If you’re old enough to drive, you probably have already discussed or heard about the topic of marijuana. The stigma against marijuana, a.k.a. cannabis, is quickly disappearing at the rate of near extinction. But the largest market that has triumphantly emerged from this subject matter is the CBD industry, creating CBD products, such as CBD oils or CBD cream for sale.
Long gone are the days of awkwardly shady transactions of buying dimebags of pot from strangers you’d rather not meet again, or feeble attempts of baking weed brownies at your friend’s house. As this billion-dollar (soon to be multi-billion) industry rapidly expands--with no clear sign of stopping--more people are taking notice. And everybody wants in. But this transformative stage is largely dependent on how the Federal Drug Administration decides to regulate the CBD market.
What is CBD?
Cannabidiol (CBD) is the non-psychoactive component of marijuana that affects the body rather than the mind, unlike tetrahydrocannabinol (THC). The natural CBD extracts activate the cannabinoid receptors in your endocannabinoid system, which regulates your immune system and bodily functions, and minimizes the connection between your external and internal sensory receptors. This helps quiet the excessive electrical and chemical activities in your brain.
Alleviating the delicate bond between your sensory receptors can have therapeutic effects on your physical body and how your mind receives those messages. CBD oils and creams are commonly used to lower anxiety, reduce inflammation, combat insomnia, relieve pain, and even treat more severe medical conditions and illnesses, such as epilepsy. Although these are positive wins for the CBD industry for consumers and businesses, the principal issue of the industry’s fragile state is its lack of regulation.
Growing FDA Involvement
The claims of CBD oil for pain management doesn’t matter if evidential support and scientific data do not support them. Because CBD products are marketed as a drug--to treat illnesses or diseases as a therapeutic effect--then the FDA needs to get involved and treat it like a drug. CBD products are definitely treated as such because most users choose CBD as alternative natural medicine, like preferring pure CBD oil for pain over pharmaceutical drugs.
FDA involvement in cannabis products is not new, but their involvement and concern are blooming as an attempt to match the growth of the mushrooming CBD market. The FDA also recognizes the growing public interest and popularity concerning CBD products, but their top priority is and always will be the protection of public health and safety. The regulation of CBD products are not only necessary but now desired, amongst serious businesses to weed out other CBD companies that prioritize profit over quality.
Some concrete steps have proved that the FDA is regarding the cannabis-related products seriously. In 2018, they passed the Farm Bill, lifting legislative restrictions by no longer regulating hemp as a controlled substance. Soon after, the FDA gave Epidiolex its stamp of approval, marking an important milestone for the CBD industry. Epidiolex is a pure CBD oil that treats two rare forms of epilepsy.
The Transportation Security Administration (TSA) has even changed its rigid policy to allow passengers to bring Epidiolex on their flights, also extending to other CBD-related products. But they still restrict the possession of THC products.
And most recently, the FDA finally held its first public hearing regarding CBD in May, allowing CBD companies, stakeholders, the public, and government officials gather together to share ideas and listen to each other during the 10-hour long hearing. More than 400 groups and individuals applied to speak before the panel, and over 100 testimonials unfolded from the public.
A public docket is also available for comments and questions for FDA consideration open until July 2, 2019.
FDA’s Top Priorities and Concern for Regulation
Some CBD companies believe that the FDA is merely butting in to restrict the free market, but that is not the case. The FDA’s main concerns are to protect public health and promote safety, especially if you pause to consider corporations who prioritize personal profit over public safety.
One particular concern is that the widespread availability and accessibility in CBD food or dietary supplements could potentially decrease commercial incentives to study CBD clinically. This would be a loss for patients who could benefit from the therapeutic effects of CBD drugs. In response, researchers now need to submit an “Investigational New Drug” application to the FDA’s Center for Drug and Evaluation and Research. Preserving incentives for research to turn its focus back on patient needs remains a top priority for the FDA.
More specifically, subpar CBD companies have been caught printing misguided information on their labeled products, such as writing wrong dosages of the CBD chemical and claiming specific therapeutic benefits without concrete evidence or research. In severe cases, the false labeling claiming to treat serious medical conditions, like Alzeimer’s disease, can cause patients to delay or thwart real medical treatment they need to improve their health.
Topics of discussion circle around the issues of safety and quality of the CBD products, how to properly implement regulations, and emphasize the importance of sound science and data to support CBD benefits. Clinical studies resulting in tangible evidence are what is going to convince the FDA. Although the FDA is taking into consideration everything, they have heard from both the public and stakeholders, their prime concern is to protect people’s health.
FDA is not the Enemy
In today’s digital era, the positive benefits of widespread accessibility and rapid spread of information are tragically paralleled with the complications of deceiving advertising claims and toxic misinformation. As more people are finding out the lucrative side of the CBD market, more untrustworthy businesses and marketers are emerging with a gold-rush mentality.
Consequently, the CBD market wants to work with the FDA, not against them, because they essentially have the same goal. Enemies are ironically other CBD companies who are taking advantage of the lack of regulation, promoting false claims, and unproven benefits. Not only is it misleading information, but some companies are also using aggressive, insincere marketing campaigns.
