If you went into a coma in 2009 and woke up in 2019, you’d likely have a lot of questions. When did every person on earth get a smartphone? Why is a reality TV star president? Why is it so hot in the summer? And after a walk through any grocery store or gas station in Seattle, what the hell is CBD?
Unless you were a hardcore cannabis enthusiast, you probably didn’t know what CBD was prior to 2010. Over the past decade, accounts of CBD, AKA cannabidiol’s, miraculous healing properties have trickled into the mainstream. You name the ailment, and CBD has been lauded as a cure for it.
While CBD has proven to be an effective treatment for certain ailments, even the most staunch believer has to admit, the marketplace is getting pretty saturated. And with something marketed as a health product, with no regulations, saturation can be poisoned by bad actors. Which is why the FDA wants to step in.
“While we recognize the potential benefits of CBD, questions remain regarding its safety,” Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, and Lowell Schiller, J.D., Principal Associate Commissioner for Policy wrote in a joint statement. “During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. Furthermore, unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases — can lead consumers to put off getting important medical care.”
The drug mentioned in that statement, Epidiolex was approved by the FDA as a treatment for Dravet syndrome, a severe seizure disorder, in June of 2018. CBD has some sound science behind it as a treatment for epilepsy and epilepsy-related conditions.
The Journal of Epilepsy’s December 2017 article “Cannabinoids in the Treatment of Epilepsy: Hard Evidence at Last?” concluded,“The results of these studies demonstrate that, at a dosage of 20 mg/kg/day, CBD added on to pre-existing AED treatment is superior to placebo in reducing the frequency of convulsive (tonic-clonic, tonic, clonic, and atonic) seizures in patients with Dravet syndrome, and the frequency of drop seizures in patients with Lennox-Gastaut syndrome.”
But what about the huge number of CBD products out there that aren’t FDA regulated, or regulated at all? The FDA identified other risks to an unregulated CBD market as well.
“The FDA also tested the chemical content of cannabinoid compounds in some of the products [not approved by the FDA], and many were found not to contain the levels of CBD they claimed to contain.” The statement reads.
In addition to CBD levels being inaccurate, or falsely labeled, a recent report by CBS Austin revealed that a lab tested 240 popular CBD products for 300 contaminants and CBD levels. The results found that ‘70 percent of products were found “highly contaminated” with heavy metals like lead and arsenic, herbicides like glyphosate (the active ingredient in RoundUp) and a host of other contaminants including pesticides, BPA and toxic mold.’ Some of the products tested were found to have no CBD whatsoever.
CBD can be derived from hemp, and hemp is now federally legal, which is another likely reason the FDA is willing and able to regulate CBD products. It’s clear that some kind of regulation of CBD products is necessary, but is the FDA the right agency for the job?
Mallory Wiebe, owner and founder of Wee Bee Kind, a “CBD Herbal Apothecary” out of Humboldt County, CA spoke with The Sesh about her thoughts on FDA regulation.
“Some CBD producers, regardless of what they say, are making products with synthetic CBD, imported CBD, with heavy metals and pesticides, or sometimes even none at all,” Wiebe explained. “So when it comes to regulating that aspect, I’m totally down. It’s so expensive, and there is snake oil everywhere, everybody has it. And a lot of the time, the products aren’t what they say they are.”
According to its website, Wee Bee Kind’s products use CBD oil that is co2 extracted from California and Oregon-grown pesticide-free plants. But not everyone takes as much care to source their CBD ethically and responsibly. Still, Wiebe is weary of FDA regulation citing fears that a desire for profit is the motivating factor of regulation.
Herbal supplements are currently regulated by the FDA as dietary supplements, and it has a spotty history when it comes to regulating dietary supplements effectively.
When asked which ailments of her customers seemed to improve the most with the use of CBD, Wiebe pointed to inflammation and anxiety.
Science is beginning to support these types of assertions. The abstract of the study “Cannabinoid Delivery Systems for Pain and Inflammation Treatment” in the journal, Molecules, reads: “There is a growing body of evidence to suggest that cannabinoids are beneficial for a range of clinical conditions, including pain, inflammation, epilepsy, sleep disorders, the symptoms of multiple sclerosis, anorexia, schizophrenia, and other conditions.”
While more research is needed, it’s clear that CBD has the potential to be a massively effective treatment for all kinds of illnesses. That is only true if the medicine is sourced responsibly, tested, regulated, and labeled with accurate dosages, however.
Whatever consumers and producers may think of the FDA’s goal to regulate CBD products, they will soon do so. On May 31, the FDA held a public hearing to obtain scientific data regarding the safety of CBD. The public submitted thousands of documents. The comment period is now closed, and Dr. Abernethy announced via Twitter in mid-July, that the FDA would release its findings in late summer or early fall, after pressure from legislatures to expedite findings.
3/3 Over 100 speakers presented at the May 31st public hearing. There are 3417 comments on the public docket with 4 days to go. Please submit comments & data by 7/16/19. We plan to report on our progress around end of summer/early fall. https://t.co/EK3FxsPq0F
— Dr. Amy Abernethy (@DrAbernethyFDA) July 12, 2019
While the public waits for the FDA’s findings and regulations, it’s important consumers are careful about what they buy, and what they believe when it comes to CBD. Knowing where manufacturers source their CBD from is a good first step. Another potential for CBD regulation is to test at the retail level, akin to the OK Program in Washington state.
It’s clear that regulation of CBD products is sorely needed. We’ll find out soon, one way or another, how effective the FDA is in their efforts to regulate a plant-based medicine like CBD.