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.

BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
BAT Adds Former Apple General Counsel Bruce Sewell to Board as Finance, Legal, Marketing and Regional Leadership Shift
British American Tobacco has appointed former Apple Senior Vice President, General Counsel and Secretary Bruce Sewell as an independent non-executive director, effective January 1, 2027. He will also join BAT's Audit and Nominations Committees. BAT Chair Luc Jobin highlighted Sewell's experience in technology, government and regulatory affairs, public-company governance and AI-company boards. Over the past 18 months, BAT has changed or announced changes to its CFO, general counsel, CMO and APMEA regional leadership, while the main board has also seen multiple changes. The appointment comes as BAT advances Horizon 2030 and its Fit2Win transformation while expanding New Categories and reshaping parts of its digital, technology and operating structure.
Business
Oct.29
AIR Global Starts Debt Refinancing Four Months After Nasdaq Listing With About $400 Million Notes Expected
AIR Global Starts Debt Refinancing Four Months After Nasdaq Listing With About $400 Million Notes Expected
AIR Limited, a wholly owned subsidiary of AIR Global, has launched an offering of U.S. dollar-denominated senior unsecured notes, with proceeds primarily intended to repay its existing term loan and revolving credit facility. AIR has not disclosed the final size, maturity or coupon; Refinitiv, citing Moody's, reported an expected issuance of approximately $400 million and a Ba3 rating. AIR had about $412.4 million outstanding under the two bank facilities at June 30 and net debt of $344.8 million. In the first half of 2026, AIR's Al Fakher-led flavored shisha molasses business generated about 99% of company revenue, while New Growth Categories including Crown Switch produced $2.2 million in revenue and remained loss-making on an adjusted EBITDA basis.
Sep.23
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.
News
Sep.10
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
JUUL2 Sued Within a Week of FDA Authorization as AJ Marketing Alleges Infringement of Programmable Vape Patent
Less than a week after JUUL2 received U.S. FDA marketing authorization on August 28, 2026, JUUL Labs was sued for patent infringement in federal court in Delaware. AJ Marketing LLC filed the complaint on September 3, alleging that both JUUL 1 and JUUL2 infringe U.S. Patent No. 8,851,068 B2. The patent covers aspects of programmable electronic vaporization devices, including controls over dose delivery, usage frequency and operating parameters. The plaintiff is seeking reasonable royalties and ongoing royalties tied to the remaining life of the patent. JUUL has not yet publicly responded to the case.
Sep.10
India Duty-Free Nicotine Pouch Sales Face Regulatory Test as ZYN, FOX Classification Remains Open
India Duty-Free Nicotine Pouch Sales Face Regulatory Test as ZYN, FOX Classification Remains Open
The Bombay High Court has ruled that airport duty-free shops are not exempt from India's domestic regulatory laws merely because they operate beyond the customs barrier, leaving in place a sales halt covering ZYN and FOX nicotine pouches at Mumbai's international airport. The court, however, did not determine that the products necessarily qualify as "drugs" under India's Drugs and Cosmetics Act. The retailers have four weeks to submit product information to the appropriate authorities, including CDSCO, which must complete its review within 30 days of receiving the submissions.
Sep.24
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
F1 Faces Renewed Pressure Over Tobacco and Nicotine Sponsorships as 67 Groups Target ZYN and VELO Ahead of Madrid Race
Ahead of the Formula 1 race in Madrid, 67 Spanish and international public-health, medical and consumer organizations have sent an open letter to F1 President and CEO Stefano Domenicali calling for an end to sponsorships linked to the tobacco and nicotine industry, including nicotine pouches, vaping products and heated tobacco. The letter focuses on Philip Morris International’s ZYN partnership with Ferrari and British American Tobacco’s long-running partnership with McLaren and exposure for VELO. The campaign follows a March letter in which more than 160 organizations worldwide made a similar request to Formula 1.
Sep.10