The safety of cannabis products has gained lots of interest in the last few years because of the rapid growth in sales of consumer cannabis products. Additionally, some surveys indicate that as many as two out of three adults support some form of legalization of cannabis and cannabis derived products. Our blog unpicks some of the complexity around their safety and explains how Evalueserve can help with the safety evaluation of consumer products like cannabis.
Consumers in many countries around the globe can purchase or be prescribed with Cannabis and Hemp products. These products are derived from the plant Cannabis sativa, and they are different to products called “marijuana”. Marijuana refers to parts or products from the plant Cannabis sativa that contain substantial amounts of tetrahydrocannabinol (THC), the substance which is responsible for altering a person’s mental state. Over 500 chemicals have been identified as being present in Cannabis sativa and it is the group called cannabinoids which have garnered the most interest from a medical and well-being perspective. Cannabidiol (CBD) is the major constituent of many Cannabis products and is no longer considered as a controlled substance in many countries. The interest and growth in sales of CBD containing products has ballooned in recent years due to quality evidence for its therapeutic and well-being use.
The safety picture of CBD and the other emerging positive therapeutic effects associated with the constituents of cannabis is not well understood. However, the safety profile of the psychoactive component THC is very well understood, and its dangers to the health of an individual are why many countries are keeping a prohibition stance on the sale of cannabis products.
THC is the component that produces the “high” associated with marijuana use. The active ingredient THC is found in parts of small portions of the plant, flowering tops and in the leaves. It stimulates cannabinoid receptors (CBRs), located on the surface of neurons in the brain, to produce psychoactive effects, it has negative effects on memory, including the inability to form new memories, and has negative impacts on attention and learning. There are several adverse acute effects of THC depending on the amount consumed and include hyperemesis syndrome, impaired coordination and performance, anxiety, suicidal ideations or tendencies, and psychotic symptoms.
What products are being consumed and how are they being consumed?
Cannabis is consumed either by inhalation through smoke or vapor where the substance is absorbed with rapid effect, or it is consumed orally in edible products, liquids, or capsules where the absorption of substance is slower and may take a few hours to take effect.
In the U.S., medical cannabis is sold legally in 37 states and recreational cannabis is legal to consume and buy in 19 states. In Canada, products of cannabis like fresh and dried flower buds, cannabis oils and capsules, seeds for cultivation and pre-rolled cannabis cigarettes are legal. Hemp, an industrial and medicinal form of cannabis containing 0.3% THC is legal for use. In other countries, CBD oils, capsules and gummy products are readily available to purchase.
No national government in Europe supports legalization of cannabis sale for recreational use, and all countries have prison sentences for illegal supply. A system of cannabis supply has been illegal but tolerated in the Netherlands since the 1970s and in Europe, since the late 1990s, decriminalization and harm reduction policies have been implemented in certain nation states. The percentage of population using cannabis varies from <1% to approximately 11% in EU nation states.
The FDA has approved several medicinal drugs that contain individual cannabinoids:
- Epidiolex, which contains a purified form of CBD derived from cannabis, was approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two rare and severe forms of epilepsy.
- Marinol and Syndros, which contain dronabinol (synthetic THC) are used to treat appetite loss that causes weight loss in people with AIDS and are also used to treat severe nausea and vomiting induced by chemotherapeutic treatment.
- Cesamet, which contains nabilone (a synthetic substance similar to THC) is also used as an anti-nausea medication during cancer treatment with chemotherapy.
What are some of the safety concerns about cannabis related products?
CBD is one of the non-intoxicating cannabinoids and there is published in vivo animal study evidence that CBD can induce developmental toxicity, affect embryo-fetal mortality, and cause central nervous system inhibition, neurotoxicity, hepatocellular injuries, spermatogenesis reduction, organ weight alterations, male reproductive system alterations, and hypotension. In clinical CBD studies for epilepsy and psychiatric disorders, it was reported that CBD-induced drug-drug interactions, caused hepatic abnormalities, diarrhea, fatigue, vomiting, and somnolence.
The consumption of marijuana via its burning and inhalation and its subsequent detrimental effects on human health are often compared to the consumption of tobacco via smoking cigarettes. There is clear evidence that marijuana smoke pollutes lungs. Cigarettes use fibre filters to reduce tar and other poisonous substances getting into the lungs of smokers. Marijuana smoking can differ significantly from cigarette smoking due to marijuana joints usually lacking filters and that there is often co-consumption with rolling tobacco. Marijuana smokers also tend to inhale a larger volume of smoke and to inhale the smoke more deeply in the lungs and for a longer duration, causing damage to the structure and cells of the lung airways and air-sacs. Unfiltered smoke from marijuana joints contains higher concentrations of a toxic class of chemicals called polycyclic aromatic hydrocarbons (PAHs) than in smoke from tobacco cigarettes. Clinical studies indicate marijuana smokers are more likely to develop respiratory illnesses than are nonsmokers and there is survey evidence that shows marijuana smokers were more likely to seek help for respiratory illnesses than people who smoked neither marijuana nor tobacco. Several research reports have confirmed that marijuana smokers are at greater risk than nonsmokers of developing cancers in tissues directly exposed to smoke, such as the lungs, mouth, larynx, pharynx, and esophagus. Cellular, genetic, and clinical studies all suggest that marijuana smoke is an important risk factor in the development of respiratory cancer for marijuana users.
