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.

Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Buys Indonesian HNB Manufacturer for RMB 90 Million, Adding OEM/ODM Capacity
Huabao International Holdings Limited will acquire 100% of PT Broad Far Indonesia through two wholly owned subsidiaries for approximately RMB 90 million. The Indonesian company manufactures and sells heat-not-burn tobacco sticks and provides OEM/ODM services. The sellers are part of a related-party group controlled by Huabao International Chair and controlling shareholder Zhu Linyao. PT Broad Far Indonesia generated $4.37 million in revenue and $177,000 in profit after tax in the first half of 2026, while net assets stood at about $326,000 at June-end. An independent valuer assessed the company’s equity at approximately RMB 93.06 million. Following completion, the HNB manufacturing operation will be consolidated into Huabao International.
News
Sep.29 by 2Firsts Perspectives
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
UK Vape Duty Starts in October as Hayati, DOJO and Others Launch Lower-Capacity Products With Lower Per-Unit Tax
The UK's Vaping Products Duty will take effect on October 1, 2026, at a flat rate of £2.20 per 10ml of vaping liquid. Ahead of implementation, DOJO, PIXL and Hayati have introduced or been reported to be adding lower-capacity tiers alongside larger products. DOJO has added a 6ml BLAST7K Fresh below its 10ml BLAST10K Fresh, PIXL offers both a 12ml 8000 and a 6ml 5K, while retailer Ninja Vapes says Hayati is preparing a 7ml 4K alongside its existing 12ml 6K. The pattern points to a growing lower-capacity tier in the UK market, although the brands have not all explicitly linked the changes to the new duty.
Sep.23
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona Turns to a 50% Retail Vape Tax as Tobacco Tax Revenue Falls 47% From 2008
Arizona's First Things First is pushing for an excise tax equal to 50% of the retail price of vaping products, estimating that the measure could generate about $100 million annually. The agency says its tobacco-tax revenue has fallen 47% from 2008 levels. Arizona has attempted to broaden its nicotine tax base in each of the past two years: a 2025 bill proposed a 50% wholesale-price tax, while a 2026 measure shifted to a 50% retail-price tax covering alternative nicotine products and vapor products. Separately, the state enacted HB 4001 this year to establish a new licensing and sales framework for alternative nicotine products.
Sep.21
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
Philip Morris Japan launched its fourth confirmed nationwide convenience-store discount campaign for IQOS ILUMA i devices in 2026 on October 26, cutting three models by as much as ¥2,000, or about $12.70. The campaign began one day after JT ended a promotion that reduced Ploom AURA to ¥1,480, or about $9.40. JT says Ploom's share of Japan's heated-products category rose from 10.9% in January 2024 to 18.3% in June 2026, a gain of 7.4 percentage points, while PMI says IQOS still held about 68% category share in the third quarter. At the same time, Japan's two-stage heated-tobacco tax adjustment has pushed stick prices higher, leaving device discounts as an increasingly important tool for lowering the upfront cost of customer acquisition.
Market
Oct.28