Quiz 10: Regulating Business
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.
The FDA, a federal supervising agency primarily responsible for improving and preserving public health by checking and controlling contaminated foods and perilous drugs, experienced bitter sour legal battles in its mission to declare tobacco products as a form of a drug that should be regulated. 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 incorporate tobacco under its authority to disclose it as a drug that is harming public well-being. Initially, the FDA was reluctant to incorporate cigarettes or other nicotine products to be labeled as drugs and bring them under their jurisdiction because of the unspecified authority conferred by statute of 1938. Nonetheless, under the commissioner of Kessler, strong efforts were strenuously put forth to regulate the nicotine products as it was proven to be addictive and had drug-like effect on humans and animals. The FDA made a special investigation to examine the effects of nicotine products and ardent efforts and lobbying techniques employed made tobacco companies conceal the manipulations they made to exempt from a high degree of regulation by the Congress. The loophole of the statute The FDC Act which authorized the FDA to classify items as a drug when the company presents health claims of their products or intents to utilize them as medical substances made inherently impossible to push its schema of regulating tobacco products. The FDA, despite providing compelling and proven evidence on the effects of smoking and making legitimate claims for exercising its authority, was not able to bring tobacco under its jurisdiction since the statute did not grant specific authority over the agency, thereby making it impossible to win its case in the SC. Therefore, it is fallacious to assert that the FDA executed any political or legal blunders leading to the defeat of its goal, which is to regulate nicotine products.
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. This resulted in a lawsuit registered by the tobacco industry against the FDA in the NC district court to halt the execution of tobacco regulation law. The FDA was disputed mainly on three grounds. The tobacco industry asserted that the FDA lack authority over tobacco since Congress did not confer any jurisdiction. Moreover, they affirmed that tobaccos did not match the description of drugs since cigarette companies did not produce health claims and the recommended restrictions on advertisement infringed the Industry's free speech guaranteed by the FA. The FDA asserted that Congress conferred it the jurisdiction to decide what compounded as drugs and following the C doctrine, it is entitled to veneration. Furthermore, its research on the effects of nicotine on animals and humans established their classification of nicotine as drugs as suitable, and the constraints proposed adhered statutory guidelines for advertisement constraints as authorized by the SC. 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 purpose of the FDC Act was to preserve public health, so it is apparent that nicotine inflicts harm towards human bodies. Therefore, branding cigarettes as devices that remitted the drug nicotine is legitimate and the FDA should have been authorized to incorporate tobacco under its discretion. The SC's rejection of the FDA's claim since the statute does not mention nicotine as a drug is under-appreciated since it overlooked the threat it posits to public health, especially kids and teenagers who consistently choked with smoking. One should note that that statute does not refute FDA the authority or revoke the ban of tobacco products and under the C law, the agency had an entitlement of veneration. The SC neglected to look beyond the lens of the statute and disregarded the fact that it as a predicament associated with health-protecting purposes. Rather than putting an outright ban on tobacco products or implementing laws that cater to the interest of some big tobacco companies, additional regulations, accompanied by offering counseling or therapeutic services would have been a better alternative to reduce the number of smokers.