Food and Drug Administration Essay

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The Food And Drug Administration (FDA) was created as a governmental entity in the United States by virtue of the 1906 Pure Food and Drugs Act passed during the administration of President Theodore Roosevelt. Health problems caused by impure foods had plagued the country since its inception, with both imported and locally produced items responsible for a variety of poisoning incidents. The publication in 1906 of Upton Sinclair’s novel The Jungle, which documented conditions in the meatpacking industry, was also influential. That book, though dedicated to exposing the harsh working conditions for immigrants, was largely received by the American public as a message about food safety.

The first national law concerning pure food had been passed in 1848 during the Mexican War. However, the growing sophistication of the food and pharmaceuticals industries in a large and rapidly modernizing economy required a much more comprehensive raft of legislation to deal with often predatory commercial interests. State-supported scientists helped farmers to improve their own produce and to introduce the modern scientific innovations in chemical additives and colorings appropriately, while also helping them to identify which of their industrial competitors may have been adulterating their products or otherwise producing sub-standard items.

From the passing of the 1906 act to 1938, the FDA in conjunction with the Bureau of Chemistry struggled to keep pace with the demands for regulation. In 1938, the FDA was greatly expanded in scope and size as a result of the Food, Drug, and Cosmetic Act (FDC) of that year. This act demanded high food safety standards and that new drugs be proved safe prior to them coming on the market. In 1962, in response to the Kefauver-Harris Amendments to the FDC, the FDA introduced new guidelines to ensure that drugs are proven effective before they are sold. In 1968, it acted to regulate microwave cookers and their radiation and subsequently followed this up by considering the safety implications of a range of catering and medical equipment. The FDA’s mandate continued to grow as new types of products were brought under its jurisdiction. Between 1990-92, the FDA worked with consumer interest groups to help devise suitable nutritional guidelines with which food producers must comply. Also in 1990, the FDA was a leading figure in trying to create international standards on food and drug safety. In 2002, it was charged with maintaining the food security of the United States in response to possible bioterrorism threats.

The FDA has seen its mandate grow as new products are introduced and as a result of the internationalization of trade. In particular, advances in medical and pharmaceutical sciences have greatly increased the complexity and time required to administer and monitor resource-intensive testing procedures. Intensification of agricultural production has also raised the potential for problems such as bovine spongiform encephalitis (“mad cow disease”) and avian influenza (“bird flu”), which demonstrate the dangers of improperly supervised livestock management. The FDA has been as active in monitoring food production facilities as it has been in considering licensing possible treatments for HIV/AIDS and other complex new medical complaints.

New legislative issues emerge from changes in diet and lifestyle, such as the plague of obesity and the threat of mature-onset diabetes. The FDA must navigate between its ability to regulate externally and its willingness to provide incentives to improve citizens’ activities and methods. Realizing that safe and healthy products can provide a competitive advantage in the consumer marketplace has been a key finding, and is likely to become increasingly important for the FDA. At the same time, the FDA is also likely to wield increasing powers in obtaining recompense for consumers from companies adjudged to have provided improper goods.

The FDA has come to oversee an enormous part of the overall economy, and has had considerable levels of resources devoted to it in its routine work of testing, monitoring, researching, and formulating policy and legislation. It plans a leadership role for itself, both nationally and internationally, in the search for cures for presently untreatable medical conditions and innovative pharmaceutical delivery mechanisms. It plans to continue its regulatory approach for product testing and to help raise standards globally. A certain culture permeates the FDA and its mandate to protect the public from the myriad natural and unnatural dangers of the world; and some people, whether members of regulated industry or not, find this culture unhelpful and even confrontational. Additionally, ideology drives some to object to the size and the power of the FDA, and consider it to intervene excessively in the profitmaking ability of commercial enterprises and that it should, therefore, undergo reform to reduce its power and influence.

Bibliography:

  1. Fran Hawthorne, Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat (Wiley, 2005);
  2. Meredith Hickman, ed., The Food and Drug Administration (FDA) (Nova Science Publishers, 2004);
  3. Marc T. Law, “How Do Regulators Regulate? Enforcement of the Pure Food and Drugs Act, 1907-38,” Journal of Law Economics and Organization (v.22/2, 2006);
  4. FDA, www.fda.gov.

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