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Tobacco Control Partners' Comments on FDA's Draft Guidance on Flavored E-cigarette PMTAs

May 12, 2026

In March 2026, FDA released the “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk; Draft Guidance for Industry." Draft Guidance provides FDA's current thinking about the topic of the guidance. The undersigned public health, medical, civil righs and community organizations conclude that the Draft Guidance fails to recognize the well-established history of signficant variations in youth flavor preferences over time, often caused by regulatory decisions, and this fundamental flaw threatens to open the regulatory door to a wide array of FDA-authorized products that would appeal and be accessible to youth, without signficant countervailing health benefits to adults who smoke.

PDF icon coalition_comments_on_flavored_e-cig_draft_guidance_5.11.26.pdf

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Federal Tobacco Control Partners' Letter on Office of Smoking and Health's Infrastructure and Funding

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Tobacco Control Partners Comment Letter to FDA on Zyn's Modified Risk Tobacco Product Applications

March 9, 2026

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.

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