Kevin Outterson, J.D., December 7, 2011 – The New England Journal of Medicine

“On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law. For the first time, Congress had given the Food and Drug Administration (FDA) authority to directly regulate tobacco products, with the aim of improving public health. And indeed, effective tobacco control would be a remarkable public health achievement — and might be possible if the law is allowed to stand. But on November 7, 2011, a federal judge in Washington, D.C., issued a preliminary injunction blocking some of its key provisions as unconstitutional restrictions on commercial speech, and the battle seems likely to end up in the Supreme Court.

“The Tobacco Control Act made three changes to cigarette warnings. First, existing warnings on cigarette packages (which have been required since 1966) must be replaced with nine new specified verbal warnings (see FDA-Mandated Warnings for Cigarette Packages), one of which must appear on every package. Second, nine new graphic images must be paired with the textual warnings on a rotating basis; the FDA selected images that it expects to have the greatest anti-smoking effect. Finally, companies must move the warnings from the side of the package and devote at least the top 50% of both the front and back panels to the government-mandated messages.

“The case decided in November, R.J. Reynolds Tobacco Company v. FDA, challenged the second two of these three changes, as implemented through an FDA rule published on June 22, 2011. The judge, Richard Leon, refused to apply the well-known Central Hudson test for commercial speech, under which the government must establish that the rule “directly advances” its “substantial” interest and is “not more extensive than is necessary.” Instead, Leon applied the more demanding “strict scrutiny” test, whereby the government’s interest must be “compelling” and the regulation “narrowly tailored” to that compelling purpose. Finding that the regulation failed this test, the court enjoined the FDA from enforcing the regulations regarding graphic images and mandatory space allocations. The Department of Justice immediately appealed this ruling. To continue reading this article, click here.