Introduction
The economic environment in the 21st century for consumable and health products has become very competitive forcing many firms to reorganize internally and to diversify production to be profitable. Due to this competition, many generic products, as well as substandard products, have emerged which can have serious implications on human health if not regulated. FDA, a government agency is mandated to regulate the manufacture and quality of most foods products as well as drugs, cosmetics, and radiation-emitting products to protect human health. Having been founded in 1938 under the Department of Health and Human Services, FDA has been aggressive in carrying out research on foods and drugs and creating standards to ensure that food and drugs are safe for human use. However, FDA has tended to relax its regulation on these products causing some serious impacts on public health. This paper will discuss the impacts of the FDA’s easing of restrictions in the 21st century.
FDA Profile
FDA (Food and Drug Administration) is a US government agency that deals with the control of human and veterinary drugs, as well as national food supply to protect public health (FDA, 2009). The agency enhances innovations for effective, secure, and cost-effective foods and drugs as well as assisting in the dissemination of scientific information to the public on the use of health improving foods and drugs. According to Berube (1998), FDA came to be in 1938 after the amendment of the former Pure Food and Drug Act, 1906 and was placed under the Department of Health and Human Services. This was a result of a tragedy that claimed over a hundred lives emanating from the consumption of the toxic drug.
The FDA is made up of several health control centers each of which deals with a specific task focusing on improving human and animal health. These centers include “Center for Biologics Evaluation and research; Center for Devices and Radiological Health; Center for Drug Evaluation and Research; Center for Tobacco Products; Center for Food Safety and Applied Nutrition; Center for Veterinary Medicine; Center for Toxicological Research; and office of Regulatory Affairs” (FDA, 2009). In addition, the agency regulates sanitary and safety of medical devices, the safety of radiation-emitting products and biological products. Moreover, the agency is responsible for issuing licenses for biological products manufacturing, ensuring blood supply is safe and cosmetics and drugs manufacturing meet the standards.
Although the FDA is mandated to protect public health, it does not regulate non-medical drug and substance abuse, health insurance, major consumer/household goods, alcohol labeling and quality, advertising not related to prescription medicine, meat and poultry, pesticides usage, and water quality and safety. All these products are regulated by specific legal units in respective departments of government (FDA, 2009).
Laws Enforced by FDA
During its enactment, FDA was mandated to enforce the safety of drugs, create food safety standards and carry out factory inspections to ensure that public safety was observed. Later on, manufacturer’s disclosures on the safety of products and medical devices were included in the regulation chart. At times, some products under FDA legislation may be found to be unsuitable for consumption/use, necessitating to be recalled from the market. FDA always steps in to withdraw the products from the market and sometimes may seek legal redress especially when there is an injury caused from the use or consumption of the said products (FDA, 2009).
To succeed in its mandate, FDA works closely with other related agencies to ensure that total public safety is observed. In addition, the FDA collaborates with various stakeholders such as research institutions by providing resources and expertise to promote healthy living. At times the FDA enters into a memorandum of understanding with government or government agencies as well as other like-minded institutions to pool resources for effective consumer protection.
Impact of FDA’s ease on restrictions
The role played by FDA in protecting public health is very important. There is therefore a need to clarify on what the agency feels there is a need to be regulated or not. For instance, the restrictions enforced on tobacco products are very important considering that tobacco is one of the leading causes of cancer disease. In addition, food safety regulation is very vital, especially where the products are produced and sold ready for consumption.
In the 21st century, the economic climate has become very complex and competitive forcing organizations to employ all means and tactics to survive. In so doing, many substandard and even harmful products may arise as firms struggle to make quick products causing potential harm to the consumers. Therefore, FDA must exert a lot of pressure on its regulations to protect the consumers. Easing the restrictions by FDA may have severe implications as explained below.
Substandard product
One of the FDA mandates is to create and enforce standards for products that fall under its jurisdiction. It should always ensure the regulations are complied with, failure to which, leads the production of ineffective products that can’t meet the consumer specific needs. Indeed, Joseph (2004) claims that medical device manufacturers should comply with the FDA regulations of standardization quality as well as produce products that are cost-effective efficiently to avoid the extra cost of rework and possible health complications.
Impact of prescription drug advertising
Prescription drugs are required to be administered by a doctor or health care specialist and should only be used according to the directions given, failure to which they may cause harmful effects on the patient. According to Pringle (2006), FDA eased the restriction on the advertisement of prescription drugs where the media even went ahead to include the name of the drug and the symptoms that can be treated using the said drug, the results of which may have been self-prescription by the patient. The impact of the eased restriction on prescription drugs is an extensive advertisement of the drugs with substitution of risk factors by over-emphasized benefits that can not be substantiated. In addition, advertising firms have cashed in on the advertisements that include disease-mongering aspects of the advertised drugs, inflating sales for the selling firm, and revenue for the advertising firm.
