Legal eagle Kevin Outterson explains the latest twists in the saga of the FDA's quest to get large, scary pictures on every cigarette package under its new regulatory muscle of the 2009 Obama-authorized Tobacco Control Act.

R.J. Reynolds sued, and federal judge Richard Leon took their side in November 2011, deciding to apply the more stringent "strict scrutiny" rule rather than the Central Hudson rule. These are the two major legal precedents that judges use to decide when government is encroaching too intrusively into commercial speech.

The new language ("Smoking can kill you," etc.) will go in effect, but not the disturbing imagery, nor the increase in warnings' size to 50% of the package. Interestingly, the tobacco companies argued that "Americans already know too much about the dangers of tobacco use and don't need new graphic warnings," which is backed up by some survey data saying that both children and adults today overestimate the risks of smoking, in terms of life expectancy.

The Justice Department appealed immediately, so expect another chapter to the saga.

Outterson K. Smoking and the First Amendment. N Engl J Med 2011;365:2351-2353.