The Protection of Human Health with FDA

Federal health protection agencies such as the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are designed to protect the health and prevent illness in the United States. The CDC, located in Atlanta, Georgia was founded in 1946, preventing malaria from spreading across the nation, especially in war areas. Founder Dr. Joseph Mountin, a strong advocate of public health issues, continued to push for the agency to extend its enterprises to other communicable diseases. In efforts to expand the agency and their projects, the CDC purchased 15 acres of land from Emory University that now serves as their headquarters. Since then, the institution has extended its mission to address all communicable diseases and “to provide practical help to state health departments when requested” (CDC). From its origins in malaria control, the CDC has developed into the nation’s leading public health agency, whose mission is to “collaborate to create the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats” (CDC).

The FDA can track its origins back further to 1848, where it created the Agricultural Division in the Patent Office. The agency’s modern regulatory functions began with the passing of the Pure Food and Drugs Act in 1906, where it was finally recognized as the Food and Drug Administration (FDA). This act, which jump started the agency’s purpose, was a law that prohibited interstate commerce between impure and misbranded food and drugs. It became responsible for providing basic elements of protection in consumers’ food and drugs that they were unaware of before then. The FDA took on the position to protect the public health by ensuring the “safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices” (FDA). The FDA is also responsible for regulating specifically, the manufacturing, marketing, and distribution of tobacco products in order to protect the nation’s public health and to minimize tobacco use by minors. Through innovative measures, it is the mission by the FDA to advance public health by helping to create safer, more effective and more affordable medical products in addition to promoting accurate, research-based information to the public necessary to improve and nourish their health (FDA). Furthermore, the FDA also contributes significantly in the United States’ counterterrorism ability by warranting the security of the food supply and fostering the development of medical products in an emergent response to deliberate public health threats (FDA). Both the FDA and CDC are federal agencies designed to protect the public health of the nation, however loopholes in legislation have stunted the work of their regulations and have kept American consumers in the dark about their health and taxpayer money.

Despite the efficiency and gravity of the the work initiated by the FDA, there are continual recalls in the system. A recall is a voluntary procedure in which a product in violation of the laws administered by the FDA are removed from shelves or are corrected (FDA). Its purpose is to reinforce the FDA’s responsibility of protecting the public’s health and well-being from products that present a risk of injury or harmful deception. In 2018, the FDA, in coordination with the U.S. Department of Agriculture (USDA), began investigations surrounding possible Salmonella and Listeria monocytogenes contamination in several vegetable products from McCain Foods USA Inc. The contamination concerns led to the recall of several products which included salads and wraps that used McCain Foods vegetables. In October, McCain Foods took precautionary measures and initiated a recall of their products out of the safety of their consumers.

Another recall that occurred this past year was due to the detection of trace amounts of an unexpected substance found in the finished product of Macleods Pharmaceuticals Limited Losartan Potassium/Hydrochlorothiazide combination tablets. The detected impurity, N-nitrosodiethylamine (NDEA), an identified human carcinogen by the International Agency for Research on Cancer, is a chemical humans may be exposed to through the ingestion of certain foods, such as cured meat and fish products. Contaminated drinking water and breathing cigarette smoke and contaminated air are other pathways of exposure to humans (EPA). The FDA has recently recalled several other medications after finding traces of the same NDEA chemical. For example, recalls were issued on certain angiotensin receptor blockers and high blood pressure medications containing the carcinogen. NDEA has been classified as a carcinogenic after being found to induce tumors in various organs. Incidences of liver, kidney, and lung tumors have increased after exposure to the substance (EPA). The recalling of products found with this carcinogenic impurity demonstrate the role the FDA has in protecting consumers from using and buying products that are potentially harmful. However, as proficient the agency may seem, the FDA has yet to recall tobacco products that contain the specific NDEA chemical and far more dangerous carcinogens. In the United States, tobacco is responsible for taking the lives of nearly 500,000 annually, while 16 million other people are diagnosed with tobacco-related disease.

The recall of certain products that contain carcinogens demonstrate the hypocrisy of the FDA’s inaction to ban tobacco products. The FDA’s concern of carcinogen exposure in the drug tablets contradicts their indifference to the 70 plus chemicals found in tobacco smoke that are also a danger to the human body. In the United States and around the world, smoking tobacco is the root of several preventable illnesses and premature deaths. It constitutes extensive costs, health related or not, to all communities. Many consumers are misled into believing that there are economic benefits involved in the tobacco industry, and while there are individuals who benefit from production, the negative effects of tobacco products outweigh the overall benefits. The American public has a very false perception of the tobacco industry's benefaction to economic activity. The public often gives more credit to the industry for their contributions to the economy while not actually understanding all the industry really offers. For example, many Americans discern the economies of the “tobacco bloc” states in southeastern United States to rely heavily on the production and manufacturing of tobacco (Warner 2000). However, out of these six states, only 1.6% of jobs are actually associated with the true tobacco divisions of the economy. Additionally, only about 1% of farmer’s income comes from growing tobacco. It is for this reason that most tobacco farmers have additional full time jobs on the side to compensate for their salary earnings. In fact, there is only one county nationwide that is dependent on its farm’s tobacco revenues. A United States Department of Agriculture economist put simply that “tobacco plays a minor economic role in most local economies where it is grown” (Gale 1998). As put by author Kenneth Warner, “the myth in the tobacco industry's economic importance argument is that a significant economic presence necessarily implies significant economic dependence.” This notions that a decrease in tobacco activity will induce a decline in the economy of the country.