This trend has conned many patients who have not only used the wrong medication, but also have lost a lot of money in purchasing drugs, yet their health has tended to deteriorate. For instance, Pringle (2004) says that drug manufacturers have dissuaded FDA interference on their profits by turning to relay ghost-written articles and press releases containing ‘experts’’ names describing the effectiveness of the drugs in question. One real case of abused advertisement was on September 30 2006 where around 24000 suits were filed against Vioxx Company over a misrepresented drug that the patients bought believing it was safe and effective yet it caused them personal injury (Pringle, 2007).
It is only after Congress intervention that some of the potentially explicit advertisements were critically reviewed, with suggestions of removal of some of the addictive drugs like sleeping medication being short-listed for censure. However, there were those opposed to the review of explicit advertisement, claiming that advertisement was a tool for educating people about ailments and treatment.
Unrestricted drug manufacturing may also cause the proliferation of generic drugs, some of which may not meet the required minimum standards. This may turn to be disastrous especially where the manufacturing firms may label them as the original and trying to maximize their profits through such misrepresentation.
Impact of unrestricted tobacco usage
Tobacco is one of the deadliest non-medication drugs and is a major contributor to cancer-related deaths. For instance, Family Smoking Prevention and Tobacco Control Act (2009) contend that, in America, cigarette smoke contains over 69 chemicals that cause cancer, contributing to around 90% of cancer-related deaths. FDA’s mandate is to curtail the use of tobacco and it has done so by instituting regulations on tobacco products usage and advertising. For instance, on 22nd September 2009, the FDA issued a ban on cigarettes containing certain flavors. Some of the banned cigarette flavors are Candy and Fruit flavored cigarettes. In easing the restriction on tobacco usage, FDA may tend to give leeway for unabated smoking habits and consequently death surge due to cancer infections. Tobacco is an addictive drug that once it gets into a person’s system, becomes hard to avoid.
According to Family Smoking Prevention and Tobacco Control Act (2009), eased restrictions have caused manufacturing firms to take advantage of the young persons by offering menthol enhanced cigarettes to addict them. This means that lack of restriction will give incentive to the manufacturing firms to manipulate the public with a motive of maximizing profits, the result of which will be excessive deterioration of public health.
Advertisements on cigarettes are also dangerous especially to young people as they tend to portray the cigarettes as a consumable product rather than a harmful product to health. Even with the label of warning, the mare advertisement of a person smoking may hurt the viewer. Therefore FDA should ban the advertisement of cigarettes or force the companies to portray pictures of affected persons on the packets or advertisements to dissuade potential smokers.
Impact of unrestricted veterinary services
FDA regulates the animals and human beings against potential diseases that may be transmitted from the animals to human beings such as mad cow disease. In doing so, the FDA aims to ensure the safety of all human beings by prohibiting the use of mammalian proteins in the manufacture of animal feeds (such as cows, sheep, and goats). In addition, the FDA prohibits the consumption of ruminant carcass unless the animal was less than 30 months old.
Easing these restrictions may have dire consequences to both the animals and human beings, especially considering that mad cow disease is a very serious and fatal disease that can spread easily between the animal and human being. Most, if not all animal feed manufacturing companies are in business to make profits, and therefore, when not strictly regulated, they may take advantage of the situation to use whatever available material to manufacture their products. In so doing, many lives may be put at a risk. In addition, lack of restrictions may result in many generic products flooding the market, some of which may not meet the required standards thereby causing harmful effects to both the animals and human beings. Another area of veterinary services that may be abused is artificial insemination and genetically engineered animals.
Impacts of unrestricted cosmetics
Cosmetics may be very harmful if not regulated. Some of the cosmetics in use may be very poisonous or corrosive and therefore they need to be well regulated to avoid injury to the users. FDA regulates the labeling and advertising of cosmetics to ensure they conform to the required standards. Ease of regulation on these may lead to the manufacturing firms, trying to create shortcuts by mislabeling the products to make huge profits. According to FDA (2009), labeling cosmetic products should not be false or misleading, should provide the relevant information which should also be displayed, and should indicate the warning of being poisonous if that is the case. In addition, FDA prohibits the advertisement of cosmetic products labeled to be approved by the FDA.
