Do you agree with the FDA that nicotine can be classified as a drug and that cigarettes can be classified as devices under the definitions in the Food, Drug and Cosmetics Act?
I agree that nicotine can be classified as a drug because it falls into the categories of the three clauses (A), (B), (C) and (D) under the definitions in the Food, Drug and Cosmetics Act:
It is article recognized in the official U.S Pharmacopoeia (Clause A) -
It is article that intended for use in the diagnosis, cure, treatment in man (Clause B). Nicotine originally is used as a therapy for certain conditions. -
It is an article intended to affect the structure or any function of the body of man (Clause C). Surely, nicotine can cause cancer, emphysema, heart disease, etc. -
And it is an article intended for use as a component of any article specified in clause (A), (B) or (C)
Since cigarettes are nicotine delivery tools, which deliver a pharmacologically active dose of nicotine to the body through buccal absorption, they can be classified as devices under the definitions in the Food, Drug, and Cosmetics Act. 2.
Did the FDA make any legal or political errors that defeated its effort to regulate tobacco?
Yes, the FDA did make a legal error that defeated its effort to regulate tobacco. If the FDA wishes to regulate a product, it must first determine that the product falls within its jurisdiction; and if the FDA held that nicotine was a drug and cigarettes were a device to deliver that drug to the body, it would have to ban them.
Secondly, by attempt to regulate the advertisements of the tobacco industry in strict manners, the FDA's regulations was argued by the tobacco industry to violate the first amendment's guarantee for the Constitutional rights to free commercial speech.
Do you agree with the decision of the U.S. Supreme Court?
No, I don’t agree with the final decision of the U.S Supreme Court when invalidated the FDA’s tobacco rule.
I believe that...
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