The FDA was challenged by tobacco companies for its new rules that required the

Question

The FDA was challenged by tobacco companies for its new rules that required the tobacco companies to put one of the FDA’s 12 picture labels on its packaging. The tobacco companies argued that their First Amendment rights were violated by the rules, forcing them to speak in a certain way using government-mandated materials. The new labels were promulgated by both the FDA and the Department of Health and Human Services (HHS) pursuant to authority granted by Congress in 2009 under the Family Smoking Prevention and Tobacco Control Act. Under the law, the following nine textual statements were to be included on cigarette labels: WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Cigarettes cause fatal lung disease. WARNING: Cigarettes cause cancer. WARNING: Cigarettes cause strokes and heart disease. WARNING: Smoking during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung diseases in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your health. The act required that these warnings and graphic labels take up 50 percent of the cigarette package label and 20 percent of all cigarette ads. After publishing the proposed rule and receiving more than 1,700 comments, the FDA published its final rule in June 2011. Explain how the tobacco companies could challenge the rules. Discuss whether the rules will be set aside. [In the case of R.J. Reynolds Tobacco Company et al. v. FDA et al., —F.3d —, 2012 WL 3632003 (D.C. Cir.)]

Explanation / Answer

As per my understanding of the law, the tobacco companies should not challenge the rules. FDA has published the final rules in June 2011, after taking into consideration the pros and cons of use of tobacco as well as public response to drafting of such rules. Moreover the rules are meant for the welfare of public at large.

The tobacco companies can not challege the authority enshrined in the Act ( the Family Smoking Prevention and Tobacco Control Act ) mentioned in the question but rightly companies are entitled to raised the issue of freedom of speech as per their First Amendment rights. No doubt FDA rules forces companies to speak in a manner which is contarary to their beliefs and against their interest. At the same time First Amendment rights must allow the factual and or true information about the use of tobacco to be conveyed in the most effective manner.

Therefore tobacco companies may challenge the findings and research reports forming basis for the FDA rules and may come out with their own and or sponsored and or independent reseach findings and reports contradicting those of FDA.

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