Cannabis and products that contain it have exploded onto the food and consumer healthcare marketplace. At the heart of this particular herb is cannabidiol (CBD). Its use has triggered a rethinking of consumer interaction with a product which is still thought to be edgy and a liability in society.
At the present time its use is still heavily regulated but countries have legalized it, not as cannabis but as hemp and products containing hemp. Hemp has a more benign connotation in society because its fibre used in clothing. However it is a more acceptable term for the cannabis plant.
Canada became the first of the G7 nations to legalize cannabis for recreational use through the Cannabis Act and Cannabis Regulations which fit hand in glove with each other. The USA is slowly following suit as they seek to understand the impact of CBD in particular on consumer mood and behaviour.
What Is CBD?
CBD or cannabidiol is one of a number of cannabinoids found in the cannabis family of plants. It is the most abundant of these types of compounds.
The use of CBD oil and CBD itself has been a pharmaceutical product or healthcare product for a number of years but new legislation really drove CBD use.
In 2018, the USA passed the Farm Bill which legalised the growing of hemp. The bill also enabled hemp-derived products containing less than 0.3% tetrahydrocannabinol (THC) on a dry weight basis to be removed from the illegal drug Controlled Substances List.
Following this ruling, hemp farming increased considerably and with it the enormous development of the CBD industry.
Market analysis according to the Brightfield Group reckons the US market for CBD products at the end of 2019 was estimated at $4 billion. Following the 2018 Farm Bill, the market increase was 562% from the end of 2018 which is an enormous rise.
Marijuana, Hemp And Cannabis
Another important distinction to make is the difference between hemp, marijuana and cannabis. Marijuana is the form of cannabis which is smoked because of its high THC content.
Hemp is the form grown for commercial production of clothing fibres even though they both refer to the same plant species. Hemp is a grain too that has a cultivation history of 10,000 years and has a much lower THC level. The cultivation of hemp has led to much fibrous stalks with a height as great as possible.
Marijuana has been cultivated to maximise the THC content with shorter plants and more leaf density. the overall cannabinoid content is also much higher.
Current US Regulations On CBD
The regulatory situation for CBD in the USA is still a complex and uncertain issue.
The Federal Food, Drug and Cosmetic Act (FFDCA) is the main piece of legislation covering all drugs and foods for sale. One section, Section 201 (ff)(3)(B) states that “a dietary supplement does not include an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.”
Section 301(II) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food (including a dietary supplement) that contains an approved drug or biological product, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public.
A good example of such a drug using CBD is Epidiolex which required significant clinical investigation for its use as an epilepsy treatment. Successful completion of the trials meant it was approved for use in the USA.
On this basis, CBD cannot be sold as an ingredient in foods or dietary supplements until the following could occur.
Come 2020, a bipartisan bill (H.R 5587) was introduced on the 13th January to the House of Representatives to amend the FFDCA so that CBD was exempt from both Sections 201(ff)(3)(B) and 301(II) of that bill. This bill however was not passed!
The FDA still contends that it is illegal to add CBD to foods or to label it a dietary supplement. The FDA does not recognize CBD as GRAS (Generally Recognized as Safe) or as a legal food additive. Because of its approval as a drug, CBD is thus still prohibited in foods under the FFDCA.
OK then, it is still illegal to market CBD containing products and whilst it is widely available, the FDA regularly issues warning letters to businesses and companies that advertise and sell products especially if they claim it treats conditions like cancer, Alzheimer’s Disease, fibromalgia and other conditions.
The FDA continues to evaluate the long-term safety of CBD where the THC level is less than 0.3%.
Consumer Attitudes In the United States
Fifteen states in the USA legalized recreational marijuana and over 30 have legalized medical marijuana. Cannabis products including edibles are illegal at the federal level.
A number of surveys have sought to understand the market for CBD products. Intertek Health Sciences examined the attitudes data from the USA using four well-developed surveys which they explained at the IFT’s online conference in 2020. We’ve attempted to summarise them here.
Corroon & Phillips (2018) collected survey data to basically work out how and why individuals were using CBD. This relied on an online survey obtained through social media. It was promoted by herbal vaporizer producers and those marketing CBD products. POLITICO/Harvard TH Chan School of Public Health examine the public’s views in CBD regulations in 2017. This was a solid examination on 1,000 randomly selected adults who were asked their views. Wheeler et al., (2020) examined CBD knowledge, attitudes and cannabis use in young adults. This too was an online survey using social media. The final report from HelloMD and Brightfield Group (HBG, 2017) looked at the experiences of the HelloMD online community. This group were asked about their perceptions and experiences of US medicinal cannabis products.
About 55% of people obtain their CBD from the dispensary, 28% from a local delivery service and the the remainder from online purchase and smaller numbers from shops or by personal growing (HelloMD & Brightfield Group, 2017).
Beliefs On CBD Regulation In The USA
Some of the conclusions from the various surveys show that over half the participants agree that CBD products should be allowed. They should be available to the public in the same manner as dietary and vitamin supplements, without first being declared as safe (56%) or effective (65%) for use by the FDA.
Frequency Of CBD Use
CBD was administered in many different ways (HBG, 2017). Most consumers apparently took CBD using different methods. The most common were vaping and oil cartridges, tinctures, topicals and edibles.
The Corroon & Phillips (2018), Wheeler et al., (2020) and HBG (2017) studies found that most CBD users took it once daily.
There seems to be quite a range in the dosage level from less than 10mg to less than 100mg. It seems from the HBG study that most consumers prefer a CBD dose less than 10mg.
Dosage To Take
The Wheeler et al., (2020) study looked at how consumers estimated or calculated the amount of CBD to use. Thus, 38% of users took a product label recommendation but only 3% relied on the healthcare provider. The remainder (21%) based their use on whether they felt an effect or not.
It seems that CBD users have a poor framework for estimating the dosage levels. In the scientific community, not much is known about the optimal dose although some researchers believe CBD has a bell-shaped dose response curve.
Interestingly, 54% agree that consumers should still be able to buy a CBD product even if the FDA considers the evidence that it is unsafe. However, 74% agree that a business marketing health claims can only do so if it has been scientifically proven.
The Intertek Health Sciences (2020) conclusion considered that CBD users took it for relieving pain, inflammation and anxiety. It was also a sleep aid. There seemed to be more than one route for each consumer and many used a variety of routes of administration. These could be by topical, inhalation and oral routes.
For many users there was confusion about the dosage level and frequency and they were obtaining their information from mostly poor and unreliable sources. There was also a situation where side effects were commonly experienced which were damaging and in some cases highly dangerous.
CBD With Alcohol
One of the most difficult areas to navigate is the combination of CBD with alcohol. The Portman Group in the UK considers that product names and descriptors such as ‘CBD gin’ and ‘rum infused with CBD’ is an issue. Alcohol and CBD is a highly problematic combination.
The references to CBD have to be proved in a factual and ‘non-emotive’ manner. All producers must seek legal advice before any products with CBD especially with alcohol, onto the market.
In the USA and Europe, over 3/4 of consumers believe that health claims must be fully researched and scientifically proven. The general feeling in the CBD user community is that safety and efficacy needs to be comprehensively investigated.