The misunderstanding comes from the thought that the consumer’s money disappears from the economy if they were to stop purchasing tobacco products. That case however, is not true at all, for the consumer would invest their money in other products and companies, generating employment in other industries just as buying cigarettes does for the tobacco industry. Several studies have made evident the fact that a decrease of spending on tobacco products would not reduce employment or damage the economy, rather reallocate the money elsewhere. The scary truth is that the tobacco industry understands this reality. It was affirmed by a US Tobacco Institute vice-president that the overall economic activity would not adversely decline in response to significantly less spending on tobacco products (Warner, 2000). In terms of numbers, it is estimated by the World Health Organization (WHO) that, on a global scale, the economic damage caused by smoking adds up to over $500 billion each year. The CDC measures that these costs include nearly $170 billion to pay the direct medical care of adults and the $156 billion to cover the lost in productivity due to premature deaths and illnesses (Xu et al., 2014). The CDC and the University of California estimated that the health care cost of tobacco related disease was at least $50 billion. Therefore, the tobacco industry is responsible for raising $11 billion in tax funds, yet it does not cover the government Medicare payments that cost taxpayers $16 billion to cover tobacco-related illnesses (Scientific American). Howard Barnum, a World Bank Senior Economist, culminates that the tobacco industry produces an annual global net loss of $200 billion after factoring in benefits of tobacco consumption to producers and consumers with the indirect costs of morbidity & mortality due to smoking. It is for this reason that taxpayers should not be indirectly responsible to cover the costs of tobacco-related illnesses, for it is not fair to charge the majority for the choices of others.

However, in 2014, a study conducted by Georgia State University, it was discovered that US taxpayers contribute 60% of the cost of smoking due to the tobacco related diseases covered by Medicaid and Medicare. Researchers found that smoking related illnesses account to the $45 billion spent per year on Medicare, the $39.9 billion in Medicaid spending per year and the annual $23.8 billion in spending for other government-sponsored insurance programs (ASH). Additionally, to combat the influence of tobacco advertisement on young consumers, Congress spends $250 million a year on anti-tobacco advertisement to counter tobacco advertising (CDC). These financial and health damages lead the Attorney Generals in several states to take legal action and sue the tobacco industry. They wanted Medicaid to be reimbursed for states having to pay taxpayer money to cover the healthcare for people sickened by tobacco use. However, the issue is that the FDA cannot regulate cigarettes because lobbyists and tobacco industries have paid congress to pass legislation protecting the tobacco industry. In section 907 of the 2009 Tobacco Control Act, it is enforced that the FDA is prohibited from “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or requiring the reduction of nicotine yields of a tobacco product to zero.” The law forbids the FDA from ordering a complete ban of tobacco products entirely, giving protection to all existing cigarettes and other tobacco products.

In order to reverse the control congress has over the FDA, it is up to the people and their representatives to challenge the legislation put in place. With the benefit of a free press in a democratic society, the media and news outlets have helped enormously in exposing the dangers of tobacco smoke. The freedom of the press introduces a transparency to the nation that exposes corruption and increases the productivity of the government. For the past two decades, the media has served the public interest by spreading anti-smoking advertisements, promoting companies that manufacture products to quit smoking, and by releasing the terrors of tobacco smoke to the people through newspapers, journals, TV shows, and radios. Though the FDA is not able to abolish cigarettes wholly, the influence of the free press on the people has helped the FDA obtain the authority to regulate the sales and manufacturing of tobacco products. With this jurisdiction, the FDA has enforced statutes in efforts to limit the use of smoking tobacco among citizens. Some of these mandates include the requirement of tobacco company owners and operators to open their manufacturing and processing facilities to the FDA every two years for inspection, allowing the FDA to enact tobacco standards to benefit public health, and to regulate nicotine and ingredient levels in products in addition to providing an ingredient list on the packaging. Additionally, the FDA can ban distinguishably flavored cigarettes with the exception of menthol and tobacco and a list of the health concerns and dangers tied to tobacco must be presented on all packaging (FDA). There have been instances, however when press outlets have acted irresponsibly in response to the exposing of the tobacco industry. In the late 90s, CBS News fabricated an interview in order to dodge a lawsuit from Brown and Williamson Tobacco Co. Regardless, it was evident to the people how dangerous tobacco products were and there was no going back after the truth was let out.

The tobacco industry has misled our country into believing it's demise would ruin the economy for too long. Their disregard for public health and ignorance for the American taxpayer has been burdening the United States for over a century. Though federal agencies such as the FDA and the CDC have been implemented to protect the public health of America, they are no match for the big money coming from lobbyists. American citizens must continue to educate themselves on the dangers of all tobacco and nicotine products that emerge each day, and vote for representatives that will protect their health and taxpayer money in congress. The people need to be reimbursed for covering the costs of other people’s poor decisions to use tobacco products, and they only way that will happen is with political action.