resembles flower from the ‘real world.’”
“In this excessive exuberance to make sure that cannabis is standardized,” she warned, “we lose the efficacy of the flower.”
Time to Normalize CBD Purity, says NORML
1:30 p.m.—America’s most iconic cannabis law reform group—NORML—called on the FDA today to meet consumer needs for CBD, making sure it is pure, affordable, and widely available without prescription.
“The rapidly evolving hemp-derived CBD marketplace sadly includes a number of bad faith actors selling the equivalent of modern day snake oil,” said NORML Political Director Justin Strekal. “With states rapidly legalizing the distribution of these products, consumers require certainty and consistency when it comes what they ingest.”
NORML members did not get to speak during this morning’s FDA hearing on CBD manufacturing, product quality, marketing, labeling, and sale. But they submitted comments asking the FDA to “craft benchmark safety and quality standards for hemp-derived CBD products in order to increase consumer satisfaction and confidence as this nascent industry transitions and matures into a legal marketplace.”
Consumer Reports finds 64 million Americans have tried CBD and 63% of them said it was very effective. Americans assume the stuff they buy online is being tested and safe, but it’s not.
NORML echoed concerns voiced at this morning’s hearing that “third-party lab testing has frequently revealed inconsistencies between the percentage of CBD advertised and the amount actually contained in the product. In many cases, actual quantities of CBD in the product is far lower than advertised. In other cases, testing has revealed the presence of THC, which may put consumers in jeopardy for legal ramifications – such as arrest or the loss of employment (due to a drug test failure). Some commercial products have also been identified to contain unwanted and potentially dangerous adulterants as well as heavy metals and solvents.”
NORML concludes: “For years, producers of these products have navigated in a gray area of the law—manufacturing products of variable and sometimes questionable quality and safety.” Now it is time for the FDA to give CBD producers clarity about maximum dosages, potential drug interactions, and what accurate labeling looks like.
12:45 p.m. — The hearing has paused for lunch until about 1:30 p.m. Eastern. We’ll be back when things start up again.
CBD Is Safe, but Claims Need to Be Based in Science
12:40 p.m. — Najla Guthrie, president and CEO of Canadian research organization KGK Science, which has conducted research into CBD and issues such as sleep, anxiety, and pain, shared some top-level takeaways around CBD efficacy and safety.
Guthrie noted that most clinical research has involved a wide range of oral CBD doses, ranging from about 100 mg to 800 mg per day. At those doses, the cannabinoid has shown low toxicity and no impact on embryonic development. Its effects on the brain also indicate that it has a near-zero potential for addiction, she said, with brain indicators that were “the exact opposite of what drugs of abuse do.”
While CBD is quite safe, she noted, “a pharmacologist might say that CBD is a dirty rather than a clean compound.” By that, clinicians mean that the cannabinoid “acts on a wide array of intercellular targets,” which could help explain why it’s seen as having so many uses.
Going forward, Guthrie suggested that the FDA allow “lawful” companies to make scientifically validated health claims and called for a separate, “standardized hemp-derived CBD symbol” that would identify products.
Let Brands Be Brands, Please
12: 20 p.m.— Yael Ossowski, deputy director of the Consumer Choice Center offers a five-point presentation that we hereby propose all speakers adopt going forward. It’s just so clear. Nice work, Yael.
Ossowski is on the side of consumers, and he wants:
- Clear labeling standards.
- Branding and advertising of CBD goods. “We have to allow companies and brands to exist,” he says. “That’s the only way consumers can differentiate between good products and bad products.”
- Appropriate age restrictions. Don’t throw a blanket 21+ rule on all CBD products. That doesn’t make sense. Consider the difference between smokable products, and edibles, when thinking about age restrictions.
- Allow companies to communicate and provide evidence for health claims.
- Learn from Canada: Don’t allow some ingestion forms while prohibiting others. Canada allowed smokable cannabis but not edibles in 2018. (Edibles are expected to come onto the market in late 2019.) That forced consumers to smoke. “Allow CBD to be infused in products, allow consumers to ingest it in the least harmful way possible,” says Ossowski.
Consumers Report: We Like CBD!
12:15 p.m.—A groundbreaking survey from Consumer Reports indicates CBD is helping millions of Americans with stress and pain. Though it appears US citizens are overly trusting of their CBD brands’ purity.
In a telephone survey of 4,355 adults, Consumer Reports found that an estimated 64 million Americans have taken CBD and 63% found it effective.
“The majority of people told us they found it effective for the thing they were trying to treat,” Gill told the FDA today.
Most powerfully, one in five CBD users stopped taking prescription drugs, and one third of CBD users stopped taking opioids—America’s number one drug overdose source.
Americans report mostly using CBD for anxiety, followed by joint pain. In terms of side effects, CBD was making people hungry or sleepy.
