A significant move has been made in the cannabis game that seems to have greater implications than the certain players intended. Following the approval of Epidiolex by the FDA in June, the DEA rescheduled approved cannabidiol (CBD) drugs in late September to allow GW Pharma to exclusively sell their product. In a carefully orchestrated and highly restricted move that benefits pharmaceutical corporations while blocking CBD supplement companies, the DEA and FDA may have made a strategic slip-up.
Just over a month ago, the DEA made a major move to reschedule CBD. This move has significant impact on cannabis consumers access to CBD-based therapies.
The Cannabis Consumers Coalition took some time to digest this critical change and think about its impact on the growing cannabis industry, and the future possibilities of businesses emerging to provide products to consumers for both adult use and medical uses. We see two distinct cannabis consumers with some overlap. Many consumers who use cannabis for recreational purposes also use cannabis for wellness, but not necessarily medicinally. An example would be using cannabis as a recovery supplement after finishing an intense workout, versus using cannabis as part of a treatment for a medical condition.
Why is the rescheduling of CBD so important?
By moving a cannabis derived CBD drug from Schedule 1 down Schedule 5, the DEA may have also opened the door for CBD supplement manufacturers in the short-term and cannabis legalization in the long-term. The fortuitous mistake was making such a dramatic rescheduling. In one drastic shift from draconian Schedule 1 to the lowest possible Schedule 5, the DEA dropped all pretense that there is a public threat from CBD made from cannabis or hemp and finally admitted there is holistic benefit. The radical downgrade to Schedule 5 acknowledges that CBD does not fit the criteria for Schedules 1-4 and has been mis-scheduled all along.
The government has finally affirmed that the cannabis compound CBD: (a) has currently accepted medical use in the United States; (b) does not have a high or medium potential for abuse; and (c) is considered neither a narcotic, stimulant nor depressant. It is also noteworthy that the FDA and DEA did not define whether CBD formulations must be cannabis or hemp derived. This fundamental scheduling shift legitimizes CBD and offers a repositioning opportunity for the cannabis industry on a federal level. Although the current scheduling shift is limited to approved CBD drugs and there are still obstacles to overcome, we believe cautious optimism is the best approach to making positive change for the cannabis industry. Having worked as advocates for the cannabis industry for many years, we’re well aware that policy change happens gradually and requires the foresight to capitalize on small breaks to effect larger outcomes.
Why aren’t all CBD products descheduled?
The DEA is taking the perplexing stance that only one CBD formulation fits the definition of Schedule 5 but all others are still Schedule 1. It’s not even clear why CBD remains in Schedule 5. A category that formerly only included narcotics, stimulants and depressants has been amended to squeeze in CBD. According to the new wording: “Schedule 5 includes narcotics, stimulants, depressants and “approved cannabidiol drugs.” Again, the DEA is admitting that cannabis derived CBD has accepted medical use, a low potential for abuse, low risk of dependence and is neither narcotic, stimulant nor depressant. If the DEA is acknowledging that cannabis derived CBD is safe, effective and does not fit the definition of a controlled substance, why is it still scheduled? Further, by admitting that CBD has health benefits, the DEA is also acknowledging that cannabis no longer fits the definition of Schedule 1. It is highly problematic to argue that a compound derived from a traditional healing plant has health benefits but the plant as a whole does not.
Now that the government is finally admitting cannabis has medical benefits and poses low risk, continuing to schedule this safe, traditional herbal remedy while leaving highly addictive, harmful substances like nicotine unscheduled is indefensible. It takes a mind-boggling act of denial to ignore the historical evidence supporting responsible use of cannabis as an herbal supplement to boost health and wellness.
Why is the government trying to block companies from selling CBD as a dietary supplement?
The role of the FDA and DEA is to protect the public. They’ve acknowledged CBD has health benefits and low risk so why is it not available to the general public as a supplement? Since the DEA has acknowledged that CBD does not pose a public safety risk, why is an effective herbal remedy being restricted from wider public consumption? The FDA has a secondary argument that cannabis products containing THC and CBD are excluded from the dietary supplement definition because the ingredients are being used and/or investigated as drugs. The problem with the exclusivity argument is that there are plenty of plants that are used as medicines and in other products. There are many traditional herbal remedies that have been rediscovered by modern pharmaceutical companies. They isolate compounds to transform natural holistic plants into targeted medicines. For example, theobromine which is derived from cacao is sold as a supplement and used as a pharmaceutical ingredient. Cacao is actually an ancient healing plant considered sacred in many cultures that is still used ceremonially as well as for medicine, supplemental energy and in food. Some other examples of healing plants that are both sold as supplements and provide chemical compounds for prescription drugs include chamomile, psyllium, goldenseal, gotu kola, periwinkle, rauwolfia, turmeric, valerian, and white willow. So, the FDA’s argument lacks merit that a safe, effective compound derived from a traditional healing plant can’t be marketed as a supplement for general health and wellness because it is sold as a medicine to target a specific disease. There are plenty of precedents that plant-based drugs and supplements can coexist within the marketplace. This benefits the public by giving them the freedom to make their own health choices.
