Tag Archives: cure

Jennifer Whetzel

Eating Your Words: How to Avoid Legal Issues Marketing Cannabis Consumables

By Jennifer Whetzel
1 Comment
Jennifer Whetzel

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.

FDAlogoHow 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.

Dr. Allison Justice

Exploration and Optimization of Drying and Curing

By Cannabis Industry Journal Staff
No Comments
Dr. Allison Justice

Cannabis Cultivation Virtual Conference Part 4

Exploration and Optimization of Drying and Curing

By Dr. Allison Justice, Vice President of Cultivation at Outco

This presentation discusses:

  • Prized French wines are aged for years in oak barrels, as are famous whiskies. Tobacco is air-, fire-, flue- or sun-cured. Cannabis, however, is quickly dried and stored in a plastic bucket. Although many cannabis growers have proprietary ways of making flower flavorful and aromatic, little to no research is available for consistency.
  • Anecdotal examples show that chemical makeup is not only dictated by the strain/cultivar, but also influenced by grow methods, drying and curing. The lack of data prompted us to research what is happening during these processes. In this session, we will present our research at OutCo of how to affect and control the chemical makeup of flower; new protocols to monitor the dry and cure of cannabis flowers so we are able to modulate the terpene and cannabinoid profiles in our strain offering; and our latest findings in this exciting field of post-harvest cannabis research.

Refining Techniques for Growing Cannabis

By Cannabis Industry Journal Staff
No Comments

As the cannabis industry in the United States and throughout the world develops, the market is getting more competitive. Markets in a number of states are experiencing disruptions that will have lasting effects for cultivators, including oversupply and supply chain bottlenecks. Now more than ever, growers need to look for ways to differentiate their product or gain a bigger market share. Looking at yield efficiency, quality improvements and analyzing the cost of inputs versus value of the crop can help growers make the right choices in technology for lighting, irrigation and pest control among other technologies.

adamplants
Adam Jacques, co-founder of Growers’ Guild Gardens and Sproutly

A series of free webinars in two weeks can help growers learn about some of the more advanced techniques in improving yield and quality. The Cannabis Cultivation Virtual Conference on May 23rd will explore a variety of tips and tricks for taking their cultivation operation to the next level. This event is free to attendees, made possible by sponsors VividGro and CannaGrow Expo.

Dr. Allison Justice
Dr. Allison Justice, vice president of cultivation at Outco

Attendees will hear from experts in cannabis cultivation on a range of topics, including breeding, drying, curing, environmental monitoring and micropropagation. Adam Jacques, co-founder of Growers’ Guild Gardens and Sproutly, will discuss some of his experience with breeding high-CBD strains in Oregon. His talk will delve into some of the proper breeding procedures, along with how to hunt for particular phenotypes and developing specific cannabinoids and terpenes.

Dr. Allison Justice, vice president of cultivation at Outco, is going to present some of her findings in drying and curing at the company. She plans on sharing her research on how the post-harvest stages can affect and control the chemical makeup of flower. She’ll also discuss some new protocols to monitor the dry and cure of cannabis flowers so we are able to modulate the terpene and cannabinoid profiles.

More information on the other speakers at this event and how to register for free can be found here.

FDAlogo

FDA Issues Warning To CBD Companies

By Aaron G. Biros
No Comments
FDAlogo

On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

 

Preventing Yeast and Mold with Two-Way Humidity Control

By Aaron G. Biros
No Comments

When a grower harvests their cannabis plants, they process it by drying, curing and trimming the plant material. Dried cannabis ready for the consumer can often sit on retail shelves for months before it is purchased. According to the Cannabis Safety Institute, trimming is the processing stage with the highest level of human handling, and thus presents the most significant opportunities for microbiological contamination.

The Cannabis Safety Institute recommends workers handling dry cannabis wash their hands periodically, generally conform to food safety rules and wear gloves at all times. In addition to these tips, looking at relative humidity is a good tool to mitigate contamination concerns like the growth of yeast and mold spores. Mold spores can grow quickly when there is enough moisture, but if the cannabis is dry enough, mold spores cannot develop.

Growers controlling the relative humidity of their finished product in the past often placed an orange peel or a wet cotton ball in a jar with dried cannabis to retain the weight from water and keep it from over-drying. Those tactics have since been improved upon using modern technology.

