The U.S. Food And Drug Administration (FDA) held its first-ever public hearing on the future of CBD derived from hemp last week. The event, which lasted 10 hours and could be seen via live stream, heard testimonies from more than 100 researchers, big pharma officials, advocates, manufacturers, and opponents. Topics covered included benefits, manufacturing, product quality, marketing, labeling, and sales of CBD-infused retail products.
The all-day discussions were “at times quite absurd with outlandish claims, inconsistent messages and an undercurrent of potential safety concerns,” according to ISI analyst Josh Schimmer.
My personal takeaway after tuning in for hours online was that the FDA is using regulations as a way to discriminate against dietary supplements in favor of Big Pharma and Big Corporations.
The saga continues.
CBD: Now You See It, Now You Don’t
According to Health Freedom News, “among the many provisions in the Farm Bill passed by Congress and signed by Barack Obama in early 2014 was Section 7606, which defines industrial hemp as distinct from marijuana and allows States to cultivate industrial hemp and CBD. Notwithstanding this law, the Drug Enforcement Agency (DEA) ignored it and on December 14, 2016 published a Final Rule that classified cannabis-derived extracts – including CBD oil – with their own category and code number to “better track these materials” but which effectively states that cannabis extract is a Schedule-1 narcotic. In fact, the Final Rule clearly reads, “[e]xtracts of marihuana will continue to be treated as Schedule I controlled substances.”
It was only five months ago in December 2018 that hemp was legalized in the Farm Bill, completely removing it from the federal Controlled Substances Act. And for a brief moment, it felt like we were no longer in Kansas anymore. That was tempered by the immediate release of a statement by the FDA that, “it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
According to cannabis attorney Rod Kight, this statement by the FDA is inaccurate. “Hemp extract as a food is an exception to section 301(ll) of the Food, Drug & Cosmetic Act notwithstanding that it contains CBD. This is because CBD is a naturally occurring constituent inherent in hemp, which has been marketed and used at least since the Civil War. The prohibition on marketing a drug in food applies only to a substance that is added to food and does not apply to a substance that is in food, even where the substance is identical to an approved drug. Additionally, hemp extract contains dozens of compounds and is not the same moiety as the FDA approved CBD drug.”
“When the farm bill passed last year, we were beyond thrilled,” adds Jonathan Miller who serves as general counsel to the U.S. Hemp Roundtable, a coalition of dozens of hemp companies. “It was a historic moment.”
After nearly four years of shutdowns and obstruction on the front lines of the CBD movement, HoneyColony itself became one of the first to sign on with Elavon/US Bank, the fifth largest bank in the nation. This allowed us to finally process orders for CBD products without the fear of repercussions.
The hemp industry meanwhile saw this as a green light and a burst of hemp-derived CBD products hit the market. About 65 million Americans have already tried CBD to date and 63 percent have found it effective, according to Consumer Reports. With big names from Martha Stewart to Kim Kardashian West now peddling CBD products, it’s safe to say that CBD has officially gone “mainstream.”
“This [new bill] ended a multi-decade prohibition on hemp,” added Miller.
But did it? Given the prior politics of CBD, I suspected that at any given moment another heavy big shoe would drop.
Sure enough, on May 15, 2019, US Bank backed out and dropped approximately 1,000 accounts, leaving many, including HoneyColony, scrambling for a processor, yet again.
The reason: financial institutions have not yet caught up with legal and regulatory compliance. Rules are still being drafted.
Big Pharma: The Perks Of Incubation
“The food with its strange evil tastes? Why should one feel it to be intolerable unless one had some kind of ancestral memory that things had once been different?” George Orwell, 1984
One could argue that the end game has always been for Big Pharma to squeeze the small players out in the dietary supplement space and gain dominion over an industry projected to be worth $20 billion by 2020.
Sounds Machiavellian I know. But consider: although CBD was set as a Schedule 1 in 2016, labeling it as having no medicinal properties, the government also patented cannabidiols as a neuroprotectant and antioxidant two decades prior, back in 1992.
In this light, of course, CBD derived from hemp needed to be removed as a Schedule 1 drug, which it was in September 2018; just three months after the FDA approved the first CBD drug: GW Pharma’s Epidiolex, used to treat severe forms of childhood epilepsy.
