Fda and Tobacco Regulation

The FDA and Tobacco Regulation
10/15/2012
MAN 4701/ 82844

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?

Under the definition of a drug in the Food, Drug , and Cosmetics Act of 1938 it is defined as a product that affects the structure or any function of the body. As a group we decided that is in fact considered a drug because as a company, the tobacco manufactures in fact knew what their product was doing to potential consumers. Due to the abundance of deaths occurring each year, we figured a ban would be best for the situation. Unfortunately, as Kessler believed, a ban would be unworkable. 1) Did the FDA make any legal or political errors that defeated its efforts to regulate tobacco?

We did believe that the FDA did make some political errors in defeating its efforts to regulate tobacco. To start with, the FDA recognized the tobacco industry to be very powerful. Also, they decided to regulate cigarettes as medical devise which did not lead to a ban. Another action that went wrong is that they didn’t impose restrictions on adult smoking, instead focused on under aged smoking. 2) Do you agree with the decision of the U.S. Supreme Court? Why or why not?

As a group, we didn’t agree with the decision of the Supreme Court. The court ended up with a 5-4 majority split. Both sides had valuable points in the argument but the Supreme Court came out on top. Defendant Justice O’Connor stated that although tobacco was one of the nation’s most troubling public health problems, the FDA had no jurisdiction over it. As stated earlier, since they considered nicotine a drug, they would have to ban them completely which was unworkable. 3) 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?

We viewed the story as determining right from wrong. We believed since the ban didn’t fall through, then there must be some sort of flaws in the government. Since banning cigarettes would save tons of lives, we figured that would be the correct approach.

4) Should congress enact FDA regulation of tobacco products even if it adds to the competitive advantage of Philip Morris?

We agreed that a regulation should be placed on tobacco products even if it adds to the competitive advantage of Philip Morris. We though the public’s health should be of the highest priority instead of worrying about a competitive advantage. With that said, if regulations were passed cigarette smoking would be passed then followed by less deaths related to tobacco usage.