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.
1. What are cannabis and marijuana?
15. Can I import or export cannabis-containing or cannabis-derived products?
Questions and Answers
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.
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.
A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).
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.
“CBD can be used to relieve multiple symptoms,” says Lin. “But you need to know what you are getting.”
Recently, at the end of a surf trip with several friends, my pal Tim passed me a pipe packed with sticky green buds. I’m not much of a social smoker (more of a one-hitter-before-chores type) so politely declined.
With these sorts of benefits, it’s little wonder that there’s a booming market for CBD—and readily willing suppliers promising miraculous results.
How CBD works
Then, he made an odd promise, for a guy brandishing a glass pipe and a lighter: “It won’t get you stoned,” he said. “It’s CBD.”
I took a little hit, and soon after, felt my body pleasantly melt into a lawn chair, my ability to socialize not at all impeded. Truth told, at the end of a physically exhausting vacation and a can of Tecate, I was already pretty relaxed. But the CBD seemed to deepen that state.
Yu-Fung Lin, an associate professor of physiology and membrane biology at the University of California-Davis School of Medicine, teaches a course on the physiology of cannabis. She says although CBD is not considered to be psychotropic—meaning it won’t alter our perception of reality or produce a feeling of euphoria—it’s still working on our brains. CBD doesn’t activate our brains’ cannabinoid receptors in the same manner as THC, but it does target a wide variety of proteins in the brain and nervous system that regulate cell activities all over the human body. By interacting with the brain’s signaling systems in various ways, it can provide relief from pain, anxiety, and nausea. Beyond our brains, says Lin, CBD may benefit our bones and immune systems and work broadly throughout the body as an anti-inflammatory and antioxidant, which may help protect cells from damages associated with neurodegenerative diseases.
“It’s a mixture of CBD, cannabidiol, THC, and the phytochemicals, the terpenoids,” Grinspoon tells High Times. “You need all three of them to get the best therapeutic effect.” For this reason, Grinspoon, Lin, and many others say that the best source for therapeutic CBD is a plant with all of its cannabinoids intact.