FDA Tobacco

FDA also requests comments on three proposed additions to the HPHC list: pulegone, furfuryl alcohol, and methyl eugenol. Public comments must be submitted to the docket #FDA-2026-N-2642 on regulations.gov by 11:59 P.M. ET on 05/26.

For the public, the HPHC list highlights certain toxic chemicals in tobacco products for which there is extensive evidence of harm, or potential harm, to human health. For industry, the list lets them know areas of focus for FDA’s review of applications for new tobacco products.

Today, FDA added 18 constituents to the list of Harmful and Potentially Harmful Constituents (HPHCs) in tobacco products to deliver transparency to the public and clarity for industry. Learn more: fda.gov/tobacco-produc…

Reminder: Submit your comments to the draft guidance, “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk” (Docket # FDA-2026-D-1817) by 11:59 p.m. EDT on 5/11 on regulations.gov. fda.gov/regulatory-inf…

⚠️These products are not “safe” or “FDA-approved.” There is no safe tobacco product, and those who do not use tobacco products should not start.

FDA issued a renewal of modified risk granted orders to Philip Morris Products S.A.’s (PMP S.A.) for two IQOS system holders and chargers and three flavors of HeatSticks products. See the products receiving modified risk granted orders: fda.gov/tobacco-produc…

@NIH These Wave 8 files contain data collected between Jan 2024 and Dec 2024, including questionnaire data, location characteristics data, and state identifier data.

New Wave 8 Restricted-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from @FDATobacco and @NIH’s National Institute on Drug Abuse. fda.gov/tobacco-produc…

On 3/11, FDA issued a draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.” Public comments should be submitted by 11:59 p.m. EDT on 5/11. fda.gov/regulatory-inf…

Reminder: On 2/10 9 a.m. – 5 p.m. ET, FDA will host a roundtable discussion with small tobacco product manufacturers to solicit input on PMTA submissions for electronic nicotine delivery systems products. Learn more: fda.gov/tobacco-produc…

Reminder: On 2/10 9 a.m. – 5 p.m. ET, FDA will host a roundtable discussion with small tobacco product manufacturers to solicit input on PMTA submissions for electronic nicotine delivery systems products. Learn more: fda.gov/tobacco-produc…

FDA has posted materials related to the modified risk tobacco product applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products. fda.gov/tobacco-produc… 📅Submit your comments to Docket # FDA-2025-N-0835-0001 by 11:59 p.m. ET on March 4, 2026.

On 2/10, FDA will host a roundtable discussion with small tobacco product manufacturers to solicit input on PMTA submissions for electronic nicotine delivery systems products. The deadline to apply to be a panelist is 1/27 11:59 p.m. ET. Learn more: fda.gov/tobacco-produc…

📅 A virtual TPSAC meeting to discuss MRTP applications submitted by Swedish Match USA, Inc. for ZYN nicotine pouch products is scheduled for Jan. 22, 2026. Meeting materials — such as a draft agenda and backgrounders — are available: fda.gov/advisory-commi…

On 2/10, FDA will host a roundtable discussion with small tobacco product manufacturers to solicit input on PMTA submissions for electronic nicotine delivery systems products. Learn how to be a panelist or listen in: fda.gov/tobacco-produc…

These products mark the first marketing decisions from the FDA’s nicotine pouch application review pilot program, an effort to improve regulatory efficiency and maintain the FDA’s rigorous scientific standards for tobacco product review.

Today, FDA authorized the marketing of 6 nicotine pouch products through the premarket tobacco product application (PMTA) pathway. Learn more and see the complete list of products: fda.gov/tobacco-produc…

FDA also published updated PDF versions of Forms FDA 4057, 4057a, 3965, and 3965a for those who do not wish to use the web-based forms. Starting 1/2/26, applicants who use the PDF versions of the forms must use these updated forms in their PMTA and SE Report submissions.

Today, FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. fda.gov/tobacco-produc…

In January 2025, FDA authorized the marketing of 20 ZYN nicotine pouch products through the PMTA pathway following an extensive scientific review. The manufacturer is now seeking to market the products with a modified risk claim, which requires additional authorization.

FDA issued a Federal Register notice announcing a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting on 1/22/26, to discuss modified risk tobacco product (MRTP) applications from Swedish Match USA, Inc. for ZYN nicotine pouch products. fda.gov/tobacco-produc…