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Breaking Down the FDA Consumer Update on Delta-8 THC
Mr. Pulak Sharma & Dr. Priyanka Sharma -- Kazmira -- The Cannabinoid Company Mr. Pulak Sharma & Dr. Priyanka Sharma -- Kazmira -- The Cannabinoid Company
For Immediate Release:
Dateline: Watkins, CO
Tuesday, July 26, 2022


Consumer Safety Concerns

We previously posted an article addressing the crack down on Delta-8 THC products and other synthetic derivatives. The lack of specificity in the 2018 Farm Bill left room for deliberate misinterpretation of the legislation and caused mass confusion with Delta-8 and other synthetic cannabinoids. Kazmira believes this rise of synthetic cannabinoids, mixed with a lack of regulation, leads to major quality and safety concerns for these products. Consumers need to be aware of these safety and quality issues before ingesting these synthetic and intoxicating products.

The loophole in which Delta-8 currently resides allows companies to dodge regulations in place for retail cannabis products. Without regulation, the quality and safety of these products come into question. The U.S. Food and Drug Administration (FDA) has gone as far as releasing a consumer update with 5 things you should know about Delta-8 THC.

  1. 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.
  2. They state that adverse event reports involving products containing Delta-8 THC are increasing.
  3. 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.
  4. 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.
  5. Delta-8 THC products should be kept out of reach of children and pets.

Delta-8 Products Not Approved by FDA (1)

The FDA is aware of the rise of Delta-8 THC products and wants consumers to be aware of the misleading marketing practices by companies and manufacturers. The consumer update states, “Some concerns include variability in product formulations and product labeling, other cannabinoid and terpene content, and variable delta-8 THC concentrations. Additionally, some of these products may be labeled simply as ‘hemp products’, which may mislead consumers who associate ‘hemp’ with ‘non-psychoactive’.” The main concern with these deceptive practices is when they involve medical claims, considering Delta-8 has not been approved by the FDA.

They have also  recently issued warning letters to five companies selling products labeled as containing Delta-8 THC in ways that violate the Food, Drug, and Cosmetic Act. This is the first time the FDA has issued warning letters for products containing Delta-8 THC. They state, “there are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug. The FDA has not evaluated whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns”.

Increases in Delta-8 THC-involved Adverse Events (2)

The Center for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory, “to alert public health departments, healthcare professionals, first responders, poison control centers, laboratories, and the public to the increased availability of cannabis products containing delta-8 tetrahydrocannabinol (THC) and the potential for adverse events due to insufficient labeling of products containing THC and cannabidiol (CBD)”. They warn that Delta-8 THC intoxication can cause adverse effects like those seen with Delta-9 THC intoxication including but not limited to lethargy, uncoordinated movements and decreased psychomotor activity, slurred speech, increased heart rate progressing to slowed heart rate, low blood pressure, difficulty breathing, sedation, and coma.

In just over a year, the FDA has received over 100 reports of adverse events involving Delta-8 THC products. Over half of those reports required some sort of intervention, such as evaluation by emergency medical services, or hospital admission. In that same timeframe, the National poison control centers received 2,363 exposure cases of Delta-8 THC products. 40% of these cases involved unintentional exposure and 82% of those unintentional exposure cases affected pediatric patients less than 18 years of age.

Delta-8 is Psychoactive and Intoxicating (3)

It’s no surprise that safety concerns are abundant with Delta-8 THC due to its psychoactive and intoxicating effects. Colorado has even passed a bill recently concerning hemp compounds and the regulation of cannabis-related products that may potentially cause a person to become intoxicated when used. The bill was proposed to regulate these psychoactive hemp cannabinoids and determine what amount of these compounds is enough to intoxicate someone.

The U.S. Cannabis Council released a report on Delta-8 THC stating, “like any medication or intoxicant, particularly one with psychoactive properties, it should be carefully regulated to ensure that it is (a) sold to adults or those authorized by law to purchase, and (b) safe for consumers and patients to use through testing, labeling, and the other regulatory requirements that are part of effective state cannabis programs”. The cannabis council clearly understands that Delta-8 is intoxicating and therefore needs regulation.

States are beginning to restrict THC isomers that are psychoactive and intoxicating. For example, New York cannabis regulators have sent warning letters saying THC isomers derived from hemp are “strictly prohibited”. The letter from the New York Office of Cannabis Management explains to hemp licensees and applicants that hemp-derived THC products “contain intoxicating qualities which are more appropriately regulated by New York’s Cannabis Control Board”, the agency that oversees medical and adult-use marijuana. In Oregon, effective as of July 1st, they became the first state to ban synthetic cannabinoids sold at grocery stores and other retailers, leaving Oregon Liquor and Cannabis Commision (OLCC) dispensary networks as the only option for retail of these products. 

Furthermore, a case study done on Delta-8 THC found, “ Hemp-derived ?8 -THC and ?9 -THC from cannabis display similar impairment profiles, suggesting that recent use of ?8 -THC products may carry the same risks as cannabis products”.

