FDA Authorizes 11 New Nicotine Pouches
On Aug. 21, the U.S. Food and Drug Administration (FDA), authorized the marketing of 11 new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The authorized products, made by Swedish Match USA, Inc., are sold under the “ZYN ULTRA” brand name and include the following:
- ZYN ULTRA Chill 9 mg
- ZYN ULTRA Citrus 9 mg
- ZYN ULTRA Cool Mint 9 mg
- ZYN ULTRA Deep Freeze 9 mg
- ZYN ULTRA Menthol 9 mg
- ZYN ULTRA Peppermint 9 mg
- ZYN ULTRA Smooth 9 mg
- ZYN ULTRA Smooth 11 mg
- ZYN ULTRA Spearmint 9 mg
- ZYN ULTRA Wintergreen Chill 9 mg
- ZYN ULTRA Wintergreen 9 mg
As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products. To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
The review of these products was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process for nicotine pouches through the PMTA pathway. The pilot streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters, and more efficient scientific reviews. The FDA has begun implementing efficiencies learned from the pilot to the review of other PMTAs. To date, the FDA has authorized 43 nicotine pouch products overall, 23 as part of the pilot program.
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