Legal Ethics Assignment

FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Request for Comments 1. Food and Drug Administration. This agency and proposed regulation interests me because since it is something that has become popular in the recent years and that it affects many people in the united states and in the world today. Yes, many people in the gaming industry smoke on a regular basics. It will not affect the business directly; just the workers in the industry. 2. The proposal is a consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. In more basic terms it is trying to get tobacco dependent treatments or mechanisms, such as electronic cigarettes, a chance to be officially approved by the FDA. 3. Six months after most people purchased e-cigarettes, 31% of these smokers said they'd quit cigarettes and two-thirds of them said they'd cut back on the number of cigarettes they smoked. A third of those who'd quit smoking also quit using e-cigarettes. But E-cigarettes have not been tested for efficacy and safety. Additionally, they are produced overseas with little oversight to ensure good manufacturing practices. To regulate this product identified chemicals and quantities that is used in this product, release pros and cons for this product, and put a warning label on the product about the risk of addiction to nicotine.
I wish to accomplish in my comment was to help the FDA is that there is pros in the use of E-cigarettes. Also, that the use of E-cigarettes is a lower and healthier risk then the use of regular tobacco cigarettes. 4. The deadline was Jan 16, 2013. 5. a. Private citizens, government officials, industry representatives, businesspeople, and corporations can all send in comments based on provided proposed regulation during the public comment period. Anyone who wishes to challenge the validity of a federal regulation after it becomes law must participate in the comment period and voice his or her concerns at that time. Some agencies hold public hearings on proposed regulations. The purpose of the hearings is to take input on the proposals and consider additional evidence and consider additional evidence and factors relevant in promulgating the final version of the rule.” Business: Its Legal, Ethical, and Global Environment, 9th Edition.

b. 1) Arbitrary and Capricious. Standard for challenging administrative agency rules; used to show decisions or rules were not based on sufficient.
2) Substantial Evidence Test. Basis for challenging the action of an administrative agency on the grounds that the rule promulgated was not based on enough evidence.
3) Failure to comply with the Administrative Procedures Act requirements of notice, publication, and public comment or input. The procedures for rulemaking must be followed in order for the regulatory process, and the resulting rules, to be valid.
4) Constitutional challenge. The regulation is unconstitutional. Dealing with regulations giving an agency authority to search records, or impose discriminatory requirements for licensing professionals.
5) Ultra Vires. Action taken beyond the scope of authority; with federal agencies, action taken that is beyond the congressional authority given in the enabling statute. c. From five legal theories, I would use Substantial Evidence Test to challenge this proposed regulation of not ban the use of electronic cigarettes. I choose this theory is based on the fact that there is enough evidence to prove that electronic cigarettes will not do the same damage to human as real cigarettes do. Because electronic cigarettes contain different chemical other than liquid nicotine, there is enough research to prove that other chemical will not affect people’s health, meaning electronic cigarettes are still a healthy alternative of cigarettes. Also, companies that manufacture electronic cigarettes claim their products do not contain carcinogens or tar or produce secondhand smoke, should be the first concern of making this regulation.