Cannabinoids
Our work
Over the past few years, the assessment of cannabinoids has been the fastest growing sector of our business. There is huge consumer demand for products containing cannabinoids, driven largely by the public interest in cannabidiol (CBD) – the major non-psychoactive component of hemp and cannabis plants. Companies are adding CBD and other cannabinoids to a plethora of consumer products (including foods, e-cigarettes, and cosmetics), and there is also much interest in the therapeutic benefits of CBD by our pharmaceutical clients. We have been tasked with assessing the safety of these products, flagging any toxicological concerns and identifying potential risks (for example to vulnerable sub-populations).
Food
Food producers and formulators are adding cannabinoids, primarily CBD, to their products, including confectionary, beverages, and “well-being” products (e.g. oral drops), which are available to the general public. This potentially poses a health risk to the consumer, as certain of these cannabinoids are associated with adverse effects. Indeed, there is some evidence that CBD is associated with adverse effects on reproduction and on liver function; as such it is advised that individuals that are pregnant, breast-feeding or taking medication should refrain from taking CBD. Further, food companies must apply for authorisation to add their CBD-containing products to the EU and UK markets. We can help with these activities.
Pharmaceuticals
CBD and THC are currently approved for use in the treatment of certain conditions (e.g. epilepsy). We have helped our pharmaceutical clients assess the ADME, pharmacology, and toxicity of CBD for medicinal applications. For example, we recently revised and updated an Investigational Brochure (IB) setting out the key pharmacological and toxicological issues concerning oral administration of CBD to patients. This IB review was submitted to the US Food and Drug Administration (FDA) and will be used by health care professionals running clinical trials in the US.
E-cigarettes and Vaping
As companies look to innovate their e-cigarette product portfolio, Research & Development (R&D) has focused on replacing nicotine (which is highly addictive) in the e-liquid with CBD (e.g. as a nicotine cessation aid). We are experienced at assessing the potential hazards and consumer risks of inhaling CBD in the aerosol of e-cigarettes. The focus of these assessments is usually the available (albeit limited) studies in humans involving the inhalation of CBD, where adverse effects (e.g. on the respiratory tract) are recorded along with effects, for example, on mood and measures of anxiety. However, the majority of the available data involves the oral route of exposure, and therefore these assessments require consideration of route-to-route extrapolation (i.e. from the largely oral toxicity dataset to the consumer inhalation exposure).
Cosmetics
Cosmetic companies are adding CBD to a myriad of their products (for example to moisturisers, shampoos, deodorants, and toothpastes), the use of which may contribute to CBD exposure via dermal absorption. We can assist with the estimation of CBD bioavailability following use in leave-on and rinse-off dermally-applied cosmetics, estimating the likely pharmacologically/therapeutically active dose of the cannabinoid, and assessing the potential risks to the consumer. A lot of relevant human data exists, notably involving the application of synthetic CBD gels to the skin of various patient groups.
Our expertise in this area
Hazard Characterisation
Our hazard assessments, generally based on in-depth searches of the scientific literature, aim to define the dose-response for all routes of each of a chemical’s toxicological propensities.
Risk Assessment
Our health risk assessments convert the toxicological hazard profile to a health-based guidance value, and compare this reference point to an estimate of human exposure.
Literature Searching
Robust risk assessments rely upon quality data. We are experienced searchers of major toxicity databases, giving us valuable access to Expert Group and primary reports.
Some of our case studies in this area
NAMs for NGRAs
Blog articles
Traditionally, toxicological risk assessment has involved identifying a point of departure (PoD) such as a NOAEL or LOAEL in a study of small creatures, adjusting it to be relevant to humans (to derive, for example, a TI or DNEL), and then calculating the margin of safety to a measured or estimated external exposure. As part of this process, toxicologists have to account for the uncertainties that arise in moving from the species, route and duration of the laboratory animal study to the real human world.
FDA memoranda: genotoxicity and carcinogenicity assessments of ENDS
Blog articles
As discussed in a previous blog post, the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) has issued several “scientific policy memoranda” that provide some great insights into the Agency’s evaluation process. In June 2024, the FDA made two new memos available that relate to the genotoxicity and carcinogenicity assessment of chemical constituents of Electronic Nicotine Delivery Systems (ENDS).
FDA memoranda: shedding light on health risk assessment of ENDS in PMTA submissions
Blog articles
In 2016, the United States (US) Food and Drug Administration (FDA) ruled that Electronic Nicotine Delivery Systems (ENDS) were to be regulated just like more traditional tobacco products, meaning that ENDS (e-cigarettes and e-liquids) are subject to premarket review requirements, despite containing no tobacco. ENDS manufacturers must therefore submit a Premarket Tobacco Product Application (PMTA) to the FDA Center for Tobacco Products (CTP) in order to have any chance of legally marketing their products in the US.
