FDA Approves Nicotine Lozenges

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FDA Approves Nicotine Lozenges

WASHINGTON -- Convenience store retailers looking to boost sales in nontraditional categories will get a boost after regulators approved the sale of nicotine lozenges.

The Food and Drug Administration (FDA) gave GlaxoSmithKline's Commit lozenge the go-ahead for over-the-counter sales. It marks the first nicotine-containing lozenge to win the agency's approval.

The FDA last spring forced off the market nicotine lollipops that a number of pharmacists were manufacturing as an alternative to nicotine patches or gum for smoking cessation. The FDA has maintained that smoking cessation products are drugs that require its approval to sell.

Another company, Star Scientific, sells a lozenge made of compressed tobacco that delivers a dose of nicotine equal to a cigarette. Because that product is sold not for smoking cessation but as an alternative to cigarettes when smokers can't puff ? such as during an airplane flight ? it argues the FDA can't regulate the product. At the request of attorneys general of 42 states, the FDA is reviewing that issue.

Glaxo's Commit lozenges come in varying amounts of nicotine. How long a smoker goes between cigarettes determines the recommended strength. Suck a lozenge when a craving hits, gradually lowering the number and strength ingested over a 12-week weaning period, the company says.

But more importantly for convenience store retailers, many of whom have been looking for ways to decrease their dependence on cigarette sales, the lozenges can provide some short-term sales relief from customers who are trying to quit smoking. The lozenges, available without a prescription, will be available next month, in 72-lozenge packs for $39.95.

The lozenges also could serve a product that drives sales. For example, customers that are trying to quit smoking now typically use a nicotine patch, which are primarily available in drugstores. Many drug outlets, primarily in urban areas, have remerchandised stores to cater to customer convenience. So when a patch customer goes to a drugstore, they are able to also do fill-in shopping for c-store staples like milk and bread.

The sale of the lozenge, if it catches on with consumers, could help sway some of those customers back to the convenience store channel.