CBD regulation: Global clampdown or treading a careful path to acceptance?
Much interest stems from CBD oil's range of beneficial health effects, with reports of its role in pain relief and alleviating seizures.
Added to an absence of major side effects even at high doses, the food and nutrition industry is looking on in hope at the prospect of working with the oil in a new wave of innovative products.
Cannabis is the plant genus name that refers to the three main species: Cannabis sativa, Cannabis indica, and Cannabis ruderalis.
These all contain both cannabidiol (CBD) and tetrahydrocannabinol (THC). While THC is the main psychoactive substance, CBD is classed as a phytocannabinoid and is said to have calming, anti-inflammatory effects.
Meanwhile, hemp is grown on an industrial scale and has many uses, from animal feed to biofuel, clothing to car parts.
Hemp seeds are high in healthy omega-3 fats and protein, and are a popular health food ingredient. They contain extremely low levels of CBD and are free from THC.
Despite scientific evidence pointing to the plant’s health benefits, the regulatory landscape has taken a cautious approach in governing its use.
Globally, its regulation could be considered a tenuous patchwork of local, national and international laws.
Inconsistent enforcement and misinterpretation about CBD-infused products made with either hemp or marijuana only add to the confusion.
So what is the regulatory situation around the world? Has any country been able to tackle the red tape surrounding this food and shake off the stigma that has dogged its use for decades?
The United Kingdom (UK)
In the UK, CBD as a supplement remains a complex area in legal terms with a borderline area existing between supplements and medicines.
The Food Standards Agency (FSA) has advised companies to contact the Borderline Section for advice on the issue, said Pablo Cano Trilla, head of legal analysis at CBD-Intel.
“What is clear is that the UK has a zero tolerance for traces of THC in supplements,” he added.
The news that the European Commission (EC) recently reclassified CBD as a Novel Food has created a few possible scenarios for Freddie Dawson, head of content at CBD-Intel.
“The most likely is that little changes,” he said. “Larger chains may choose to drop CBD food/food supplement lines until there is approval but it is likely CBD will still be available on the market.”
If CBD in food and supplements are removed from the market for an extended period, CBD-Intel expects to see a scenario similar to what was seen with nicotine in certain situations post EU Tobacco Products Directive (TPD) implementation.
Here CBD users may well migrate to other products with the likelihood of e-liquid adoption in the UK.
Since June 2018, all CBD products in France must prove they contain no trace of THC, which means many products currently on the market - including THC-containing full-spectrum products - are not permitted, according to Elba Manzanilla, senior legal analyst for Europe at CBD-Intel.
Subject to the THC restrictions, and the CBD being extracted from fibre or seeds, oils and other edibles, CBD products may be permitted as long as they comply with food legislation.
This potentially includes the novel ingredient guidance – though at the time of writing it is unknown whether any French authorities have plans to implementing this.
“Germany has again effectively imposed a zero tolerance policy on THC in CBD food items,” says Berta Camps, CBD-Intel legal analyst.
“Beyond that we also believe Germany will subject CBD products to the EU novel food guidance in the near future.”
Commenting on current regulatory status of CBD in the UK, France and Germany, Dr Mark Tallon, managing director of UK food law consultant Legal Foods, said rules regarding novel foods legislation for CBD and extracts would remain in the same medicine/novel foods regulatory frameworks.
“We already know medicinal classifications are divergent across Member States as are Novel foods considerations and this will continue to occur post Brexit,” he said.
“However, the UK may, dependant on the future relationship be able to set its own internal rules on novel food classifications resulting in a set of products lawful in the UK but not across other EU Member States.”
America and Canada
In the United States, the Hemp Farming Act, passed as part of the 2018 Farm Bill, attempted to provide further clarity of industrial hemp.
Despite the Act’s best efforts, the Food and Drug Administration (FDA) has stated on numerous occasions that CBD is not legal as an ingredient in food, beverages, and supplements.
While the CBD content in hemp seed oil is low, hemp buds and flowers remain a meaningful source of CBD. Food, beverage and supplement products labelled as "full spectrum hemp extracts" are available that do not specify CBD content.
In Canada, recreational and medicinal cannabis is legal with edibles expected to become fully legal in October this year.
However, CBD is not considered a legal Natural Health Product (NHP), which currently excludes its use in dietary supplement-type products.
Uruguay became the first country in the world to legalise cannabis for both medical and recreational adult use in 2017.
