Last week, prompted by an article in the Wall Street Journal about the booming sales of nicotine lollipops with names like Nicostop and Likatine, the U.S. Food and Drug Administration announced that it was looking into their legality. What started out as a well-intentioned effort to help smokers quit just may have backfired.
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Nicotine pops look a lot like regular lollipops, but they smell a little weird and leave a sour aftertaste. Most contain either 2 mg or 4 mg of a chemical called nicotine salicylate and sell for about $3 apiece. They're made by independent pharmacists, who have long had the right to mix various active ingredients, usually following a doctor's orders, into preparations that aren't commercially available.
Folks who smoke more than 1 1/2 packs a day are supposed to start with the 4-mg pops and work their way down to 2 mg after a couple of weeks. The idea is not to suck on the things continuously but only when the urge to smoke becomes overpowering. Once the craving has passed, you're instructed to put the lollipop back in its reusable bag. One pop is supposed to replace four or five cigarette breaks.
So, how well do the nico-pops work? "I've had mixed success," says Dr. Rene Harper, an assistant professor at the Medical College of Georgia, who has prescribed the lollipops to patients who had failed to quit smoking with either nicotine gum or patches. Some of his patients found they either were too expensive or didn't pack enough of a punch. Still, Harper says, "there may be some advantage to the lollipop. It may work faster than gum." Experts suspect the pops probably won't cause lung cancer, but heart disease can't be ruled out.
They definitely deliver enough nicotine to produce a buzz. A former smoker reports that after sucking on a lollipop for a few minutes and then putting it aside, he found himself thinking about it all the time. He finally had to throw the rest of it away. Adults who are using the lollipops regularly should take care not to leave them lying around within the reach of children.
The idea of making nicotine lollipops seems to have come to several different pharmacists, who saw the sucking candies as an alternative for smokers who couldn't stand the taste of Nicorette, the FDA-approved nicotine gum. The pops quickly caught on, thanks in part to aggressive Web-based marketing. One supply house reports that orders for nicotine salicylate from pharmacists rose 17-fold last year--enough to make at least 335,000 pops (up from 19,500 pops in 2000).
Probably no one would have noticed if a few pharmacists hadn't had the bright idea of selling the lollipops over the counter, without requiring a prescription. They justified this by noting that Nicorette has been sold without a prescription since 1996; one pharmacist says he actually got the go-ahead from his state pharmacy board. The problem is that Nicorette gum is backed by years of research, whereas the lollipops are not. Also, no one would ever mistake peppery-tasting Nicorette gum for candy.
Enter the Campaign for Tobacco Free Kids, which has long argued that the FDA should regulate all nicotine-delivery vehicles, including cigarettes. When a staff member for the group discovered that he could order nicotine lollipops over the Internet without a prescription or even an inquiry about his age, the group started raising a stink.
Industry watchers expect the FDA to take some kind of action within the next few weeks. At least one pharmacy that had been producing its own pops--compounding them, in the jargon of the trade--and selling them over the counter, isn't waiting for the FDA crackdown. "This was our first venture into otc compounding," says William Johns, owner of Peoples Custom Rx in Memphis, Tenn. "I've decided we will sell them only by prescription until this all gets sorted out."