CBD oil may help you quit a problematic addiction. One of the most exciting new areas of research related to CBD is its potential for helping with addiction. CBD has been proposed as a way to help people who are addicted to tobacco or even who are addicted to cannabis—a much rarer problem than tobacco addiction, but nevertheless a major issue for some people.
Your product is not generally recognized as safe and effective for the referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.