New smoking legislation expands FDA control over promotion of, ingredients in tobacco products

Legislation enacted by President Obama represents a significant expansion of the FDA’s power to regulate tobacco advertising and to influence the manufacturing of tobacco products.

After passing by a Senate vote of 79-17, the Family Smoking Prevention and Tobacco Control Act was signed into law on June 22, 2009. The passage of the bill was the culmination of at least a decade’s worth of effort and collaboration among a number of lawmakers, professional medical societies like the American Heart Association, the American College of Cardiology, the American Cancer Society, the American Lung Association and a coalition of many other public health advocates and organizations.

But what does it really mean for the health care community?

Some feel that although the ultimate goal of the legislation is important, the FDA could potentially have difficulties effectively implementing some of its stated goals due to potential overextension from its other obligations.

“The FDA has larger problems on its hands regulating drugs and devices, and to add this to their already loaded portfolio might be unwise,” Carl J. Pepine, MD, chief medical editor of Cardiology Today, said in an interview. “It is good for the FDA to have authority over marketing and advertising, but it cannot control the age of tobacco sales, cannot restrict where it is sold, cannot make it available by prescription only and cannot act directly to modify the nicotine component. It is hard to know how this will all fall out.”

Despite the logistics of the legislation’s impending implementation, Pepine and Timothy J. Gardner, MD, immediate past president of the AHA and medical director of Christiana Care’s Center for Heart and Vascular Health in Wilmington, Del., agree that the treatment of patients who were physically addicted to the nicotine should be a priority of any future anti-tobacco efforts.

Timothy J. Gardner, MD, wants to see smoking addiction tackled in future anti-tobacco efforts. Source: Louise Thomas, Center for Heart & Vascular Health

“One of the things I would like to see in follow-up is that we become more capable of dealing with the addiction aspects of smoking that clearly are responsible for many people who continue to smoke despite their desire to stop and despite their understanding that smoking is harmful to them,” said Gardner. “That is an aspect of the anti-tobacco effort that we really need to concentrate on.”

According to a document from the American Lung Association, the legislation will add a new chapter to the Federal Food, Drug and Cosmetic Act for the regulation of tobacco products, and it alters the current standard. Tobacco products will no longer be regulated under the “safe and effective” standard but will instead be regulated under the “appropriate for protection of public health” standard. Warning labels must also now encompass the top 50% of the front and rear panels of the packaging. The legislation does not grant the FDA the power to ban nicotine entirely (a power retained by Congress), although the agency does now have the authority to require the reduction of nicotine in current and future tobacco products and also to make recommendations for nicotine levels in tobacco products.

“The FDA looks forward to taking on this challenge and in doing so will partner with public health leaders at our sister agencies, at the state level and in localities all around the country,” FDA commissioner Margaret A. Hamburg, MD, said in a statement on the agency’s website. “The FDA will perform its duties by using the best available science to guide the development and implementation of effective public health strategies to reduce the burden of illness and death caused by tobacco products.”

The agency may also further regulate the content of tobacco advertising and promotion. Regulations slated for implementation no more than 15 months from the legislation’s enactment include a ban on any remaining tobacco sponsorships of sports and entertainment events, a ban on outdoor advertising near schools or playgrounds (upon an FDA review) and the authority to limit advertising in publications with significant teen readership. Tobacco companies also may no longer conduct free giveaways of nontobacco items in exchange for coupons or proofs of purchase, and retailers who do not verify age for all over-the-counter sales of tobacco products will be subject to federal enforcement and penalties.

“This is an important incremental step, and the empowerment of the FDA is a sign that the government is worried about the health effects of tobacco products, which is appropriate,” Gardner told Cardiology Today. “That is what the FDA was established for.”

Gardner cautioned that the legislation would not eliminate smoking among youth or adults, but he hopes that the agency’s increased authority will help curb the cultural appeal of smoking.

“All of us are hopeful that the culture suggesting that smoking is cool and socially acceptable will be further reduced by the FDA’s ability to limit inappropriate claims and to really emphasize the fact that tobacco products are dangerous and harmful to one’s health,” Gardner said.

James T. Dove

According to James T. Dove, MD, past president of the ACC, provisions in the legislation will expand the powers the FDA has to regulate the content of tobacco products itself, representing a significant increase in the agency’s authority from its previous role.

“Perhaps the most powerful piece of the legislation is the ability to regulate the product itself,” Dove told Cardiology Today. “Certainly, we have had all kinds of efforts regulating the advertising and keeping it away from children, and all those things have been in place in the past. Elimination or reduction of harmful ingredients is a huge hammer to put on the tobacco industry.”

The CDC has estimated, based on statistics gathered between 2000 and 2004, that about 443,000 U.S. deaths each year are directly attributable to smoking, including 126,000 attributable to smoking-related ischemic heart disease. Although smoking prevalence in the general population has declined since 1998 through 2007, only Utah met projections for the Department of Health and Human Service’s Healthy People 2010 initiative.

Dove, a member of Cardiology Today’s Editorial Board, said that previous educational efforts originally designed to be implemented by individual states have not had the desired overall effect on nationwide and statewide smoking reduction and that the new legislation aims to change that.

“The states had a lot of tobacco settlement money allocated for that educational purpose in the past, and for the most part they did not educate the public adequately on the dangers of tobacco,” he said. – by Eric Raible