If there has been one unexpected development to emerge from the marijuana legalization movement, it’s the popularity of cannabidiol, the non-intoxicating compound of the cannabis plant that is often referred to simply as CBD. What began as a super-secret medicinal component of the cannabis plant, one that Dr. Sanja Gupta told the world was a miracle cure for epilepsy, ended up finding its way to mainstream appeal through hemp-based supplements in various forms.
Not only can CBD be extracted from the cannabis plant, but it is also derived from industrial hemp. This is where the craze sort of took off to new heights because pop culture learned that they could use these kinds of products without the risk of being hunted down by police and sentenced to prison.
Hemp-derived CBD products, which are sold in the form of gummies, drinks and even suppositories, are now considered by a large part of the population to be a mighty, voodoo healer, of sorts, for conditions ranging from anxiety to chronic pain. Because the American population has a renewed sense of wellness (and perhaps a nagging fear of death), these products are being bought up online and at convenience stores and truck stops at a rate of lunatic enthusiasm that has this business sector on the brink of raking in somewhere in the neighborhood of $2 billion annually.
In other words, all of this CBD shit, regardless of whether it is real medicine or snake oil, is big business.
Yet something unexpected happened last year that has changed the landscape for CBD in a lot of ways — the federal government legalized industrial hemp production. Although the United States has imported industrial hemp for decades, the agricultural community has not had the freedom to cultivate this cash crop since it was lumped in with the nationwide ban on the cannabis plant back in 1937.
But the passing of the latest Farm Bill brought an end to this ban, giving farmers the opportunity to obtain a license to make hemp part of their plow and pick repertoire. But in doing that, there now seems to be some question of whether the CBD products that were sold last year can continue to be part of the market without the approval of the U.S. Food and Drug Administration (FDA).
In fact, just weeks after the Farm Bill was signed into law by President Trump, FDA commissioner Scott Gottlieb released some information that was mostly bad news for CBD manufacturers.
“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S,” Gottlieb said in a statement.
Basically, this means if a company produces CBD gummies and it claims that they will help with anxiety or any other condition, the FDA needs it to enter into the approval process that all pharmaceutical companies must endure before bringing a new product to market. Now the CBD sector is being forced to pump the brakes. Not only is the drug game an expensive one to get into – the cost to bring a medicine to market is in the billions of dollars – there are no guarantees that it will be approved. Only 12 percent of those seeking FDA approval make the cut, because, well, they have to prove through a series of clinical trials that it is an effective treatment for a specific ailment.
Now, you might be thinking, I heard the FDA approved CBD at some point last year. Well, this is true to some degree, but the consent was not a far-reaching. GW Pharmaceuticals did receive FDA approval for its CBD-based epilepsy drug called Epidiolex. The drug has been proven “safe and effective” for the treatment of this disease and this disease alone and cannot be prescribed for any other condition, such as cancer. For that to happen, the company would have to show the FDA that Epidiolex can also help ease nausea and other nasty after-effects of chemotherapy treatments.
But in no way did the FDA provide CBD with the green light to be distributed all over the country for anxiety, pain or anything else for that matter. Its approval was exclusively for Epidiolex.
The CBD debacle has caused an uprising, of sorts, in states, like Maine, which recently imposed a ban on CBD products. Although marijuana is legal for recreational use statewide, officials with the state’s Department of Health and Human Services have ordered CBD edibles to be removed from shelves because the FDA has not given its seal of approval as a food additive. The new policy means that anyone wanting to use CBD edibles “medicinally” must enroll in the states medical marijuana program. Oddly enough, the state is still allowing health food stores and grocery stores to continue selling CBD items that can be smoked or vaped. Only edibles fall in line with the FDA’s rules.
In New York City, health officials recently banned CBD-infused beverages and food, citing the vaguely-worded FDA against food items that have not been federally approved.
“Until cannabidiol (CBD) is deemed safe as a food additive, the Department is ordering restaurants not to offer products containing CBD,” a spokesperson told Inverse.
Some lawmakers have petitioned the FDA in hopes that it will revise its policy on CBD products and allow them to carry on as they have over the past few years. Senators Ron Wyden and Jeff Merkley of Oregon sent a letter to Gottlieb last month demanding that the FDA change its policy on hemp-derived CBD, allowing it to continue being manufactured and sold without FDA approval. The letter suggests that CBD ban will present financial hardships rather than benefit, which goes against the intentions of the Farm Bill. Hemp and CBD producers are “poised to make real economic gains for their communities once these regulations are updated,” the lawmakers wrote.
In truth, all of this confusion surrounding the legality of CBD in certain aspects of modern day commerce is really just a product of continued federal marijuana prohibition. As long as the cannabis industry continues to try and claim that marijuana, regardless of whether it is CBD or THC or the combination of the two, has therapeutic benefits, those companies will be forced to back those claim up with the FDA. Yet, if Congress were to push legislation – like the 420 bill – and legalize the leaf nationwide like alcohol, this would take the regulatory affairs out of the hands of the FDA entirely. At that point, people could use cannabis derivatives for any reason they see fit.
But until that happens (or until the FDA makes some revision in its policy) CBD manufacturers can be expected to endure some challenges. It remains to be seen, however, just to what extent those troubles will lead.
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