Petition Argues for Deregulation of Nicotine Products

FDA warnings and packaging regulations on nicotine aids may encourage smokers to keep smoking, according to a petition issued by 2 cessation groups.

Pharmacies dispensing OTC nicotine replacement therapy (NRT) products may soon face more questions from patients. 2 smoking cessation groups are pressing the FDA to revise labeling and packaging restrictions they believe discourage smokers from using nicotine gums, lozenges, and patches in place of cigarettes.

The petition, developed by the Association for the Treatment of Tobacco Use and Dependence and the Society for Research on Nicotine and Tobacco, argues that strong warnings against the combination and extended use of NRT products are inconsistent with current scientific research. This argument is corroborated by a recent study indicating that nicotine patches may be more effective when used beyond the recommended 10- to 12-week timeframe.

The groups are also opposed to packaging restrictions that prohibit retailers from selling the products in smaller quantities and at lower prices. Smaller pack sizes, they argue, would encourage dubious smokers to try some of the products without being forced to invest a significant amount of money.

Lower price points would also allow smaller retail outlets, such as gas stations and convenience stores, to carry NRT products alongside single-dose packs of OTC painkillers and cold medicines. As an added bonus, smokers who might normally purchase cigarettes in these locations would have the opportunity to choose a nicotine patch or gum instead, which could lead to increased cessation.

In an accompanying report on barriers to the use of NRT products, researchers found that clinicians rarely provide counseling to patients on the use of medications to quit smoking. “Without effective advice and direction from a medical professional,” the petition points out, “a smoker must rely on NRT packaging and labeling to assess effectiveness and safety.”

In the absence of appropriate packaging labels or proper clinical counseling, pharmacists can play an important role in helping smokers make informed decisions about NRT.