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Lancet antitobacco series launches as ACC chides FDA inaction

London, UK – A special series of papers in the Lancet this week reviews the successes, failures, and ongoing challenges in beating back the “global tobacco epidemic,” including a report from FDA scientists touting the impact of the 2009 Tobacco Control Act in the US. That act gave the FDA much more sweeping legislative control over tobacco products, including labeling requirements.

The report, however, comes within weeks of an announcement from the FDA that it would not be challenging a US court of appeals decision ruling that graphic packaging on cigarettes was unconstitutional. That inaction prompted a letter April 25, 2013 from the American College of Cardiology (ACC) decrying the FDA’s decision [pdf below].

“What our letter to the FDA points out is that the FDA had not exhausted their legal strategies and probably should have taken this to the next level as opposed to recommending more research, because I think the research is fairly clear-cut on the impact of smoking, the CV risks of smoking, and what happens when you restrict smoking,” ACC president Dr John Gordon Harold told heartwire.

Studies have also indicated that graphic packaging has an impact on smokers, including prompting them to try to quit.

“From a professional society point of view, we don’t think this is an issue of freedom of speech, we think this is an issue of education and communication. The graphic images are showing reality—that’s what physicians see in the office and that’s what we see clinically all the time.”

Harold’s letter to FDA Commissioner Dr Margaret A Hamburg notes that graphic warning labels on cigarettes are already law in Australia, Canada, and Uruguay and that studies indicate packaging changes have a significant impact on smoking rates in the population.

Instead of challenging the ruling, the FDA has said it will “undertake research to support a new rule-making consistent with the Tobacco Control Act.”

The FDA’s decision, however, “not to forge ahead to the Supreme Court on this particular regulation and, instead, to conduct more research will delay implementation of graphic warnings, thereby delaying much-needed reductions in smoking among both adolescents and adults,” the ACC letter reads.

Across the pond

In fact, another one of the other papers in the Lancet series singles out the nonuniform use of print and pictorial warnings on cigarette packaging in Europe (along with underuse of mass-media campaigns and taxation) as a key failure of antitobacco efforts in Europe [1]. Only Belgium, France, Hungary, Latvia, Malta, Romania, Spain, and the UK have adopted the use of pictorial warnings on packaging, the paper notes.

But that, Harold points out, is still significantly better than the US.

“It’s unfortunate that we continue to fall behind many of our European and global colleagues on this important topic,” he told heartwire. “We are late to the table here, and this is an opportunity for legislation that we’ve been given and it’s going to require additional appeals.”

Harold pointed out that the Lancet paper by FDA staffers Corrine G Husten and Lawrence R Deyton does, appropriately, recount a number of important antitobacco wins as a result of the Tobacco Control Act [2]. Among them: increased pricing on tobacco products, smoke-free policies, countermarketing campaigns, advertising restrictions, etc. And the article itself acknowledges that legal challenges, such as the unconstitutionality claim argued successfully against graphic labeling, among others, have hampered progress.

“Some of the comments in the Lancet article are right on: the approach is multifaceted and we have to celebrate our success but also focus on our opportunities,” Harold said. “We’re talking about incremental progress, and this is a celebration of where we’ve come from the Surgeon General’s report back in the 1960s. . . . We’ve come a long way, but have we caught up to our European and Commonwealth colleagues? No. I think we can do more.”

A Commentary accompanying Husten and Deyton’s paper also points out that 175 countries have signed onto the Framework Convention on Tobacco Control; the US is not one of them [3].

Asked why freedom-of-speech concerns managed to trip up the new packaging rules in the US, Harold referred to the power of the tobacco lobby in the US and the big money behind it. But acknowledging that tobacco dollars are also being heaped on antismoking battles in other parts of the world, Harold agreed the US had some unique hurdles. “In the economies of many of our Southern states, tobacco plays a tremendous [role],” he said. “I think that our political microcosm is perhaps a little bit different than in other parts of the world.”

ACC letter on FDA decision not to appeal graphic warnings


1. Britton J and Bogdanovica I. Tobacco control efforts in Europe. Lancet 2013; 381:1588-1595.

2. Husten CG and Deyton LR. Understanding the Tobacco Control Act: Efforts by the US Food and Drug Administration to make tobacco-related morbidity and mortality part of the USA’s past, not its future. Lancet 2013; 381: 1570-1580;

3. Cohen JE. Saving lives with the US Tobacco Control Act. Lancet 2013; 381:1513-1514.


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