Tag Archives: cure

FDA, FTC Issue Warnings to Delta 8 Copycat Cannabis Companies

By Cannabis Industry Journal Staff
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Last week, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) sent out warning letters to six different companies for selling copycat food products that contain Delta-8 THC. In a press release published on July 5, the FDA and FTC said they sent out letters to the following companies:

  • Delta Munchies
  • Smoke LLC (also known as Dr. S LLC)
  • Exclusive Hemp Farms/Oshipt
  • Nikte’s Wholesale LLC
  • North Carolina Hemp Exchange LLC
  • The Haunted Vapor Room
The Haunted Vapor Room, Dope Rope Bites

The products in question look exactly like common name brand foods like chips, candy and other snack foods. The FDA says they are concerned they might be mistaken for traditional foods, accidentally ingested by children or taken in higher doses than intended. “The products we are warning against intentionally mimic well-known snack food brands by using similar brand names, logos, or pictures on packaging, that consumers, especially children, may confuse with traditional snack foods,” says Janet Woodcock, M.D., principal deputy commissioner at the FDA. “The FDA remains committed to taking action against any company illegally selling regulated products that could pose a risk to public health.”

The FDA has sent out dozens of other warning letters to cannabis companies over the years for illegal marketing, mostly involving misbranding/mislabeling issues. A more common reason for a warning letter is making unsubstantiated health claims. In 2022, the FDA sent out 33 warning letters to CBD companies, including some that were marketing CBD as a cure for Covid-19. In 2021, they sent out a number of warning letters to companies marketing OTC drugs with CBD in them.

FDAlogoBack in May of last year, the FDA sent out their first warning letters to companies selling Delta-8 THC products, then issued a consumer update and warning about the compound a month later. The FDA and some industry stakeholders are concerned not only about the psychoactive substance itself, but also the way it is produced that could use potentially harmful chemicals.

This is the first time since 2019 that the FTC has gotten involved, when they issued similar joint letters to companies making unsubstantiated health claims. “Marketing edible THC products that can be easily mistaken by children for regular foods is reckless and illegal,” says Samuel Levine, director of the Bureau of Consumer Protection at the FTC. “Companies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.”

An Inside Look at the Creation and Growing Popularity of Solventless Cannabis Products

By Tim Nolan
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A top product trend this year is the rise of solventless cannabis products, according to recent statistics from cannabis market analyst firm BDSA. In fact, from June 2021 to June 2022, BDSA research also showed that the category grew an average of 132% each month.

Copperstate Farms

Nearly all cannabis products start with cannabis concentrates, which are made with a solvent that contains the desirable compounds from cannabis. Solventless concentrates however are made from the cannabis flower without the use of any chemicals and are becoming popular among businesses and consumers. This broad category of cannabis products includes everything from hash to live rosin.

Mitch Lindback, Lab Director at Copperstate Farms, has been growing and extracting cannabis for 15 years and has over a decade of experience working with cannabis derivatives. “Solventless is the truest expression of the cannabis plant,” he says.

Copperstate Farms is one of the largest greenhouse cannabis producers in North America and home to 1.7 million square feet of canopy and 40 acres under glass. Here is an inside look into the company’s solventless creation process:

The Harvest

One of the most important growth factors in cannabis is light, so cannabis grown in full-spectrum light often brings the best flower to harvest. In the weeks before harvesting, the lab conducts a test wash on cannabis plants before hand-selecting which will be used in rosin. Plants are selected based on appearance, aroma and test wash results. On harvest day, all flowers are lightly hand-trimmed and frozen within two hours of harvest.

The Wash

The wash system

Using only chilled RO water and minimal ice, our cannabis extraction experts gently break the trichome heads off the fresh-frozen cannabis using a stainless-steel wash system, by gently agitating the flower. Then they collect the 73μ-159μ trichome heads while pushing the immature trichome heads and stalks to pass through collection bags with a cold spray wash.

The Press

After carefully freeze drying, sifting and packing the hash into double-wrapped mesh rosin bags, Copperstate Farms uses rosin presses to gently express the nectar from the trichome heads using a little heat and a lot of pressure.

The Cure

All live rosin goes through a minimum 7-day cure. “We have found through extensive analytical testing that curing rosin for a minimum of seven days increased its terpene content by over 30 percent,” Lindback says.

The final product: live rosin

The extensive process to create solventless cannabis products is time and energy intensive, but leads to quality offerings, like full melt hash and live rosin. In fact, the solventless category is “primed for premiumization and growth in legal cannabis markets,” according to BDSA retail sales analytics. This is especially true in the dabbable concentrate product category and predicted in the vaping concentrate category as well.

