Citing Public Health Needs, FDA Alters Labeling Standards for Smoking Cessation Products

| 01 April 2013 |  By 

The US Food and Drug Administration (FDA) has, in response to three citizen petitions submitted to the agency, agreed to modify the labeling of nicotine replacement therapies (NRT) to indicate that consumers are allowed to use other NRTs and infrequently smoke when attempting to quit smoking using an NRT.


Nicotine replacement products have been on the US market for nearly three decades, and are commonly used to wean users of tobacco products off the substances by substituting and then gradually reducing the dose of nicotine that the consumer receives.

The nicotine replacement products have been available as over-the-counter (OTC) since the mid-1990s, allowing them to be used without a doctor's supervision so long as the product adheres to an FDA-approved monograph for its labeling and use.

But the products' existing warning labels have garnered criticism by several prominent health groups, including the New York Department of Health, the Association for the Treatment of Tobacco Use and Dependence, the American Cancer Society Cancer Action Network, and the American Lung Association.

At issue to the groups are the products'-which take the form of gum, patches and lozenges-warnings not to use NRTs while smoking or with other NRTs. Concomitant use could result in a patient being exposed to even more nicotine, making it harder to quit or subjecting the user to heightened health risks.

The groups said this warning, while well-intentioned, had negative effects on consumer health. Some smokers read the warnings as an ultimatum, with just a single cigarette being seen as cause for the termination of their smoking cessation plan.

FDA issues similar warnings for many drug products, advising consumers-sometimes in the strongest possible terms-that they should not take two drugs simultaneously or take more than the recommended dose.

The difference here, the groups said, is that smoking kills approximately 443,000 people each year-a massive toll that far outweighs the increased risks associated with the co-use of NRTs. Further, the groups contend that many associate nicotine with the full risks of tobacco products-not so, though it is indeed a carcinogenic substance.

A New Framework for Warnings

In a Notice of Findings and Citizen Petition response, both posted on 1 April 2013, FDA said it largely agreed with the groups' assessment, and was thus making changes that will allow the labeling on NRT products to be modified. Specifically, FDA said it "intends to allow the modification of these statements based on sponsor submissions as set forth in a Notice of Findings."

"In light of currently available evidence, these statements are no longer believed to be necessary in their current form to ensure the safe and effective use of over-the-counter nicotine replacement therapy products for their approved intended use as aids to smoking cessation," the agency said in its Notice of Findings, posted on 1 April 2013 in the Federal Register.

The labeling change will also permit users of NRTs to use multiple NRT products concomitantly, a change based on FDA's finding there is emerging evidence of increased efficacy at promoting smoking cessation. The statement was originally written otherwise due to a lack of evidence at the time of the product's approval and subsequent switch to OTC status, FDA explained.

"Upon reviewing the published reports of these and other studies, we have determined that the concomitant use of OTC NRT products with cigarettes or with other nicotine-containing products does not raise significant safety concerns," FDA concluded. Regulators added that they were aware of "few reports of adverse events arising from the use of NRTS products while smoking or using another NRT product."

Sponsors wishing to take advantage of the new labeling rules will be "encouraged" to submit a labeling supplement to FDA to modify the statements, which in turn will be reviewed by FDA's Center for Drug Evaluation and Research (CDER).

The previous statement, "Stop smoking completely when you begin using the [NRT product]," will be permitted to be substituted with the wording, "Begin using the [NRT product] on your quit day."  Another line instructing people not to use the NRT product if they "continue to smoke, chew tobacco, use snuff or use [a different NRT product] or other nicotine containing products" should be deleted, FDA said.  


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