Niconovum welcomes new NRT rules

The U.S. Food and Drug Administration has recommended changes to the warnings and directions for use of over-the-counter nicotine replacement therapy (NRT) products, allowing more people to use these products effectively for smoking cessation, according to a note included on Reynolds American Inc’s website.

“This is a very beneficial step by the FDA and will provide individuals who desire to stop smoking more realistic ways to do so,” said Tommy Payne, president of Niconovum USA, which is an RAI subsidiary and which markets Zonnic nicotine gum in Iowa.

“Currently, smokers are directed to stop using tobacco products prior to using NRT products such as gum, lozenge or patch, and to use these products for no longer than 12 weeks,” the note said.

“The FDA recommends using an over-the-counter NRT products on the quit day, even if the individual is not immediately able to stop smoking. The proposed changes also allow for use longer than 12 weeks following the advice of a health care provider.

“Makers of NRT products must obtain FDA approval to change existing labels and directions of use.

“In making the recommendations, the FDA concluded:

* “No significant safety risks have been identified associated with the use of NRT products for longer than the labeled 12 weeks of use;

* “There are no significant safety concerns specific to the concomitant use of over-the-counter NRT products with cigarettes or with other nicotine-containing products; and

* “Currently marketed over-the-counter NRT products do not appear to have significant potential for abuse or dependence.”