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A round of warning letters reiterated FDA's stance that cannabidiol (CBD) can't be marketed in dietary supplements, leaving unanswered the question of whether the agency will move to shut down companies that continue to promote their products as supplements.
February 12, 2016
FDA is cracking down on marketers of CBD in warning letters that may not bode well for consumers like Darrell Burns.
Sixty-two-year-old Burns has suffered nerve pain for the last 20 years. Burns, who has endured 12 surgeries on his peripheral nerves and taken a number of experimental medical drugs, began trying CBD last year to help treat his condition.
“I found the CBD oil worked even better [than other treatments], was cheaper, had less potential side effects," the Kansas City, Missouri resident said in a phone interview.
Burns is among a growing number of Americans who have found CBD to be beneficial in treating a variety of ailments from epilepsy to pain. About six weeks ago, he ordered US$600 in CBD oil.
“It gave me better total body relief than anything in the last 10 years I have tried," he said.
But Burns’ supplier of CBD oil now finds herself in the crosshairs of federal regulators. Karen Butler, who operates a number of websites including one that markets CBD oil and put our publication in touch with Burns, recently received a letter from Ilisa Bernstein, an FDA official in Silver Spring, Maryland.
FDA advised Butler of PainBomb LLC that claims on her websites and literature render her products unapproved drugs. What’s more, although Butler markets her “35.5% Cannabidiol" as a dietary supplement, FDA has concluded CBD products are excluded from the definition of a dietary supplement.
Butler is not alone. The letter to her was part of a batch of eight letters delivered to marketers of CBD, a hemp-derived product that the Drug Enforcement Administration (DEA) still considers a marijuana derivative and Schedule I drug in spite of certain state laws that have legalized medical marijuana and CBD in particular.
FDA’s stance in the warning letters is consistent with its position in a question and answer webpage that was posted last year on medical marijuana. But the warning letters, dated Feb. 4, leave unanswered the question of whether regulators will move to shut down marketers that continue to sell CBD in dietary supplements.
Michael Felberbaum, an FDA spokesman, declined to comment beyond the letters.
In several letters, FDA stated its conclusion that CBD products are excluded from the definition of a dietary supplement because CBD is the subject of substantial clinical investigations that have been made public. The agency referenced GW Pharmaceuticals’ investigations concerning two medicines, Sativex and Epidiolex. Although FDA acknowledged an exception if CBD was marketed as a dietary supplement or conventional food before the drug investigations were authorized, the agency concluded CBD doesn’t meet the exception.
“FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition … but you may present FDA with any evidence that has bearing on this issue," Berstein wrote to Butler.
Butler, a resident of northern New Mexico, is peeved the drug trials are the supposed reason she can’t market her CBD as a supplement.
“Who tests for 8 ½ years?" she said in a phone interview, referencing GW Pharmaceuticals’ trials. “During that time, we are supposed to not have access to CBD? That’s ludicrous."
She said the pharmaceutical drugs being studied bear no resemblance to her products.
“They are not using the same products as any of us are selling," said Butler, who noted CBD includes very little THC, the psychoactive ingredient in marijuana. “I don’t care when they started their stupid study."
Stephen Schultz, vice president of investor relations with GW Pharmaceuticals, said the company’s drug Sativex—a mouth spray that is roughly half THC and half CBD—has been approved in 28 countries outside the United States for spasticity due to multiple sclerosis. In 2013, the company announced the opening of a phase 3 investigational new drug (IND) application with FDA to evaluate Sativex.
London-based GW is coming to the end of phase three of the clinical trials on Epidiolex, which Schultz described as a “pure CBD compound" that is used to treat Dravet and Lennox-Gastaut syndromes, rare forms of epilepsy. Phase three includes four placebo-controlled trials.
“We will actually communicate the results of those trials beginning in March," he said Friday in a brief phone interview. “We will be able to know for sure what the efficacy and safety of … pure CBD is because we’ll know that against the placebo."
