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With this disregard for the basic principles of science, the FDA is undermining literally decades of public education about the severe hazards of cigarette smoking. The FDA is negating the benefits we have accrued from the tobacco companies halting their own undermining of the public's appreciation of smoking's hazards because the agency is now doing that work for the tobacco companies.

Readers who see that Dr. Fiore has declared no conflicts of interest might naturally assume that he has no conflicts of interest to report.

5. In 2009, Senator Rockefeller sponsored and supported legislation that protected menthol cigarettes by exempting them from the flavored cigarette ban in the Family Smoking Prevention and Tobacco Control Act.

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.


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