With popular annual holidays like 7/10 (the cannabis community’s holiday for celebrating oil products, dabs and concentrates) gaining traction, solventless products are predicted to grow in market share and are worth cannabis companies looking into producing as demand rises among consumers who are always looking for innovative products that feature solventless concentrate.

To learn more about Copperstate Farms, visit www.copperstatefarms.com.

FDAlogo

FDA Issues First Warning Letters for Delta-8 THC

By Cannabis Industry Journal Staff
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FDAlogo

In an unprecedented move, the U.S. Food & Drug Administration (FDA) has issued warning letters today to companies selling products containing delta-8 THC. In total, the FDA sent out five warning letters to companies for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Image from the FDA’s consumer update on Delta-8 THC

The violations include illegal marketing of unapproved delta-8 THC products as treatment for medical conditions, misbranding and adding delta-8 THC to food products. Back in September of last year, the FDA published a consumer update on their website, seeking to educate the public and offer a public health warning on delta-8 tetrahydrocannabinol, otherwise known as delta-8 THC.

Delta-8 THC is a cannabinoid that can be synthesized from cannabidiol (CBD) derived from hemp. It is an isomer of delta-9 THC, the more commonly known psychoactive cannabinoid found in cannabis. Delta-8 THC does produce psychoactive effects, though not quite as much as its better-known cousin, delta-9 THC. Many regulators and industry stakeholders are increasingly concerned about the rise in popularity of delta-8 products, namely because of the processing involved to produce it. Delta-8 THC is often synthesized using potentially harmful chemicals.

The FDA has a history of sending a lot of warning letters to companies marketing CBD products inaccurately and making drug claims. Earlier this year, they sent a number of letters to companies claiming that CBD can cure or prevent Covid-19.

FDAlogoAccording to Janet Woodcock, M.D., principal deputy commissioner at the FDA, they are getting more and more concerned about the popularity of delta-8 THC products sold online. “These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” says Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The FDA sent warning letters to the following companies selling delta-8 THC products:

  • ATLRx Inc.
  • BioMD Plus LLC
  • Delta 8 Hemp
  • Kingdom Harvest LLC
  • M Six Labs Inc.

The Top 4 Things Cultivation Directors Should Discuss With Their Operations Manager Right Now

By Lucas Targos
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Communication is key for efficient interaction between cultivation and business functions at any cannabis operator. So, what are the top four things cultivation directors should be discussing with their operations manager right now, as we face an uncertain Summer 2020 and unique COVID-related challenges (product demand uncertainty, reduced workforce, and immediate response to problems and issues):

  • Labor requirements
    • Operators should be discussing “Who, and what, do I need to operate this facility and how do I make operations more streamlined without diminishing quality, consistency, and yield?”
    • Efficient operations should focus on labor workflow and circulation and document a clear understanding of how employees will move through the spaces while doing their jobs.
    • Having a “less labor” philosophy and understanding—a ‘first in and first out’ mentality—drives down cost of production.
    • By limiting employees’ need to cross paths and segregating processes (e.g. harvest, distro, packaging) in a facility, you can maintain biosecurity and limit the risks of cross-contamination
    • When working with fewer staff members, everyone should be trained to:
      A greenhouse facility that urban-gro helped bring to operation.
      • Operate all necessary equipment
      • Perform keys tasks like nutrient deliver or preventative maintenance
  • Supply chain
    • What sort of products do I use to cultivate, process, distribute and how will potential shortages affect my use/cost related to these?
      • Consider products and supplies that you can order in bulk
      • Examine and update your chemical regime to focus on products that are cheaper to freight ship, and located within the US or even your state
      • Mitigate the risk of availability by using products that are have no shelf-life or expiration issues, and those where the supply chain has not yet had disruptions
  • Automation and technology
    • What’s the availability to allow for remote monitoring and controls?
      • Cultivators can take some of the load off the reduced staff by automating critical tasks
      • Remote monitoring solutions will also allow for faster notification of crop issues
      • Integrating preventative maintenance tasks like equipment schedules and maintenance can increase efficiency
  • Yield expectations
    • Ensure that conversations on yield expectations are as transparent as possible and set realistic and achievable goals
    • Build business models based on the correct numbers that take into account productions numbers on ‘high yield’ genetics versus lower-yielding plants (yield versus price)
    • Ensure you have a detailed plan that combines both plant density and production goals
dry cannabis plants

How to Grow Cannabis Plants for Concentrate Production

By Andrew Myers
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dry cannabis plants

While flower is still the most popular way to consume cannabis, the concentrates market is booming. Some predict concentrates will be nearly as popular as flower by 2022, with an estimated $8.5 billion in retail sales. That’s a lot of concentrates and, chances are, cannabis producers are already feeling the pressure to keep up.

