For example, the agency has warned companies to stop selling CBD products that they claim are intended to prevent, diagnose, treat, mitigate or cure serious illnesses such as cancer, Alzheimer's disease, psychiatric disorders and diabetes. In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. This change in the law could result in a more streamlined process for researchers to study cannabis and its derivatives, including CBD, which fall under the definition of hemp, a result that could accelerate the development of new drugs containing hemp. It is important to note that the FDA has not approved any other cannabis product, derived from cannabis or cannabidiol (CBD) currently available on the market.
OTC drugs must be approved by the FDA or meet marketing requirements without a request for a new drug approved under federal law, including drugs containing CBD, regardless of whether CBD appears on the label as an active ingredient or as an inactive ingredient. The Food and Drug Administration (FDA) has not approved any other CBD product and there is very little information available about CBD, including its effects on the body. As part of the review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. The FDA had already sent warning letters to other companies that were illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of Act FD&C.
The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved application for a new drug. Unlike the FDA-approved CBD drug, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) that makes therapeutic claims, have not been evaluated by the FDA to determine if they are effective for treat a particular disease or have other effects that may be reported. Misleading, unproven, or false claims related to CBD products can lead consumers to postpone important medical care, such as diagnosis, treatment and appropriate supportive care. In addition to violations related to FDA-regulated products containing THC delta-8, several of the warning letters describe additional violations of Act FD&C, including the marketing of CBD products that claim to treat medical conditions in humans and animals, the promotion of CBD products such as dietary supplements and adding CBD to food for humans and animals.
The FDA has not approved any drug containing CBD other than a prescription drug for the treatment of seizures associated with the tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome in human patients. As part of these actions, the FDA analyzed the chemical content of cannabinoid compounds in some of the products, and it was found that many did not contain the levels of CBD they claimed to contain.
