FDA to Require Graphic Warnings on Cigarette Packages, Tobacco Ads

Public Invited to Comment on Proposed Rule

November 12, 2010 01:15 pm News Staff

Smokers will be starkly confronted with the potential consequences of their habit every time they buy a pack of cigarettes under the terms of an FDA proposed rule(edocket.access.gpo.gov) published Nov. 12 in the Federal Register.

[WARNING: Cigarettes cause fatal lung disease graphic]

"Every pack will become a mini-billboard that tells the truth about smoking," FDA Commissioner Margaret Hamburg, M.D., said during a Nov. 10 news conference(www.fda.gov).

The Family Smoking Prevention and Tobacco Control Act(www.govtrack.us) signed into law by President Obama last year gave the FDA the authority to regulate tobacco products, while also requiring that cigarette packages and advertisements have larger and more visible graphic health warnings.

Hamburg said that when the new rule is finalized, manufacturers will be required to devote half of the front and back panels of cigarette packages to the warnings, which are getting a significant update for the first time in 25 years.

For the first time, the warnings will include a statement reflecting the fact that tobacco products are addictive. Another warning -- one of nine new cautionary messages -- says that tobacco products can kill people.

Check Out New, Revamped Ask and Act Resources

The AAFP has updated and augmented its resources for Ask and Act, the Academy's tobacco cessation program.

According to Pam Rodriguez, AAFP's tobacco control manager, the new resources include Ask and Act wall posters, which are available in English and Spanish.

A guide(2 page PDF) that discusses the need to integrate tobacco cessation into electronic health records, or EHRs, has been updated to include "meaningful use" and payment information.

Other updated resources include:

The updates come just in time for the Great American Smokeout, which is scheduled for Nov. 18.

The Academy also has updated its program guide(www.tarwars.org) for Tar Wars, which includes new supplemental activities and a new letter for parents.

"Blunt" New Tobacco Warnings Spotlight Smoking's Dangers

Hamburg said the facts are being presented "directly and bluntly" to raise public awareness about the dangers of smoking, encourage adult smokers to quit and discourage youth from starting.

Tobacco use is the leading cause of premature and preventable death in the United States, according to HHS, accounting for more than 400,000 deaths each year. Thirty percent of all cancer deaths are related to tobacco.

Unlike the tiny warnings that currently reside on the side panels of cigarette packages, the new larger warnings will be accompanied by graphic images.

The grim photos released by HHS include one image of a dead body in a coffin and another showing a cadaver bearing a toe tag and lying on a morgue table. A third depicts an emaciated, deathly ill young woman lying in a hospital bed.

"Some of the images are very powerful," Hamburg said. "That is the point."

The public will have from Nov. 12 until Jan. 11 to comment on the 36 images the FDA has developed. HHS will select nine of those images for use, based in part on comments received, before issuing its final rule in June 2011.

Tobacco companies will have until September 2012 to begin using the warnings in their packaging and print advertisements. Marketers will be required to devote 20 percent of print advertisement space -- specifically, at the top of all ads -- to the warnings.

"We want to make sure people get the real message about smoking when they pick up a pack of cigarettes or see an advertisement for cigarettes," said Hamburg, who added that Canada, Australia and the European Union already have similar warning requirements.

The FDA has taken several steps since it was given authority to regulate the tobacco industry last year. The agency already has prohibited the use of the terms 'light," "low" and "mild" in cigarette marketing and packaging; banned cigarettes with fruit, candy, and spice flavors; and restricted the sale and marketing of tobacco products so that young people are less likely to be exposed to tobacco ads.

"It's been a very busy first year," Hamburg said.

FDA's Action One Piece of Comprehensive HHS Plan

The announcement of the proposed rule coincided with HHS' rollout of a broader strategic plan(www.hhs.gov) for tobacco control.

Assistant Secretary for Health Howard Koh, M.D., M.P.H., said during the news conference that the initiative has four pillars:

  • improving public health by strengthening the implementation of evidence-based tobacco control interventions and policies in states and communities;
  • changing social norms about tobacco use by engaging the public, including via a mass media campaign intended to prevent tobacco use initiation and to promote and facilitate cessation;
  • leveraging HHS systems and resources to create a society free of tobacco-related disease and death, including through the enhancement of "health care provider incentives to promote tobacco cessation treatment efforts"; and
  • expanding research and surveillance, including creation of an annual report on tobacco data showing progress toward the Healthy People 2020 objectives of reducing the number of adult smokers from 20 percent to 12 percent in the next 10 years.

Here is a brief look at some other recent tobacco control efforts:

  • According to HHS, the Patient Protection and Affordable Care Act allows people in private and public health plans access to recommended preventive care, including tobacco cessation services, at no additional cost.
  • The American Recovery and Reinvestment Act, or ARRA, allocated $225 million to support local, state and national programs to promote comprehensive tobacco control and expand tobacco quitlines.
  • The Children's Health Insurance Program Reauthorization Act raised the federal cigarette tax by 62 cents per pack. Koh said that for every 10 percent increase in the price of tobacco products, use decreases by 4 percent.