CBD “suddenly” possessed the medicinal properties (it really had all along). If it remained a Schedule 1 drug, it would never have been able to be prescribed.
Epidiolex’s key ingredient is CBD — albeit synthetic and isolated. The lifting of the federal ban (conveniently) places CBD under the regulatory purview of the FDA. Exactly where Big Pharma wants it.
The FDA has since warned companies that because CBD is now viewed as a drug, it cannot be added to food or beverages or marketed as a dietary supplement in interstate commerce. It would be like putting a drug like Ativan in salad dressing. The notion is ridiculous given the plant compound’s established healing profile.
CBD, Confusion & Misinformation
Since CBD oil is out of the bottle, so to speak, the FDA has agreed to provide pathways for regulatory approval. But will the rules be reasonable? Will they favor Big Pharma? And will the information on CBD be accurately reported on in the mainstream?
“Questions remain regarding the safety considerations raised by the widespread use of these products,” FDA officials wrote in a Federal Register notice about last week’s hearing. FDA Acting Commissioner Ned Sharpless kicked off the hearing by stating that “We’ve seen an explosion of interest in products including CBD, [but] there is much we don’t know.”
Wrong. Sharpless isn’t exactly on point. There’s a lot that we do know. Government officials and Big Pharma reps would just like the masses to think otherwise. However, the health benefits of CBD have been established by a variety of studies. Furthermore, the World Health Organization report found CBD to be safe and nonaddictive.
The irony is that government red tape is what stifles more independent research from going forward, to begin with.
Meanwhile, we’ve already seen misinformation in the mainstream (no longer a real surprise with reporters not doing any investigative digging, but regurgitating) positioning Epidiolex as the only prescription medication (read: safe brand) containing CBD.
For instance, Buzzfeed reported:
“The truth is, the only thing CBD may treat effectively — through clinical trials on humans — is severe forms of childhood epilepsy. All other claims are based purely on anecdotes.”
Many mainstream news outlets — post-hearing — are now making it seem like you’re putting yourself at risk if you buy a CBD dietary supplement because the hype outshines the science. This is what would be dubbed today as an “alternative fact.”
“Since this keeps coming up; for those of you that believe or repeat the falsehood that cannabis ‘simply hasn’t been researched,’ there is plenty of research,” says Master Herbalist Elizabeth Moriarty. “There are plenty of clinical trials in the US alone and in other nations as well.”
The rewriting of truth is reminiscent of Orwell’s 1984. (As a bonafide journalist with critical thinking skills, it’s incredulous to witness.)
CBD Derived From Hemp: Regulation & The Medical Mafia
While regulation and the welfare of the people are certainly vital, the FDA — a.k.a the medical mafia — is not exactly the poster child for safety. According to a 2011 report by the Institute for Safe Medication Practices, prescription drugs were associated with two to four million people in the U.S. that year, experiencing “serious, disabling, or fatal injuries, including 128,000 deaths.”
With this said, there is no question that there are a lot of shoddy products and slimy people in the CBD dietary supplement space that tarnish the industry. The abuse and greed in the marketplace paints a picture of negligence and gives the FDA justification to step in.
“The rapidly evolving hemp-derived CBD marketplace sadly includes a number of bad faith actors selling the equivalent of modern-day snake oil,” says NORML Political Director Justin Strekal.
Many of the speakers at the hearing underscored the need for quality testing and safety standards, as much of the CBD currently available is substandard or mislabeled with incorrect amounts of CBD or even THC, the intoxicating ingredient in cannabis; in addition, some products include impurities like pesticides and bacteria.
Currently, commercially marketed CBD-infused products are not subject to explicit federal regulations. As a result, many CBD products have 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 as containing unwanted and potentially dangerous adulterants as well as heavy metals and solvents.
“For years, producers of these products have navigated in a grey area of the law — manufacturing products of variable and sometimes questionable quality and safety,” concluded the National Organization for the Reform of Marijuana Laws ( NORML) a non-profit organization based in Washington, DC.
“Now it is time for 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.”
For those of us on the front lines of the CBD movement from the get-go, we recognize it’s up to responsible business owners to apply science to create quality and effective CBD products.
The FDA has set no timeline to regulate CBD products, and its evaluation is likely to continue over the coming months. Electronic or written comments will be accepted until July 2, 2019. To speak up, go here.