FDA Asks Whether ZYN Nicotine Pouches Deserve Lower-Risk Labels
Published Date: 6/18/2025
Notice
Summary
The FDA is inviting the public to comment on Swedish Match U.S.A.'s applications to label their ZYN nicotine pouches as lower-risk tobacco products. This affects anyone interested in tobacco product safety and marketing, with comments open starting June 18, 2025. The decision could change how ZYN products are sold and perceived, possibly impacting the market and consumer choices.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Specific ZYN flavors/strengths under review
FDA has filed MRTP applications from Swedish Match U.S.A. for specific ZYN oral pouch products, including multiple flavors (Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth/Original, Chill/Classic, Menthol/Fresh) at 3 mg and 6 mg nicotine strengths. The company is seeking a modified risk order under section 911(g)(1) of the FD&C Act, and FDA notes the eventual decision could change how these ZYN products are sold and perceived, possibly impacting the market and consumer choices.
Public comment opens for ZYN MRTPAs
You can submit electronic or written comments on Swedish Match U.S.A.'s modified risk tobacco product applications for ZYN starting June 18, 2025. FDA will post redacted application documents on its website and on regulations.gov, and will set a closing date that is at least 180 days after this notice and at least 30 days after the final documents are posted; the closing date will be announced at least 30 days in advance.
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