FDA Regulation of Tobacco Products in the United States - Essay Example

FDA Regulation of Tobacco Products in the United s Drugs and drug use is an important topic in society today. According to Hart and Ksir, use of drugs by an individual bears different effects, depending on the nature and type of the drug (1-2). Although some drugs are meant to cure illnesses, when taken in overdose, these result in negative effects. Similarly, other drugs, which are illegal, such as marijuana, are harmful to human health. Tobacco is equally harmful, although it is not a drug in itself, but rather, a carrier of nicotine, which is highly addictive. Therefore, smokeless tobacco, dip, chew, and other tobacco products contain a considerable amount of nicotine. Nicotine is highly used in the United States, and acts as a sedative and stimulant. Therefore, tobacco use exposes one to addiction, and cellular damage and mouth cancer, in the case of smoking. Nonetheless, the long-term effects of smoking tobacco are cancer, heart disease, and lung disease (Hart and Ksir 224-226). Tobacco use, including cigarettes and smokeless tobacco, is identified as causing most of the deaths and illnesses experienced in the United States. According to “Campaign for Tobacco-Free Kids,” approximately 400,000 people die in the Unites States every year, because of health problems resulting from different use of tobacco (WEB). This is more than the number of deaths in the country, which are caused by car accidents, suicides, homicides, and fires, among others, combined. Nonetheless, tobacco growing can be traced to the 1600’s. The tobacco plant was an indigenous plant, which has its roots in North and South America. This grew as a herb, which had medicinal value. In North America, tobacco planting was practiced starting the 1600’s, and the funds acquired was used to continue the American Revolution (Hart and Ksir 222). Until 2009, there was no regulation of cigarettes, use of smokeless tobacco, and other tobacco products in the United States, despite the high health risks this present to users. This paper will therefore, address the Food and Drug Administration (FDA) regulation of tobacco products in the USA, reasons for regulation, and some of the issues that complicate FDA’s regulatory process. The issue of regulation of tobacco products has had a rather long history in the United States of America. It was only in 2009 that President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which is also called the “Tobacco Control Act”. This granted the FDA the mandate to regulate tobacco products in the country. Nonetheless, this issue can be traced to the 1960’s and beyond (Devton 167). This raised great concern among some health bodies, when in 1964; the Surgeon General’s Report found out and warned that tobacco smoke results in cancer and heart disease. Basing on this and other reasons, between 1990 and 1996, David Kessler, who was then a commissioner in Food and Drug Administration (FDA), set out a serious discussion about the issue (Brandt WEB). Since FDA is a body that is concerned with the safety of consumer goods, the FDA considered that regulating tobacco would be helpful in improving the safety standards of the people, who consumed tobacco products. Nonetheless, in order to successfully achieve this, the FDA was required to prove that cigarettes and smokeless tobacco were considered as drugs by the Federal law. Therefore, immense research and studies by FDA commenced in 1992, with an aim of determining that tobacco products are harmful to people’s health. Dr. Kessler and FDA therefore, sought to regulate tobacco products in the market. When companies manufacturing tobacco products sued FDA over its intention to regulate tobacco products, the US Supreme court in the year 2000 made a ruling, which clarified that the FDA’s powers were limited, thus did not extend to the regulation of tobacco products. The Supreme Court argued that such powers and mandate to regulate tobacco would have to be granted by the US Congress, when it is passed as a law (Brandt WEB). Nonetheless, people, including organizations and individuals, hold different views about the FDA and its regulation of drugs. While some believe that this is important in society, others feel otherwise, and consider it inappropriate for FDA to regulate tobacco and tobacco products. Nonetheless, the main aim of FDA in wanting to regulate tobacco and tobacco products was to utilise the available scientific proof about the dangers of tobacco, and develop important public health strategies, which would be instrumental in reducing the number of deaths and different illnesses, which result from tobacco use and use of tobacco products (Public Health Law Center WEB). According to Kennedy, the habit of smoking among the United States population can be prevented. Kennedy considered the empowering of FDA with powers to regulate tobacco and tobacco products, as an effective way of helping to reduce the number of people in America, who die every year from health complications and diseases, which emanate from cigarette smoking (Web). FDA is considered to be the most appropriate regulatory body to address the regulation of tobacco