FDA Announces Plan to Tackle Tobacco Use … Someday

Anyone hoping to see the federal government implement an aggressive campaign to reduce disease and deaths caused by cigarettes and other tobacco products might have to continue holding their breath a bit longer.

The agency suggested that more study was needed. But some critics think enough is known to act now.

Visual: Stas Svechnikov/Unsplash

While broadly welcomed by public health advocates as an important step to further curb tobacco use, many of the commitments in a new plan to tackle the problem, announced last Friday by Food and Drug Administration Commissioner Scott Gottlieb, actually involve gathering more input for future policies, rather than taking action now.

“We expect to take meaningful steps in 2017 to advance important regulatory components that address the key aspects of this new policy,” FDA spokesman Michael Felberbaum said in an email message to Undark. “We do not have any additional details to share at this time.”

That strikes some public health advocates as a bit of foot-dragging. “A lot of these issues they’re raising that they say they have to consider have been considered, have been researched, have been studied,” says Eric Lindblom, director for tobacco control and food and drug law at the O’Neill Institute for National and Global Health Law at Georgetown University. Lindblom has a long resume for developing tobacco control policies to improve public health, including a 2011-2014 stint at the FDA’s Center for Tobacco Products.

“FDA saying that ‘We’re going to look into nicotine reduction,’ without also saying, ‘We’re going to issue a proposed rule before the end of this year, or before June of next year,’ just opens the door to continued discussion and talking and all the rest, without actually ever getting anything done,” Lindblom said.

As it stands, tobacco use is America’s leading cause of preventable disease and death, according to the FDA, and cigarette smoking alone kills some 480,000 Americans annually, a Surgeon General’s Report stated in 2014. In response, Gottlieb has committed the agency to gather input on, among other things, the potential benefits of lowering the nicotine levels in cigarettes, and the role of new flavored tobacco products in both attracting young people to use them, and in possibly helping current smokers switch to “less harmful forms of nicotine delivery” — a likely reference to vaporizers and e-cigarettes.

Federal regulations currently forbid the sale of tobacco products, including e-cigarettes, to youths under 18 years old. They also limit cigarette vending machines to adult-only establishments, prohibit tobacco companies from sponsoring events or distributing free samples of nearly all types of tobacco products, and require prominent health warning statements on tobacco products and their advertisements.

A 2009 federal law has also funded public education campaigns that the FDA says have kept hundreds of thousands of kids from starting to smoke. Most people who smoke start before they turn 18.

The new plan’s primary theme throughout is to reduce nicotine to “non-addictive” levels in cigarettes. With less nicotine, the thinking goes, youths would be less likely to get addicted. And anyone who wanted to quit smoking could transition to vaping or e-cigarettes to get a nicotine fix. These products are not exactly healthy, but they are less harmful than cigarettes.

The idea to reduce nicotine in tobacco products is a good one, and it has been discussed in government and other policy circles for several years, Lindblom says. But stricter tobacco regulations to save a lot more lives — based on strong existing science and industry input — could be easily drafted, made available for public comment, and implemented in short order if federal leaders decided to make it so.

To be sure, signing off on final FDA regulations would eventually require buy-in from President Trump, Secretary of Health and Human Services Thomas Price, and others at the Department of Justice, the Office of Management and Budget, and the White House domestic policy team, which would take time. But Lindblom also wonders if the plan’s focus on nicotine reduction is a “smokescreen,” as he put it, for extended deadlines — also included in the new plan — for tobacco companies to comply with FDA public health regulations on e-cigarettes and other products that have entered the market in recent years. For now, these products are avoiding regulations that already apply to cigarettes and chewing tobacco.

A more responsible approach for public health, he says, would have been to keep previous deadlines in place for big companies such as Philip Morris and R.J. Reynolds, which employ many lawyers and have other resources to help them meet new standards. For smaller companies, deadlines could be applied on a case-by-case basis.

The decision to extend the deadlines was not made lightly, Felberbaum, the FDA spokesman, said. They will “provide time for the agency to provide guidance to manufacturers of these newly-regulated products to help inform their product applications with the goal of having a clearly defined, efficient, and predictable regulatory pathway for tobacco products,” he wrote.

The agency’s new plan drew general praise from the Campaign for Tobacco-Free Kids. But in a prepared statement, Matthew Myers, the campaign’s president, questioned the extended deadlines on newer tobacco products.

“The long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush, and banana smash, to stay on the market with little public health oversight,” the statement continued. “There is no reason to allow these products to stay on the market while developing and implementing the comprehensive strategy.”

Stock prices for tobacco companies Altria Group (maker of Marlboro and Parliament brand cigarettes under subsidiary Philip Morris), British American Tobacco (maker of Dunhill, Lucky Strike, Pall Mall, Kool and other brand cigarettes), and Vector Group (maker of Eve brand cigarettes through a subsidiary), dropped at the end of last week and have not rebounded to levels earlier in that week. Major tobacco companies reportedly have been preparing for years for regulations on newer tobacco and nicotine delivery products.

“These principles have long been the core of our efforts in transforming the tobacco industry,” British American’s Reynolds American division said in a statement responding to the FDA plan that was published July 29 in the Denver Post.

Other bureaucratic issues might have thwarted regulatory progress in the past. The staff and leadership at the FDA Center for Tobacco Products has been ready for years to develop more effective rules to reduce smoking-related deaths and to try to get them implemented, Lindblom says, but the agency has been blocked by other parts of the federal government.

One quick way to save lives sooner would be for President Trump to set deadlines before the end of his four-year term, directing the FDA and other relevant agencies to finalize and implement policies to significantly reduce smoking deaths and disease.

“If he says that, it’ll happen,” Lindblom says. “If he doesn’t say that, we’re probably going to see the same delay that we saw throughout the Obama administration, where nothing actually gets done.”