Concentrates refer to products made from processing cannabis – often resulting in much higher THC or CBD percentages. The category includes oils, wax, dabs, shatter, live resin and hash. Consumers are increasingly drawn to these cannabis products for their near-immediate and intense effects. They’re often consumed through vaporization, dabbing or sublingual absorption and are sometimes favored by those who want to avoid smoking. Cannabis growers who have traditionally focused on flower yields may decide to prioritize quality and potency levels in order to tap into these changing consumer tastes.

What Growers Should Focus on to Produce High Quality Concentrates
We’ll let you in on a little secret: making good concentrates starts with good flower. If you’re starting with low-quality flower, it’s impossible to create a high-quality concentrate. Whatever qualities inherent to the flower you’re starting with will be amplified post-processing. So, really, the concentrate-making process starts at the seedling level, requiring the right care and attention to coax out the results you’re looking for.

Tetrahydrocannabinol (THC), just one of hundreds of cannabinoids found in cannabis.

But what makes good flower? While this can be a subjective question, those producing concentrates generally look for flowers with big, abundant trichomes. Trichomes are the small, dewy structures found across the cannabis plant on buds, leaves and even the stem. They’re responsible for producing the plant’s cannabinoids and terpenes – the chemical compounds that give a strain its unique benefits, aroma and taste. Evolutionarily, trichomes attract pollinators, deter hungry herbivores and provide some defense against wind, cold and UV radiation.

Generally, trichomes indicate how potent the flower is. Plus, what we’re most often looking for when making concentrates is higher cannabinoid and terpene profiles, while also ensuring absolute safety.

What measures can growers take to produce crops that are ideal for concentrate production? Start with the following:

Avoiding Contaminants
Just like you would wash your fruits and vegetables before consumption, consumers want to be sure there’s no dangerous residuals in the concentrate they are ingesting. Growers can avoid any post-process residuals by taking a few key steps, including:

  • Photo: Michelle Tribe, Flickr

    Cutting out the pesticides. Any pesticides that are on your flowers before they go through processing will show up in your concentrates, often even more – you guessed it – concentrated. This is a serious health concern for consumers who might be sensitive to certain chemicals or have compromised immune systems. It’s dangerous to healthy consumers, too. Rather than spraying hazardous chemicals, growers could consider integrated pest management techniques, such as releasing predatory insects.

  • Limiting foliar spraying. Some growers will use foliar spraying to address nutrient deficiency or pest-related issues through delivering nutrients straight to the leaves. However, this can also result in contaminated concentrates. If you really need to spray, do it during the vegetative stage or investigate organic options.
  • Taking the time to flush the crop. This is a critical step in reducing potential contaminants in your concentrate, especially if you’re using a non-organic nutrient solution or fertilizer. Flushing simply means only giving your plants water during the final two weeks of flowering before harvest, resulting in a cleaner, non-contaminated flower and therefore a cleaner concentrate.

Perfecting the Indoor Environment
When cultivating cannabis indoors, growers are given ultimate control over their crop. They control how much light the plants receive, the lighting schedule, temperature and humidity levels. Creating the ideal environment for your cannabis crop is the number one way to ensure healthy plants and quality concentrates. There are many factors to consider when maintaining an indoor grow:

  • Temperature regulation. Trichomes are sensitive to temperature changes and start to degrade if they’re too hot or too cold. To maintain the best trichome structure, you’ll want to maintain an ideal temperature – for most strains, this falls between an idyllic 68 and 77 degrees.
  • Adequate light. For plants to perform photosynthesis indoors, they’ll need an appropriate light source – preferably one that is full-spectrum. Full-spectrum LEDs are able to closely replicate the sun and provide ample, uniform light to your crop. Another selling point for LEDs is their low heat output, making it much easier for growers to regulate ambient heat.

    dry cannabis plants
    Rows of cannabis plants drying and curing following harvest
  • CO2. Another necessary ingredient for photosynthesis is CO2. Providing your indoor crops with CO2 can boost plant size and yields and, therefore, provides more surface area for trichomes to develop and thrive.
  • Cold snap prior to harvest. Some growers rely on this age-old tactic for one last push before harvest – lowering their temperature for a few days right at the end of the flower cycle. They believe this puts the plants into a defense mode and will produce more trichomes in order to protect themselves.

