The U.S. Drug Enforcement Agency (DEA) has notified GW Pharmaceuticals (NASDAQ:GWPH) that it no longer considers Epidiolex (cannabidiol) a controlled substance. The change is effective immediately.
Sorry but your 2nd statement doesn’t follow. For CBD edibles to be fully legal, it not only needs to be not a controlled substance, it also needs to be GRAS listed.
Would the FDA have to take any action to define CBD as an appropriate food ingredient?
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Yes, i believe we’d need explicit say so from them. Someone correct me if I’m wrong.
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I think that just because it’s not a drug does not make it a safe food additive.
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Would it not now be considered a dietary supplement?
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Possibly. But being a dietary supplement doesn’t qualify it to be included in a food product. So trying to make something clearly identifiable as a food like a CBD soda could still land you in trouble.
As it stands with the FDA you cannot add CBD to any dietary supplement or edible/consumable product for humans or animals, this falls mostly under the FD&C Act (Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA). As stated before, CBD is not GRAS and the FDA’s policy on it is fairly accessible and public. Most CBD companies selling CBD in these forms online have not yet received any warning letters or disciplinary actions despite clearly violating these terms, however there is a considerable list of companies which have received warning letters. I would guess the FDA doesn’t have resources to prioritize going after every company, that doesn’t mean they wont.
This is a “your mileage may vary” situation at best, the DEA re/descheduling a compound =/= FDA approval. The forms of CBD products that appear to be ok by the FDA are topicals, hemp seeds, and hemp seed oil.
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Well actually the FDA has no authority over dietary supplements. What they do have authority over is if you try and sell a drug AS a dietary supplement. That, you can’t do. So their case was that CBD is a drug thus it can’t be sold as a dietary supplement. If that’s no longer the case then that argument may no longer hold up. I do not know enough about the law to say anything about the implications of this change.
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This is true. However, the FDA can become involved with certain dosages or dosage forms. Ferrous sulfate is a nutritional supplement that can be purchased over the counter and also is prescribed at higher dosages. Epidolex is 20,000mg per box; so it will be interesting to see where they make the cutoff for CBD to be sold over the counter as a DS. Also, I believe the charge would fall under being misbranded which can carry some significant punishments.
This is true, thank you for the clarification
All CBD payment processors now all accept ingestible CBD (this is a recent change)
Many only allowed for topicals.
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so can I make cbd edibles or nah
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Definitely maybe.
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I’m not an attorney and can’t speak for your license/state etc, but I can get your website and banking and payment processing and tech stuff rolling appropriately.
CBD or otherwise. (Square for CBD)
Anything… to be considered higher risk or conversions that don’t have THC in there name I have a full website / direct bank payment solution, this solution can work for delivery / pickup orders for licensed THC dispensaries.
Did Edibles rules change during the IFR? I guess I’m missing out on the cbd edibles concern.
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