FDA Exercises New Authority to Regulate Tobacco Products, But Some Limits Remain

With great fanfare, the US Food and Drug Administration (FDA) on September 22 announced a ban on certain flavored cigarettes that, the agency says, are aimed at enticing children to smoke.

“Almost 90% of adult smokers start smoking as teenagers, and these flavored cigarettes are a gateway for many children and young adults to become regular smokers,” said FDA Commissioner Margaret Hamburg, MD, at a press conference announcing the ban.

Many in the antismoking community hailed the ban, which was the first mandated public action taken by the FDA under the powers granted it through enactment of the Family Smoking and Tobacco Control Act on June 22 (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ031.111.pdf).

“Banning the marketing and use of strawberry, chocolate, and other flavored cigarettes will help slow the rate of addiction among young smokers, prevent disease, and save millions in health care costs down the line,” said Sen Tom Harkin (D, Iowa) in a statement.

“The ban on candy- and fruit-flavored cigarettes is a critical step to end one of the most insidious tactics the tobacco industry has used to target and addict children,” said Matthew L. Myers, JD, president, Campaign for Tobacco-Free Kids, in a statement.

Yet one flavor was specifically excluded from the ban—menthol, the most prevalent flavoring in cigarettes. That protection has enraged some in the public health arena, who say menthol not only is the chief flavoring used to attract young smokers, but also has a particularly damaging effect in the black community.

Those skeptical of the ban note that the banned flavors make up only about 0.2% of the US cigarette market. By comparison, menthol-flavored products account for about 30% of that market. Surveys have found that nearly 75% of black smokers use menthol cigarettes. Among teen smokers, 81% of blacks smoke menthol cigarettes, compared with 32% of whites and 45% of Hispanics.

William S. Robinson, MA, executive director of the National African American Tobacco Prevention Network, said that over the years, his organization had worked hard to get FDA tobacco oversight, but it backed away from endorsing the law when it discovered menthol would be specifically excluded from the flavoring ban. “Although we want federal regulation of tobacco products, you cannot compromise to get the bill's passage, as other mainstream antitobacco advocacy groups argued,” Robinson said. “So we withdrew our support.”

Robinson made his ire known last year as Congress considered similar FDA tobacco oversight legislation. In June 2008, he joined a former surgeon general and 7 former secretaries of Health, Education, and Welfare in sending a letter of protest to senators and representatives. The letter stated, in part, “By failing to ban menthol, the bill caves to the financial interests of tobacco companies and discriminates against African Americans—the segment of our population at greatest risk for the killing and crippling smoking-related diseases. It sends a message that African American youngsters are valued less than white youngsters.”

As a compromise, the law does require the creation of a Tobacco Product Scientific Advisory Committee, which is required to produce within 12 months of its establishment (which has already occurred) a report and recommendation to the secretary of the Department of Health and Human Services on the “impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.” Also, the law states that the initial ban on flavored cigarettes does not limit the government from taking future action on menthol.

Proponents of the new law acknowledge that the continuing presence of menthol-flavored cigarettes is not ideal, but add that political realities and the unknowns surrounding the economic and legal consequences of removing a product that is used by a significant percentage of the smoking public required deferring action on the issue. They hope the advisory committee report will serve as an impetus for the administration to reduce menthol's presence.

“With millions of menthol smokers, it will be important for the FDA to determine the best way to protect smokers who use menthol products,” said Myers in an interview. “If the FDA concludes menthol should be banned, it will be banned. But no one wants to do so in a manner that creates a black market for the product, and no one wants menthol smokers to switch to other forms of tobacco use.”

Myers also reminded those who worry about the menthol exemption from the mandated flavoring ban that the regulatory landscape over tobacco has gotten better. “Until the enactment of the legislation, there was not a government agency that had the authority to reduce the industry's ability to provide menthol to smokers,” Myers said. “Today there is an agency with the authority to do that.”

