FDA Approves Marketing of Nicotine Pouches: A Safer Way to Quit?

The FDA has approved nicotine pouches, finding them lower risk than cigarettes and potentially helpful for quitting tobacco, while enforcing strict youth advertising restrictions.

The U.S. Food and Drug Administration (FDA) has approved the marketing of 20 ZYN nicotine pouch products after a thorough scientific evaluation through the premarket tobacco product application (PMTA) process. This marks the FDA's first authorization of products known as nicotine pouches, which are small synthetic fiber pouches containing nicotine meant to be placed between a person's gum and lip ().

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Nicotine Pouches as a Safer Alternative to Cigarettes and Smokeless Tobacco

Citing the public health standard mandated by the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA concluded that the authorized nicotine pouches, which contain significantly lower levels of harmful substances than cigarettes and most smokeless tobacco products, present a reduced risk of cancer and other serious health issues. Additionally, there is evidence suggesting that these nicotine pouches may aid current users of cigarettes and other tobacco products in successfully quitting these more harmful alternatives.

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FDA's Evaluation of Public Health Benefits Over Risks

"To grant marketing authorizations, the FDA requires ample evidence that new products provide more benefits to public health than risks," said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA Center for Tobacco Products, in an agency press release. "In this instance, the data demonstrate that these nicotine pouch products meet this standard by offering benefits to adults who switch completely from cigarettes and/or smokeless tobacco products to these alternatives."

FDA's Commitment to Preventing Youth Access to Nicotine Products

The FDA stressed that this authorization does not imply the nicotine products are completely safe, but rather that they meet the criteria of offering more benefits than risks. The agency also stated that it will closely monitor the marketing of these products to prevent youth exposure and will enforce "strict restrictions" on digital, television, and radio advertisements.

Reference:

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review - (https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review)

Source-Medindia

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