One study published in the Journal of Natural Products two weeks ago proposes using the cannabinoid CBDA in conjunction with vaccines to prevent SARS-CoV-2 (Covid-19) infection. The study was conducted in a lab and says that cannabinoid acids (CBGA, THCA-A, CBDA, etc.) can bind to the SARS-CoV-2 spike protein, blocking cell entry and effectively prevent infection.
Another study published in Science Advances claims cannabidiol (CBD) inhibits SARS-CoV-2 replication and helps prevent infection by inducing endoplasmic reticulum stress response and innate immune responses. The study was conducted in cells and mice, but also had groups of human patients that tested positive for Covid-19 less after taking CBD. “In matched groups of human patients from the National COVID Cohort Collaborative, CBD (100 mg/ml oral solution per medical records) had a significant negative association with positive SARS-CoV-2 tests,” reads the abstract.
Two studies in Israel, one proof-of-concept study and one early-stage clinical trial, have just launched examining the effects of CBD on patients already infected with Covid-19.
The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.
All of this research already underway does not mean that cannabis prevents Covid-19. In fact, one clinical trial in Brazil that has finished, found no evidence that CBD helped patients with mild Covid-19. Published in the Cannabis and Cannabinoid Research Journal, patients with mild Covid-19 received 300 mg of CBD for 14 days or a placebo. The study suggests that clinical trials should be conducted for the effects of CBD on patients with severe Covid-19, not just mild symptoms.
The clinical trial in Israel that is trying to study the effects of CBD on patients with severe Covid-19 is having trouble finding participants because the newer Omicron variant mainly produces only mild to moderate symptoms.
It is far too early to tell if any of these studies will show evidence of cannabis treating Covid-19, let alone if they mean cannabis products can be used as a treatment or preventative for Covid-19. However, the research is significant and we should keep an eye on any developments that come from those studies.
“The latest hubbub is an example of both the promise of cannabinoids — components of cannabis — as potential therapies, but also the hype around them, which can far outpace the evidence that they work. It’s left researchers and consumer advocates scrambling to warn people that patients shouldn’t be turning to over-the-counter products or recreational marijuana in hopes that it might protect them from Covid-19.”
With much of the world shutting down and many of us forced to take refuge behind our own doors, we have some time to reflect on what actions led to this. There has been, in my opinion, a clear disconnect between our actions and health outcomes. We need to bridge this gap; We now have a moment to build that bridge. We can start by reassessing our endpoint measurement of health and disease and focusing on what leading measures will impact our lagging results. Think of it as HACCP-lite or home office HACCP. Small changes in the way we think and behave can lead to significant change.
Lagging measures – Lagging measures make great headlines and typically measure an outcome. These are easily quantifiable and therefore receive a good deal of the focus.
Leading measures – Leading measures are inputs that happen during the process and in advance of an outcome. Leading measures are often difficult to quantify.
This week, Nathan started a “Germ Jar” activity with his kids to track washing.
We are currently focused on the lagging measures for a communicable disease, COVID-19. Illness and death numbers stemming from the pandemic continue to rise, as is expected with more available testing. It is easy for us to dwell on these numbers as they climb and dominate the news. A study in Australia last decade indicated that just over 1% of those experiencing flu like symptoms sought treatment and eventually got tested. I’m not going to use the tip of the iceberg cliché, but there it is. Focusing on the rapidly rising rates of COVID may be easy to do, but it won’t help our future selves.
What we should be doing during this time, however, is looking at our own leading behaviors and how changing them can help prevent this situation from reoccurring.
Here are some inputs we can rethink:
Hand washing – The average American uses the restroom 6-7 times per day. This week I started a “Germ Jar” activity with my kids (spring break week!) to track washing. If we wash our hands every time we use the restroom and every time we eat, that’s roughly 10X per day. Our leading indicator of household health, then, is 10 hand washes per day. This principle can, and should be applied to workplaces, including schools, airports and hospitals. What if we had mandatory handwashing prior to airport security and boarding? My estimation is that data would indicate a sharp decline in illness and transmission rates.
Disinfecting/Sanitizing – Similar to hand washing, cleaning surfaces serves as a vital indicator of future health. Examples, such as this District in Freeport, Il, indicate that increasing frequency of disinfecting can lead to a dramatic decrease in numbers sick. In my new office setting, we have set a goal via the Germ Jar of 3 times per day wiping down high touch surfaces. As we reenter close-proximity society, we need to have a better understanding of what high touch surfaces are, both for those who are tasked to clean them, as well as those that are doing the touching. Reduction of touches coupled with above washing behaviors post-touch can help prevent disease transmission.
Nathan’s daughter adding to the Germ Jar
Monitoring – Lastly, we need to do a better job at monitoring ourselves and our environments. In my new office, we have enacted a temperature check every morning and night. If we practiced symptom reporting (coughing, sneezing, chills) and monitored temperature in other settings, such as offices and schools, could we start to see pockets of infection and trends? Taking it a step farther, while we invest a tremendous amount of time and money into protecting our food supply from foodborne illness, we rarely discuss preventive monitoring for other diseases, such as influenza and now COVID-19. Technologies are rapidly coming available that will allow us to perform quick diagnostics of both individuals and environments. If we were to monitor the air and surfaces of a school nurse’s office, would we find data that could prevent transmission of disease? Can we transfer HACCP-lite to additional (all) settings?
