American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids
oppose orders authorizing this claim because Swedish Match has failed to meet the statutory standard for the following reasons:
1. FDA’s past authorizations of a similar claim for General Snus should not determine whether the pending applications for ZYN nicotine pouches are granted because the
Tobacco Control Act requires product-specific analyses.
2. Significant differences between ZYN and General Snus – in use rates, relevant toxicology, flavors, and marketing – clearly warrant different consideration.
3. The applicant’s reliance on the “Swedish experience” is misleading and of limited relevance.
4. The applicant did not submit sufficient data on consumer perception or behavior change related to the proposed modified risk claim and this specific product.
