CBD is currently a controlled substance under the Single Convention. CBD products may therefore only be imported or exported under very specific conditions. Any import or export must meet all of these criteria and may only be done:
Hemp-seed oil is oil made from pressing the grain of hemp plants. It is processed like other oil seeds, such as canola. In order for hemp-seed oil to be exempt from the Cannabis Act, it can’t contain more than 10 parts per million of THC.
To cultivate any cannabis plants that you intend to sell, you must have a federal licence issued under the Cannabis Act.
Deliberately adding phytocannabinoids to such products is not permitted.
Industrial hemp is cannabis that contains 0.3% THC or less in the flowering heads and leaves.
All phytocannabinoids are regulated under the new Cannabis Act. The Act came into force on October 17, 2018.
As a result, CBD and products containing CBD are subject to all of the rules and requirements that apply to cannabis under the Cannabis Act and its regulations. This includes CBD derived from industrial hemp plants, as well as CBD derived from other varieties of cannabis.
As an isolated substance, CBD is not a controlled drug. However the process of extracting or isolating CBD from the cannabis plant may co-extract other cannabinoids and products could unintentionally include other non-psychoactive or, more significantly, psychoactive cannabinoid substances.
Kit Malthouse MP, Minister of State for Crime and Policing, wrote to the Chair of Advisory Council on the Misuse of Drugs (ACMD), to seek advice on the issue of CBD products which are not medicines; specifically on the controlled cannabinoids that could be present and the concentrations that they could be present at.
Cannabidiol (CBD) is a non-psychoactive cannabinoid present in the cannabis plant (Cannabis sativa L) along with many other cannabinoids that may either exhibit psychoactive or non-psychoactive properties.
CBD plant extract or plant isolates have gained salience as an ingredient in food supplements and in some cosmetic products, and there has been a proliferation of such products, available online and on the high street.
The report on the international ring trial on CBD and controlled cannabinoids in consumer products will be published on the Government Chemist website later this month.
A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.
26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.
Research and Expanded Access
FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.
A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.
A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.