FDA Tobacco

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[FDA Tobacco @FDATobacco]

The review of these products was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process of nicotine pouches through the premarket tobacco product application (PMTA) pathway.

[FDA Tobacco @FDATobacco]

Today, the FDA authorized the marketing of 4 new nicotine pouches made by Helix Innovations LLC, under the “on!” brand name: Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg, and Autumn Spice 2 mg. https://t.co/suN3fH6ja9

[FDA Tobacco @FDATobacco]

Note: By 11/14, applicants should use the CTP Portal NextGen web forms (or PDF forms, if unable to submit online). The FDA eSubmitter forms for PMTA and SE Reports will be discontinued on 11/14.

[FDA Tobacco @FDATobacco]

FDA encourages the use of web-based forms in the CTP Portal NextGen for premarket tobacco product applications and substantial equivalence reports. Applicants can efficiently create, validate, and submit forms directly in the portal. Learn more: https://t.co/mLPDILCoaL

[FDA Tobacco @FDATobacco]

New Wave 8 Public-Use Files from the Population Assessment of Tobacco and Health (PATH) Study are now available from @FDATobacco and @NIH https://t.co/dAlRcRppZh

These Wave 8 files contain questionnaire data collected between Jan. 2024 and Dec. 2024.

[FDA Tobacco @FDATobacco]

FDA focused the review on the accuracy of the claim, relative health risks of the products to people who use tobacco, consumer understanding of the products, data regarding youth risk, and the potential impact to the population as a whole.

[FDA Tobacco @FDATobacco]

Today, FDA issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products.

Learn more: https://t.co/WgG6cuC67Q

[FDA Tobacco @FDATobacco]

The proposed rule is available for public comment. Submit your comments to Docket # FDA-2025-N-7130 on https://t.co/DqDW2vTqf5 by 9/14. Comments must be submitted within 75 days of publication in the Federal Register.

[FDA Tobacco @FDATobacco]

FDA proposed a rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products and conduct on-site inspections abroad. https://t.co/h2Y5eLArFL

[FDA Tobacco @FDATobacco]

If finalized, the rule would require foreign manufacturers to register with FDA and provide product information before importing into the U.S. Foreign manufacturers would be subject to the same requirements and FDA inspections as domestic manufacturers, closing a regulatory gap.

[FDA Tobacco @FDATobacco]

@AmJPrevMed Based on the number of youth prevented from using e-cigarettes, FDA estimates the campaign also blocked more than $42 million in sales of unauthorized e-cigarettes that would have been used by youth during the same period.

[FDA Tobacco @FDATobacco]

An @AmJPrevMed special issue shares the science, strategy, and public health impact of “The Real Cost” youth tobacco prevention campaigns, including a new commentary by Dr. Bret Koplow, acting director of FDA’s Center for Tobacco Products. https://t.co/jrCSiBIFh4

[FDA Tobacco @FDATobacco]

@AmJPrevMed A study included in the special issue found that the e-cigarette prevention campaign prevented nearly 450,000 American youth from starting to use e-cigarettes between 2023 and 2024.

[FDA Tobacco @FDATobacco]

During 2022–2025, current overall tobacco use, e-cigarette use and cigarette use declined among U.S. high school and middle school students. Current use of nicotine pouches also remained low and stable during 2024–2025.

[FDA Tobacco @FDATobacco]

FDA is sharing findings from the 2025 National Youth Tobacco Survey (NYTS). Learn more: https://t.co/ZvQzdgLUNx

[FDA Tobacco @FDATobacco]

View application materials and submit comments on VLN® King and VLN® Menthol King modified risk renewal applications. No deadline currently set for public comments.

Applications: https://t.co/0QZ780YeEW

Comment: https://t.co/orF558hJmY

[FDA Tobacco @FDATobacco]

FDA and @NIH are co-sponsoring a free Population Assessment of Tobacco and Health (PATH) Study Data User Workshop for academic faculty, researchers, and grad students on 8/11-12 and 9/17-18. Learn more and apply by 6/29: https://t.co/DhJWpIBgK4

[FDA Tobacco @FDATobacco]

View application materials and submit comments on VLN® King and VLN® Menthol King modified risk renewal applications. No deadline currently set for public comments.

Applications: https://t.co/0QZ780YeEW

Comment: https://t.co/orF558hJmY

[FDA Tobacco @FDATobacco]

As part of the FDA’s commitment to transparency, the agency is posting this assessment to inform applicants and the public, and so that it may be cited by FDA staff conducting scientific reviews.

[FDA Tobacco @FDATobacco]

FDA posted a programmatic environmental assessment of the agency’s review of premarket tobacco product applications for new tobacco products in the “other” category, like nicotine pouches, lozenges, discs, tablets, gums, dissolvable tobacco products, etc. https://t.co/czBPIogvI2