1 Centers for Disease Control and Prevention, Healthy People 2010: Objectives for Improving Health, Tobacco Use, at 27-3, available at http://www.healthypeople.gov/document/pdf/volume2/27tobacco.pdf.

2 Family Smoking Prevention & Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009). See also 21 U.S.C. § 321 (2009).

3 21 U.S.C. § 301 (2000).

4 Obama Signs Bill Putting Tobacco Products Under FDA Oversight, CNNPolitics.com, June 22, 2009, http://www.cnn.com/2009/POLITICS/06/22/obama.tobacco/index.html.

5 Prior to passage of the Act, the growing of tobacco was regulated by the Department of Agriculture, the advertising of tobacco was regulated by the Federal Trade Commission under the Fair Packaging and Labeling Act, 15 U.S.C. §§ 1451-61, and the Federal Cigarette Labeling and Advertising Act, 15 U.S.C. §§ 1331-41, the distribution of tobacco was controlled under the Jenkins Act, 15 U.S.C. §§ 275-378, and the Contraband Cigarette Trafficking Act, 18 U.S.C. §§ 114; 2341-46, tobacco products were taxed under 26 U.S.C. § 52 (2000). See U.S. Dep't of the Treasury, Alcohol and Tobacco Tax and Trade Bureau, Tobacco FAQs and Answers, July 25, 2007, available at http://www.ttb.gov/tobacco/faq_answers.shtml.

6 See generally Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44,619 – 45,318 (Aug. 28, 1996).

7 21 U.S.C. § 301.

8 See 61 Fed. Reg. at 44,397.

9 FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 159-61 (2000).

10 Compare Pub. L. No. 111-31, 123 Stat. 1776, 1796 (“The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health.”), with FDCA, 21 U.S.C. § 355 (2000) (stating that no new drug may be introduced into interstate commerce without a demonstration of safety and effectivenesss), and 21 U.S.C. § 360(c) (2002) (stating that a device may not be marketed in interstate commerce without adequate assurances or demonstration of its safety and effectiveness).

11 123 Stat. at 1781.

12 123 Stat. at 1786-89; 21 U.S.C. § 321.

13 Id. at 1794.

14 Id. at 1783.

15 Id. at 1807.

16 Id. at 1780.

17 Id. at 1791-1801.

18 Id. at 1803.

19 Id. at 1799.

20 Id. at 1797.

21 Id.

22 Id. at 1788.

23 A cigarette or any of its components may not contain any natural or artificial flavors, herbs or spices, other than tobacco or menthol, including “strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or the tobacco smoke.” Id. at 1799.

24 U.S. Dep't of Health and Human Servs., Fact Sheet Flavored Tobacco Products, http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/UCM183214.pdf (last visited Dec. 3, 2009).

25 U.S. Dep't of Health and Human Servs., FDA Parental Advisory on Flavored Tobacco Products – What You Need to Know, http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/FlavoredTobacco/UCM183262.pdf (last visited Dec. 3, 2009).

26 Stephanie Saul, Black Lawmakers Seek Restrictions on Menthol Cigarettes, N.Y. Times, June 1, 2008, at C3.

27 Gandhi, Kunal K. et al., Lower quit rates among African American and Latino menthol cigarette smokers at a tobacco treatment clinic, 63 Int. J. of Clinical Prac. 360, 360 (2009)CrossRefGoogle Scholar (finding lower short-term quit rates and higher relapse rates).

28 See id. (finding that Latinos and African Americans had lower quit rates compared with whites); see also Paul Smalera, Cool, Refreshing Legislation for Philip Morris, Slate, June 8, 2009, http://www.thebigmoney.com/articles/judgments/2009/06/08/cool-refreshinglegislation-philip-morris?page=full (stating that menthol cigarettes were also linked to 14.6% of all African-American deaths in 2006).

29 Smalera, supra note 28.

30 123 Stat. at 1804. Additionally, the Act requires FDA to provide a report and recommendation to the Committee on the impact of use of menthol flavor in cigarettes on the public health, particularly among children, African Americans and other minorities. Id.; 21 U.S.C. § 301 (2000).

31 Mark Drajem & Lorraine Woellert, Clove Cigarettes May Prompt U.S., Indonesia Dispute, Bloomberg.com, May 19, 2009, http://www.bloomberg.com/apps/news?pid=20601070&sid=a9YjoELUY1jU.

32 Id.

33 Id.; see also World Health Organization, Tobacco: deadly in any form or disguise, 2006, at 21 available at http://www.who.int/tobacco/communications/events/wntd/2006/Report_v8_4May06.pdf.

34 Id.

35 Drajem & Woellert, supra note 31. The WTO will get involved in resolving Indonesia's trade complaint if there is a question of disrimination. Id.

36 Id.

37 Id.; see also Centers for Disease Control and Prevention, Bidis and Kreteks, May 29, 2009, http://www.cdc.gov/tobacco/data_statistics/fact_sheets/tobacco_industry/bidis_kreteks/ (describing various facts about bidis and kreteks).

38 See Ghandi, supra note 27, at 360.

39 Citizens Petition to the United States Food and Drug Administration, July 27, 2009, available at http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064809fdd56&disposition=attachment&contentType=pdf.

40 Letter from Lawrence R. Deyton, Director, Center for Tobacco Products, Food and Drug Administration, to Dennis S. Lane, National Coalition of Associations of 7-Eleven Franchises, at 1, available at http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480a29623&disposition=attachment&contentType=pdf (denying petition).

41 Federal Cigarette Labeling and Advertising Act, 15 U.S.C.A. § 1332 (2009), defines “cigarette” as “(A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and (B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in subparagraph (A).”

42 Chapter IX of the FDCA currently applies only to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

43 Complaint at 5, Kretek Int’l, Inc. v. U.S. Food and Drug Admin., No. 1:09-cv-01835 (D.D.C. Sept. 22, 2009), available at http://www.fdalawblog.net/files/kretek---complaint.pdf.