products in the United States. This is because this organization is highly experienced in the regulation of consumer products, considering the number of years they have conducted their practice in the country. Additionally, the FDA has the necessary scientific knowledge, skills, and expertise. It is also known to be objective and unbiased in its practice (Kennedy WEB). On the other hand, the organization, “Campaign for Tobacco-Free Kids” shares a similar view with Kennedy on the role of FDA in regulating tobacco and tobacco products in America. According to this organization, tobacco is the only legalized product in the United States, which is highly addictive when used, and results in a considerable number of deaths in the country every year. The use of tobacco leads to cancer, heart disease, and lung cancer, which is responsible for approximately 87% of all deaths from tobacco use in the country. “Campaign for Tobacco-Free Kids” estimates that in the United States, close to 3,000 children become addicted to smoking everyday, and close to a quarter of these will succumb to health complications related to tobacco use. Manufacturers of tobacco products had developed various strategies, which attracted the youth and children to smoking. For instance, the flavored cigarettes encouraged young children to smoke. In the United States therefore, approximately 2.7 million children are regular smokers, and as past trends show, 900,000 of these are more likely to die prematurely, due to tobacco use related health problems (Campaign for Tobacco-Free Kids WEB). Nonetheless, regulation of tobacco and tobacco products by FDA was expected to reduce the number of deaths occurring as a result of tobacco use. Even though the Congress, in 2009, during the administration of President Obama, granted the FDA authority to regulate tobacco and tobacco products, there has not been much change or improvements realized after this major development. Therefore, this shows that there exist a variety of factors, which hinder the successful adoption of the Family Smoking Prevention and Tobacco Control Act (Redhead 4: Gottlieb WEB). Nonetheless, most companies that manufacture tobacco products were highly opposed to the move by FDA and its intention to regulate tobacco and tobacco products (Public Health Law Center WEB: Gottlieb WEB). Nonetheless, it is no doubt that after being granted authority to regulate tobacco products, FDA would face more harsh opposition and obstacles in its implementation of this law. After the enaction of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), where the FDA was authorized with regulation of tobacco and tobacco products, today, more than one million people have died in the United States, from tobacco-related complications (Campaign for Tobacco-Free Kids WEB). In addition, the Federal government has continued to spend more than $38 billion on the issue of tobacco use and related complications. Similarly, each state in the United States today spends approximately $7.3 billion on the issue of tobacco and related health problems. Therefore, this shows that the authority by FDA to regulate tobacco and tobacco products has not realized the expected results. Nonetheless, various factors act as obstacles to the effective function of FDA in regulating tobacco and tobacco products. One of the main factors that complicate the way FDA regulates tobacco and tobacco products is the companies that manufacture tobacco products. Before the enaction of the Family Smoking Prevention and Tobacco Control Act (FSPTCA), the companies that manufacture tobacco products had intensified their advertisements. It is approximated that the tobacco industry spent more than $8.2 billion each year, and about $22.5 million each day on advertising the tobacco products (Campaign for Tobacco-Free Kids WEB). The increased advertisements and marketing of tobacco products therefore led to an increase in the number of consumers, especially children, as most of the advertisements were more appealing to children. Many youth in the US were already exposed to a myriad of tobacco advertisements. Although FDA and other health related organizations enlightened the public about the harm in tobacco use, when enticing advertisements of tobacco products flooded the media, most children and youth did not base their decision about smoking on informed choice. These would therefore, be easily lured into smoking and using other tobacco materials by the power of the advertisements. Once children and the youth start to smoke, it is challenging for them to quit, therefore, they become more exposed to the health risks, which tobacco and tobacco use present. When FDA was authorized to regulate tobacco products, most people, including youth and children, in the population were already smoking, and it is hard for most of them to cease smoking today (Campaign for Tobacco-Free Kids WEB). Another issue that complicates the way FDA regulates tobacco and tobacco products is the way FDA has focused only on the prevention of youth and adolescent smoking (Basham WEB). The regulation of tobacco products by FDA does not wholly address the aspect of adult smoking. Additionally, FDA does not