Fortunately, the FDA has left a loophole that offers an opportunity. “There is an exception...if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.”
Since the door has been left open, it is time for the cannabis industry to seize the opportunity. It is now more important than ever to submit evidence to the FDA (and the media) that cannabis has a long history as a traditional herbal remedy and was widely sold over-the-counter as an herbal supplement prior to 1937 in the U.S. Not only does this pre-date the current cannabis pharma drugs but it also fits the definition of a GRAS (generally regarded as safe) dietary ingredient that was “sold in the United States in a dietary supplement before October 15, 1994.” Eighty-one years later, the truth is finally being revealed that there were no public safety reasons for blocking the sale of cannabis as a supplement.
How can the cannabis industry transform this new development into a win-win?
The government has basically acknowledged that they erroneously scheduled cannabis products. It may have started with CBD but the whole house of cards can now be toppled. The FDA and the DEA are on shaky ground to reschedule CBD for a single product which may be why there is the disclaimer that the FDA is “not aware of any evidence” that would reveal the public safety argument is tenuous.
The trick here is to transform this opportunity into a win-win. Instead of the needless turf battle between seasoned cannabis players and the new pharma kids on the block, let’s all agree that there’s plenty of room for multiple players in the green game. The industry continues to grow domestically and internationally so it’s time to shift the paradigm, divide the territory and allow everyone to profit.
We recommend a few key steps to achieve this new conceptual framework to increase the momentum towards full federal legalization. First, instead of talking about “medical” and “recreational” cannabis, we pivot to “medical” and “supplemental” cannabis. These rebranded categories fall in line with the FDA’s drug and supplement categories to empower the legalization argument. By rebranding from “recreational” or “adult use” to “supplemental use,” we promote a traditional herbal remedy and encourage responsible consumption. Recreational consumers will still have access to products as supplements to enhance their well-being while the semantic change offers a healthier way for them to approach cannabis. This rebranding will make the idea of legalization more acceptable politically since it focuses on people’s freedom of choice to enhance their health and wellness.
By following this distinction between medical and supplemental use of cannabis, the pharmaceutical companies are protected and can ensure their market. As established by the FDA, only drugs approved to treat specific diseases can market their products with disease claims just as Epidiolex has been tested and approved by the FDA to treat a specific form of epilepsy. The supplement companies can only market their products according to the FDA and FTC guidelines with the disclaimer that they are “not intended to diagnose, treat, cure or prevent any disease.” The FDA has only been targeting companies selling CBD supplements that are making medical claims. The solution is to stop making unsubstantiated claims and follow FDA supplement marketing guidelines. The onus is also on supplement manufacturers to follow labeling guidelines, good manufacturing practices (GMP) and FTC marketing restrictions. This carves up the market and ensures the public interest is served with safe drugs and supplements.
Second, we submit evidence to the FDA and educate the public on the holistic history of cannabis to make a clear case for the same status as other traditional herbal remedies. Cannabis has been used for thousands of years as an herbal remedy with particular evidence from recent centuries in Traditional Chinese Medicine (TCM), Indian Ayurveda, as well as in the U.S. as an over-the-counter health supplement.
Third, we focus on the complete descheduling by the DEA of all CBD formulations and revision of FDA guidelines to allow the marketing of pharmaceutical drugs targeting specific diseases and herbal supplements for structure and function claims only. This includes petitioning the FDA to grant GRAS status with clear evidence that prior to 1937 cannabis was sold as an herbal supplement.
Fourth, we follow the same approach for cannabis products containing THC with the two-track approach of medical use and supplemental use. Again, supplement marketing must avoid all disease claims but can follow traditional claims. According to the FTC: “Claims based on historical or traditional use should be substantiated by confirming scientific evidence, or should be presented in such a way that consumers understand that the sole basis for the claim is a history of use of the product for a particular purpose. A number of supplements, particularly botanical products, have a long history of use as traditional medicines in the United States or in other countries to treat certain conditions or symptoms.”
Welcome to the new win-win strategy for the cannabis industry to provide safe, effective botanical products to improve the minds, bodies and spirits of consumers. Yes, it will take time but without vision and a big dose of optimism, we wouldn’t have made it this far with the majority of the public now supporting federal legalization. And we can finally evolve from the erroneous scheduling, controls, and groundless prohibitions to a more mature, inclusive industry that can compete in the international market.