FDA Extends Comment Period for Tobacco Manufacturing Standards Proposal

Aug.29.2023
FDA Extends Comment Period for Tobacco Manufacturing Standards Proposal
The FDA has extended the comment period for its tobacco manufacturing standards proposal until October 6, 2023.

According to a report from halfwheel on August 28, the US Food and Drug Administration (FDA) has proposed a regulation called the "Tobacco Product Manufacturing Practice Requirements" (TPMP) on March 10th this year. The FDA has extended the comment period for this regulation proposal by an additional 30 days, allowing for more time for public input. The FDA will accept comments on the proposal until October 6, 2023.


The final elimination management plan rules of the bill will impose new requirements on tobacco product manufacturers regarding the manufacturing, design, packaging, and storage of their products.


The proposed bill includes requirements aimed at safeguarding public health, such as minimizing or preventing pollution and limiting additional risks by ensuring product consistency.


Reference


The Food and Drug Administration (FDA) has announced an extension to the comment period for the proposal on standards for tobacco manufacturing.



Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
Athletes Back Skoka's $21.5 Million Nicotine Pouch Venture: Can Its Consumer Health Founder Make an FDA-Focused Strategy Pay Off?
U.S. nicotine pouch startup Skoka Inc. has raised $21.5 million and committed $15 million to an FDA regulatory and scientific research program. Founder Dan Aziz previously built dietary supplement brand Premama, which was acquired by Dr. Reddy's Laboratories in 2023. Skoka is combining proprietary formulations, ingredient transparency and equity investment from professional athletes. The company submitted a bundled PMTA covering 55 products on October 1, 2026. Aziz said Skoka declined an opportunity to enter retail in 2025, prioritizing product research and regulatory submissions instead. It now targets a U.S. retail launch in 2027, subject to FDA requirements. Its products have not received marketing authorization.
Business
Nov.04
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City Opens Lottery for 55 Vape Retail License Slots Across 23 Community Districts, Including 28 in Brooklyn
New York City's Department of Consumer and Worker Protection (DCWP) opened applications on November 2, 2026, for a lottery covering tobacco and electronic cigarette retail dealer licenses, with a deadline of 5 p.m. New York local time on November 30. According to the city's October 1 notice, 55 electronic cigarette retail license slots are available across 23 community districts, including 28 in Brooklyn, alongside 322 tobacco retail license slots across 41 districts. Businesses must enter the lottery and, if invited, complete licensing requirements within 65 days. New York City continues to restrict e-cigarette retail sales to tobacco-flavored or unflavored products, while city retail licenses do not replace FDA product marketing authorization.
Market
Nov.04
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
Product | BAT Expands VELO Peach Ice Medium to FamilyMart Stores Nationwide in Japan
British American Tobacco Japan (BAT Japan) expanded VELO Peach Ice Medium to FamilyMart stores nationwide in Japan from September 7, 2026. The oral tobacco product first launched on July 6 and had previously been sold through VELO's official online store, glo Store Ginza and tobacco retailers. It combines peach flavor with menthol cooling at a Medium strength level and is priced at JPY 360. Japanese tobacco retailers list 15 pouches per pack. The move adds the new SKU to an existing nationwide FamilyMart distribution network for VELO rather than marking the brand's first entry into the convenience-store chain.
Sep.15
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
Product | BAT Launches VELO WRKS Nicotine Pouches in Sweden, Introducing Dual-Compartment Cans With Two Flavours
British American Tobacco (BAT)'s VELO brand launched the VELO WRKS nicotine pouch range in Sweden on November 2, 2026. The initial release features three Dual Can variants, each containing two separate flavours in a dual-compartment container. Each can holds 20 slim pouches with 8mg of nicotine per pouch and retails for SEK 52.99. According to VELO, the first release, Drop 1, is limited to 75,000 cans and will remain available until February 2027 or while stocks last. VELO positions WRKS as a platform for testing new product concepts and has introduced an online consumer feedback survey. EU trademark records show BAT applied to register VELO WRKS in March 2026 under Class 34, covering nicotine pouches, e-cigarettes, heated tobacco products and other tobacco-related goods.
product
Nov.03