Following Best Practices Post-Harvest
You made it to harvest – you’re almost done!

When harvesting and storing your plants, handle them with care to reduce damage to trichomes. If you’re planning on immediately making concentrates, you can move forward to the drying and curing process. If you’re going to wait a few weeks before processing, freeze your plants. This will preserve the cannabinoid and terpene profiles at their peak.

As the cannabis industry continues to expand, more consumers are likely to reach for concentrates at their local dispensaries. It makes sense that businesses want to diversify their offerings to satisfy customers looking for the most effective way to consume cannabis. As with any cannabis-derived product, producers will want to prioritize quality and safety – especially in the concentrate market.

Fungal Monitoring: An Upstream Approach to Testing Requirements

By Bernie Lorenz, PhD
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Mold is ubiquitous in nature and can be found everywhere.1 Cannabis growers know this all too well – the cannabis plant, by nature, is an extremely mold-susceptible crop, and growers battle it constantly.

Of course, managing mold doesn’t mean eradicating mold entirely – that’s impossible. Instead, cultivation professionals must work to minimize the amount of mold to the point where plants can thrive, and finished products are safe for consumption.

Let’s begin with that end in mind – a healthy plant, grown, cured and packaged for sale. In a growing number of states, there’s a hurdle to clear before the product can be sold to consumers – state-mandated testing.

So how do you ensure that the product clears the testing process within guidelines for mold? And what tools can be employed in biological warfare?

Mold: At Home in Cannabis Plants

It helps to first understand how the cannabis plant becomes an optimal environment.

The cannabis flower was designed to capture pollen floating in the air or brought by a pollinating insect.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

Once a mold spore has landed in a flower, the spore will begin to grow. The flower will continue to grow as well, and eventually, encapsulate the mold. Once the mold is growing in the middle of the flower, there is no way to get rid of it without damaging the flower.

A Name with Many Varieties

The types of spores found in or around a plant can make or break whether mold will end with bad product.

Aspergillus for example, is a mold that can produce mycotoxins, which are toxic to humans2. For this reason, California has mandatory testing3for certain aspergillus molds.

Another example, Basidiospores, are found outside, in the air. These are spores released from mushrooms and have no adverse effects on cannabis or a cannabis cultivation facility.

Fungi like powdery mildew and botrytis (PM and Bud Rot) typically release spores in the air before they are physically noticed on plants. Mold spores like these can survive from one harvest to the next – they can be suspended in the air for hours and be viable for years.

How Mold Travels

Different types of spores – the reproductive parts of mold – get released from different types of mold. Similar to plants and animals, mold reproduces when resources are deemed sufficient.

The opposite is also true that if the mold is under enough stress, such as a depleting nutrient source, it can be forced into reproduction to save itself.4

In the end, mold spores are released naturally into the air for many reasons, including physical manipulation of a plant, which, of course, is an unavoidable task in a cultivation facility.5

Trimming Areas: A Grow’s Highest Risk for Mold

Because of the almost-constant physical manipulation of plants that happen inside its walls, a grow’s trimming areas typically have the highest spore counts. Even the cleanest of plants will release spores during trimming.

Best practices include quality control protocols while trimming

These rooms also have the highest risk for cross contamination, since frequently, growers dry flower in the same room as they trim. Plus, because trimming can be labor intensive, with a large number of people entering and leaving the space regularly, spores are brought in and pushed out and into another space.

The Battle Against Mold

The prevalence and ubiquitous nature of mold in a cannabis facility means that the fight against it must be smart, and it must be thorough.

By incorporating an upstream approach to facility biosecurity, cultivators can protect themselves against testing failures and profit losses.

Biosecurity must be all encompassing, including everything from standard operating procedures and proper environmental controls, to fresh air exchange and surface sanitation/disinfection.

One of the most effective tactics in an upstream biosecurity effort is fungal monitoring.

Ways to Monitor Mold

Determining the load or amount of mold that is in a facility is and always will be common practice. This occurs in a few ways.

Post-harvest testing is in place to ensure the safety of consumers, but during the growing process, is typically done using “scouting reports.” A scouting report is a human report: when personnel physically inspect all or a portion of the crop. A human report, unfortunately, can lead to human error, and this often doesn’t give a robust view of the facility mold picture.

