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A drug is defined in Section 321(g) of the Food, Drug and Cosmetic Act (FDCA), in pertinent part, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" (the "disease" or "therapeutic benefit" prong) or "articles (other than food) intended to affect the structure or function of the body of man or other animals" (the "structure/function" prong)

7 The carbon monoxide in the smoke competes with oxygen in the blood to form carboxyhemoglobin, leading to cell hypoxia and impaired cell respiration

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