Water activity is a measure of the relative humidity immediately adjacent to the product, according to Bob Esse, vice president of research at Boveda. “Cannabis’ relative humidity will reach equilibrium with the surrounding environment over time, which is why it is so critical to manage this adjacent atmosphere,” says Esse. “Moisture content is the total water present in the product and is a variable that changes in its relationship to water activity from one strain or type of product to the next.”

Back in 1997, Boveda first patented two-way humidity control. For the last 20 years, that company has made humidity control products for packaging in a variety of industries, like wooden musical instruments, pharmaceuticals, medical devices, electronics, tobacco, photos and documents and perhaps most notably for keeping cigars at the right humidity level in a humidor. According to Charles Rutherford, business development director at Boveda, he saw people buying their products meant for cigars, but using them with cannabis. About six years ago, they started developing a product specifically for the cannabis market.

The science behind it is relatively simple, says Rutherford. “Certain salts saturated in water can naturally regulate humidity- we just developed a cannabis-specific humidity level and patented the packaging around it that purifies the water and can come in direct contact with cannabis,” says Rutherford. “Using water activity meters and a moisture isotherm test, we determined the most appropriate range of humidity levels that cannabis will remain stable.” That range turned out to be between 59% and 63% humidity level for the properties in dried cannabis to stay the same.

According to Rutherford, it is a little more complex than just a range to stay in. “There are different humidity levels that certain strains prefer, but there are personal preferences, regions and other factors to consider when determining the levels of humidity ideal for cannabis,” says Rutherford. “We wanted to understand what people consider to be perfect.” In their research they found that depending on the region of the country, that humidity level varies considerably. “Using a water activity meter we could tell exactly what people prefer,” says Rutherford. Colorado, for example, prefers significantly drier cannabis than the Pacific Northwest, according to their findings.

Right now, Boveda has two-way humidity controllers set at 62%, 58% and soon they will have an under 50% option (appealing to the Colorado market). Using a device to accurately control the humidity level in cannabis can help growers and retailers prevent contamination from the biggest source of concern: water. “There is a ton of talk about pesticide contamination, but the reality is even if the flower is grown organically, you can still encounter safety problems when the moisture level is off,” says Rutherford. From a medical perspective, keeping dried cannabis at an ideal humidity level helps stabilize the properties of it, maintaining the medical efficacy. “If this is something people use for a medicine, it should be at an ideal condition,” says Rutherford. “Quantifying and understanding what humidity level is right is what we are helping accomplish.” For patients with compromised immune systems that need safe, consumable cannabis, a humidity control device can help prevent contamination and ensure a certain degree of safety in their medicine.

On a retail level, the packaging insert can extend the shelf life of products and maintain the quality. “The world has known for decades that 70% humidity level for cigars is ideal,” says Rutherford. “The cannabis world hasn’t had a moisture standard or understanding of what is proper until very recently.” That 62% humidity level determined after commissioned testing is a good standard to reference when determining your own ideal humidity level.

Growers also recognize the value in keeping their cannabis at the right humidity level beyond the obvious safety concerns. “As cannabis dries out and loses its humidity, the overall weight is reduced,” says Rutherford. “Precision humidity control gives a uniform humidity throughout the flower, leaving out the mystery for growers and maintaining weight, meeting the nexus between quality and weight.” According to Rutherford, growers have an incentive to package their cannabis a little on the wet side. “Because it weighs the most when wet, it is sold by weight and it will lose moisture over time, the incentive to deliver product that will dry out over time- that can create a lot of problems by having high moisture content.” For the first time ever, people can dramatically extend the shelf life of dried cannabis, instead of letting products naturally deteriorate and go bad over time. “For the first time ever, it allows you to extend the shelf life of dried cannabis for aging cannabis like wine and cigars,” says Rutherford.

The data from that Cannabis Safety Institute report, collected by AquaLab and CannaSafe Analytics using a vapor sorption analyzer, shows a cutoff of 65% relative humidity. These findings give the industry a lot of guidance in working to reduce the amount of yeast and mold contamination, says Bob Esse. “If your dried cannabis is above 65% relative humidity and you are a retailer, you should send that product back to the grower because it wasn’t dried properly, is vulnerable to mold and yeast spores and thus not safe for the consumer,” says Esse.

Pointing to the report, Esse says foods with high moisture content are able to support robust microbial population growth, which can lead to bacterial and fungal infections. “Water activity is what impacts whether microorganisms can grow or not.” By using two-way humidity control technology, growers and retailers can mitigate risks of contamination, improve quality and extend the shelf life of their products.