Nicotine Gum Labels Revised by FDA to Help Smokers Quit

Users of smoking-cessation products such as GlaxoSmithKline Plc (GSK)’s Nicorette gum will be able to use the products longer and in combination with other therapies under new U.S. Food and Drug Administration labeling rules.

Glaxo and other makers of over-the-counter nicotine- replacement products can seek new labels that would let people continue smoking cigarettes when they start the treatments and use more than one therapy at a time, the FDA said today in a Federal Register notice. The companies can also advise users to talk to doctors if they want to continue use beyond 12 weeks.

Consumer and public health groups had sought the changes, saying the current labels were too restrictive and may have discouraged people from buying smoking-cessation products. Tobacco use is the leading preventable cause of death and disease in the U.S., leading to 443,000 deaths annually, according to the Centers for Disease Control and Prevention.

“FDA hopes the recommended changes will allow more people to use these products effectively for smoking cessation and that tobacco dependence will decline in this country,” FDA Commissioner Margaret Hamburg said in a statement.

The FDA’s notice is a response to petitions filed in 2008 by the New York Commissioner of Health and in 2010 from the University of Maryland School of Law and another from four patient and consumer groups, including the Campaign for Tobacco- Free Kids.

Quit Day

The FDA’s decision is based on accumulated evidence over the 30 years since nicotine-replacement products were first approved “to suggest that the current labeling provisions on concomitant use and duration of use may no longer be necessary to ensure the safe use of” the over-the-counter therapies, according to the notice.

The FDA pointed to a “well-known and highly regarded study” that followed smokers given free nicotine gum for as long as five years. The adverse effects were described as minor and transient, the agency said. Patches currently can be used for eight or 10 weeks, the FDA said.

New labels would advise users to begin using a nicotine- replacement product on their “quit day” rather than to “stop smoking completely” when they begin use.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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