& How Does It Increase Consumer Safety?

In mid-April, Colorado legislators introduced SB22-205, which addresses the growing regulation issues of intoxicating cannabinoids masquerading as CBD products. The purpose of this bill is to regulate cannabis-related products that can cause a person to become intoxicated when consumed. This involves all intoxicating cannabinoids, including synthetics such as Delta-8, & Delta-10. Kazmira was one of the few hemp-based CBD companies in support of this bill, which would ultimately limit hemp products to a maximum of 20 mg THC per container or 2 mg THC per serving. The bill even stated that violations to this limit would result in civil financial penalties.

An amendment was proposed that ultimately delays and dilutes the bill, while not setting any limits on THC per container. At length, this amendment can be summarized into four parts:

• Authorizes the Colorado Department of Public Health and Environment (CDPHE) to promulgate rules to prohibit chemical modification, conversion, or synthetic derivation of intoxicating THC in final products.
• • Includes Delta 8, 9, 10 and other isomers
• Directs the Marijuana Enforcement Division (MED) to create a task force to study intoxicating hemp products and make legislative and regulatory recommendations for the regulation of industrial hemp, with a report to be produced by January 1, 2023.
• • Task Force will start by September 1, 2022.
  • Task Force to have 20 different stakeholders, including representatives from the hemp and marijuana industry at all levels, attorneys, consumers, patients, and government officials.
  • Appointments for hemp participants would be made primarily by the CDPHE.
• Adds a new provision to the Consumer and Commercial Affairs Title, where an unfair and deceptive trade practice relating to hemp is to be considered a violation. This provision was necessary to obtain the funding outlined below.
• Dispenses to the Colorado General Attorney (CGA) $587,347 from the marijuana tax cash fund to enforce on consumer protection and antitrust. These funds will cover 3 new full-time employees (FTE) and other required tools and resources for enforcement.

Kazmira’s concern with this amendment is that it delays an urgent need for action on limiting the amount of THC in consumer hemp products, which is currently a major consumer safety issue for hemp derived products. However, we are optimistic that the task force will reach the conclusions needed to address consumer safety and move forward with this regulation.

Why Does this Bill Matter?

In the UK, the government has recently passed similar regulations, limiting the amount of THC in hemp to 0.2%. In addition, they’ve limited the THC content in CBD products to 1 mg THC per container. The UK government released a Consumer CBD Products report that states, “The remit of this report was to recommend a ‘low’, trace level for the controlled phytocannabinoids in consumer CBD products under the MDA [Misuse of Drugs Act] and so consideration was given to the maximum dose of ?9-THC that would be unlikely to produce any psychoactive effect (i.e. elevation of mood or ‘high’). The Working Group considered that a ?9-THC dose of 1 milligram (mg) was unlikely to produce significant psychoactive effects”. 

This rule is very conservative compared to the 20 mg THC per container limit that the original Colorado bill proposed. The UK is clearly erring on the side of safety when it comes to THC. The report goes on further to say, “It has been reported that single inhaled doses of ?9-THC as low as 2 mg can produce psychoactive effects (Zuurman, et al., 2008), (Klumpers, et al., 2012)”.

In the U.S. this bill has come at a time where we are seeing an increase of intoxicating synthetic cannabinoids being produced and marketed as naturally derived hemp products, by exploiting a loophole in the 2018 Farm Bill. This rise in intoxicating synthetic cannabinoids has led to the FDA recently issuing warning letters for the first time to five companies with products containing Delta-8 THC. It is clear that the FDA considers this to be a huge consumer safety issue which supports the need for urgent action in Colorado.  

Hemp Gets Political

Organizations in opposition to this bill included the US Hemp Roundtable and Colorado Hemp Association, along with several hemp-based CBD manufacturers, and other hemp industry stakeholders. Their argument was primarily that this form of regulation, especially limiting THC amount per serving and container, would essentially eliminate full-spectrum hemp products. Likewise, these companies would have to discontinue all current products that exceeded the 20 mg THC per container limit, otherwise a hefty fine would be imposed.

In support of this bill, along with a few hemp derived product companies and Vicente Sederberg LLP, was the marijuana enforcement division and several other marijuana businesses. It’s clear why marijuana related stakeholders are in support of the bill, because hemp companies are not currently taxed or regulated for selling products with THC levels consistent with some recreational marijuana products.

The amendment was brought about as a compromise for both sides. As with most compromises, each party isn’t completely satisfied with the amendment that’s been proposed. There are still a lot of questions and issues left unresolved that need to be negotiated.

