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Ohio Takes Action against the CBD Industry

Ohio Takes Action against the CBD Industry

The Ohio Board of Pharmacy has just passed a regulation that CBD products can only be sold in state licensed dispensaries.
Here is the new regulation.
https://assets.documentcloud.org/documents/4793384/Clarification-on-CBD-Oil.pdf

Although around 50 licenses have been issued, currently there are no dispensaries in operation and it is estimated that it will take many months before the dispensaries pass the necessary inspections to operate. So what happens until the dispensaries open? Here’s what the board says:

“Until dispensaries are operational, no one, including board licensees, may possess or sell CBD oil or other marijuana related products. Violation of Ohio Revised Code or Ohio Administrative Code can subject a licensee (person or entity) to administrative or criminal action.” Gulp!

And just to remind you. CBD is still illegal under federal law and can’t be sold as a dietary supplement in interstate commerce. My earlier post on CBD discussed the federal status. Here it is:

rickjaffeesq.com/wp-admin/post.php?post=890&action=edit

Still not convinced? here are two Q&A’s from the FDA’s website page on marijuana:

“2. Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
There is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For more information on this provision, including an explanation of the phrase “marketed as,” see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.

13. Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added?
A. No. Under section 301(ll) of the FD&C Act, it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the Act) or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not called our conclusions into question.”

Translation: CBD is not a dietary supplement, it’s a schedule I drug. And that’s regardless of the oft asserted but incorrect safe harbor of less than .3 percent THC.

I’m sure you’ve noted that the FDA treats THC and CBD as the same, at least from a regulatory point of view, them both being illegal.
That’s what I’ve been telling people in my post and verbally, that the THC content is irrelevant in determining whether the product is legal. It’s just about what part of the plant is used as I explained in my prior post.

The good news: Neither the DEA nor the FDA seem to be in a particular hurry to stop companies from selling CBD oil or people using it.
One partial reason for this might be that the FDA has just approved a purified CBD oil product called, Epidiolex, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

In the short term, I don’t think much will change, and the companies will still push out huge quanities of CBD products, but maybe not so much in Ohio. It will be interesting to see what kind of enforcement action is taken. I suspect the Ohio Board of Pharmacy has limited resources, so if anything will be done, I would expect it would come from the AG’s office, as it has a bigger stick and more resources.

Rick Jaffe, Esq.
www.rickjaffeesquire.com
www.rickjaffeesquire@gmail.com