FDA Proposes Large Graphic Health Warnings On Cigarettes
The US Food and Drug Administration on Wednesday unveiled proposals for new, larger graphic health warnings to appear on cigarette packs and advertisements, which once finalized will represent the biggest change in more than 25 years; the actions are part of a broader government campaign to help smokers quit and stop children taking up smoking.
The new Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that was signed into law by President Obama in June last year, “requires that cigarette packages and advertisements have larger and more visible graphic health warnings”, said the FDA in a statement.
To this end, the agency has issued a proposed rule, Required Warnings for Cigarette Packages and Advertisements, showing the new labels that it wants to appear on packages and advertisements.
The proposal contains a total of 36 graphic color images showing the negative effects that smoking has on health.
There are nine different health warnings, each with four proposed graphic images, carrying the following text:
WARNING: Cigarettes are addictive.
WARNING: Tobacco smoke can harm your children.
WARNING: Cigarettes cause fatal lung disease.
WARNING: Cigarettes cause cancer.
WARNING: Cigarettes cause strokes and heart disease.
WARNING: Smoking during pregnancy can harm your baby.
WARNING: Smoking can kill you.
WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
WARNING: Quitting smoking now greatly reduces serious risks to your health.
Each image is large, covers half the pack, and shows the stark reality of the potential negative health consequences of being a smoker. For example, the one that accompanies the text “Cigarettes cause cancer” portrays a medium close up of an emaciated patient with no hair lying in a hospital bed.
The new Act requires that the FDA issue the final regulations containing the color images by 22 June 2011, and that the warnings themselves must appear on cigarette packages and advertisements 15 months later.
The FDA is inviting public comment on the 36 proposed images until 9 January 2011.
After that, the agency will undertake a comprehensive review of the available scientific evidence, the comments from the public, and also the results from a study covering 18,000 people, before selecting the final nine graphic and textual warning statements.
Once the final rule takes effect on 22 September 2012, companies will not be allowed to make cigarettes in the US for sale or distribution in the US without the new health warnings on their packages, and manufacturers, importers, distributors and retailers will not be allowed to advertise cigarettes without the new graphic health warnings. And by one month later, 22 October, manufacturers will not be allowed to distribute cigarettes for sale in the US that do not carry the new graphic health warnings.
The new warnings are part of a broader campaign by the US Department of Health and Human Services (HHS) that Assistant Secretary for Health Dr. Howard K Koh announced on Wednesday. The Ending the Tobacco Epidemic: A Tobacco Control strategic Action Plan outlines specific, evidence-based actions, including:
* The Affordable Care Act: allowing people to sign up for tobacco use cessation and other preventive care programs at no extra cost in their public or private health plan.
* The American Recovery and Reinvestment Act (ARRA): 225 million dollars has been ploughed into local, state and national efforts to promote tobacco control and expand “quitlines”.
* The Prevent All Cigarette Trafficking Act (PACT): to stop illegal sale of tobacco products to young people, and through mail order and over the internet.
* The Family Smoking Prevention and Tobacco Control Act (FSPTCA): gives the FDA powers to regulate the manufacture, marketing and distribution of tobacco products: eg. progress has already been made in restricting the use of “light”, “low” and “mild” to describe cigarette strength, and restricting the sale and distribution of smokeless tobacco products to young people.
* The Children’s Health Insurance Program Reauthorization Act (CHIPRA): raised federal tax on cigarettes to 62 cents per pack, as part of a “proven strategy” to reduce tobacco use among young people and other “price-sensitive” groups.
The HHS said that while there has been some progress toward creating a society free of tobacco-related death and disease, smoking is still very high among certain populations such as those on low income and within some racial and ethnic groups. These populations include people with mental illness and substance abusers.
Koh told the media that:
“We are at an unprecedented time in our nation’s history to protect the public’s health from tobacco use, the leading cause of preventable, premature death in the United States.”
“It will take renewed commitment from every sector of society to end the tobacco epidemic,” he added.
The HHS said tobacco use kills 443,000 Americans a year, and is the leading cause of preventable premature death in the US, with nearly one third of all cancer deaths linked to tobacco.
HHS Secretary Kathleen Sebelius said every day nearly 4,000 young people try a cigarette for the first time, and 1,000 take up smoking on a regular daily basis.
“Today marks an important milestone in protecting our children and the health of the American public,” she added.