Over the next weeks and months, we are going to be inundated by the spike in COVID illnesses and deaths. During this time, it is on each of us to realize how our past behaviors led to the state we are in. When we return, viruses will not be absent from the world, our hospitals, schools, offices or our bodies. We can, starting now, begin to measure and change our leading behaviors and begin to shape a healthier future.
Selling in a grey market isn’t for the faint of heart. You have to deal with the stigma surrounding your products and services, the potential for legal troubles, along with bureaucratic hurdles that all businesses face.
Acceptable marketing language surrounding consumable THC and CBD products encapsulates all of these issues, and it’s why everyone in the industry needs to pay close attention to what they’re saying. One innocent turn of phrase could have the Food & Drug Administration (FDA) shut down your business faster than you can say, “Oops.”
Avoiding this fate means making some adjustments to how you think about your marketing language, but this knowledge quickly becomes rote. Take a moment to learn how to protect yourself so that you can run your business rather than run afoul of the law.
Food, Drugs and Dietary Supplements
Scroll through Instagram for a few minutes and you’ll encounter a deluge of companies making claims about cannabis and CBD products. Many, if not most, are going about it incorrectly. Part of the confusion surrounds the fact that under the FDA’s rules, foods, drugs and dietary supplements are treated differently.
How does the FDA decide what’s what? Based on how you advertise the product. If labeling suggests the substance is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or is an “article” (other than food) intended to affect the structure or any function of the body of man or other animals,” the FDA will regulate it as a drug.
The language and regulations surrounding drugs are extremely strict. On December 20, 2018, the FDA put out a statement reiterating that these rules are in effect for cannabis products. In other words, you can only make a drug claim if you have received approval from the FDA on your New Drug Application (NDA). Since approval requires hundreds of millions of dollars worth of clinical trials, this option is out of reach for most companies.
The rule states that you may not say that your product diagnoses, cures, mitigates, treats or prevents any disease, or any recognizable symptom of a disease. Disease is defined as: damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunction it (e.g. hypertension). Examples of diseases would include cancer, multiple sclerosis, epilepsy, autoimmune diseases, Lyme disease and more. In other words, you couldn’t say your product “prevents memory loss due to Alzheimer’s” or “treats symptoms of fibromyalgia.”
If you’re making any claims about curing anything in your cannabis business name, product name, packaging, web copy, advertising or marketing materials, you are at risk for breaking these rules and getting caught. The FDA’s regulations dovetail with the Federal Trade Commission’s truth-in-advertising laws, which state that your claims must be backed by legitimate research (such as peer-reviewed journal articles or double-blind studies) and must not mislead consumers. These rules are already being enforced within the cannabis industry, so pay close attention to what you’re putting out there.
An example of a warning letter the FDA sent to a CBD products company making health claims
However, you can’t avoid penalties by using this kind of language and claiming your product is a dietary supplement or food, either. According to the FDA, products that contain THC or CBD cannot be sold as dietary supplements. Their reasoning for this decision is that THC and CBD are active ingredients in FDA-approved drugs, such as Epidiolex and Dronabinol. Active ingredients in approved drugs may not be introduced into the food supply as dietary supplements or otherwise.
The language rules surrounding food can be equally complex. Foods approved by the FDA can make nutritional claims about how a nutrient impacts the structure/function of the body, such as “Calcium builds strong bones.” The problem for cannabis products is that these statements need to be authorized or qualified by the FDA and have significant scientific evidence and consensus. However, this consensus doesn’t exist for THC and CBD, meaning that you’re barred from making these kinds of claims.
Note that these rules don’t just apply to human supplements. They also apply to ones for pets. Many people don’t realize that a supplement for a pet is considered an “illegal drug of low regulatory concern.” But if you add in THC or CBD, a supplement becomes an illegal drug of—you guessed it—higher regulatory concern.
At a Loss for Words?
By now, you may be wondering what you can actually say to market your product; it may feel as though there are more restrictions than guidelines. Fortunately, the FDA hasn’t left us completely out at sea.
Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. The FDA published a final rule in the Federal Register in 2000 defining strict rules that govern the types of statements that may be used on a label without prior review of the agency. These are called structure/function claims. According to the FDA, “Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body.” In contrast, statements that claim to diagnose, cure, mitigate, treat or prevent disease require prior approval by the FDA and are only for products that are approved drugs. Don’t use any of those words. Ever.
You can use the following words in your cannabis product names, advertising or marketing, as long as you’re not connecting them to a disease state: restore, support, maintain, raise, lower, promote, regulate, stimulate. You must specifically state that the claim relates to a non-disease condition; otherwise, you’ll be in trouble with the FDA. To go back to an earlier example, you cannot say that your product “prevents memory loss due to Alzheimer’s.” However, stating that your product “helps maintain a healthy brain” is fine.
Just because we’re in a strange place under federal law operating our businesses every day doesn’t mean that we should disregard fundamental rules and regulations that all businesses must follow. Following these rules does more than keep our enterprises out of trouble. It reinforces the idea that our industry is responsible, legitimate, and—perhaps most importantly—here to stay.
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Another study published in Science Advances claims cannabidiol (CBD) inhibits SARS-CoV-2 replication and helps prevent infection by inducing endoplasmic reticulum stress response and innate immune responses. The study was conducted in cells and mice, but also had groups of human patients that tested positive for Covid-19 less after taking CBD. “In matched groups of human patients from the National COVID Cohort Collaborative, CBD (100 mg/ml oral solution per medical records) had a significant negative association with positive SARS-CoV-2 tests,” reads the abstract.
