WHO does not recommend cannabidiol for medical use. Initial evidence from animal and human studies (i.e. a controlled study in the New England Journal of Medicine and other reported individual cases) shows that its use could have some therapeutic value for seizures due to epilepsy and related conditions.
At its November 2017 meeting, the WHO Expert Committee on Drug Dependence (ECDD) concluded that, in its pure state, cannabidiol does not appear to have abuse potential or cause harm. As such, as CBD is not currently a scheduled substance in its own right (only as a component of cannabis extracts), current information does not justify a change in this scheduling position and does not justify scheduling of the substance.
Not scheduling a substance means that it is not subject to strict international controls, including for production and supply. Its legal status in countries is something for national legislators to decide. Some countries have eased regulations around cannabidiol, to consider products containing CBD to be medical products. These include Australia, Canada, Switzerland, the United Kingdom, and the United States of America.
Cannabidiol is one of several (probably 200) compounds of the cannabis plant.
However, where CBD is produced for pharmaceutical purposes as an extract of cannabis, cannabis extracts and tinctures are included in the 1961 UN Single Convention on Narcotic Drugs. A fuller review of extracts or preparations containing almost exclusively CBD will take place in June 2018, when the WHO expert committee will undertake a comprehensive review of cannabis and cannabis related substances.
It has been widely reported that WHO officially recommended on December 14, 2017 that cannabis compound cannabidiol (CBD) not be internationally scheduled as a controlled substance.
Some people have been using cannabidiol to calm spasms during epileptic fits. The New England Journal of Medicine also published a study lately saying there is some evidence it may be effective during epileptic seizures. This means it could have some medical use but more evidence is needed.
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.”
We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.
11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
Questions and Answers
9. Can THC or CBD products be sold as dietary supplements?
If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)
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.
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.
We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.
This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.
In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.
As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.
We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.