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From Health Law Daily, April 23, 2013

Supreme Court declines tobacco industry’s petition for certiorari, paves way for FDA to design graphic package labels

By Sarah E. Baumann, JD

On April 22, 2013, the U.S. Supreme Court declined to hear a case filed by tobacco companies challenging certain aspects of the 2009 Family Smoking Prevention and Tobacco Control Act (the Act) (P.L. 111-31) without comment, paving the way for the FDA to require anti-smoking images to appear on tobacco product labels. Anti-smoking advocates applaud the decision, but the tobacco industry promises more litigation. Implementation of the FDA’s graphic labeling requirement is far from reality, as an earlier federal court decision blocked the FDA from implementing the labeling requirement, forcing the agency to rethink the images and propose new rulemaking.

Petition for certiorari. According to the tobacco companies’ petition for certiorari in American Snuff Co. v U.S., the Family Smoking Prevention and Tobacco Control Act “imposed myriad restrictions on truthful, non-misleading speech to adult tobacco consumers concerning lawful tobacco products. The industry specifically took issue with labeling requirements that would require companies to include graphic anti-smoking images on tobacco products taking up 30 to 50 percent of the front and back of product labels. The nine FDA-approved images included a man exhaling smoke through a tracheotomy hole, a cadaver post-autopsy, a premature baby in an incubator, and an infant surrounded by smoke.

Underlying case. In 2012, the U.S. Court of Appeals for the Sixth Circuit ruled that the graphic labeling requirements were reasonably related to the prevention of consumer deception. It further found constitutional provisions prohibiting tobacco companies from advertising the decreased risks of modified risk tobacco products without prior FDA approval and prohibiting marketing through brand-name sponsorships, merchandise, sample products, and free gifts upon purchase.

Conflicting ruling. However, later that year, the U.S. Court of Appeals for the District of Columbia Circuit ruled for R.J. Reynolds Tobacco Company in a separate case, R.J. Reynolds Tobacco Co.v Food & Drug Administration. It specifically found that the FDA did not submit evidence that the inclusion of graphic images on tobacco labels would accomplish its goal of reducing smoking rates. It thus vacated the FDA regulation and remanded it to the agency.

Impact. Although the Supreme Court’s action seems to give credence to the FDA’s labeling decision, the Obama administration has already stated that it will not continue to defend the labels, forcing the agency to consider new labeling in order to conform with the District of Columbia appellate court ruling. The FDA will then need to enter the federal rule-making process, which could last years; the agency could face challenges along the way. Cigarette labels were last updated nearly 30 years ago—it seems it could be several more years before they change again.

MainStory: TopStory SupremeCtNews TobaccoNews

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