Cannabinoid Isomers Such as Delta-8: Navigating Regulations and Safety Concerns

Blogs | <b>Stuck on Compliance</b>

Delta-8 and delta-10 have gained considerable traction over the past year. Although these cannabinoid isomers fall in an extreme grey area, consumers are driving up demand. They can be purchased in many different forms and are commonly found in vaping products, gummies, and tinctures. Since these isomers are commonly derived from hemp extract, many consumers see delta-8 and delta-10 as a lawful hemp-derived good that provides a psychoactive effect. Per a new stance from the federal government, vaping products with these isomers fall under the 2018 Farm Bill. Even with the Food and Drug Administration’s (FDA) stance regarding the 2018 Farm Bill exempting hemp from the Controlled Substances Act (CSA), the popular edible cannabinoid isomers are not automatically legal.

Unraveling Cannabinoid Isomers

There is much discussion as to whether these isomers, as an edible, meet the definition of a controlled substance. To make it more confusing, these cannabinoids are derived from the legal hemp plant, so there is much to unravel here.

When it comes to isomers as a whole, in the 2018 Farm Bill, hemp is defined as “any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” It appears the loophole falls with the clearly defined “delta-9” and not the broad definition “tetrahydrocannabinol (THC).” If delta-8 and delta-10 do not contain delta-9 and are derived from hemp, what’s the issue? The issue is that these hemp-derived isomers have a psychoactive effect, hence regulatory oversight is inevitable. To make matters more confusing (or more clear-cut for some), the Drug Enforcement Administration (DEA) issued an interim rule declaring, “all synthetically derived THC remain Schedule I Controlled Substance.” That is until May 19, 2022.

On this date, there was a court ruling in California regarding delta-8 vapes, and it was found that delta-8 THC derived from hemp is lawful and eligible for trademark protection, a federal appeals court ruled in a vaping dispute. The three-judge panel sided with a company called AK Futures and said that delta-8 THC is not a controlled substance under federal law if it comes from hemp. The ruling still did not address the legality of selling edible delta-8 THC products unfortunately. It seems that the responsibility to regulate these products will still fall to states for now, and vape products now fall to the FDA to regulate.

States Have Unique Stances on The Allowance of Cannabinoid Isomers

Currently, 15 states have banned these isomers and many more are under review. Many companies selling delta-8 and delta-10 are doing so online where states do not have clear regulatory oversight. However, states are continuing to crack down and this may not be allowed much longer. Manufacturers of these products interpret the 2018 Farm Bill as allowing these isomers, however, because they are chemically created and not extracted from raw hemp plant material. The legality of these isomers as an edible seems to depend on which state you reside in and on varying interpretation of the regulations. States are taking notice; some states have issued strict bans on these products, while some states are still allowing production and distribution. Here are examples of where some states are in allowing these cannabinoids. Since Delta-8 was one of the first to emerge, most of these breakdowns are delta-8 focused. Please realize that due to the new FDA stance these could change at any time.

Colorado

As of May 14, 2021, the Colorado Department of Public Health and Environment (CDPHE) and the Marijuana Enforcement Department (MED) recently published bulletins revealing that THC isomers such as delta-8 and delta-10 cannot be manufactured in Colorado or used in Colorado cannabis products. CDPHE further explained that chemically modifying or converting any naturally occurring cannabinoids from industrial hemp is non-compliant with the statutory definition of “industrial hemp product.”

Arizona

Though Arizona regulations do not reference delta-8, their regulations reference general “tetrahydrocannabinols.” Due to this use of the general term, delta-8 is technically considered a controlled substance in Arizona. That being said, according to their particular laws, you could make your own delta-8 and even share it with your friends, but you can't sell it. Technically, you are only allowed to sell any derived intoxicating cannabinoid in a licensed dispensary.