A large chunk of Americans are getting their CBD from a good source—40% of respondents got their CBD from a dispensary. By contrast, 25% were buying CBD online, where quality varies widely and products can be laced with dangerous chemicals.
Most Americans care more about price than purity, too. Only 13% of respondents said their chief concern was safety. Most said their concern was price. Half of respondents were very confident that regulations were in place.
It’s clear Americans use CBD, like CBD, and expect the FDA to be keeping their CBD pure.
US Has a Kafka-esque Research Approval Process
11:40 a.m.—Researcher Elise Weerts testifying in front the FDA today made it crystal clear how insane cannabis research is in America.
She’s a DEA-approved researcher of Schedule I controlled substances, but she faces at least eight or nine levels of approval before she can touch cannabis.
By contrast, “my 21-year-old son can walk into a store and buy [any cannabis product] and I cannot. I cannot purchase, store, or test that product. It is illegal for me to do so. Because I am following the regulations of the DEA or FDA,” she said.
“It’s a very circular process and can take months and months. But it does bother me my 21 year-old kid could take it and I can’t touch it—unless I’m consuming.”
"I have a DEA Schedule One license to study cannabinoids. My 21-year-old son can walk into a store and purchase it, I cannot. That's really it in a nutshell." Powerful summary of the problem with #CBD regulation from Elise Weerts of .@CPDD19 #FDACBDHearing #Cannabis
— Raj Chander (@raj_chander) May 31, 2019
Reefer Madness Is Alive and Well
11:37 a.m.—Because it adds nothing to the discussion, we are generally ignoring the people who get up and spend their two minutes railing against the demon weed. But you should probably know that they’re here, and they’re unleashing the same old ridiculous claims we’ve heard for decades. I just heard one guy say: “The reality is, these people are criminals.” I think he was referring to us here at Leafly—oh no, wait, he was referring to everyone in the legal cannabis industry.
One woman in the past hour told the FDA, in all seriousness, that no other drug, “including heroin,” comes close to the damage caused by marijuana. Tales of psychotic ER patients, addiction, and suicide dominate these narratives. “Don’t believe the marijuana billionaires and their deceitful campaign,” one woman said. “I beg the FDA not to reclassify THC or CBD.”
For the record: The FDA does not have the power to reclassify THC or CBD. They are here to gather information for future FDA regulations regarding CBD products only.
So—we’ll ignore the crazy talk, but you should know that these folks are still out there and federal officials are hearing them.
#FDACBDhearing impressions: In general, speakers are concerned about the lack of regulatory guidance and relevant research to support such guidance were it to be given. It’s unfortunate that decades of prohibition have made such supportive research impossible.
— Morgan Hopkins, CPA (@totheMORGan) May 31, 2019
Hallucinating on Fake CBD
11:20 a.m.—Michelle Peace, a forensic toxicologist from Virginia, warned the FDA this morning that Americans are being poisoned by fake CBD products bought online and in places like truck stops in Virginia.
She recited a list of poisonings where her lab was able to obtain a sample of the drug the subject took. Products advertised at “100% CBD extracts” were found to contain a variety of dangerous chemicals, including dextromethorphan, which is found in cough medicine and can cause hallucinations.
Other products advertised as CBD have been found to be laced with “synthetic cannabinoids”—those are man-made variations on THC and other natural cannabinoids, which can be very dangerous.
Peace detailed an instance of a CBD product laced with dangerous synthetic cannabinoid “5F-ADB,” which is associated with emergency room overdose deaths in Europe.
Peace described a 79 year-old woman who had been hallucinating for days after she took a product that claimed to contain CBD, but was actually laced with a synthetic cannabinoid. Her grandchildren had told her to take CBD for arthritis.
Many of the drugs laced into fake CBD are so exotic, they won’t show up in standard drug screens at poison control clinics, Peace said.
Does It Really Contain CBD?
11:00 a.m.— Bill Gurley from the University of Arkansas’ College of Pharmacy airs some depressing but not surprising results from a survey his team did of CBD products purchased in Mississippi.
They had more than two dozen CBD products tested in their lab. Basically they found labeling fraud in nearly every single one. Some had no CBD whatsoever. Other products had more than twice as much as labeled. The variety was all over the map.
Here at Leafly we’ve long known this to be true: The only products that are lab-verified, in which the product in the bottle matches the claim on the label, are those sold through state-licensed cannabis dispensaries.
Bill Gurley/U. of AR for Medical Sciences, College of Pharmacy: Study of products on the market in MS found wide variability in terms of what product purported to contain and their actual #CBD and #THC content. #FDACBDhearing pic.twitter.com/toVSSxWN4A
— Jonathan A. Havens (@RegulatoryAtty) May 31, 2019
Hot Topicals Question
10:58 a.m.—Longtime medical cannabis researcher Dr. Igor Grant of UC San Diego told the FDA this morning that, to his knowledge, medical science has no idea if cannabis rubbed on the skin works.
