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 a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.
A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.
Research and Expanded Access
A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.
A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.
As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.
When you harvest oil from the entire plant, you get every potential beneficial compound the plant has to offer, including not just CBD, but dozens of other cannabinoids and scent compounds called terpenes.
CBD or cannabidiol oil is derived from the cannabis sativa (hemp) plant. Instead of using the seeds, CBD is extracted from the flowers, leaves, stems, and stalks of matured hemp plants. CBD oil can be extracted through several methods, including carbon dioxide, ethanol, and even olive oil. The extraction method can play a part in the quality of CBD oil.
What is CBD Oil?
With surging interest in CBD since the U.S. Farm Bill passed in late 2018, you may be curious about the difference between hemp oil and CBD oil. Unheard of only a few years ago, both hemp and CBD oil are proliferating store shelves, but there are significant differences between these two products.
We put together a guide to help you learn about the similarities and differences between the two hemp derivatives, how to figure out what you need, and where to get the right product.
You can take CBD oil topically, or you can ingest it or take it under the tongue. When choosing a CBD oil, do not be swayed to select purely on cost, as this is one industry where you get what you pay for.
However, medical research on marijuana is severely restricted by federal law.
The defining difference between hemp and marijuana is their psychoactive component: tetrahydrocannabinol, or THC. Hemp has 0.3% or less THC, meaning hemp-derived products don’t contain enough THC to create the “high” traditionally associated with marijuana.
Hemp, marijuana and cannabanoidals
Michigan State University provides funding as a founding partner of The Conversation US.
Brandon McFadden receives funding from U.S. Department of Agriculture.
One would assume, then, that hemp-derived CBD should be federally legal in every state because the THC levels don’t surpass 0.3%. But CBD occupies a legal gray area. Several states, such as Nebraska and Idaho, still essentially regulate CBD oil as a Schedule 1 substance akin to marijuana.