FDA Authorizes 20 ZYN Nicotine Pouches for Modified Risk Marketing Claim
By
Center for Tobacco Products
Summary
The FDA has authorized 20 ZYN nicotine pouch products to be marketed with a specific modified risk claim — that switching completely from cigarettes to ZYN pouches reduces exposure to certain harmful chemicals. This is the first time the FDA has granted such a modified risk authorization for a nicotine pouch product. The authorization is based on scientific evidence showing significantly lower levels of harmful constituents in ZYN compared to cigarettes. However, the FDA emphasizes that ZYN products are not safe or FDA-approved, and the claim cannot suggest they are less harmful than smoking, only that they reduce exposure to specific chemicals. The decision applies to various ZYN flavors and strengths, including Chill, Smooth, Spearmint, and Wintergreen in 3mg and 6mg variants.
Source
bskyFDA Authorizes 20 ZYN Nicotine Pouches for Modified Risk Marketing Claimfda.govKey quotes
· 5 pulledToday's action marks the first time the FDA has authorized a modified risk claim for a nicotine pouch product.
Importantly, this action does not mean that these products are safe or 'FDA approved.' All tobacco products are harmful and potentially addictive.
The claim authorized today does not say that these products are less harmful than cigarettes, but rather that switching completely from cigarettes to these products reduces your exposure to certain harmful chemicals.
The FDA's authorization of a modified risk claim for ZYN nicotine pouches is a significant step in the agency's efforts to provide adult smokers with accurate information about potentially less harmful alternatives.
The agency will continue to monitor the marketplace and take action as necessary to protect public health.
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