“We have no idea if these products are absorbed or are effective,” he said.
He implored the FDA to cut some of the red tape around researching cannabis, so scientists can catch up to what the public is doing.
“There is a kind of slowness that can be improved,” he said. “We are rapidly getting behind the curve in terms of what is happening in the real world and what patients are utilizing.”
Dr. Grant has run the Center for Medical Cannabis Research at UCSD for many years. His center proved the efficacy of THC for neuropathic pain. The molecule’s toxicity is “certainly no worse” than other pain drugs.
In lieu of faster federal research approvals, Dr. Grant said he’s turning to end-use survey data, especially in concert with other state agencies in California.
Consider Drug Interactions
10:56 a.m.—Barry Goodell from the University of Wisconsin raises the question of unintended consequences and CBD’s interaction with other drugs.
“It really wasn’t until the FDA’s Epidiolex clinical development program that we began to really appreciate and understand the clinical ramifications of these drug interactions,” he says. That program focused on interactions with anti-seizure drugs, but “the effect of CBD on other drugs may go beyond just anti-seizure drugs.”
Barry Gidal, @UWMadPharmacy – potential for significant CBD drug-drug interactions via CYP450 pathways. Warfarin’s active enantiomer goes way up, so INR elevated with CBD. Also, recent case report of elevated tacrolimus levels with CBD. @MDEdgeTweets #CBD #FDACBDhearing
— Kari Oakes (@KariOakes) May 31, 2019
Looking for Adverse CBD Effects
10:17 a.m.—One theme that’s emerging: FDA officials are very interested in finding any data on adverse effects related to CBD. I don’t think they’re focusing on this in a biased way, like they’re looking for any dirt they can find on CBD. It’s more that preventing harm to public health is their first duty—actual efficacy of the product, really, is secondary or in some cases not even their concern—and I think they want to be very clear, transparent, and lay down a public track record in which they’re seeking any and all data regarding potential harm.
So far, a number of the panelists’ follow-up questions have come in this area. They’ve asked doctors, hemp-based CBD manufacturers, and grocery store industry reps about any data they have regarding negative interactions between consumers and CBD.
One doctor said he’s seen no major negative side effects, and the FDA official pressed him. “What about minor side effects?” The doctor recalled only a mild headache, or fatigue as relatively rare side effects he’s seen.
Meg Olsen/@CRN_Supplements: #FDA doesn’t have luxury of time. 3-5 years is far too long. Products are already flooding market. Already regulation and authority in place. Q: Can you provide data on safe dosages? Esp. for specific forms. A: Yes, we’ll submit. #FDACBDhearing
— Jonathan A. Havens (@RegulatoryAtty) May 31, 2019
Pharma Researcher: Let Us Work
9:16 a.m.—Robert Discordia, a vice president at Corbus Pharmaceuticals, tells the FDA panel that his company has been developing a drug that uses synthetically created cannabinoids to treat cystic fibrosis and two other serious conditions. But because cannabinoid-based products have been treated as Schedule I drugs, Corbus has experienced significant delays and difficulty in developing the drug. And “it’s not medical marijuana,” he says. “It focuses on immune systems outside the brain.” The drug is more than a year behind, in terms of development, where it would be if the federal government’s illogical classification of cannabis was not in place.
Discordia’s points are valid and well taken, but they might be more effectively delivered to the DEA and the Dept. of Justice, which hold the keys to Schedule I status. Still, I’m glad he’s here raising these issues with the FDA to make sure they don’t over-regulate CBD and create similar problems for other companies developing cannabis-derived drugs.
Correction: Corbus products are synthetically produced and are not derived from cannabis.
First Laetrile Reference
At 8:42 a.m. we have our first Laetrile reference, from Russell Kamer, a doctor who represents a group called Partners in Safety. The great cancer cure that wasn’t, Laetrile exploded in the 1970s as an underground, unregulated product that was supposed to have amazing health benefits for people struggling with cancer. Turns out, it didn’t. You can read all about it here. Believe me when I tell you this won’t be the last reference to Laetrile we hear today.
“CBD is sold in an even less regulated way” than medical marijuana, Kamer complains. And he’s right. In most legal medical states, medical cannabis is highly state-regulated and in the best states is subject to lab testing for potency and purity. That includes CBD products sold by state-licensed companies. CBD products sold outside those regulated systems have none of those safeguards for consumers. “As a practicing primary care physician,” Kamer says, “every day I see a patient who is taking CBD. Some purchase online, at a gas station, or even at flea markets. Most of these products have no independent lab analysis.” Again, true.
Kamer urges the FDA officials to not allow CBD to become “a successor to laetrile,” and implies that it is “the next challenge of quackery.”
