Deck 9: Regulating Business

Question 1

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?

Answer 1

The FDA, a federal controlling agency primarily responsible for improving and preserving public health by checking and controlling contaminated foods and harmful drugs, underwent legal battles in its mission to declare tobacco products as a form of drugs that should be regulated. Initially, when the organization ASH appealed the FDA to affirm its authority over tobacco products and to declare nicotine as a drug and cigarette as the device, it repudiated their request by asserting that the FDC Act authorized identifying a product as a drug when the company presented health claims for their products or intended to use them as medical substances. In addition, the FDA maintained that since tobacco enterprises failed to produce health claims for tobaccos or pronounce the intention that nicotine is used for pharmaceutical impacts on the human body, it had no legitimate authorization. However, under the commission of Kessler, a new era ushered in. He pushed strenuously to bring tobacco under the jurisdiction of the FDA. Several efforts were taken to implement their set protocols to control tobacco products effectively.
The FDC Act, enacted by Congress in 1938, empowered the FDA to monitor pharmaceutical devices and the safety of novel medicines and to investigate the production plants of standardized commodities. The act establishes universal descriptions of drugs and devices and authorizes the agency to determine which substances and objects befall into these classifications. This enactment prompted the FDA to include tobacco under its authority to disclose it as a drug that is harming public well-being. The legal conflict between the FDA and the tobacco industry spiraled when President Clinton approved the proposals delineated by the FDA commissioner Kessler and declared to regulate tobacco products. It resulted in a lawsuit registered by the tobacco industry against the FDA in the North Carolina district court to halt the execution of tobacco regulation law. The tobacco industry appeared victorious, which directed the FDA to take up the final matter in the highest authority, i.e. the SC. The U.S SC, in a 5-4 decision, passed a judgment in support of the tobacco industry and nullified FDA's nicotine products rule. Their decision favor limited regulation of tobacco products, a ruling that presents long term effects on public well-being.
The story reveals flaws in the regularity process and the American government since it enacted a partial regulation that served the interests of major tobacco companies. It is evident that tobacco products such as cigarettes are a menace to public health, and hence, a stringent regulation is required to check children and teenagers from getting addicted. However, the government was more concerned with vested political interests and fall prey to the lobbying technique employed by the tobacco industry. In addition, the SC also neglected to look beyond the lens of the statute and disregarded the fact that it as a predicament associated with health-protecting purposes.

Question 2

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

Answer 2

The tobacco industry still faces regulation even after the defeat of the FDA's tobacco regulation rule in the SC. It funded billions of dollars in 25 years to healthcare system M to treat smokers' ailments. In addition, they agreed to curb endorsements and the application of logos on publicity things as a kind of agreement. To remunerate from this loss, the tobacco companies increased the rate of cigarettes. The agreement converted into the national tax to smokers, which ultimately led to a drop in the percentage of smokers. Following the end of the FDA's journey in the SC, the company PM, the largest U.S. tobacco corporation, resolved that certain constraints are required. As a result, the FSPTC Act was introduced in 2007 to monitor the tobacco industry, but not identifying tobacco products as drugs and devices.
The new act would enable the FDA to halt diluted nicotine products, lessen nicotine percentage, prevent flavors and savors that could attract children, and monitor advertisements and publicity to curb juvenile interests. It mandates the tobacco industry to get permission from the FDA for every new product. Despite authorizing the FDA to prevent the induction of new cigarette labels, it does not have jurisdiction over the older toxic brands that are already existing in the market. Therefore, the agency is entrusted with the role of protecting public health but coerced to permit the marketing of commodities carrying thousands of poisons and carcinogens. PM backed the bill as it would boost the expenses of supervisory acquiescence for smaller adversaries. The publicity restrictions and the obligation to get approval would render it impracticable for new labels to contend with the already established brands and check the company from launching new products until they are proven as suitable for public health.
With the negativity connected with the new bill, a lot of advocators of the tobacco regulation concluded that this proposal is equivalent to not having any form of regulation. Nonetheless, Congress should enact the FDA control of tobacco products despite adding a competitive edge to PM since it is a form of bargaining as a complete regulation is intrinsically improbable. Additionally, the states are already addicted to tobacco money since the tobacco industry is a high revenue generation for the government, so a complete halt is dubious. Furthermore, strict regulation on tobacco products as drugs and devices can lead to a surge in illegal activities and an increase in the costs of cigarettes.

Question 3

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?

Answer 3

The FDA, a federal controlling agency primarily responsible for improving and preserving public health by checking and controlling contaminated foods and perilous drugs, underwent bitter sour legal battles in its mission to declare tobacco products as a form of a drug that should be regulated. Initially, when the organization ASH appealed the FDA to affirm authority over tobacco products and to declare nicotine as a drug and cigarette as the device, it repudiated their request by asserting that The FDC Act authorized classifying any items as a drug only when the company presented health claims for their products or designated to be utilized them as medical substances. In addition, the FDA maintained that since tobacco enterprises failed to produce health claims for tobaccos or pronounce the intention that nicotine is used for pharmaceutical impacts on the human body, it had no legitimate authorization. However, under the commission of Kessler, a new era ushered in. He pushed strenuously to bring tobacco under the jurisdiction of the FDA. Several efforts were put forth to implement their set protocols to control tobacco products effectively.
The FDC Act, enacted by Congress in 1938, empowered the FDA to monitor pharmaceutical devices and the safety of novel medicines and to investigate the production plants of standardized commodities. The act establishes universal descriptions of drugs and devices and authorizes the agency to determine which substances and objects befall into these classifications. This enactment prompted the FDA to include tobacco under its authority to disclose it as a drug that is harming public well-being.
The FDA can label nicotine as a drug and cigarettes as devices under the FDC ACT 1938 since nicotine has an addictive effect on the formation or function of humans or animals and cigarette is the device where nicotine is added to create a drug-like impact on humans and animals. Various research and thorough investigations have confirmed that smoking and lung cancer are closely associated. It is worth noting that the mortality rates for smokers are 170 percent higher than non-smokers and the mortality augmented, depending on the number of cigarettes inhaled. Nicotine can be marked as a type of pediatric illness that stifled mostly teenagers and children, and it is a huge peril to public well-being. Therefore, the act of the FDA to classify nicotine as harmful substance and cigarettes as the device for taking nicotine should be undoubtedly supported.

Question 4

Did the FDA make any legal or political errors that defeated its efforts to regulate tobacco?

Question 5

Do you agree with the decision of the U.S. Supreme Court? Why or why not?