One republican sponsor has actually pulled his name from the bill after amendments were proposed. Senator Don Coram’s support for this bill was predominately for regulating synthetic THC isomers including Delta-8 and Delta-10. Coram offered his own amendment to include more affiliates of the hemp industry on the task force, which was denied. He ultimately pulled his name from the bill stating, “he was never involved nor invited to participate in the drafting of the amendments…”

0.3% THC is Arbitrary and Confusing to Consumers

Non-intoxicating products are what CBD is all about. Cannabidiol is a non-psychotropic compound, used to provide natural benefits with no intoxication. Currently, without the bill, hemp products must be less than 0.3% THC. This means that in a product like a chocolate bar that weighs 100 grams, you could have as much as 300 mg total THC. The 0.3% THC limit is contentious and based on our example, allows for more than enough THC to intoxicate someone. This can be incredibly dangerous when the consumer believes they’re taking a non-intoxicating CBD product. Colorado already limits edible retail marijuana products to have no more than 100 mg THC per product, while this 0.3% limit can allow hemp products to potentially contain more THC than retail marijuana products.

0.3% might seem miniscule and negligible, but numbers can be deceiving. For example, have you ever looked at a product and noticed that the active ingredient is displayed in very small amounts (generally less than 1%) compared to the inactive ingredients? Yet, clearly this ingredient is considered “active” for a reason.  The same can be said with the 0.3% THC limit in CBD products. Imagine a bottle of Nyquil with a 1 fluid ounce serving size, equivalent to about 30,000 milligrams. The active ingredient in Nyquil for cough suppressant is Dextromethorphan Hbr and consists of 20 milligrams per serving. When we do the math, we can see that Dextromethorphan Hbr only makes up .06% of Nyquil. Though it seems like a small percentage, that small amount is clearly enough to be considered active. Likewise in a hemp product’s case, that small percentage can be intoxicating.

In addition to intoxication, there are health risks associated with THC, specifically with edible products. The Center for Disease Control and Prevention (CDC) warns that marijunana edibles can, “… [2] Cause intoxicating effects that last longer than expected, depending on the amount ingested, the last food eaten, and medications or alcohol used at the same time. [3] Be unpredictable. The amount of tetrahydrocannabinol (THC), or the concentration or strength, is very difficult to measure and is often unknown in edible products. Many people who use edibles can be caught off-guard by their strength and long-lasting effects.”

The Colorado Department of Public Health & Environment has recognized that THC is a safety issue for consumers and subsequently drafted regulation 6 CCR 1010-21 to require that manufacturers of CBD products display the amount of all cannabinoids, including THC, in milligrams contained in a single serving of the product as well as in the entire container. Without these guidelines, it falls on the consumers and retailers to calculate the amount of THC contained in a product, based only on the federal upper limit of 0.3% by weight.

Relating back to intoxicating synthetic cannabinoids, the FDA released a consumer alert on Delta-8 THC and its serious health risks. This report outlined five things to know about Delta-8 THC. They caution that Delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put the public health at risk. They’ve been receiving more and more adverse event reports involving Delta-8 THC containing products. They warn consumers that Delta-8 THC has psychoactive and intoxicating effects, potentially even more concerning than the intoxicating effects of naturally occurring hemp compounds. They warn that Delta-8 THC products often involve the use of potentially harmful chemicals to manipulate the concentrations of delta-8 THC claimed in the marketplace and, in addition, Delta-8 THC products should be kept out of reach of children and pets.

Retailers Beware of Deceptive Practices

Deceptive practices and marketing of intoxicating compounds is prevalent in the CBD industry. Not only is this an issue for consumers but retailers as well. Recently, a retail chain in Colorado mentioned to our founders that, “CBD products on our shelves have virtually no THC in them because 0.3% is so tiny”. After showing the retailer the math and breaking down what 0.3% THC really means, the retailer was shocked when they realized that a CBD product on their shelf actually contains a whopping 60 mg of THC. This retailer was under the assumption that because the product has less than 0.3% THC, that it was free of THC, when in fact 60 mg THC in a CBD product is unquestionably an intoxicating amount. This indicates the problem that both consumers and retailers are being misled and misinformed by CBD manufacturers, which is why the need for a THC limit in milligrams is necessary. The phrase less than 0.3% THC is factually misleading and most certainly does not mean THC free.

Why Does Kazmira Support the Original Intent of this Bill?

The original bill would have created a thriving CBD industry in the long run; however, consumer trust is crumbling. There are countless marijuana products masquerading as CBD products from hemp. This includes Delta-8 THC products, hemp derived Delta-9, as well as high amounts of THC in CBD products. Focusing on the latter, the amount of THC allowed in these CBD products remains arbitrary and as we’ve mentioned, creates significant safety hazards for consumers.

Furthermore, without the bill, the industry will face a credibility problem with large consumer packaged goods (CPG) companies. As it stands today, the large CPG companies see an industry in its infancy with no commitments to safety or quality. Because of these twisted incentives, inevitably, this will lead to a race to the bottom. Only when these companies can be assured that there is a healthy ecosystem that has gone through proper quality and safety checks, will they enter the market. This bill is an important step in the right direction for the hemp industry. Now is the time to tip the scales towards consumer safety by regulating CBD products and limiting intoxicating cannabinoids.