FDA Authorizes First Nicotine Pouch Products, ZYN, for Marketing
Jan 16, 2025, 04:41 PM
The U.S. Food and Drug Administration (FDA) has authorized the marketing of 20 ZYN nicotine pouch products, marking the first time such products have received approval through the premarket tobacco product application (PMTA) pathway. This decision follows an extensive scientific review, which concluded that the products meet the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act, considering the risks and benefits to the population as a whole. The FDA's evaluation showed that these nicotine pouches could benefit adults who smoke cigarettes or use other smokeless tobacco products by providing a safer alternative, with the potential to reduce exposure to harmful constituents. The authorization includes various flavors such as Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen, available in two nicotine strengths: 3 milligrams and 6 milligrams. Despite the approval, the FDA emphasized that these products are not safe and should not be used by youth or non-tobacco users. The agency will closely monitor marketing practices to prevent youth access and appeal, with stringent restrictions on advertising to ensure it targets only adults aged 21 and older. The FDA also noted that while youth use of nicotine pouches remains low, they are committed to taking action if there's a notable increase in youth initiation. The company has stated intentions to implement additional measures to restrict youth access, reduce youth appeal, and limit youth exposure to their labeling and advertising.
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California • 25%
New York • 25%
Florida • 25%
Texas • 25%
6 mg • 25%
Both equally popular • 25%
Other strengths • 25%
3 mg • 25%
No change • 25%
Significant reduction • 25%
Moderate reduction • 25%
Increase • 25%
No • 50%
Yes • 50%
3 mg • 25%
Other strengths (if introduced) • 25%
Equal sales • 25%
6 mg • 25%
Cool Mint • 10%
Menthol • 10%
Wintergreen • 10%
Spearmint • 10%
Smooth • 10%
Peppermint • 10%
Chill • 10%
Cinnamon • 10%
Citrus • 10%
Coffee • 10%