A Regulatory: The Food and Drug Administration

The core of the Food and Drug Administration is to uphold consumer protection, of public health. The first law created by King John of England, in 1202 called the Assize of Bread, prohibited adulteration of bread with ingredients from ground peas, and beans (FDA Basics, 2010). Federal control allowed inspecting drug supply of imported medications in 1848 (FDA Basics, 2010). Since the evolution of the administration, science continues to improve the health of the consumer. The FDA keeps abreast of developments, by regulation products. The regulations have to keep up with social, cultural, and economical change for the developments related to food and drugs. 
History and Health Care Influence 
The origins of the FDA begin with Lewis Caleb Beck in the mid-1800s performing a chemical analysis of agricultural products prior to the Department of Agriculture inception (FDA Basics, 2010). The title of the department changed in 1930 to the Food and Drug Administration. 
The Food and Drug Administration responsibility is, “protect human, and veterinary drugs, biological products, and medical devices, nations food supply, cosmetics, and products that emit radiation” (FDA Basics, 2010). The FDA evaluates innovations of medicines and foods for effectiveness, safety, and. The FDA provides the consumer, science-based information they need to use medicines and foods to improve their health (FDA Basics, 2010). 
Source and Scope of Authority 
In 1906, congressional legislation implemented the Pure Food and Drug’s Act (FDA Basics, 2010). This act currently incorporated in to the Food Drug and Cosmetic Act prohibiting interstate commerce of adulterated and misbranded food and drugs. 
The Food Drug and Cosmetic Act (FD&CA) is a federally enacted law on which the department operates. The FDA follows the Administrative Procedure Act to issue regulations. The Act gives the FDA rulemaking functions. FDA regulations are not part of the FD&CA. The FDA follows Good Guidance Practice Regulations that describes the stance of the regulatory issue (FDA Basics, 2010). 
Structure and Responsibilities 
The Center for Toxicological Research Organization supports the product centers by providing scientific technology, training, and technical expertise. 
Office of Regulatory Affairs Organization provides leadership and direction of product centers, research center, and office of Regulatory Affairs. 
The Center for Biologics Evaluation and Research Organizations regulates products for vaccines, blood, and gene therapy. This center monitors allergenic, tissue, and tissue products like bone, skin, and sperm. The department also works with transplantation of non-human cells, and tissues organs into humans. 
Center for Devices and Radiological Health Organization regulates medical devices from thermometers to dialysis machines. This center approves devices such as implants, and prosthetics. Monitoring includes radiation safety. 
Center for Drug Evaluation and Research Organization regulates over-the-counter and prescription medications. This department is responsible for items like toothpaste, and sunscreen. The products have pharmaceutical properties. 
The FDA approval process has specific steps for medication. The process begins with laboratory and animal testing. Next, testing on human subjects for safety and effectiveness evaluation. Following this, the manufacturer submits a New Drug Application. A biologic requires a Biologic License Application. The application includes, the test results, manufacturing information to ensure proper manufacturing, and the proposed label. If after review shows the benefits outweigh the risk, and manufacturing a quality product the medication meets the approval guidelines. The department is responsible for counteracting bio-terrorism, drug preparedness’, and natural disaster response. 
Center for Food Safety and Applied Nutrition Organization regulates most foods and additives, excluding meat, infant formulas, dietary supplements, and cosmetics. The FDA inspects food facilities along with the state agencies. This department regulates cosmetics to ensure safe and proper labeling. FDA approves cosmetic dyes. In 1994, The Dietary Supplement Health and Education Act amended the (FD&CA) to regulate the safety and labeling of dietary supplements (FDA Basics, 2010). The definition of a dietary supplement is a product taken by mouth intended to add dietary ingredients. 
Center for Tobacco Products Organization regulates tobacco cigarettes, rolling, and smokeless tobacco. This center is responsible for Regulatory issues and policy issues with the Family Smoking Prevention and Tobacco Control Act of 2009 (FDA Basics, 2010). 
Center for Veterinary Medicine regulates feed, drugs, and devices for animals. The FDA monitors the manufacturing and distribution of food additives and drugs given to animals. This includes meat used for human consumption. 
Example 
The Center for Drug Evaluation and Research Organization, wrote to General Mills, the manufacturer of Cheerios warning the manufacture that Cheerios statement regarding the cereal helps lower cholesterol. The FDA told General Mills to remove the statement, “diets rich in whole grain foods can reduce the risk of heart disease” (FDA calls cheerios and “unapproved drug,” 2009). The FDA warned the statements were violations of the FD&CA. The FDA informed General Mills that Cheerios is an unapproved drug that must go through the drug approval process (FDA calls cheerios and “unapproved drug”, 2009). 
Conclusion 
The Unites States Food and Drug Administration a department of the United States Department of Health & Human Services protects and promotes health by regulating more than just food, drugs, and cosmetics. The FDA works in more than an advisory capacity. The FDA works in conjunction with international programs to promote the safety and welfare of the consumer. The FDA conducts criminal investigations and institute sanctions. The department ensures emergency preparedness, and response to bio-terrorism. 


References 
FDA Basics (2010) Retrieved on February 12, 2010 from The Food and Drug Administration http://www.fda.gov/AboutFDA/Basics/default.htm 

FDA calls cheerios and “unapproved drug” (2009) Retrieved on February 12, 2010 from USA Today Magazine (138): p14-15. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=f5h&AN=43741553&site=ehost-live