Banning certain flavorings in cigarettes and the creation of a scientific advisory committee are not the only charges given the FDA by the new law. The law also authorizes the agency to greatly curtail the tobacco industry's ability to indirectly advertise to youths. To achieve this, by April 2010, the FDA will ban sponsorships of sporting and entertainment events using tobacco product brand names and logos, prohibit the sale or giveaway of clothing or other items bearing the brand name or logo of a tobacco product, and restrict distribution of free samples to adults-only facilities.

Also, by July 2010, the FDA will prohibit tobacco manufacturers from using the terms “light,” “low,” and “mild” on tobacco products. And by July 2011, packaging will need to comply with rules for new warning labels that constitute the top halves of the front and rear panels of cigarette and smokeless tobacco products. Regulations requiring graphics on labels depicting the health risks of smoking will also be issued at that time.

In addition, the agency will require tobacco manufacturers and importers to submit information by January 2010 about the ingredients and additives in tobacco products, a description of the nicotine content and delivery, and the health consequences of tobacco products.

Cheryl Healton, DPH, president and chief executive officer of the American Legacy Foundation, said the law will quickly change the smoking landscape. “The fact that the law bans the terms ‘light’ and ‘low’ and ‘mild’ is a big plus, because what we know historically is that literally millions of American smokers, instead of quitting, switched to these kinds of products,” Healton said. “The restrictions on advertising are also a great step forward.”

Added Myers, “The law creates an opportunity for the FDA to transform tobacco marketing, tobacco products, and how Americans perceive tobacco products. If it uses the authority given to it, the FDA will cut back tobacco marketing that has the greatest impact on kids.”

But the law also limits FDA authority. The agency cannot ban all tobacco products, order the complete removal of nicotine from tobacco products, raise the minimum age to purchase tobacco products to older than 18 years, or confine the sale of tobacco products to certain retail outlets.

Michael Siegel, MD, MPH, professor of community health sciences at Boston University's School of Public Health, said the law puts the FDA in the awkward position of approving certain tobacco products—products known to be deadly. “The law says the FDA is in charge of regulating this product but prefaces the regulations by saying you cannot ban the product or you cannot regulate what kinds of stores it is sold in,” Siegel said. “With so many restrictions, the FDA's hands are tied—and they are tied in each of the ways in which it could really make a difference.”

Stanton A. Glantz, PhD, professor of medicine at the University of California, San Francisco, is concerned about the makeup of the 12-member scientific advisory committee, which will include 3 nonvoting members representing tobacco interests. “The product regulation aspects that the committee will be considering are very complicated,” Glantz said. “And as for these industry people on the committee, I think they will make a lot of mischief.”

Joel L. Nitzkin, MD, MPH, chair of the American Association of Public Health Physicians' Tobacco Control Task Force, called the law “severely compromised” and speculated that certain elements of the regulations will ultimately be found to be unconstitutional. Indeed, several tobacco manufacturers and a tobacco retailer filed a lawsuit on August 31 in a Bowling Green, Ky, federal court arguing that the law infringes on their First Amendment rights to communicate with adult tobacco consumers about their products.

Nitzkin also argued that the law legitimizes the continuing presence of cigarettes, the most harmful tobacco delivery system, while restricting tobacco users' abilities to learn of safer alternative delivery products, such as smokeless tobacco. “If you could have honest communications with current smokers about alternatives, you would honestly reduce death rates,” said Nitzkin, who is also a private health policy consultant in New Orleans. “But not allowing other tobacco products to honestly state their risk profile is a major policy error.”

Siegel suggested that the public health community, by compromising too much on the details of the legislation, missed an opportunity to make a real difference in eliminating tobacco use in the United States. He noted that the legislation was, for the first time, considered before a Congress mostly sympathetic to the antismoking cause, and that it will be carried out by an executive branch that is also sympathetic. “All the stars were aligned to get a good piece of legislation passed,” Siegel said. “In the future, it will be harder.”