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This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.

(See: Zhu S-H, et al. Four hundred sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control. Published online ahead of print on June 17, 2014.)

"Smoking is no more hazardous than taking an exam in terms of its acute respiratory effects."


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