address the main factors leading to smoking in children. Instead, FDA has drifted all of its attention on the restriction of tobacco marketing, leaving out the risk factors associated with smoking in children and youth. Additionally, Basham argued that in the FDA regulation of tobacco products, there is evidence of some degree of disconnectedness and disparities in factors such as education, smoking status, and poverty, yet these are essential in understanding and addressing adult smoking (WEB). Additionally, so far, the tobacco industry employs various antics in the regulatory process. For instance, this industry has filed more than four lawsuits to oppose and block some of the provisions in Tobacco Control Act. This therefore, poses as a challenge to the efforts of FDA in the regulatory process (Gottlieb WEB: Public Health Law Center WEB). Personally, I have considerable knowledge about tobacco and its effects, including statistics of deaths resulting from tobacco use in the United States. It is clear that this is one of the most harmful substances, as it contains nicotine, which is addictive, and smoking it causes cancer; therefore, it is inappropriate for tobacco products to be legalized and sold out to the public without any degree of regulation. This approach will only result in more detrimental consequences in the country. Therefore, by coming up with the idea of regulating tobacco and tobacco products, the FDA was right and was promoting the safety and health of many citizens. The high number of deaths caused by tobacco use has negative impacts on the economy, as the population is core in economic development of a country. Therefore, regulation of tobacco products is a crucial element contributing to tobacco control. The Family Smoking Prevention and Tobacco Control Act (FSPTCA), FDA has been quite instrumental in tobacco control. This is the first time in the United States that the authority to regulate tobacco has been given to FDA. This is a big responsibility, considering that tobacco has never been regulated in the United States in the recent past. One of the factors that make this a difficult task is the fact that the tobacco industry has been booming, yet regulation will cut down on its profits in a major way. Therefore, since most companies in the tobacco industry are well established, it is possible for these to look for ways of undermining FDA and its regulation, in order to make more profits. Hence, it is no surprise that to date, the Tobacco Control Act that was implemented in 2009, has not yet achieved its major goal in the United States. In conclusion, before the Tobacco Control Act, many people in the United States, who were consumers of tobacco products, died from health complications related to tobacco use. This was the case, because the manufacture, sell, distribution, and use of tobacco products in the United States had not been regulated. FDA considered it important to take the mandate of regulating tobacco in the United States, in order to promote health and safety of citizens. However, after the adoption and implementation of the Tobacco Control Act in 2009, deaths resulting from tobacco use in the United States have persisted. Today, approximately 400,000 Americans lose their lives to health complications, which are related to tobacco use. Therefore, this shows that there are a considerable number of issues, which complicate how FDA will effectively implement this Act. Nonetheless, companies that produce tobacco products in the United States have developed new strategies to undermine the Tobacco Control Act, and its effectiveness. Therefore, in order to ensure the effectiveness of this Act, FDA should develop effective strategies, which will address the loopholes and challenges in its practice. Additionally, collaboration and partnership with the local and federal government, and the public health community will help FDA to improve on its effectiveness as far as tobacco regulation is concerned. Works Cited Basham, Patrick. “Keep FDA Away from Tobacco.” CATO Institute, 2009. Viewed 24 April 2013 < http://www.cato.org/publications/commentary/keep-fda-away-tobacco> Brandt, Allan. “FDA Regulation of Tobacco — Pitfalls and Possibilities.” The New England Journal of Medicine, 359:445-448, July 31, 2008. Devton, Lawrence. “FDA Tobacco Product Regulations: A Powerful Tool for Tobacco Control,” Public Health Reports, 126: 167-169, March–April 2011, Viewed 22 April 2013, < http://www.publichealthreports.org/issueopen.cfm?articleID=2597> Gottlieb, Scott. “FDA's New Tobacco Scheme, And Its Legislative Underpinnings, May Go Up In Smoke.” Forbes. 8 March 2013. Viewed 24 April 2013 Hart, Karl and Ksir, Charles. “Drugs, Society, and Human Behavior.” 14th Ed. London: McGraw Hill. Kennedy, Edward. "The Need for FDA Regulation of Tobacco Products." Yale Journal of Health Policy, Law, and Ethics: Vol. 3 (1), Article 5, 2003. Viewed 24 April 2013, Public Health Law Center. “FDA Tobacco Action Center.” Viewed 24 April 2013 < http://publichealthlawcenter.org/topics/tobacco-control/fda-tobacco-action-center> Redhead, Stephen. “FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009.” New York: DIANE Publishing, 2009. Read More