There are no other FDA-approved drugs that contain CBD. According to Act FD%26C, any product intended to treat a disease or that has a therapeutic or medical use, and any product (other than a food) intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD product other than a prescription drug for humans to treat severe and rare forms of epilepsy. There is very limited information on other CBD products marketed, which are likely to differ in composition from that of the FDA-approved product and have not been evaluated for potential adverse effects on the body.
Epidiolex, a prescription drug that helps treat two types of rare seizure disorders, is the only CBD product approved by the FDA. Currently, the only CBD product approved by the Food and Drug Administration is a prescription oil called Epidiolex. It is approved to treat two types of epilepsy. In addition to Epidiolex, state laws regarding the use of CBD vary.
While CBD is being studied as a treatment for a wide range of conditions, such as Parkinson's disease, schizophrenia, diabetes, multiple sclerosis and anxiety, research supporting the drug's benefits remains limited. Consumers can also postpone important medical care, such as diagnosis, treatment and appropriate supportive care, due to baseless claims related to CBD products. The Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act (Act FD%26C). This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency's rigorous public health standards.
Shokoohinia also recommends seeking a third-party certificate of analysis, which can show the amount of CBD or THC contained in the product and whether it has been tested for contaminants, pesticides, heavy metals and mold. Health experts recommend consulting a healthcare provider and using CBD and THC products with caution. Most THC and CBD products are not regulated and therefore cannot enforce health claims, as the FDA has not evaluated the safety, side effects and quality of many CBD and THC products. Other violations include the marketing of CBD products as dietary supplements and the addition of CBD to food for humans and animals.
A recent study of 84 CBD products purchased online showed that more than a quarter of the products contained less CBD than the labeling. 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. Today's actions come at a time when the FDA continues to explore possible avenues for various types of CBD products to be legally marketed. The FDA had already sent warning letters to other companies that were illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious illnesses, such as cancer, or that otherwise violated Act FD%26C.
There are many unanswered questions and data gaps about the toxicity of CBD, and some of the available data raise serious concerns about the potential harms of CBD. The revised consumer update describes specific safety issues related to CBD products, such as possible liver damage, interactions with other medications, drowsiness, diarrhea, and changes in mood. .