Grocers to Dermatologists, They’re All Here
To give you an idea of the incredible variety of speakers giving their elevator pitches to the FDA, here’s a screenshot of the speakers appearing in just one 20-minute segment:
Marijuana Victims Testify
8:35 a.m.—Members of a group called the Marijuana Victims Alliance seem to be out in force at the hearing, and it feels like we’re going to be hearing their stories throughout the day. They’re all wearing the same t-shirt, for one thing. A woman whose 25-year-old son killed himself tells the FDA panel her story: “My son was the consumer. His suicide note said ‘Marijuana destroyed my soul.'” Her son Andy, she says, was a medical marijuana patient, and “I want you to know the devastation marijuana has brought to our family,” she says.
This is a heartbreaking story, and full sympathy to this person. At the same time, this hearing is about CBD, not THC, which is non-intoxicating and has no known addictive properties, according to the World Health Organization.
Importance of the WHO Report
8:27 a.m.—A speaker from the US Hemp Roundtable references the World Health Organization’s 2018 review of CBD, which found it safe and non-addictive. I wouldn’t be surprised to hear that report referenced as a touchstone throughout the day today. It’s a big one—the clearest endorsement of CBD’s safety (if not efficacy) by the UN’s globally known and trusted health agency.
It’s Not Just About CBD Patients
8:25 a.m.—We here at Leafly tend to focus on the importance of CBD to medical patients, but there are a lot of stakeholders here representing other aspects of the product, from hemp farmers to veterinarians. Early on here we’ve got a run of speakers advocating for Virginia hemp farmers, who see their colleagues over in Kentucky prospering with their hemp fields and want a piece of that action. Somebody from the Hemp Feed Coalition talks about the growing use of hemp as forage for stock animals. It’s fascinating to see who this hearing brings out of the woodwork.
Tough to Dose
8:19 a.m.—Tory Spindle, a Johns Hopkins University researcher who’s done a lot of work on tobacco vaping, cannabinoid compounds, and various drug delivery systems, tells the FDA panel that dosing cannabis-derived products will be extremely difficult. He notes the differences in delayed onset between smoking, vaping, and edible ingestion. This is fairly well known, but seems like a good bit of foundational information early in the session.
‘Maelstrom of Claims’
8:17 a.m.—Peter Pitts, president of the Center for Medicine in the Public Interest, starts the public comment period with a full two-minute blast against what he calls the “aggressive and misleading marketing campaigns” around CBD, with its “maelstrom of claims and shoddy standards.” There’s no dosing data, no production quality standards, nothing known about harm or help regarding chronic long-term use of CBD, he adds. “We know nearly nothing,” he says.
FDA Commissioner: FDA Will Act
8:00 a.m. EDT — And we’re off! The meeting opens with remarks from acting FDA Commissioner Ned Sharpless. Sharpless stepped into the job recently, after Commissioner Scott Gottlieb stepped down earlier this year. (Gottlieb’s interest in CBD actually led to this hearing; previous FDA commissioners had ignored it, but Gottlieb recognized both the potential benefits and risks, and spurred the agency to action, so honestly it’s a shame he couldn’t be here for this.)
Sharpless, former director of the National Cancer Institute, delivers some smart, sharp notes. He opens by correctly and easily pronouncing both delta-9 tetrahydrocannabinol and cannabidiol, which is something 99% of most lawmakers fail to do. So that inspires confidence.
Today, FDA is holding a public hearing to obtain scientific data & info about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis/cannabis-derived compounds. Read my opening remarks: https://t.co/nW1AcksKVp pic.twitter.com/G9Gh5eG0I4
— Dr. Ned Sharpless (@FDACommissioner) May 31, 2019
“Hemp is no longer a controlled substance under federal law” due to the passage of the 2018 farm bill, he notes. And the farm bill specifically called out the FDA’s regulatory authority over hemp and hemp-derived products, specifically drugs and food products.
Sharpless makes clear this is not a mere curiosity for the FDA. The agency has a number of senior officials working on this, and looks to be on a path to create significant, long-lasting federal regulations on CBD.
No Drugs in Food
Sharpless brings up what could be a really important point: “Federal law prohibits drugs from being added to food.” CBD is clearly a drug, he says. The FDA last year approved Epidiolex, which is essentially pure CBD, as a prescribed drug. What that means, he says: “CBD and THC cannot lawfully be added to food or marketed as a dietary supplement.”
This seems important.
Sharpless also has a number of questions he’d like answered. How much CBD is safe to consume in a day? How does it interact with other drugs? What if a pregnant woman takes it? What if a child consumes it? “These questions represent significant gaps in our knowledge,” he says.
The FDA has an internal working group looking at these and other issues, he says. Members of that working group are here today on the 10-member FDA panel hearing comments.