AAFP Urges FDA to Expedite Final Rule on Cigarette Warnings

About 3 million Americans could start smoking before new requirements for cigarette warnings take effect, the AAFP said in a recent letter (2-page PDF; About PDFs) to the FDA. That's because the Family Smoking Prevention and Tobacco Control Act President Obama signed into law in 2009 allows manufacturers more than a year to comply with the new regulations.

The act requires, among other things, cigarette packages and advertisements to have larger and more visible graphic health warnings. Specifically, manufacturers will be required to devote half of the front and back panels of cigarette packages to the warnings.

But, although the law was enacted in June 2009, it wasn't until November 2010 that the FDA published a proposed rule (43-page PDF; About PDFs) to implement this provision of the law, the Academy pointed out in its Dec. 22 letter. At that time, the agency also unveiled 36 graphic images (5.28-MB Zip file; About Downloading) it was proposing for use in the warnings and invited the public to provide comments before Jan. 11.

According to the act, however, the cigarette warning provision does not become effective until 15 months after publication of a final rule.

Given the 17-month delay already experienced between enactment of the law and the issuance of a proposed rule for implementation, the Academy urged the FDA "to publish the final rule as expeditiously as possible."

The letter also stated that although the AAFP "recognizes that 'fifteen months' is specified in the statutory language, we must also draw attention to the approximately $12.5 billion spent in 2006 by tobacco companies on advertising and promotion. As the proposed rule states, tobacco companies frequently employ large marketing and advertising experts. The tobacco industry is accustomed to continuously updating cigarette packaging and advertisements."

Therefore, the letter added, "AAFP feels an additional 15 months after publication of a final rule is an excessive amount of time for the tobacco industry to comply with these new requirements."

According to the Substance Abuse and Mental Health Services Administration, an estimated 6,600 Americans become new smokers every day. Thus, about 3 million people could become new smokers during the 15-month compliance period, the letter said.

Despite its criticism of the implementation timeline, the AAFP lauded the FDA for its proposed new graphic warnings, which include a photograph of a dead body in a coffin and another showing a cadaver on a morgue table.

"The use of these graphics and revised statements will help minimize tobacco use through the warnings' increased ability to communicate the many health risks attributable to cigarette smoking," said the Academy.

The AAFP also voiced support for a proposal that new warnings include information about specific tobacco cessation resources, such as the quitline number (800) QUIT-NOW. In addition, the Academy provided details about its Ask and Act tobacco cessation program, which encourages family physicians to ask all patients about tobacco use and then act to help them quit.