1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interest 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 submitted as either a separate Word document (.doc) or Adobe file (.pdf). This means you will submit two attachments to the Week 2 Dropbox: (a) a Word document with the questions and your answers and (b) a copy of the proposed regulation you used 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 which 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 choose to do so)?
(See the textbook’s discussion of the Administrative Procedure Act.) If the proposal passes, identify and explain the five legal theories you could use in an attempt 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 2–3 paragraphs long. (15 points)
1-FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices commodities close to the daily lives of all Americans. FDA rules have considerable impact on the nation’s health, industries and economy. My concern is that under 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 statement that characterizes the relationship of any substance to a disease or health-related condition (e.g. a claim that calcium may reduce 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 episode served to heighten awareness of the fact that an increasing proportion of the food consumed domestically is imported, and much of it from countries that do not have well established food safety systems. It also began to focus attention on the fact that FDA’s funding has not kept up with the responsibilities that have been heaped upon it over the past several years, and that FDA will need additional legal authority to effectively address some 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 regulation 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 FDA’s rule, state and local jurisdictions started stepping into the breach. A number of localities have banned 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 issue is the increasing concern of the status of federal regulation of foods and other products that contain nanomaterial. Both proponents and skeptics of nanotechnology hold the view that industry has raced ahead of regulatory 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 various 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 provision 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 facility 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 company 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 meet the statutory standard of significant scientific agreement. FDA’s strict application of the statutory standard was held to violate the First Amendment of the US Constitution, which protects against government infringement of speech that is not false or misleading.
In response to those court decisions, FDA should develop a process for approval of qualified health claims; in order to attempt and describe the strength of the scientific evidence that supports a claim. Qualified health claims 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 approving them altogether. It remains to be seen how the controversy will be resolved, given that FDA’s current approach was essentially forced on it by the judiciary. (www.iflr.msu.edu/iflr/courses/united_states_food_laws)
FDA gov Homepage – U.S Food and Drug Administration homepage; Retrieved form
www.fda.gov January 19th, 2013
US FDA Food Regulations/FDA Beverage Regulations; Retrieved from
www.registrarcorp.com/fda-food/index.jsp? January 20, 2013
Importing Food Products into the United States; Retrieved from
www.fda.gov/Food/InternationalActivities/Imports/default.htm . January 20, 2013 United States – FDA Food Labeling Regulations; Retrieved from
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