Another tool is agar plates. These petri dishes can be opened and set in areas suspected to have mold. Air moves past the plate and the mold spores that are viable land on the dishes. However, this process is time intensive, and still doesn’t give a complete picture.

Alternatively, growers can use spore traps to monitor for mold.

Spore traps draw a known volume of air through a cassette.The inside of the cassette is designed to force the air toward a sticky surface, which is capable of capturing spores and other materials. The cassette is sent to a laboratory for analysis, where they will physically count and identify what was captured using a microscope.

Spore trap results can show the entire picture of a facility’s mold concerns. This tool is also fast, able to be read on your own or sent to a third party for quick and unbiased review. The information yielded is a useful indicator for mold load and which types are prevalent in the facility.

Spore Trap Results: A Story Told

What’s going on inside of a facility has a direct correlation to what’s happening outside, since facility air comes infromthe outside. Thus, spore traps are most effective when you compare a trap inside with one set outside.

When comparing the two, you can see what the plants are doing, view propagating mold, and understand which of the spore types are only found inside.

Similar to its use in homes and businesses for human health purposes, monitoring can indicate the location of mold growth in a particular area within a facility.

These counts can be used to determine the efficacy of cleaning and disinfecting a space, or to find water leaks or areas that are consistently wet (mold will grow quickly and produce spores in these areas).

Using Spore Traps to See Seasonality Changes, Learn CCPs

Utilizing spore traps for regular, facility-wide mold monitoring is advantageous for many reasons.

One example: Traps can help determine critical control points (CCP) for mold.

What does this look like? If the spore count is two times higher than usual, mitigating action needs to take place. Integrated Pest Management (IPM) strategies like cleaning and disinfecting the space, or spraying a fungicide, are needed to bring the spore count down to its baseline.

For example, most facilities will see a spike in spore counts during the times of initial flower production/formation (weeks two to three of the flower cycle).

Seasonal trends can be determined, as well, since summer heat and rain will increase the mold load while winter cold may minimize it.

Using Fungal Monitoring in an IPM Strategy

Fungal monitoring – especially using a spore trap – is a critical upstream step in a successful IPM strategy. But it’s not the only step. In fact, there are five:

  • Identify/Monitor… Using a spore trap.
  • Evaluate…Spore trap results will indicate if an action is needed. Elevated spore counts will be the action threshold, but it can also depend on the type of spores found.
  • Prevention…Avoiding mold on plants using quality disinfection protocols as often as possible.
  • Action…What will be done to remedy the presence of mold? Examples include adding disinfection protocols, applying a fungicide, increasing air exchanges, and adding a HEPA filter.
  • Monitor…Constant monitoring is key. More eyes monitoring is better, and will help find Critical Control Points.

Each step must be followed to succeed in the battle against mold.

Of course, in the battle, there may be losses. If you experience a failed mandatory product testing result, use the data from the failure to fix your facility and improve for the future.

The data can be used to determine efficacy of standard operating procedures, action thresholds, and other appropriate actions. Plus, you can add a spore trap analysis for pre- and post- disinfection protocols, showing whether the space was really cleaned and disinfected after application. This will also tell you whether your products are working.

Leveraging all of the tools available will ensure a safe, clean cannabis product for consumers.


References

  1. ASTM D8219-2019: Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center (B. Lorenz): http://www.astm.org/cgi-bin/resolver.cgi?D8219-19
  2. Mycotoxin, Aspergillus: https://www.who.int/news-room/fact-sheets/detail/mycotoxins
  3. State of California Cannabis Regulations: https://cannabis.ca.gov/cannabis-regulations/
  4. Asexual Sporulation in Aspergillus nidulans (Thomas H. Adams,* Jenny K. Wieser, and Jae-Hyuk Yu):  https://pdfs.semanticscholar.org/7eb1/05e73d77ef251f44a2ae91d0595e85c3445e.pdf?_ga=2.38699363.1960083875.1568395121-721294556.1562683339
  5. ASTM standard “Assessment of fungal growth in buildings” Miller, J. D., et al., “Air Sampling Results in Relation to Extent of Fungal Colonization of Building Materials in Some Water Damaged Buildings,” Indoor Air, Vol 10, 2000, pp. 146–151.
  6. Zefon Air O Cell Cassettes: https://www.zefon.com/iaq-sampling-cassettes
Jennifer Whetzel

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

By Jennifer Whetzel
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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
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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
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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.

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FDA Issues Warning To CBD Companies

By Aaron G. Biros
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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.”