GM520: Legal, Political, and Ethical Dimensions
May 11, 2008
Week 2 TCO B Homework
1. State the administrative agency which controls the regulation.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Service which main responsibility is to control the regulation of Food and Drug administration and is under the control of the United States federal executive departments.
i. Explain why this agency and your proposed regulation interests you (briefly).
This agency interest me because I have a deep concern about the types of food and drugs that enter into our Caribbean market and other third world countries. After ...view middle of the document...
Explain why this agency and your proposed regulation interests you (briefly). How will this proposed regulation affect you or the business in which you are working? Provide the URL to the website where the regulation change proposal is located. (Check your URL to be sure it takes the reader to the actual regulation). (10 points)
2. Describe the proposal/change. (10 points)
Response: From the FDA Summary, â€œamending the health claim regulation entitled â€˜Soluble fiber from certain foods and risk of coronary heart disease (CHD)â€™ to add barley betafiber as an additional eligible source of beta-glucan soluble fiber.â€ The agency has come to the conclusion that there is significant scientific agreement and evidence in the public domain to support this claim. Currently, certain whole oat and whole grain barley products are included in the regulation.
3. Write the public comment which you would submit to that proposal. If the proposed regulation deadline has already hit, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points)
Response: Both of my parents had extremely high cholesterol, which has been passed onto my generation. Since I have high cholesterol that I am unable to control without medication, I am pleased to see food additives being developed that will aid in improved cholesterol results. With the increasing costs of health care and prescription drugs, I disagree with the public comment made by Ms. Barbara Sachau on February 25, 2008. The research and development studies on this product by multiple and independent parties offers a great deal of encouragement to those of us with cholesterol problems. The latest statistics show that cardiovascular disease, which includes CHD and stroke, is the leading cause of death in women in America and most developed countries.
4. Provide the "deadline" for...