The Legal and Regulatory Environment of Business

Facts 

Regulatory agencies are the bodies bestowed with the duty to monitor the operations and the quality of products and services offered to the people in various organizations and industries. Some of the operations are a threat to the lives of the people, animals, as well as the environment. Such authorities are responsible for giving a chance to the organizations to continue producing quality products that do not affect the lives of the people and supply them in the market. In this essay, I will focus on the case of Food and Drug Administration (FDA) v. Brown & Williamson Tobacco Corporation . FDA is responsible in controlling the quality of tobacco products produced and supplied in the market while Williamson Tobacco Corp is responsible in the production of various tobacco products supplied in the market in various countries ( Apollonio & Glantz, 2017 ). 

Issues 

FDA had issued some sanctions to the tobacco products in 1996 regarding the labeling, promotion, and marketing of the products to the adolescents and children in the society. A group of tobacco products was not happy about the sanctions, and they responded by filing a suit aimed at challenging the FDA’s authority sanctions against the production, advertising, promoting, and marketing their products. FDA was determined with the authority allowing them to regulate any products falling under their mandate of the restrictive products as stipulated in the Act ( Cahoy, Reed, & Pagnattaro, 2015 ). With such authority, FDA decided to promulgate various regulations relating to the labeling, marketing, and promotion of tobacco products to young people including children and adolescent youths. 

Rule 

The case was heard in United States District Court in North Carolina. The court determined that FDA was a body mandated with the regulation of tobacco products and the actions of promoting, marketing, and advertising the products were allowed. The court was against the promotion and advertising restrictions sanctioned by FAD against the tobacco companies, as they exceeded their authority of the body as mandated under section 360(e). The matter was reversed in the Court of Appeals arguing that the Congress had not offered a jurisdiction to FDA to regulate and monitor the production, marketing, promoting, and advertising of the tobacco products ( Cahoy, Reed, & Pagnattaro, 2015) . The main issue was whether the FDA is mandated to regulate the production of the tobacco products, as it is customarily marketed. 

Analysis 

The court affirmed that the authority to regulate tobacco products was not bestowed under the FDA body as customarily marketed. According to the Congress, FDA does not have the entire jurisdiction and authority over the regulation of the production, advertising, and marketing of the tobacco products. The authority was supposed would be inconsistent with the regulatory scheme was undertaken by FDA as other parties and authorities would weigh into the regulatory mandate ( Apollonio & Glantz, 2017 ). For example, FDA documented that tobacco products are not safe for consumption due to the concerns of misbranding the devices and drugs in the market. The court determined that it was not the mandate of the FDA body to declare the tobacco products unsafe but should have removed the products from the market due to the advertising, marketing, and promotion issues reaching the children and the adolescents. 

Conclusion 

Considering the entire case, it could be concluded that the Congress was not focused on directing the FDA to remove the tobacco products in the market, as it was the duty of the FDA to deal with the products in the market. The Congress focused on ensuring that the jurisdiction of FDA does not cover the tobacco products ( Cahoy, Reed, & Pagnattaro, 2015 ). The implementation of regulatory agencies and laws should be in line with ethical concerns in the society. Therefore, the tobacco companies should have considered the ethical concerns of marketing the tobacco products reaching the children and adolescents in the society. 

References 

Apollonio, D., & Glantz, S. A. (2017). Tobacco Industry Research on Nicotine Replacement Therapy: “If Anyone Is Going to Take Away Our Business It Should Be Us”.  American Journal of Public Health ,  107 (10), 1636-1642. 

Cahoy, D., Reed, O. L. & Pagnattaro, M. (2015). The legal and regulatory environment of business . New York, NY: McGraw-Hill Education