Production of Delta-8 Products Involve Potentially Harmful Chemicals (4)

Kazmira has discussed the risks with synthetic cannabinoids and how novel cannabinoid molecules created through synthesis are chemically very different from their naturally derived counterparts. The HAN Health Alert states, “CBD can be synthetically converted into delta-8 THC, as well as delta-9 THC and other THC isomers, with a solvent, acid, and heat to produce higher concentrations of delta-8 THC than those found naturally in the cannabis plant. This conversion process, used to produce some marketed products, may create harmful by-products that presently are not well-characterized”. Delta-8 products are then being marketed as naturally derived, although any products on the market with D8, have been synthetically produced. Synthetically produced compounds contain “enantiomers” when created in the lab. Enantiomers may have an inherent toxicity and interact with the human body in a unique and potentially harmful way, since they do not exist in nature. 

According to an article by Project CBD, “When synthetically producing a molecule, it’s often the case that it will spontaneously form into equal proportions of every possible chirality; in chemistry this is called a racemic mixture. This means that a significant portion of synthetically made cannabinoids may exist in a non-natural chirality.” Nature makes one chiral version of a molecule whereas synthetically produced compounds could contain multiple chiral versions. Without studying these non-naturally occurring compounds, we have no way to know how they’ll interact with the human body. 

John Eickhoff, CSO and chief chemist at Rocky Mountain Extraction Services, says, “It’s absolutely paramount to differentiate between chiralities, because our bodies experience them as different molecules. It’s about getting the customer the information on what they’re actually buying and what they’re actually ingesting. This topic is so nuanced that it’s difficult for the run of the mill consumer to look at a CBD product and ask, which enantiomer is this? Is this a racemate or is it natural? We have to look out for the consumer that may not even know to ask these questions.”

The FDA warns further that, “final Delta-8 THC products may have potentially harmful contaminants due to the chemicals used in the process, and there is uncertainty with respect to other potential contaminants that may be present or produced depending on the composition of the starting raw material”. The U.S. Cannabis Council backed research done by ProVerde Laboratories on 16 unlicensed Delta-8 THC products. According to the report, several products contained compounds not allowed by state law in regulated cannabis products. Compounds included the metals chromium, nickel, copper, and lead. Several of the products even contained residual traces of solvents at levels not safe for human consumption. Some of these solvents included methanol, hexane, ethyl acetate, heptane, acetone, and isopropanol.

Delta-8 THC Not for Children or Pets (5)

Possibly the most obvious of the FDA’s 5 things to know about Delta-8 THC and potentially the most dangerous, is that Delta-8 THC products should be kept out of reach of children and pets. The warning letters sent out by the FDA are not only to address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses in humans and animals, but also violations to drug misbranding and Delta-8 THC being infused into edibles such as gummies, chocolates, and caramels. FDA Principal Deputy Commissioner Janet Woodcock, M.D. even states, “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children”.

One article addresses chemically made THC from CBD, specifically Delta-8. Since it’s derived from hemp, Delta-8 is ending up in candies and other products sold at gas stations and convenience stores, even in states that have not yet legalized marijuana. The marketing of these products can be deceptive and appealing to children. Another article goes on to say, “a big issue with delta-8 is that it’s not required to follow the same rules as cannabis. That’s why delta-8 products can look like children’s cereal or gummy bears. The packaging can be flimsy, and people can even sell open items, cookies, in stores”. Aside from no quality control and safety checks, a huge concern with Delta-8 products showing up in these types of stores is that there might not be an age limit on who can purchase these products. This can result in children purchasing and consuming Delta-8 products unknowingly.

Because of FDA Inaction, More States are Stepping in to Ban Delta-8 THC

With lack of regulation from the FDA since the passing of the 2018 Farm Bill, states are having to step up to try and sanction these intoxicating hemp compounds. According to a MJBizDaily article, over a dozen states have already begun passing legislation regarding banning or regulating the synthesizing of hemp extracts into intoxicating cannabinoids, specifically Delta-8. The article goes on further to explain how Tennessee couldn’t decide on whether to ban Delta-8 THC or pass a bill that sets safety standards to address the surge of unregulated and potentially dangerous lab-synthesized products. Ultimately, they didn’t do anything, and the state was left with unregulated intoxicating THC products sold without age requirements or safety control.

The confusion surrounding Delta-8 THC makes it hard for states to regulate these intoxicating compounds and ultimately doesn’t allow much order when it comes to sanctioning final products with Delta-8 THC. One example is the recent SB22-205 bill in Colorado that was amended therefore it pushed this issue to state health authorities, delaying regulations, and requiring a decision to be made only after more research has been done. Virginia had decided to limit certain intoxicating hemp extracts, but due to politicians not being able to agree on criminal penalties for cannabis offenses, has put a pause on this bill until 2023.

It’s not enough to have the FDA release a consumer update and send out warning letters about products containing Delta-8 THC. The FDA needs to address and sanction the major concerns surrounding the quality and safety issues of this unregulated intoxicating hemp cannabinoids market. Since the passing of the 2018 Farm Bill, the FDA was given permission to control CBD use in food and drugs yet has not authorized any cannabinoid products without a prescription. Furthermore, not much has been done on the FDA’s part to regulate sales of hemp extracts including CBD, despite repeated efforts from the industry to do so. If the FDA is not going to do their part, we will look to the next Farm Bill to clarify and regulate the growing concerns around consumer safety and quality issues when it comes to Delta-8 THC.

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Name: Pulak Sharma
Title: CEO
Group: Kazmira LLC
Dateline: Watkins, CO United States
Direct Phone: 720-531-1634
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