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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