FDA clarifies position with CBD. It's a drug

https://hemptoday-net.cdn.ampproject.org/c/s/hemptoday.net/fda-signals-it-will-treat-all-cbd-as-drugs-heightening-urgency-of-legislation/amp/

Tldr two major companies who applied for cbd to be in fda approved supplements were shot down citing cbd is a drug

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That HIA lawsuit against the DEA over the IFR/AIA got dismissed back in May as well

Old news. You should know the fda can’t say if a natural molecule is a drug. How dare they.

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It might be easier to understand how some of the alphabet organizations work when they say “this is a drug”. What really happened is some other organization jumped through their hoops and was the first one to do so saying pretty much “hey we want to make health claims, here’s some research and applications saying that this compound does this and that, and therefore this CBD stuff is a drug” Signed, epidiolex.

FDA responds after checking their work. “OK, you are right, there ARE health benefits here, and so we agree its a drug since nobody has yet”

And then it’s set in stone. You cannot use that compound as its been classified as a drug compound. Drugs cannot be put in food, and because there’s no other approvals of the compound in other use, sorry. Dietary supplements can’t contain drugs. So saying its a supplement doesn’t work either. The industry has just been walking this made up self construed rule to justify making this ok. We’ve all been playing with fire since day one. Remember when we were all operations in the hemp industry that intermediate work is ok, even if it’s over 0.3%, so we were all operating in the gray until DEA clarified it was still illegal? Same thing.

So here we all are, wanting to get CBD to the masses but legally, its been registered as a drug. So food is a no-go. Some states like mine (NC) even made clarification on this law saying hey you can’t make edibles with the compound because it’s a drug. They didn’t make it illegal, they are just clarifying and reinforcing the FDA’s ruling which is federal (unless state overrules this like cannabis laws).

EPA does this too. You can’t legally make a hippy cottage craft bug spray containing any registered pesticide. Almost every cottage good, artisan bug spray and sunscreen is illegal. I’ll use bug spray since I had this happen to me. I did a ton of R&D and made a badass, natural bug spray using EO’s. The best natural bug repellent is Lemon Eucalyptus. Unfortunately some larger compaines like OFF, Cutter, Johnson & Johnson, CVS’s brand, Avon and a few others jumped through the EPA hoops and said “hey, EPA… this lemon eucalyptus stuff actually repels bugs… here’s the data!” EPA says “yes you are right, I see your data. It does work. So we agree. this is now considered a pesticide” Therefore you cannot use the compound in any of your products as it’s registered as a pesticide.

Now of course this would be detrimental for something so basic and simple but beneficial. So both EPA and FDA have this sort of inclusion so others can make these products as well. Another example is menthol and camphor. On their own they are just essential oils. but combined… well cause some company did the work it’s classified as a drug. Lidocane too. So FDA has the OTC monograph list. Basically saying “ok hey we know that this compound is a drug and is beneficial and we can let others make it too. but ONLY if you follow the rules and make it the exact same way as the others” You can call this the “me too” registration. Going back to the bug spray… I was able to make a “me too” argument. However I have to follow the rules of what they approved and can only use that compound in 30% concentration. No more, no less. Because it deviates away from what they said was OK before if I want to legally introduce using less of the active compound to market I have to go through the long and arduous task of registration of a new “pesticide”.

So while long winded and rambling I wanted to say all of this that knowing how these controlling bodies work and why, it should be no surprise that this statement came out. Knowing this, I hope this helps you learn how to navigate regulations, where to comply, and where to stay in the gray.

Signed,
Not a lawyer

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Seriously, the amount of doublethink and cognitive backflipping by people. They’re just lucky the powers that be move slowly.

“it’s not psychoactive” “it’s from hemp, not cannabis” “It’s not a drug” All statements of idiots, or people trying to manifest a legal reality that doesn’t exist.

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