Evolving regulation of nicotine

If you’re using nicotine gums, lozenges, or patches to quit smoking, the FDA has good news for you. It’s also good news for the producers of these products, such as pharmaceutical company GlaxoSmithKline. The agency announced yesterday that it’s revising its labeling requirements for nicotine replacement therapy (NRT) as an aid to smoking cessation:

The Food and Drug Administration says smokers who are trying to quit can safely use over-the counter nicotine gum, patches and lozenges for longer than previously recommended in a move to help millions of Americans kick the habit.

Current labels suggest consumers stop smoking or using other products containing nicotine when they begin using the products to help them quit and that they should stop using nicotine replacement products after 12 weeks at most.

The federal agency said Monday that the makers of gum and other nicotine replacement products can change the labels that say not to smoke when using the products. The FDA also said the companies can let consumers know that they can use the products for longer periods as part of a plan to quit smoking, as long as they are talking to their doctor.

This is a sensible move. Nicotine, taken in small doses and divorced from the carcinogens produced by combusting tobacco leaves, is not particularly worrisome. And any small harms that could accrue from using these products certainly pale in comparison to the alternative of continuing to smoke. So this looks like a good decision from the FDA.

What’s interesting, though, is the timing. The FDA has indicated that this month it will announce new proposed rules expanding the reach of its tobacco authority, deeming additional items to be tobacco products covered by the Tobacco Control Act. Among these may be e-cigarettes, an increasingly popular alternative to smoking that delivers nicotine via vapor.

E-cigarettes haven’t been studied nearly as extensively as traditional NRT products, but evidence that consumers use them to reduce or quit consumption of cigarettes continues to grow. A new study to that effect came out last week, in fact. And though there have been some concerns about e-cigarettes, no reasonable person believes they even approach the dangers of the real thing.

The question is whether the FDA’s Center for Tobacco Products will allow e-cigarettes to continue as a viable approach to harm reduction or whether it will subject them to the full slate of regulations applicable to cigarettes. As I documented in my Atlantic article, the thicket of rules enforced by the CTP can be absolutely paralyzing, with the agency failing to rule on a single new product application in its three years of operation.

It’s at this point that one must mention the new director of the Center for Tobacco Products, Mitch Zeller. Zeller took over on March 4, stepping down from his pharmaceutical consulting position at Pinney Associates. His big client at Pinney? GlaxoSmithKline.

Neither Zeller nor the CTP are responsible for yesterday’s announcement about NRT labeling, which came from the FDA’s Center for Drug Evaluation and Research. However the relationship will be one to consider when and if the agency issues new rules regarding e-cigarettes. Hopefully the agency will take same the sensible approach to these potential competitors to traditional NRT as it has to GlaxoSmithKline’s own products.

Additional note: Buried at the end of Michael Felberbaum’s article linked above was this tidbit:

Meanwhile, the FDA said it is missing a Monday deadline to submit three tobacco-related reports to Congress, which the agency said are nearing completion. It also is missing another deadline to publish a consumer-friendly list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives.

There are no penalties for forgoing the deadlines outlined in the 2009 law that gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing.

Keep up the good work, FDA!