FDA Set Low Standards for Nicotine Product Approval

Aug.12.2022
FDA Set Low Standards for Nicotine Product Approval
FDA sets low review standards for tobacco companies in determining the safety of nicotine products.

I'm sorry, but "smolaw11" is not a phrase or sentence that requires translation as it is not written in any language. It appears to be a username or a code. Please provide the correct text for me to translate to standard journalistic English.


In an article for Filter, Alex Norcia explained that the US Food and Drug Administration (FDA) has set a lower standard for review of nicotine products in its Center for Tobacco Products (CTP) to determine their suitability for preserving public health than for companies submitting tobacco product applications before they go to market.


Filter has cited documents obtained through the Freedom of Information Act, which describe procedures such as batching and bracketing that allow CTP to apply conclusions to product categories rather than individual evaluations. According to Alex Norcia, "Despite the extremely burdensome bureaucratic demands placed on applicants, the agency is pleased to have found ways to complete its paperwork.


It is evident that the FDA allows itself to take effective shortcuts, but it denies applicants," said Clive Bates, Director of The Counterfactual, in an interview with Filter Magazine.


The issue at hand is that the FDA's extensive process is a considerable waste of time and resources for applicants, but ultimately, it is something that the FDA evaluators cannot manage. Without this shortcut, the PMTA process would become a nightmare for human resources. Therefore, the FDA allows itself to achieve the efficiency it should provide to applicants by blending and packaging thousands of almost identical products.


Statement:


This article is compiled from third-party information and is intended for industry-related exchanges and learning.


This article does not represent the viewpoints of 2FIRSTS and we cannot confirm the authenticity or accuracy of its content. The translation of this article is only for industry-related research and exchange.


Due to limitations in translation proficiency, the translated article may not fully reflect the original text. Please refer to the original text for accuracy.


2FIRSTS maintains full alignment with the Chinese government on any statements and positions related to domestic, Hong Kong, Macau, Taiwan, and foreign affairs.


The copyright of compiled information belongs to the original media and author. If there is any infringement, please contact us for removal.



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.

Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
Senate Democrat Wyden Probes Trump Administration Vape Policy Shift, Seeks Records From HHS and Reynolds American
U.S. Senator Ron Wyden, the Democratic ranking member of the Senate Finance Committee, has launched an investigation into flavored vape policy changes and requested records from the Department of Health and Human Services (HHS), Reynolds American and Botanic Tonics. The investigation focuses on a timeline involving Reynolds American’s $5 million donation to MAGA Inc. in April 2026 and subsequent vape policy developments. Wyden said the review aims to examine potential links between political donations, corporate communications and government decisions. The investigation does not represent a finding of wrongdoing.
Innovation
Aug.07 by 2Firsts Perspectives
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.
Sep.26
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23
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
Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
Juul Sublicense Reshapes Vuse Alto Patent Bill as Court Ends R.J. Reynolds’ 5.25% Royalty Obligation to Altria
According to Law360 on August 31, 2026, a federal judge in North Carolina ruled that a patent sublicense between R.J. Reynolds Vapor Co. and Juul Labs Inc. relieves Reynolds of its obligation to continue paying royalties to Altria Client Services LLC over Vuse Alto. A jury had previously found that Vuse Alto infringed three Altria patents and awarded approximately $95.2 million in past damages, after which Reynolds was ordered to pay an ongoing royalty equal to 5.25% of positive net sales. The new ruling finds that a valid sublicense can eliminate future infringement, potentially ending what Altria described as hundreds of millions of dollars in future royalties.
Sep.01
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
Logista France says tobacco consumption outside France’s official tobacconist network has become a large and structural market phenomenon, but official and industry estimates differ sharply. France’s TAFE study estimates that 17.7% of tobacco consumption escaped domestic taxation in 2023, with most of that volume attributed to cross-border purchasing rather than street sales. Some industry studies use broader off-channel definitions and put the figure above 50%. Meanwhile, French Customs seized 547.94 tonnes of tobacco in 2025, up 12%, showing continued pressure from illicit trade.
Sep.04