Kentucky

Kentucky is well-known for their hemp cultivation. Would a state that is deeply involved in the hemp industry allow such cannabinoids like delta-8? Well, for now it is allowed, but many lawmakers and the department of agriculture are trying to ban it. Because it has been allowed for so long, this would upset many businesses in the hemp industry.

Florida

In contrast with states taking an abrupt illegal stance, Florida is quite the opposite. According to the Florida Department of Agriculture and Consumer Services, “Delta 8: At this time, any hemp product intended for human or animal ingestion or inhalation which is sold in Florida must comply with all Florida statutes and rules.” It appears Florida has not banned delta-8 or delta-10 products.

Texas

Delta-8 is allowed in Texas, for now. The Texas Department of Health and Human Services recently announced that delta-8 is a controlled substance, and is therefore illegal. Cannabidiol (CBD) and hemp companies decided to go against this claim in court. While there are no laws expressly prohibiting the usage of delta-8 cannabinoids, there are also no laws outright legalizing its usage. This leaves delta-8 in a legal grey area, which is currently being fought from one side and then the other in court.

Consumer Safety Concerns with These Cannabinoids

If you are a manufacturer or distributor of these cannabinoid isomers, we encourage you to do your research and consult with an attorney. It is much better to be safe than sorry in these kinds of scenarios. Allay Consulting has several different clients that are operating in states where these derivative cannabinoids are allowed, and most of them are even taking it to the next level when it comes to compliance by getting certifications such as current good manufacturing practice (cGMP) and International Organization for Standardization (ISO) 9001. To me this shows that not all of these companies are “fly by night,” but are actual good businesspeople who want to do right by their customers. Many want to create safe products, and I am excited to say that those are the companies that will last when the Food and Drug Administration (FDA) does start to get involved.

There are plenty of legal issues surrounding delta-8 and delta-10, but are these products safe to consume? This topic should speak not only the consumer but also the manufacturers and distributors. We needed a cannabis chemist’s perspective for the safety coverage of these isomers. Josh Jones, PhD, is an organic chemist and founder of Jonesing Labs. Josh further explained, “As for the current production of Δ8-THC, or other THC isomers converted from hemp cannabinoids (or simpler starting materials), these reactions should be performed using pharmaceutical (expensive!) production techniques to minimize unintended side-reactions and to understand impurity profiles. But I don’t know of any producers or hemp testing labs that offer comprehensive impurity profiling of such reaction products. If this could be done, then we’d likely not have the concern we do over semi-synthetic conversions in the cannabis markets. Still the Wild West…”

It seems there are unknown amounts of residual catalysts in cannabinoid isomers. If these products are not regulated and not held to rigid testing requirements, consumers may be subjected to dangerous by-products. As with all products, do your research before buying, producing, and selling these cannabinoid isomers.

I personally believe that there is a place in this industry for all derived cannabinoid products, but the issue for me is that they are not being correctly regulated. Sine the FDA still hasn’t given any guidance or regulations to the industry regarding health and safety of CBD products, they don’t have a foundation to stand on when looking at these other isomers. Proper regulation is necessary for the survival of this industry, and local and state health departments many times don’t have the bandwidth or resources to regulate these cannabinoids. Regulation technically should fall to the FDA since hemp-derived cannabinoids are technically federally legal. There are potentially thousands of these derived cannabinoids that have still yet to be discovered, so these will be the first of many that will need to be properly regulated. Hopefully the government starts to act sooner rather than later to prevent more gray areas that could potentially cause unsafe products.

Many aren’t looking forward to this kind of regulation, but without it we are endangering the future of the hemp and cannabis industry as a whole. When something goes wrong that causes a bulletin, recall, disposal, or—God forbid—a death, it makes our industry look bad in its entirety and steers new customers away from wanting to buy products. As an industry we need to realize that consumer and product safety now falls to company owners, and we need to take responsibility for how we are handling products. Putting in place a good product safety plan, becoming FDA compliant, or getting cGMP certification will put your cannabinoid company miles ahead, and will protect you in the long run.

About the Author

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com