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.

Bret Koplow Takes Permanent Charge of FDA Tobacco Center After Pushing Faster PMTA Reviews, as HHS Emphasizes Innovation and Access to Lower-Risk Alternatives
Bret Koplow Takes Permanent Charge of FDA Tobacco Center After Pushing Faster PMTA Reviews, as HHS Emphasizes Innovation and Access to Lower-Risk Alternatives
The U.S. Department of Health and Human Services has named Bret Koplow permanent director of the FDA’s Center for Tobacco Products, ending his period as acting chief. Koplow has spent years working on tobacco regulation, law and policy inside the FDA and, while serving as acting director, pushed for faster PMTA reviews and nicotine pouch review pilots. HHS also said CTP will prioritize innovation and access to less harmful alternatives for adult smokers while continuing efforts to protect youth.
Sep.09
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
Sep.19
Philippines Mandates Safety Certification for Nicotine Pouches, Gives Industry 12 Months to Comply
Philippines Mandates Safety Certification for Nicotine Pouches, Gives Industry 12 Months to Comply
The Philippines Department of Trade and Industry has placed nicotine pouches under mandatory product certification through Department Administrative Order No. 26-07, Series of 2026. Nicotine pouches must obtain a Philippine Standard, or PS, license before they can be manufactured, imported, packed, distributed or sold in the country. The regime requires testing for nicotine content, pH and water activity, while packaging must disclose nicotine strength, ingredients, allergens, batch information, the PS certification mark and prescribed health warnings. Existing market participants have a 12-month transition period to comply.
Regulations
Oct.12
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
Special Report | How Capital Is Reassessing the Global Tobacco and Modern Nicotine Industry: Lessons from a New York Forum
Capital is reassessing the global tobacco and modern nicotine industry as heated tobacco, vaping and nicotine pouches reshape demand, profitability and regulation. At the 2026 New Approaches Summit in New York, investors and analysts examined whether smoke-free growth can sustain earnings, how regulation shapes startup value, and whether shareholder engagement can be more effective than divestment. The debate points to a broader shift: tobacco transition is increasingly becoming a capital-allocation, governance and valuation question.
Capital Markets
Oct.05
2Firsts First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
2Firsts First Look|China to End VAT Export Rebates on Vape Devices and Nicotine in April 2027, Following Earlier Removal for HTP Devices and Nicotine Vapes
China's Ministry of Finance and State Taxation Administration announced on October 12, 2026, that value-added tax (VAT) export rebates for vape devices, nicotine and its salts, and certain non-combustible inhalation products will be eliminated from April 1, 2027. The measure adds four tobacco- and nicotine-related customs codes, including 8543400010, which covers vape devices and qualifying empty pods. China previously eliminated rebates for nicotine-containing vaping products and devices under code 8543400090 in April 2026. According to industry classification information held by 2Firsts, the latter currently corresponds to heated tobacco devices. Export excise tax refund and exemption arrangements will remain unchanged.
Special Report
Oct.12
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden Finds ZYN Ingredient Labels Noncompliant Over Generic Flavoring Disclosure, Swedish Match Faces SEK 2 Million Monthly Penalty
Sweden's Public Health Agency has found ingredient labels on ZYN nicotine pouches sold by Philip Morris International subsidiary Swedish Match to be noncompliant, according to Dagens industri. The products' packaging listed 10 to 13 ingredients, compared with 11 to 42 in regulatory submissions, with multiple flavoring ingredients grouped under the generic term "aromer." The agency ordered corrective action, warning of a conditional penalty of SEK 2 million per month for noncompliance. The order applies only to products manufactured after the decision becomes legally effective and does not require recalls. Swedish Match disputes the agency's interpretation and plans to appeal.
PMI
Oct.22