Seneyda Morel The FDA and Tobacco Regulation

1. Do you agree with the Food and Drug Administration 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? Yes. I do agree with the FDA that nicotine can be classified as a drug. Nicotine is a very addictive substance that satisfies smokers cravings therefore it should be classified as a drug. As mentioned in the drug definition part (c) articles other than food intended to affect the structure, or any function of the body of man and other animals. Nicotine is a drug that causes addiction, and with time severe illnesses. This product as stated in the text killed over 400,000 Americans per year. I also agree that cigarettes can be classified as devices because they contain substances such as nicotine which is a drug. 2. Did the FDA make any legal or political errors that defeated its efforts to regulate tobacco? Shalalas staff thought the regulations imposed by the FDA were a political Blunder. A majority of the key provisions in the draft were only catered to adolescents. Kessler also wanted to escape the dilemma that was occurring by labeling cigarettes medical devices which is illegal. The advertising restrictions were unconstitutional. 3. Do you agree with the decision of the U.S. Supreme Court? Why or why not? I do agree with the decision of the Supreme Court. Although the FDA was never granted the regulation of tobacco it still had Restrictions. As mentioned in the text in 1998 tobacco companies agreed to pay 256 billion over 25 years to settle suits by state

attorneys general seeking to recover billions in Medicaid dollars paid out to treat smokers illnesses. National tax on smokers was imposed and about 17% was used for treating smoke related illnesses. According to statistics smokers fell from 24% in 1999 to 21 % by 2004. In conclusion the Supreme Court found it inevitable to regulate tobacco, and as adults we must know what is in our favor, and what is not. The states generate huge income figures from taxing cigarettes which generates more jobs. Do you believe that the story reveals flaws in American government and the regulatory process, or do you believe that the story reveals a system that, despite faults, is ultimately responsive and just? My point of view, it was highly difficult to regulate Tobacco Cigarettes are bad to the public health, and they did attempt to regulate it, but instead it caused a controversy between legislation. Therefore this story reveals a revenue system. In no way did they inform the public that this was good for your health, instead they proposed to have it difficult for adolescents to acquire and wanted to teach adults about the effects it may have. At the end of the day they were responsive, and attempted in every way they could, to have it regulated.

5. Should Congress allow newly proposed FDA regulation of tobacco products even if it adds to the competitive advantage of Philip Morris?

NO. By enacting FDA regulation of Tobacco products they could accomplish public health goals but at the same time it would not have the power to regulate existing brands off the market. If a certain brand had more harmful substances than another that was

already in the market, it too should be regulated. At the end of the day it would not work to his advantage because of his reputable products having the possibility of regulation.