A Look at Warning Labels

FDA, HHS propose extremely graphic images for cigarette packaging

WASHINGTON -- As part of a broader strategy that the U.S. Department of Health & Human Services (HHS) said will help tobacco users quit and prevent minors from starting, the agency has unveiled a new comprehensive tobacco control strategy that includes proposed new "bolder" health warnings on cigarette packages and advertisements.

The strategy includes a proposal issued by the U.S. Food & Drug Administration (FDA) titled "Required Warnings for Cigarette Packages & Advertisements." Specifically, the proposed rule details a requirement of the Family Smoking Prevention &[image-nocss] amp; Tobacco Control Act that nine new larger and more noticeable textual warning statements and color graphic images depicting the negative health consequences of smoking appear on cigarette packages and in cigarette advertisements.

The public has an opportunity to comment on 36 proposed images through January 9, 2011.

Once final, these health warnings on cigarettes and in cigarette advertisements will be the most significant change in more than 25 years, HHS said.

By June 22, 2011, FDA will select the final nine graphic and textual warning statements after a comprehensive review of the relevant scientific literature, the public comments and results from an 18,000-person study.

Implementation of the final rule on September 22, 2012, will ultimately prohibit companies from manufacturing cigarettes without new graphic health warnings on their packages for sale or distribution in the United States. In addition, manufacturers, importers, distributors and retailers will no longer be allowed to advertise cigarettes without the new graphic health warnings in the United States. By October 22, 2012, manufacturers can no longer distribute cigarettes for sale in the United States that do not display the new graphic health warnings.

"When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes," said FDA commissioner Margaret A. Hamburg. "This is a concrete example of how FDA's new responsibilities for tobacco product regulation can benefit the public's health."

David Howard, spokesperson for .J. Reynolds Tobacco Co., told CSP Daily News, "We are currently reviewing the 140-page notice issued today. It is important to note that the legality of requiring larger and graphic warnings is part of our lawsuit that is currently pending in the 6th Circuit Court of Appeals. A hearing on the matter is expected to occur sometime next year."

Winston-Salem, N.C.-based Reynolds American Inc., parent company of R.J. Reynolds, is part of the suit with Greensboro, N.C.-based Lorillard Inc. and others. According to an Associated Press report, they have argued that the warnings would relegate the companies' brands to the bottom half of the cigarette packaging, making them "difficult, if not impossible, to see."

In addition to the announcements made yesterday, other recent tobacco control and prevention efforts include: The Affordable Care Act is giving Americans in private and public health plans access to recommended preventive care, such as tobacco use cessation, at no additional cost. The American Recovery & Reinvestment Act (ARRA) invested $225 million to support local, state and national efforts to promote comprehensive tobacco control and expand tobacco quitlines. The Prevent All Cigarette Trafficking Act (PACT) aims to stop the illegal sale of tobacco products over the Internet and through mail order, including the illegal sale to youth. The Family Smoking Prevention & Tobacco Control Act (FSPTCA) gives FDA the authority to regulate the manufacture, marketing and distribution of tobacco products. It has restricted the use of the terms "light," "low" and "mild"; banned characterizing fruit, candy and spice, flavors from cigarettes; and put in place restrictions on the sale and distribution of cigarettes and smokeless tobacco products to youth. The Children's Health Insurance Program Reauthorization Act (CHIPRA) raised the federal cigarette tax by 62 cents per pack.

Richmond, Va.-based Philip Morris USA said in a statement that it "supported several of the initiatives cited [by HHS] regarding tobacco issues. The company supported legislation to give the [FDA] regulatory authority over tobacco products, the [PACT] Act and has encouraged states to spend tobacco settlement funds on health-related initiatives and underage tobacco use prevention. Philip Morris USA has actively participated in the FDA's rulemaking and public comment processes and plans to do the same on this proposal."

Click here to read the full report.

And click here to view all of the proposed warning labels.