Many consider the country to be the most advanced of all Latin American countries in terms of CBD and cannabis regulation, where the legislation was signed into law in 2013.
Uruguay wants to position itself as the regional hub in growing, refining and processing medical cannabis for export.
Colombia has also emerged out of the shadows as a country with liberal cannabis laws. The country legalised medical cannabis and cultivation in 2015.
Its favourable climate and cheap labour force are its two trump cards, as Colombia continue to build on its reputation as a global production hub.
At least seven Canadian companies grow cannabis in Colombia and, together, they have invested around €88.3m ($100m) in the market there.
Meanwhile Mexico manufacturers that obtain pre-market authorisation can legally sell CBD products with a content of less than 1% THC.
This means Mexican consumers can find CBD products on the shelves, such as food supplements, cosmetics and beverages.
Mexican policymakers also proposed a bill at the end of 2018 to approve medical and recreational cannabis.
Fellow sleeping giant of Latin America is Argentina, which legalised CBD and cannabis for medicinal and scientific research purposes back in March 2017.
Its progress in legislation has been tainted though by the rise of a significant black market for cannabis products due to a lack of enforcement.
“The law is ambiguous and as a result there are different interpretations of what exactly is permitted under the regulations in various regional jurisdictions,” according to Trilla.
In November last year, the government of Jujuy, a province in the northwest, announced plans to develop the world’s biggest legal cannabis farm (14,000 hectares) through a joint venture between Cannabis Avatãra State Society - a company that it owns - and US firm Green Leaf Farms.
Meanwhile, in the western province of San Juan, better known for its wine and olive oil, Canada’s Wayland Group recently bought land to grow medical marijuana.
Perhaps in contrast to Argentina’s progress, Brazil remains severely limited and what is currently allowed in the country is medical only, according to Nate Erskine, analyst at CBD-Intel.
In addition, domestic production is “almost non-existent” - although there are signs that this may be changing.
In November 2017, the Brazilian Association of Cannabis Hope Support (Abrace Esperança) got legal authorisation to produce CBD oil for medical purposes - the first Brazilian entity licensed to produce and sell CBD.
Finally, Chile, a country with one of the biggest raw hemp producers in the LATAM region with several joint projects with international firms.
Chile initially decriminalised home-grown cannabis back in 2005 and in 2015. Here, its government approved an application from non-profit health organisation Fundacion Daya for cannabis cultivation for medical purposes.
However, selling the plant or its derivatives such as the buds, CBD extracts or oils is illegal.
Nevertheless, consumer acceptance is high and the country has one of the highest consumption rates in the region, says Euromonitor analyst Zora Milenkovic.
Regulatory restrictions appear to have stagnated overall industry acceptance of hemp oil supplements.
CBD extracts are permitted for use only in pharmaceutical drugs, which are available solely via the Special Access Scheme. In Australia, CBD falls under the Poisons standard as a schedule 4 prescription-only medicine.
"In Australia, products containing CBD are prescription-only medicines and cannot be used in products such as foods or cosmetics," a spokesperson for Australian regulator, the Therapeutic Goods Administration (TGA) said.
All products — excluding fibre and seed — derived from cannabis are considered drugs and may only be used for medical or scientific purposes.
"CBD products manufactured in Australia may only be supplied, imported or exported for medical or scientific purposes, as per the requirements of the international drug conventions," the spokesperson added.
While this does not prohibit supplement companies from conducting clinical trials on CBD or medical cannabis, it does not permit them to sell supplements containing CBD extracts in Australia.
In India, residents can only import medical cannabis if given special permission by their doctors. These products tend to be expensive, putting them out of reach of many patients' hands.
This year could provide a breakthrough, however, as medical cannabis products could gain manufacturing approval.
New hemp-based medicines meant to alleviate epilepsy and help in cancer pain management are set to be manufactured and sold in India this year.
In the Philippines, legislators have approved House Bill 6517, also called the Act Providing Compassionate and Right of Access to Medical Cannabis and Expanding Research into its Medicinal Properties and for Other Purposes.
The bill makes the use of medical marijuana legal for patients suffering from debilitating medical conditions that cause wasting, chronic and severe pain amongst others.
However, any progress in terms of marijuana for health uses in India and the Philippines is limited to pharmaceuticals and medicine. No provisions have been made for dietary supplements or nutraceuticals, in which the presence of hemp or CBD remains illegal.