The Tobacco Control Act: Legal Issues in 2013 and Beyond

Transcription

1 The Tobacco Control Act: Legal Issues in 2013 and Beyond David B. Clissold Director Hyman, Phelps & McNamara, P.C. April 24, 2014

2 Tobacco Products ScienJfic Advisory CommiLee (TPSAC) TPSAC advises FDA on issues relajng to tobacco products. Twelve members knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluajon, or use of tobacco products. Specifically responsible for advising FDA about: The use of menthol in cigareles. The effects of dissolvable tobacco products. Modified risk applicajons. The effects of the alterajon of nicojne yields from tobacco products and threshold level for dependence. 2

3 TPSAC February Lorillard Tobacco and R.J. Reynolds file suit in U.S. District Court for the District of Columbia alleging that certain TPSAC members have financial conflicts of interest because of their expert tesjmony in tobacco lijgajon and their financial relajonships with pharmaceujcal companies that make smoking cessajon products. May FDA moves to dismiss the suit, claiming that the plainjffs lack standing to enforce conflict of interest rules and that enforcement of conflict of interest requirements is not subject to judicial review. July Judge Leon denies the defendants mojon, allowing lawsuit to proceed. 3

4 TPSAC and Menthol July TPSAC issued report on menthol. Menthol cigareles have an adverse impact on public health in the United States. There are no public health benefits of menthol compared to non- menthol cigareles. Removal of menthol cigareles from the marketplace would benefit public health in the United States. On July 23, 2013, FDA issued an Advance NoJce of Proposed Rulemaking (ANPRM) to take public input on potenjal opjons for regulajng menthol in cigareles including: Tobacco product standards. Sale and distribujon restricjons. 4

5 More Research on Menthol FDA plans to support new research on menthol including: Menthol s likely effect on smoking cessajon. Menthol s likely effect on alempts to quit. The levels of menthol in cigarele brands and subbrands. The agency is also funding three menthol- related studies: GeneJc differences in taste percepjons in tobacco use. Assessing human exposure to smoke- related toxins and carcinogens by comparing cigareles with different levels of menthol. Effects of menthol and nonmenthol compounds in various tobacco products on both tobacco addicjon and toxicants of tobacco smoke. 5

6 Graphic Warnings The Family Smoking PrevenJon and Tobacco Control Act directed FDA to issue a regulajon requiring that cigarele packages display graphic warning labels covering 20 to 50 percent of the product packaging. On June 22, 2011, FDA published a final rule requiring color graphics depicjng the negajve health consequences of smoking. 6

7 Graphic Warnings August A divided three- judge panel of the D.C. Circuit ruled that intermediate scrujny under Central Hudson applied and found the regulajon unconsjtujonal under this standard. December The court denied the government s pejjon for panel rehearing and rehearing en banc. FDA decides not to seek further judicial review. 7

8 Graphic Warnings March The Sixth Circuit upholds the warning label requirement using Zauderer rajonal basis standard. Ban on conjnuity programs did not advance substanjal government interest. Ban on color and imagery (black on white tombstone adverjsing ) is vastly overbroad. 8

9 Graphic Warnings October Tobacco companies file pejjon for writ of cerjorari raising First Amendment challenges to: Graphic warnings. Modified risk tobacco product requirement (prevents informing consumers about lower- risk products, such as smokeless tobacco). Color adverjsements, brand name sponsorships and merchandise, sample products, and gigs. April The United States Supreme Court denies the pejjon. 9

10 Deeming RegulaJons September 16, RepresentaJves Waxman (D, CA), DeGeLe (D, CO), Pallone (D, NJ), and Dingell (D, MI) send Dr. Hamburg, Commissioner of FDA, a leler urging FDA to issue deeming regulajons that would assert jurisdicjon over electronic cigareles. On the same day, these representajves sent a leler to the Chairmen of the House CommiLee on Energy and Commerce, SubcommiLee on Oversight and InvesJgaJons, and SubcommiLee on Health urging a Congressional hearing on e- cigareles and other tobacco products. Trends in the use of e- cigareles, cigars, and pipe tobacco. Statutory changes needed to bolster FDA s ability to regulate these products. 10

11 THANK YOU! David B. Clissold Hyman, Phelps & McNamara, P.C Please Visit the FDA Law Blog 11