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Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses, and we have issued several warning letters to such firms.
Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter Drug Review.
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