FOOD AND DRUG ADMINISTRATION v. BROWN & WILLIAMSON TOBACCO CORPORATION 120 S. Ct
ID: 346483 • Letter: F
Question
FOOD AND DRUG ADMINISTRATION v. BROWN & WILLIAMSON TOBACCO CORPORATION
120 S. Ct. 1291 (2000)
O’CONNOR, J.: This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use. In 1996, the Food and Drug Administration (FDA), after having expressly disavowed any such authority since its inception, asserted jurisdiction to regulate tobacco products. The FDA concluded that nicotine is a “drug” within the meaning of the Food, Drug, and Cosmetic Act (FDCA or Act), and that cigarettes and smokeless tobacco are “combination products” that deliver nicotine to the body. Pursuant to this authority, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. The agency believed that, because most tobacco consumers begin their use before reaching the age of 18, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease.
Develop a 300 word case study using the following format: facts, issues, rule, analysis, and conclusion.
Discuss the purpose of regulatory agencies and how laws are balanced with ethical concerns.
Cite a minimum of two peer-reviewed references.
FOOD AND DRUG ADMINISTRATION v. BROWN & WILLIAMSON TOBACCO CORPORATION
120 S. Ct. 1291 (2000)
Explanation / Answer
There us hardy a doubt about tobacco's role in promoting the spread of use related ailments and contributing to premature deaths worldwide. In 1996, FDA asserted jurisdiction to regulate the tobacco products by describing them as drugs and cigarettes and other tobacco products as devices that delivered nicotine into the body. The tobacco company brown and Williams challenged the authority of FDA, claiming that the matter does not come under purview of FDA. Supreme Court ruled in favour of Brown and Williams ruling out FDA's authority. Court ruled that tobacco is not a drug and the cigarettes etc. can't be termed as devices hence FDA is not authorised to regulate tobacco and its products.
The role of regulatory agencies is to monitor detect and curb the practices which are against the laws and ethical principles or are harmful for the society for the public good. However, each agency has its purview and domain of work . The legal framework aims to regulate and curb the practices which are against the ethics of nature and potentially harmful tocertain group of people with or without their knowledge.
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