Annette Brown
Week 2 – Administrative Procedure Act

Food and Drug Administration (FDA) Menthol Cigarette Regulation – This interests me because I use to smoke menthol cigarettes and was curious why they wanted to ban menthol flavoring.

2. Describe the proposal/change – The FDA and Tobacco Products Scientific Advisory Committee after reviewing all scientific literature on menthol cigarettes, they concluded recommendation proposal of the removal of menthol cigarettes for the marketplace would benefit public health in the U.S.

3. Public comment – The FDA is studying whether to ban menthol cigarettes from the marketplace for the betterment of our country. However, this introduces illegal use, sale and distribution of a currently legal product. Menthol cigarettes will be added to the underground market for sale that tends to involve organized crime.

I totally understand the health implications of cancer from cigarettes period. I feel the FDA may want to take a different avenue than banning menthol cigarettes. Hence, it needs to be given careful contemplation and look at form all the various perspectives including minor consequences if banned.

4. The FDA public comment deadline currently is September 23, 2013. I may be extended to allow for more comments and review.

5. The FDA will afford the public a meaningful opportunity to participate in the rulemaking process. After the comment period is over, the agency has three choices about what to do with the proposed rules. The first choice is simply adopt the rules. The second choice is to modify the proposed rules and go through the process of public comment again. If the modification is minor however, the APA allows the agency to adopt a modified version of the rule without going through the public comment period again. The final choice of the proposing agency is to withdraw the rule. Some rules have so many comments pointing out their impracticability that they withdraw from the promulgation process. Those parties who made comments on the rule during the proposal stage can challenge on several different grounds. There are five legal theories I can use to carry out my dispute in court.

* Formal Rule Making – this simply requires the agency to show evidence to support the proposed rule after the comment period is over and they have three choices * The Arbitrary and Capricious Standard for challenging an Agency Action – this mean you have to prove that the rule is arbitrary, capricious, abuse of discretion, or in violation of some other law * The Substantial Evidence Standard for Challenging an Agency Action – this means that the regulation is unsupported by substantial evidence test * The Constitutional Standard for Challenging an Agency’s Actions – this means that the regulation has to be proven unconstitutional by searching records and such * The Ultra Vires Standard for Challenging an Agency’s Action – “Beyond it’s Powers” this means regulation cannot operate outside of the authority given to the agency

The best way to challenge the rule proposed by the FDA would be; The Substantial Evidence Standard of Challenging an Agency Action. This states that the rule is unsupported by substantial evidence. This is the only challenge. The rule does not meet any of the scientific theories that the FDA thought it would. FDA proposed that menthol was more additive and harmful than non-menthol cigarettes. Not true. This is one of their reason to ban menthol cigarettes.