Legal Ethics Assignment Essay

1. Food and Drug Administration. This agency and proposed regulation interests me because since it is something that has become popular in the late 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 second-stringer 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 breed tobacco dependent treatments or mechanisms, such as electronic cigarettes, a chance to be officially approved by the FDA.3. Six months after intimately people purchased e-cigarettes, 31% of these smokers said theyd submit cigarettes and two-thirds of them said theyd cut back on the number of cigar ettes they smoked. A third of those whod quit smoking also quit using e-cigarettes. But E-cigarettes have not been tested for efficacy and safety. Additionally, they are adduced overseas with little oversight to ensure favorable manufacturing practices. To regulate this product identified chemical substances 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 colony to nicotine. I wish to accomplish in my footnote 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 consequently 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 base on provided proposed regulation during the public comment period. Anyone who wishes to challenge the validity of a federal regul ation 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 say Test. Basis for challenging the action of an administrative agency on the grounds that the rule promulgated was not based on full 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) fundam ental challenge. The regulation is unconstitutional. Dealing with regulations giving an agency potential 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 peoples health, meaning electronic cigarettes are still a healthy alternative of cigarettes. Also, companies that manufacture electronic cigarettes claim their prod ucts do not contain carcinogens or tar or produce secondhand smoke, should be the first concern of making this regulation.