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: (1) a Word doc with the questions and your answers and (2) a copy of the proposed regulation you used for this assignment. (10 points) The Food and Drug administration controls the act. This interests me because I believe all tobacco products should have better oversight and warning labels. E-cigarettes are not viewed as a health concern, despite releasing vapor which contains carcinogens. This proposed action is step closer for the FDA to gain more control on how all tobacco products are made and distributed, especially in regards to better warning labels. The proposal will not affect me.
2. Describe the proposal/change. (10 points)
The proposal wants to deem products meeting the definition of “tobacco product,” to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The FDA wants to extend the Agency’s “tobacco product” authorities to all other categories of products, except accessories. The FDA also wants to extend the Agency’s “tobacco product” authorities to all other categories of products, except premium cigars. This includes E-cigarettes. Finally, the FDA is proposing to prohibit the sale of “covered tobacco products” to individuals under the age of 18 and to require the display of health warnings on tobacco products under their control. The FDA is taking this action to address the public health concerns associated with the use of tobacco products. 3. Write the public comment which 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) “As a person who is a previous tobacco user, I wish the FDA would take this act further by outlawing tobacco use once and for all.
Tobacco is a drug, is addictive, and does much more harm than good. In fact, the only good coming from tobacco is the corporations making a profit on people’s addictions”. I wish to increase awareness. Even though this new act would help give the FDA more control on tobacco products and issue more serious warning label, it is still not far enough. 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) The deadline for which the comment period ends is August 8, 2014. 5. a. Once you have submitted your comment, what will you be 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.)
Once the deadline date for comments has expired, the document will be published in the Federal Register for additional comment. Those parties who made comments on the rules during the proposal stage can challenge the validity of the rules in court. b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have the regulation declared invalid and overturned in court.
1. Arbitrary and/or capricious, an abuse of discretion, or in violation of some other law. Without such evidence, the rule can be held arbitrary and capricious.
2. The regulation is unsupported by substantial evidence. Substantial evidence requires that more convincing evidence exist in support of the regulation than against it.
3. Involves the rule that a regulation can be set aside if the agency did not apply with the APA requirements of notice, publication, and public comment or input. The procedures for rulemaking must be followed in order for the regulatory process and resulting rules to be valid.
4. The regulation is unconstitutional.
5. Ultra vires. An ultra vires regulation is one that goes beyond the authority given to the agency in its enabling act. c. 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? The best way to challenge the regulation would be the second theory stating that the regulation is unsupported by substantial evidence. Big tobacco has fought for many years regarding the health claims against their products. Despite the fact there have been numerous studies on the negative health effects caused by inhaling and second hand smoke, big tobacco companies fight these claims with more addictive chemicals in their products. This would be a chance for tobacco companies to fight back with their own evidence of health claims in order for the courts to limit the FDA’s authority over tobacco.
Kubasek, N., Brennan, B. A., & Brown, M. N. (2012). The legal environment of business: A critical thinking approach. Upper Saddle River, N.J: Pearson. Regulations.gov. (n.d.). Retrieved from http://www.regulations.gov/#!docketDetail;D=FDA-2014-N-0189