CITMA Seminar: PENDING LITIGATION AGAINST fdA

1. CITMA Seminar:PENDING LITIGATION AGAINST fdA Reena Raman, Esq. Associate Kleinfeld Kaplan & Becker LLP Washington, DC www.kkblaw.com November 17, 2009

2. Commonwealth Brands v. US • Filed August 31, 2009 - Western District of Kentucky • Parties: • Plaintiffs: Commonwealth Brands, Inc., ConwoodCo., Discount Tobacco City & Lottery, Inc., Lorillard Tobacco Co., National Tobacco Co., RJ Reynolds Tobacco Co. • Defendants: FDA • Seeking declaratory judgment and injunction to prevent FDA from enforcing certain marketing provisions

3. Commonwealth Brands v. US • Provisions Challenged as Violating the 1st Amendment: • Ban on color and graphics in most advertising • Mandated warnings • Prohibition on the sale of “modified risk tobacco products” without prior approval • Ban on certain outdoor advertising • Ban on brand name sponsorship of events • Ban on brand name merchandise • Ban on references to FDA • Ban on distributing product samples • Ban on combination product marketing • Ban on promotions offering gifts for the purchase of cigarettes or smokeless tobacco • State/local authority to adopt additional, more restrictive laws

4. Commonwealth Brands v. US • Government has to show: • The restrictions are intended to further a substantial government interest • The restrictions directly advance the government interest • The restrictions are narrowly tailored and not more extensive than necessary to advance the government interest

5. Commonwealth Brands v. US • Status: • Nov. 5, 2009 • Judge denied plaintiffs’ motion for preliminary injunction to prevent FDA from enforcing the modified risk provision • Judge noted that plaintiffs have “little likelihood of success on the merits of their facial First Amendment challenge” to the modified risk provision • Nov. 30, 2009: Motions for summary judgment due

6. BBK Tobacco & Foods v. FDA • Filed Oct. 7, 2009 – District of Arizona • Parties • Plaintiff: BBK - distributor of flavored rolling papers • Defendant: FDA • Plaintiff’s Argument • FDA’s Q&A states that the flavor ban applies to rolling papers BUT • Flavored rolling papers sold separately do not meet the definition of “cigarette” and therefore are not subject to the ban on characterizing flavors • Seeking declaratory judgment and injunction to prevent FDA from regulating flavored papers

7. BBK Tobacco & Foods v. FDA • Status: • FDA has not filed its answer • Nov. 3, 2009: Plaintiff filed a motion for summary judgment • Nov. 17, 2009: Defendant to respond and file cross motion • Dec. 1, 2009: Bench trial

8. Kretek Int’l v. FDA • Filed Sept. 22, 2009 – DC District • Parties • Plaintiff: Kretek - cigar importer and distributor • Defendant: FDA, HHS • Plaintiff’s Argument • FDA’s Q&A states that the flavor ban applies to cigarettes, as defined in the FSPTCA, even if labeled as cigars or little cigars • Because cigars do not meet the definition of cigarette, they are not subject to the flavor ban – FDA must preserve the established distinction • Seeking declaratory judgment and injunction to prevent FDA from regulating its clove cigars as cigarettes under the FSPTCA

9. Kretek Int’l v. FDA • Status: • Only the complaint has been filed • FDA has not filed an answer