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Re: Gladys Thong post# 80817

Thursday, 04/27/2023 12:10:13 PM

Thursday, April 27, 2023 12:10:13 PM

Post# of 82811
Why no investor interest in CVSI-007?

This November 2020 article might help to explain and why that lack of interest is not likely to change.

Azim Chowdhury, a partner at Keller & Heckman’s Washington DC office, said any company seeking to introduce a CBD/nicotine product could face the full weight of the US Food and Drug Administration (FDA)’s scrutiny for traditional nicotine products.

“Anything that contains tobacco-derived materials could fall within the meaning of a tobacco product under the Food, Drug, and Cosmetic Act,” Chowdhury explained. “If something was a CBD product that was mixed with a tobacco-derived product, then the question is, ‘Is it a tobacco product, and therefore subject to the premarket authorisation requirements that apply to all new tobacco products?”

FDA warning letters

Chowdhury mentioned that even an Arizona company manufacturing nicotine-infused toothpicks received FDA warning letters related to traditional tobacco product regulations.

“If someone is mixing CBD with nicotine or something else and they want to go market with a health claim about some therapeutic benefit like smoking cessation, no matter what, they are going to have to go through the drug approval process to make that claim,” Chowdhury said.

Some in the CBD industry believe nicotine is the last thing the market needs, even if it’s intended to help addicted smokers quit.

“CBD is rooted in so much good, to attach it to something with so much negativity, I just don’t see any reason for that,” said Jason Mitchell, co-founder and co-CEO of HempFusion.

“The spirit of it seems good – but as much as I admire the thought that goes into this, I find it irresponsible. Nicotine is a very addictive chemical. You have to ask yourself how ethical that is. You’re literally trying to create a body of users. That’s the Philip Morris model.