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FDA Eases Restrictions on Tobacco-Replacement Products

Action comes in response to complaints from health care stakeholders (Apr. 1)

The FDA has announced that it is revising its restrictions on the use of agency-approved over-the-counter (OTC) nicotine-replacement therapy (NRT) products, which include gum, transdermal patches, and lozenges. These products are designed to help people stop smoking by supplying controlled amounts of nicotine to ease the withdrawal symptoms associated with a quit attempt.

Currently, the FDA-approved labeling for OTC NRT products instructs consumers to stop smoking when they begin using the product and not to use the product in combination with cigarettes or other nicotine-containing products (including other NRT products). The labeling also recommends a specific duration of use of up to 12 weeks, depending on the product, and instructs consumers to stop using the NRT product at the end of that period. In addition, consumers are advised to consult a physician if they feel they need to continue using the NRT product for longer than the recommended course of treatment.

According to the FDA, however, stakeholders in the public health and health care provider communities have suggested that these labeling statements may prevent the effective use of OTC NRT products for smoking cessation. Stakeholders have argued that the statement advising against concomitant use of the NRT products with cigarettes may cause some smokers to abandon quit attempts if they experience a lapse (e.g., if they have a cigarette while using an NRT product). Further, stakeholders have argued that the use of more than one NRT product (e.g., patch plus gum) is more effective for some smokers than the use of a single NRT product in achieving cessation, and that current labeling discourages such use.

With regard to the duration of use, stakeholders have also argued that the use of OTC NRT products beyond the labeled treatment period may increase the chances of quitting for certain smokers. These stakeholders have asserted that no safety concerns are associated with concomitant use of OTC NRT products with other nicotine-containing products, or with the use of OTC NRT products for longer than the labeled duration of use.

In response to these arguments, and based on extensive evidence, the FDA has announced that statements in the current labeling of OTC NRT products related to the concomitant use of those products with other nicotine-containing products can be modified. Specifically, the agency says that the statement instructing consumers not to use an 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. In addition, the instruction to “stop smoking completely when you begin using the [NRT product]” should be changed to “begin using the [NRT product] on your quit day.”

The agency is also modifying the statement in the labeling of OTC NRT products that directs consumers to stop using the NRT product at the end of the recommended treatment period. Currently, the labeling states that “it is important to complete treatment. Stop using the [NRT product] at the end of [x] weeks. If you still feel the need to use [the NRT product], talk to your doctor.” This will be changed to read: “it is important to complete treatment. If you feel you need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Source: HHS/FDA; April 1, 2013.

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