FDA Authorizes Modified Risk Marketing Claim for ZYN Nicotine Pouch Products
The U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders allowing 20 ZYN nicotine pouch products to be marketed with a specific reduced-risk claim. The authorization permits Swedish Match USA to state that adult smokers who completely switch from cigarettes to ZYN have a lower risk of developing mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis than those who continue smoking cigarettes.
The decision represents a significant regulatory milestone for the nicotine pouch category and reflects the FDA’s determination that the available scientific evidence supports communicating reduced-risk information to adult smokers who completely switch from combustible cigarettes.
For convenience stores, the authorization provides greater regulatory clarity for one of the fastest-growing segments of the other tobacco products (OTP) category. The order also reinforces the FDA’s recognition that scientifically substantiated modified-risk claims can play a role in informing adult consumers about lower-risk alternatives to combustible cigarettes. Retailers should note that only the FDA-authorized ZYN products covered by the MRTP order may use the approved modified-risk claim.
The FDA’s modified risk authorization applies to the following 20 ZYN nicotine pouch products (3 mg and 6 mg strengths):
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
Read the full FDA announcement: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-20-zyn-nicotine-pouches-be-marketed-specific-modified-risk-claim
