A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.
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.
15. Can I import or export cannabis-containing or cannabis-derived products?
Questions and Answers
A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.
There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.
FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.
In 1996, California re-legalised medical marijuana and numerous other states did the same over the next 10 years. A number of other countries also relaxed cannabis laws, making way for essential trials and research to learn more about the plant and the impact CBD and over 120 other cannabinoids have on the human body. But laws surrounding CBD and cannabis use in the UK remain very tight.
But the real understanding of how CBD and THC (and since, other cannabinoids and terpenes besides) interacts with the human body first came to light when the first endocannabinoid, Anandamide, was found in the 1990s, quickly followed by the discovery of an unknown molecular signaling system: the endocannabinoid system. A totally transformational moment in cannabis study.
CBD law in the UK – a 2021 overview
However, while this has been going on, the drug class of cannabis has bounced up and down between being a Class B and Class C drug and the largest hemp (cannabis sativa) farm in the UK, largely used for home-grown CBD products, was ordered to destroy its crop without having their license renewed due to confusion over cultivation and harvesting guidelines.
You should always buy CBD oil from a trusted brand like Kloris – one with good independent reviews and who’s stocked with major retailers like Boots and Amazon who have stringent quality checks.
So, where does CBD come in?
This presents a problem for the CBD industry, as there is very little CBD found in these parts – CBD is mainly found in the flowers and leaves, which are still treated the same as high THC cannabis and have to be destroyed, making the crop uneconomical.
Ever since the herbal supplement boom in the US, a $49 billion-a-year industry in motion since 2010, CBD sales have increased exponentially. Combine this with a surge in anxiety levels across America and you have a thriving industry. As such, many are critical as to the benefits of CBD, especially given the lack of clinical evidence and the glorified language surrounding it.
Instead, CBD has been praised anecdotally as a “miracle cure” for both pain and stress relief.
However, this is not to be confused with the legalisation of medical marijuana, which is a much more divisive issue worldwide.
CBD oil tinctures
How sustainable is cultivating CBD?
CBD oil is legal in a vast array of countries nowadays. Therefore, despite some previous confusion, it would not show up on a drug test as it is not an illegal substance. Countries with legalisation include the United States, Argentina, Belgium, Bulgaria, Canada, Colombia, Denmark, Germany, Netherlands, Sweden, Uruguay and the United Kingdom.
Cannabis Sativa plant growing in Canada
The controversy surrounding marijuana comes from the fact that it contains THC, known to produce psychotropic effects.
Does CBD come from the marijuana plant?
In the UK, while almost all cannabinoids are controlled substances under the Misuse of Drugs Act 1971, CBD is not. Bulgaria was the first in Europe and the United Kingdom is also leading the way, having just started selling CBD products en masse in popular health chain Holland & Barrett. The products must have less than 0.2% of THC in them in order to be sold, according to the Home Office.
Hemp oil deriving from the seeds of the plant can also be used for cooking and provides protein powder, so virtually none of the plant is wasted. What’s more, industrial hemp absorbs a vast amount of CO2, when compared with any other commercial crop.