Food Regulations Essay Example for Free

feed Regulations Essay1.State the administrative agency which controls the man witness. Explain wherefore this agency and your proposed pattern wager you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how? Submit a copy of the proposed regulation along with your responses to these five questions. The proposed regulation can be ex correspondted as either a separate Word document (.doc) or Adobe file (.pdf). This means you will submit deuce attachments to the Week 2 Drop box (a) a Word document with the questions and your answers and (b) a copy of the proposed regulation you holdd for this assignment. (10 points) 2.Describe the proposal/change. (10 points)3.Write the public comment that you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points) 4.Provide the deadline by wh ich the public comment must be made. (If the date has already passed, please provide when the deadline was). (5 points) 5. Once you have submitted your comment, what will you are legally entitled to do later in the promulgation process (if you should need to do so)?(See the textbooks discussion of the Administrative Procedure Act.) If the proposal passes, identify and explain the five legal theories you could use in an onrush to have (any) administrative regulation declared invalid and overturned in court. Which of these challenges would be the best way to challenge the regulation you selected for this assignment if you wanted to have the regulation overturned and why? Answer all of these questions for 5 even if you are in favor of your proposed regulation. The response to question 5 should be a minimum of 23 paragraphs long. (15 points)1-FDA publishes rules that establish or modify the way it regulates nutrients, drugs, biologics, cosmetics, radiation-emitting electronic product s, and medical devices commodities close to the daily lives of all Americans. FDA rules have grand impact on the nations health, industries and economy. My concern is that chthonian the federal law, a claim that a food is intended to diagnose, cure, mitigate, treat, or prevent disease makes that food a drug, and is unlawful.However, federal law provides for FDA approval of a health claim, which is a differentiatement that characterizes the relationship of any substance to a disease or health-related condition (e.g. a claim that calcium may undertake the risk of osteoporosis). Under the statutory standard for approval, the claim must be supported by significant scientific agreement. (www.iflr.msu.edu/iflr/courses/united_states_food_laws)2. The adequacy of federal oversight of food safety recently became the subject of intense media and Congressional scrutiny. The issue came to national prominence when contaminated food caused the death and illness of hundreds of people. The episo de served to heighten sentiency of the fact that an increasing proportion of the food consumed domestically is imported, and much of it from countries that do not have head established food safety systems. It also began to management attention on the fact that FDAs funding has not kept up with the responsibilities that have been heaped upon it over the past several years, and that FDA will need superfluous legal authority to effectively address approximately problem areas they have adequate funding and resources. FDA covered the overall food safety systems of the countries, as well as their food safety systems such as specific commodity areas i.e. seafood, including molluscan shellfish, imported meat products, vegetables and dairy products (excluding Grade A pasteurized milk products). (www.fda.gov/Food/InternationalActivities/Imports/default.htm)3. The controversy over trans-fat offers an example of how one kind of regulation at the federal level can beget other forms of regul ation at the state level. In 2006, an FDA regulation went into effect that requires listing the amount of trans-fat present in a packaged food on the label of that food. FDA did not go so far as to ban the use of trans-fat, something that some consumer groups were advocating. However, shortly after the issuance of FDAs rule, state and local jurisdictions started stepping into the breach. A number of localities have illegalise the use of trans-fat in restaurant foods, and some states, such as California, have begun to follow suit. Faced with a patchwork of local requirements and the potential for adverse publicity, some major restaurant chains have reformulated their products to eliminate the use of trans-fat, however, nations wide has not complied or just finds a loophole to go around the system in avoiding such regulations.another(prenominal) issue is the increasing concern of the status of federal regulation of foods and other products that contain nanomaterial. Both proponents a nd skeptics of nanotechnology hold the view that industry has raced fore of restrictive authorities in bringing nanotech products to market, thereby increasing the potential for consumer injury and environmental harm. Thus, there is at least some support for stronger regulatory oversight of nanotech products in general, and of nanotech foods, including food additives and dietary supplements in specific. Recently, FDA announced that it will hold a public hearing to seek input on heterogeneous aspects of its approach to regulation of nanotechnology.FDA likely will follow up on that hearing with the issuance of guidance documents specific to the product categories that it oversees. (www.mondaq.com/unitedstates/x/146784/Healthcare+Food) 4. By law, anyone should participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows the public input and carefully considers the comments when it draws up a final rule. Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. FDA will act to implement a readying of the FDA Amendments Act of 2007 that requires FDA to establish a reportable food registry, and that requires any person who submits a registration for a food adeptness under the Bioterrorism Act of 2002 to also notify FDA of instances of reportable food.A reportable food is one for which there exists a reasonable probability that use of, or exposure to, the food will cause serious adverse health consequences or death, the same standard that currently applies to Class I recalls, so the practical effect of the new provision should make it mandatory for companies to notify FDA of a Class I recall situation. FDA Petitions require careful preparation by the submitter, they spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but most come from regulated industry or consumer groups. For example, a drug beau monde might request a change in labeling for one of its products a food company might ask that its product be exempted from some provision of a regulation or a consumer group might petition FDA to tighten regulation of a certain product. (RegistrarCorp.com/FDA-Food)5. Health claims have been the subject of considerable controversy. After protracted litigation, federal courts ruled that FDA cannot impose an outright ban on claims that have some scientific support but fail to digest the statutory standard of significant scientific agreement. FDAs strict application of the statutory standard was held to violate the First Amendment of the US Constitution, which protects against government infringement of reference that is not false or misleading.In response to those court decisions, FDA should develop a process for approval of adequate health claims in order to attempt and describe the strength of the scientific evidence that supports a claim. Qualified health c laims should be the subject of controversy in their own right. Some observers believe that qualified health claims are as likely to mislead as to inform consumers, and opposition to their use has grown to the point where Congressional representatives have asked FDA to stop approbative them altogether. It remains to be seen how the controversy will be resolved, given that FDAs current approach was essentially forced on it by the judiciary. (www.iflr.msu.edu/iflr/courses/united_states_food_laws)ReferencesFDA gov Homepage U.S Food and dose Administration homepage Retrieved formwww.fda.gov January 19th, 2013US FDA Food Regulations/FDA Beverage Regulations Retrieved fromwww.registrarcorp.com/fda-food/index.jsp? January 20, 2013Importing Food Products into the United States Retrieved fromwww.fda.gov/Food/InternationalActivities/Imports/default.htm . January 20, 2013 United States FDA Food Labeling Regulations Retrieved fromwww.ladas.com/BULLETINS/1994/0694Bulletin/US_Food