Cannabis use disorder is described as the impairment of psychological, physical, and social functioning due to continuous use of cannabis. THC is the main substance that is responsible for marijuana reinforcement causing altered brain neuronal function and thereby modifying conscious experience that impacts anxiety, memory, motivation, and sleep. Chronic use can lead to mental health problems that can be diagnosed as a psychotic disorder.
Examples of how these products are regulated
USA
According to the Controlled Substances Act (CSA) of 1970, cannabis is considered as a Schedule I drug, because of its high potential for abuse. No currently accepted medical use in the United States have been reported due to lack of accepted safety for use under medical supervision. Recreational use of cannabis is legalized in 19 states and in the districts of Columbia in May 2022. The main psychoactive ingredient in cannabis, THC is legalized in 18 states for medicinal purposes and low THC products that have a THC concentration ≤ 0.3% are legal in other 10 states for medicinal purposes.
Industrial Hemp fibre production using low THC content (<0.2%) plants have been legalized in some EU member states and this cannabis derived material is used for textiles. No national rule has been imposed for cannabis seeds. Smoking of cannabis for medicinal purposes have been completely banned in EU member states. Individual EU member states have approved cannabis-based products for medicinal purposes, for example extracts of cannabis in Sativex® is a mouth spray used to treat multiple sclerosis. The medicine Bedrocan has cannabis flowers in dried form for vaporizing or making tea and has various therapeutic indications. The European Commission considers that CBD qualifies as a novel food provided it meets the conditions of EU legislation on novel foods.
According to Misuse of Drugs Act 1971, cannabis is considered as a Class B drug under Part II, Schedule 2. Also according to Misuse of Drugs Regulations 2001 (MDR 2001) it is listed as a Schedule 1 drug and is listed in Misuse of Drugs in England, Wales and Scotland by Order 2015 (2015 Order). It is illegal to possess, supply, produce, import, or export this drug with the exception of using it in research under license from the Home Office. Products containing CBD in the UK are legal for sale and consumption if they contain less than 0.2% THC.
India
In India, the prohibition of cultivation, production, possession, sale, purchase, consumption of cannabis has been imposed by Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985. However, the NDPS act does not apply to leaves and seeds of the cannabis plant. When CBD is extracted from the leaves of the cannabis plant and contain less than 0.3% THC, then it is legal to be made and be sold.
Evalueserve can help you assess the safety of cannabis-based consumer products
The Chemical Safety & Regulatory Affairs (CSRA) team in Evalueserve is a global team of toxicologists, regulatory scientists, chemists, and project managers, who together deliver a broad range of toxicology and risk assessment services in multiple industry domains. We cover human and environmental safety assessments as well as claims and clinical use reporting, data gap analysis and QSAR/Read across methodologies.
We are knowledgeable about chemical safety and risk assessment evaluation in a wide range of products that cannabis ingredients and materials that are used in cosmetics, personal care products, vaping products, food and nutritional products, and medical devices. Our expert team of toxicologists can assess both natural cannabis ingredients and synthetic cannabis related chemicals. We have extensive experience of toxicologically profiling and risk assessing products consumed orally or by inhalation. We have specialist knowledge of chemicals produced by heating cannabis derived products into an inhaled vapor, with many occurring because of thermal transformation during the heating process.
Our toxicologists will search and retrieve all relevant and publicly available knowledge on these chemicals to identify known hazards. We have digital solutions that accelerate the data summarization work, which in turn facilitates a faster risk assessment process. Our proprietary methods comprehensively search and retrieve information from over 70 databases in a fast and efficient manner, giving the toxicologist more time to evaluate the information.
We will summarize data on chemical properties, use cases, and toxicological findings, such as acute and general toxicity, irritation and sensitization potential, reproductive and development toxicities, carcinogenicity, and genotoxicity. We also collate and use expert review analysis and regulatory health values in assessments designed to protect the general population and specific consumer populations. Our toxicological profiles support risk assessments of human exposure predictions of these chemicals in acute, chronic, and lifetime settings.
The CSRA team can evaluate the environmental safety and impact of materials and ingredients in your cannabis-based consumer products, supporting sustainable product development.
Evalueserve can also provide you with a data repository of your toxicological profiles and data, connecting safety data, product use, ingredient/material choice, and supplier information. This gives you fast access to critical information on the product safety in your portfolio. Our team can assist with regular updates to critical safety information so that your risk assessments are kept up to date.