Ease of restriction may also allow the manufacturing firm to misrepresent the cosmetic product as a drug or medication, which may be very dangerous especially where the claims can not be justified. Under the Federal Food, Drug, and Cosmetics Act, a cosmetic that claims to have treating capabilities must be termed as a drug but not cosmetic and must be approved by health experts as safe and secure to be used as such. Cosmetics also include non-manufactured products such as tattoos, ear piercing, and other body modification cosmetics. All these cause some effects to the body and therefore must be regulated to ensure they don’t adversely affect the health of the person.
Impact of medical devices and radiation-emitting products
Proper use of medical devices is very important. In addition, the quality of the products may be very important to function effectively towards protecting human health. Unrestrictive regulations may provide an opportunity to the manufacturing company to produce substandard products which may not only be harmful to the patients but also may turn out to be a cost burden.
Some of the radiation-emitting products are very harmful and therefore should only be used when the situation demands. For instance, an x-ray should only be used when there is a need for scanning internal injuries. Overexposure of the body to these radiations may turn fatal especially when it is considered that they have a side effect of cell mutation (FDA, 2009). Some radiations, like the one from green laser pointers, are very powerful and may have a very severe effect on the health of a person.
Mitigation to the impacts
Due to the effects of the misrepresentation and possible harmful effects of the ease of restrictions on various products under the FDA, there must be strict regulations to ensure that the lives of people are protected. According to Family Smoking Prevention and Tobacco Control Act (2009), government intervention is important to hold the perpetrators of tobacco use accountable for their actions and to regulate the manufacture of tobacco products based on standards, labeling, and marketing. In addition, advertising and promotion should be regulated to safeguard kids and promote public health as well as creating structures that will offer assistance to those who would like to quit smoking yet are addicted. The FDA should apply all the expertise it has to ensure that recurrent effect of tobacco usage does not occur.
The ease of advertising or prescription drugs has harmed the health of the public. Therefore, FDA needs to act strictly on the limits of advertisements that should be permitted. For instance, Pringle (2004) is in the view that explicit advertisement of the prescription drugs should be restricted as it does not tend to educate patients on medication but tends to act as a conduit through which mass drug marketing is done which may be a great health hazard.
FDA should also be strict on food security to avoid cases of food poisoning. The regulations should be enforced to ensure that all the manufacturers of food products comply with the regulations and produce products that meet the minimum standards put in place. A registry for reporting food problems is important to ensure that all issues arising from the consumption of substandard or unsafe food products are being addressed by FDA. FDA should also ensure that all, manufacturers include information about the ingredients and other relevant information on the label of the products to enable the consumer to understand the product well.
Regulation on cosmetics should also be enforced to ensure that no harm is caused through the use of the cosmetics. Labeling should be as per the standard and should include all the relevant information about the product. FDA should ensure that the products are safe for use by human beings and that they don’t contain any adulterated substance or even poisonous substance.
The recent manufacture of green radiations directed at aircraft has proved to be very hazardous especially due to the high level of radiation it emits. In this view, government intervention is important to establish standards that the radiation should meet to avoid causing a threat to public health. Some of the radiations are illegal and therefore consumer consciousness should be enhanced to avoid being duped especially purchasing them online.
Conclusion
FDA is a vital agency in the protection of human health. The 21st-century business environment has advanced a lot and becomes very competitive such that lack of regulation will give the competing firms a chance to employ all means to make profits, even if it means putting the health of the consumers at a risk. In this case, the FDA should apply strict regulations on all products that fall under it to ensure that the health of the consumer is protected at all times. However, during the 21st century, the FDA has eased its restrictions especially on prescription drugs advertisements which have caused a lot of misrepresentation by the manufacturers leaving many patients suffering due to substandard or even wrong medication. In addition, tobacco control has been an issue whereby manufacturing firms have tried to label cigarettes with enticing flavors to attract many consumers, an aspect that has raised a lot of eyebrows. Consumer protection, therefore, remains the core business of the FDA through collaboration with the Federal government and other like-minded agencies.
References
Berube, J. E. (1998). The Politics of FDA Reforms. The Journal of Head Trauma Rehabilitation: 2009. Web.
Family Smoking Prevention and Tobacco Control Act. (2009). Family Smoking Prevention and Tobacco Control Act. The Library of Congress Thomas. Web.
FDA. (2009). US Food and Drug Administration website. Web.
Joseph, V. (2004). MES reduces FDA compliance costs: medical device manufacturers face stringent regulations. 2009. Web.
Pringle, E. (2004). Big Pharma’s Battle Over Direct to Consumer Advertising. 2009. Web.