Marketers may end up taking advantage of people, prioritizing financial gain over public safety, causing more harm and damage. It’s an unfortunate fact that marketing companies and CBD competitors take the deceitful route, but it’s not surprising. Like any other rapidly growing business, choosing personal profit over public concern is a pattern we’re not unfamiliar with.
Proper education and awareness are just as important as the scientific benefits of CBD products. Not only do proponents of CBD products want to work with the FDA to weed out the real enemy, but they need to if they want to defeat the real enemy: deceitful CBD businesses and marketing companies. FDA regulation would help weed out the impostors and limit exploitation of an unregulated market.
Why the CBD Market is Growing so Fast
There are quite a few moving parts of the CBD industry that add to its exponential growth. This is a rare time where the baby boomers are turning into elders, while the millennials are well into their adulthood--these two combinations are lucrative to any market, but they make a special formula for the CBD industry.
The older generation grew up during progressive times (i.e., sexual revolution and the civil rights movement) that gave them a huge advantage of enlightenment and boosted their tolerance of more forward-thinking ideas. And with old age comes its hindering physical symptoms of body aches and joint pain, which individuals are quickly learning about CBD arthritis cream or CBD oil for pain management. CBD cream and oils are appealing because they are a low-risk alternative medicine compared to pharmaceutical drugs that often contain addictive qualities and harmful side effects.
The natural element of CBD creams also attracts young folk. Wellness trends have become increasingly popular without a sign of slowing down. Millennials are all about how to improve their physical and mental health, treating the body and mind as one, which is why cannabis products are so appealing. From ingesting CBD gummies and drinking CBD cocktails, to applying CBD-infused chapstick and CBD cream, the market continues to expand.
On another note, cannabis is becoming more politically and medically acceptable as well. Marijuana remains illegal under federal law, but 10 states have passed laws to legalize the purchase and possession of recreational marijuana, while 33 states legalized the cannabis plant for medical usage.
Additionally, online sales are the driving force for the CBD industry. Advantages of this include business’ ability to curate their brand and use tactical marketing strategies to match their consumers--both the old and young. You can now buy CBD oil online, easier than ever. The CBD market announced their step into the mainstream when they entered large retail stores, opening the door wide open without knowing how to close it back up.
Nature vs. Science
Ever since the FDA approved Epidiolex, the pure CBD oil to treat epilepsy, people are finally acknowledging the medical benefits made possible from natural ingredients in alternative medicine, rather than solely relying on traditional, modern methods. But the two doesn’t necessarily have to stay divided.
People often forget that modern medicine surfaced from the roots of natural methods, but the evolution of pharmaceutical drugs came about because of the need for quality consistency and substance control. Not to mention ridding of adverse side effects. For instance, a common cancer treatment called Taxol was inspired by the natural extracts of a yew tree but needed years of research and development in the laboratory before scientists could figure out how to turn the raw toxic ingredients into a safe synthetic version.
A rare outlier of the cannabis industry is the company Kannalife who believes that the benefits of working with pharmaceutical companies outweigh the complications. The synthetic-focused company wants to follow the pharmaceutical path, rather than fight to have CBD recognized as a supplement.
Kannalife focuses on synthetic versions of the natural cannabinoid and is working on a compressed compound that could contain more potency and increase the safety of CBD intake. An example concerns Epidiolex, which is naturally derived from CBD, but the serious risks of long-term ingestion is predicted to involve liver damage. A synthetic version could erase that risk.
The Big Takeaway
So where does the FDA stand now?
Although the May hearing marked important stepping stones of CBD safety and growth, no one reached any substantial decisions regarding concrete regulations--but that’s to be expected with such big factors still at play. The hearing did offer an informative insight into the industry and provided much-needed clarity concerning legal regulations on the CBD market. One would hope so, as it was the first-time businesses, researchers, patient advocates, physicians, government officials, and citizens all came under one roof to fairly discuss this convoluted topic.
The FDA will remain unyielding on its commitment to evaluating the regulatory framework of this new market in favor of the people’s safety and well-being. They will continue to promote the importance of using clinical studies, evidential support, and scientific data regarding CBD products and their effects. Obtaining sound research, safe approaches, and public input will also help guide their direction.
People may fear the FDA came too late to the game, but with no sign of the public attention or corporate interest stopping anytime soon, stakeholders and CBD companies can be hopeful that the FDA will prioritize their involvement.
At last month’s hearing, FDA acting commissioner Dr. Ned Sharpless said he agreed that drugs do offer critical therapeutic value, emphasizing the importance of finding supported data necessary to develop regulated drugs derived from cannabis. He continues to state that the agency “does not have a policy of enforcement discretion with respect to CBD products.”
However, the FDA said a smaller agency has formed in response to the urgency of the CBD industry’s desire for regulation. Whether or not this will speed up in nearing months to come, or take longer than promised, the future of the CBD market regarding the FDA is left undecided, though one thing is for sure: CBD is here to stay.