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FDA Relaxes Limits on Nicotine Replacement Therapy


The Food and Drug Administration (FDA) announced Monday it will relax restrictions on the use of over-the-counter nicotine replacement products. The changes will apply to patches, gum and lozenges, Reuters reports.

Consumers are currently instructed to stop smoking once they start using one of these products, and to only use them for 12 weeks. The FDA says it will eliminate these restrictions, because they may be causing some smokers to give up trying to quit if they smoke while they are using the treatment.

“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 A. Hamburg, MD, said in a statement.

The agency noted that after reviewing scientific evidence, it has concluded using cigarettes and other nicotine products at the same time “does not raise significant safety concerns.”

The FDA stated people using nicotine replacement products should still use them for the length of time indicated on the label. “However, if they feel they need to continue using the product for longer in order to quit, it is safe to do so in most cases,” the FDA noted.

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