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Without FDA approval - the patch is just an OTC product that the customer has to come out-of-pocket to purchase.

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That is where the patch currently is(an OTC product), if I read between the lines(with my LOTR glasses) I guess I could place it within the current FDA process, but it currently is not being looked at by the FDA.

There is currently only one FDA approved CBD product:

https://www.fda.gov/consumers/consumer-update...r-cannabis

https://www.fda.gov/news-events/press-announc...vere-forms