He said GW anticipates filing an application for a new drug in the fourth quarter of 2016.
CV Sciences, Inc., formerly known as CannaVest Corp., a wholesale supplier of CBD, disagreed with FDA's conclusion that the drug trials preclude CBD from being marketed as a dietary supplement.
“Despite the FDA’s Q&A Posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, as the investigations that were publicized were not substantial, due to being limited in number and preliminary in nature, thereby rendering the IND preclusion inapplicable," said Stuart Tomc, the company's vice president of human nutrition, in an emailed statement.
"We produce products from outdoor grown agricultural hemp that contain fatty acids, phytocannabinoids, terpenes, plant sterols, chlorophyll and naturally occurring vitamin E, with no other ingredients," Tomc added. "It’s clearly a botanical extract, not a pharmaceutical drug.”
Richard Richardson, the CEO of Dose of Nature in Provo, Utah, one of eight CBD marketers who received a letter from FDA, also referenced possible distinctions between his CBD and the medicine under drug studies. He expressed an understanding that the drug trials applied to “purified" rather than “naturally occurring" CBD.
“The products of Dose of Nature have been formulated using refined hemp oil that is produced from commercial hemp plants grown in Europe," Richardson said in an email to Natural Products INSIDER. “This oil contains naturally occurring trace amounts of CBD, but not in the concentrations that are found in pure CBD crystals or powder."
The medical community is still studying the pros and cons of CBD. While the American Epilepsy Society has cited “promising results" of a phase two study of Epidiolex, the organization said further studies are needed to confirm the results. And in a recent letter to the Nebraska Legislature and state Sen. Galen Hadley, the American Epilepsy Society contrasted GW’s CBD with the “artisanal cannabis products" in Colorado and other states where CBD is legal. The letter referenced a study by a team at Children’s Hospital of Colorado.
“This study found that artisanal ‘high CBD’ oils resulted in no significant reduction in seizures in the majority of patients and in those for whom the parents reported improvements, these improvements were not associated with improvement in electroencephalograms (ECGs), the gold standard monitoring test for people with epilepsy," American Epilepsy Society Director Michael Privitera, M.D., said in the Dec. 30, 2015 letter.
“Additionally, in 13 percent of cases reviewed seizures worsened with use of cannabis and in some patients there were significant adverse events," added Privitera, professor of neurology at the University of Cincinnati (UC) and director of the Epilepsy Center at the UC Neuroscience Institute.
That hasn’t stopped marketers from touting the purported medical benefits of CBD. In the warning letters, FDA cited literature associating CBD with the treatment of such diseases as arthritis, autism, AIDS, cancer, multiple sclerosis and schizophrenia. Even if FDA considered CBD a legal dietary supplement, marketers of supplements are not supposed to make drug or so-called disease claims.
“The claims on your websites and accompanying literature establish that the products are drugs … because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease," FDA advised PainBomb’s Butler.
Butler said she is amending her websites and literature; Richardson also said his company “will take all necessary steps to comply" with FDA.
“I have shipped to many countries," Butler said. “I have distributors everywhere. I’m going to have to call all of them and update all their brochures."
This isn’t the first time FDA has targeted CBD marketers. About one year ago, the public health agency advised six companies in warning letters that statements on websites, social media and product labels established the products were intended to treat diseases, which rendered them unapproved new human or animal drugs. FDA tested the products and found seven of them didn’t even contain the chemicals that are found within the Cannabis sativa plant: cannabinoids.
FDA’s recent warning letters were sent to ABC Productions, Dose of Nature, Green Garden Gold, HealthyHempOil.com, Michigan Herbal Remedies, Morguetorium LLC, PainBomb and Sana Te. A number of the companies didn’t respond to requests for comment.
Said Richardson: “We hope to see further clarification from the FDA regarding the status of both pure CBD isolate and the naturally-occurring CBD in whole plant hemp extract in the future."
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