On 15 April we issued a client Advisory summarising the current regulatory environment in Europe and the US for foods and cosmetics containing cannabidiol (CBD).
The status of such products, however, remains uncertain in several important respects. This note therefore identifies areas where developments or clarification are currently anticipated and addresses the use of CBD in vaping products.
National and International Control Measures
Following consideration by the World Health Organization (WHO) Expert Committee on Drug Dependence (ECDD), on 24 January 2019 the Director General of WHO wrote to the Secretary General of the United Nations recommending that cannabis and cannabis-related substances be rescheduled in the international drug control framework. The reported reason for the recommendation is to facilitate the trade in such compounds for medical and scientific purposes.
The ECDD proposed that preparations considered to be “pure” CBD should not be scheduled within the International Drug Control Conventions by adding a footnote to the entry for “cannabis and cannabis resin” in Schedule I of the Single Convention on Narcotic Drugs (1961) (the Single Convention) to read “Preparations containing predominantly cannabidiol and not more than 0,2 percent of delta-9-tetrahydrocannabidiol are not under international control”.
One of the legal implications of this recommendation would be to leave nominally pure CBD preparations (with less than 0.2% tetrahydrocannbidinol (THC)) outside the strict control imposed by the Single Convention on all substances listed in its Schedule 1, such as cannabis, heroin, cocaine and opium. The UN Commission on Narcotic Drugs in Vienna discussed the adoption of this recommendation on 24 June 2019. The background documentation may be accessed via its WHO page.
EU Decision on Foods Containing CBD
In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods, as a history of consumption has not been demonstrated. As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as novel. This categorisation applies to the extracts themselves and also any products to which they are added as an ingredient (such as hemp seed oil). Synthetically obtained cannabinoids are also considered to be novel.
The Novel Food Catalogue is not legally binding, but is used as a reference by many authorities in the EU for the purposes of the Novel Food Regulation ((EU) 2015/2283). This change to the Novel Food Catalogue may therefore mean that authorities in the Member States refuse to permit supply of foods and food supplements containing cannabinoids, pending formal approval by the European Food Standards Agency (EFSA) under the Novel Food Regulation.
This practical test will come with the outcome of the first application to the EFSA for a CBD food, which was submitted by Cannabis Pharma s.r.o, for a food supplement containing CBD for adults with a daily intake of up to 130mg. A spokeswoman for EFSA announced at the beginning of June that the European Commission is currently examining this request which will then be transferred to EFSA for further technical and scientific assessment. If the application is successful, the European Commission will issue an implementing regulation adding CBD as a food/ingredient to the list of approved novel foods within seven months. That approval will also specify any applicable conditions of use (e.g., maximum daily intake) or labelling requirements. Any product which differs from the approval will require a further application under the Novel Food Regulation.
In the meantime, manufacturers, distributors and consumers in the EU market may find that the sale of CBD containing foods and food supplements is disrupted unless the products may benefit from the transitional provisions of the Novel Foods Regulation. These allow CBD food products that were lawfully on the market before 1 January 2018 to continue on the market provided an application for an authorisation is submitted before 2 January 2020.
CBD in Vaping Products
Vaping or vaporization products, sometimes referred to as “e-cigarettes”, use battery power to heat an element to disperse a solution of propylene glycol or glycerine, water, flavouring and sometimes nicotine, resulting in an aerosol that can be inhaled by the user. Vaping does not create smoke and does not rely on combustion.
It is possible to produce vapor with herbal ingredients if the herbs are placed on top of a surface that heats up to the right temperature for vaporization. To vaporize, the herb must be heated enough so that the plant releases its chemicals in the form of vapor, but not hot enough that the plant burns. The perfect temperatures for vaporizing are between 350°F and 450°F to ensure that vapor is produced without ignition.
Whether the process involves combustion and whether nicotine is contained in the relevant products are key factors for the purposes of classification from a legal perspective. The Tobacco Product Directive (2014/40/EU) regulates not only tobacco products but also products based on plants, herbs or fruits which contain no tobacco, “herbal product for smoking”. However, these rules apply only to products consumed via a combustion process (i.e., smoking) or which contain nicotine.
It is also common to see the term “e-cigarette” used by different competent authorities to refer to vaping products, however, only products that can be used for the consumption of nicotine-containing vapour via a mouth piece are legally an “electronic cigarette” under the Tobacco Product Directive. The definition of electronic cigarette under the Directive also covers any components of the product, including cartridges, tanks and the device without cartridge or tank.
It follows that e-liquid products that do not contain nicotine when sold (e.g., disposable electronic cigarettes and 0% nicotine e-liquids) are not deemed to fall within the scope of the Tobacco Product Directive, but are regulated under the EU General Product Safety Directive 2001/95/EC and its corresponding national implementing acts, as a consumer product. There has been, so far, no suggestion that vape products including CBD should be classified as foods (the definition of food applies only to substances that are “ingested”) subject to the rules on novel foods referenced above, although some official clarification on this point has not yet been provided.
The General Product Safety Directive imposes requirements concerning the safety of products intended for consumer use, however, there are important divergencies among the EU Member States on the practical scope of the Directive. Currently, there is no harmonisation on how EU Member States treat non-nicotine electronic cigarettes with some countries, such as Greece, imposing a general ban and the UK imposing labelling requirements for those e-cigarettes that do not contain nicotine when sold but can be used to contain nicotine.
Some stakeholders advocate that non-nicotine products should meet the same quality standards as equivalent nicotine-containing products (controlled under the Tobacco Products Directive) in terms of production and emissions generated from the device and to prevent distortion of the market[i] which emphasizes the need to issue specific regulations to control these products to effectively ensure consumer safety.
CBD Products in the U.S.
In the US, Congress legalized hemp and its derivatives, such as CBD, through The Agriculture Improvement Act of 2018, enacted in December of last year. Although hemp-derived CBD is now legal, CBD derived from marijuana is still prohibited.
Additional restrictions apply at the federal level, depending on how the hemp-derived CBD is used. The US Food and Drug Administration currently takes the position that CBD cannot be used in foods or dietary supplements because it is the active ingredient in an approved drug Epidiolex. The Food Drug and Cosmetic Act sections 201(ff)(3)(B)(i) and (ii) exclude from use in a food or dietary supplement any ingredient that is the subject of clinical drug trials or is an active ingredient in an approved drug, unless the ingredient was used in foods or dietary supplements prior to that time. CBD can, however, be used in cosmetic products, subject to FDA regulations for all cosmetic products, including requirements that the products be safe, not misbranded, and promoted without drug claims. Over the last few months, FDA has requested comments and held a public hearing on use of CBD in food and dietary supplements, suggesting that its position is still evolving and may change.
Hemp and hemp-derived CBD cosmetic products that meet federal standards must still comply with individual state laws in the states in which they are sold. Currently, these laws range from outright prohibitions to no restrictions at all. Some states that permit CBD products are imposing additional regulatory requirements on top of those imposed by the U.S. FDA. These include state-specific testing requirements (to ensure 0% or a low level of THC) and warning labels. States laws are changing rapidly in this area as states seek to catch up with the federal legalization of hemp, with at least 15 states amending their laws in the last few months to allow hemp-derived CBD products to be sold within their states. Bills are pending in other states, which may be enacted before the end of this year.
[i] UK Department of Health. Government response to the consultation on the revised Tobacco Products Directive (2014/40/EU) of January 2016.