FDA faces scrutiny over safety of nicotine alternatives

Aug.04.2022
FDA faces scrutiny over safety of nicotine alternatives
FDA under scrutiny for lack of action on synthetic nicotine ban and delayed PMTA process. Review to be conducted by Reagan-Udall Foundation.

As we all know, the FDA has come under scrutiny for approving safer nicotine alternatives and related issues. Last month, the agency faced harsh criticism from Senators Dick Durbin (Democrat, Illinois) and Susan Collins (Republican, Maine). In a letter, the senators cited a news report and criticized the FDA for its lack of action on the "synthetic nicotine ban," stating that the FDA "appears to have once again failed to protect our nation's children.


Similarly, Chairman of the Smoke-Free Kids campaign, Matt Myers emphasizes that the FDA should exercise its authority and remove the products from the market. "All unauthorized synthetic nicotine products are now illegal, and according to the law, they must be removed from the market now, not at some uncertain date in the future.


Furthermore, the FDA has faced continuous condemnation for failing to complete the PMTA process in a timely manner at the designated deadline. Adding insult to injury, the FDA has also been forced to pause its recently issued Juul marketing denial order (MDO), citing the need for more thorough review.


Of course, to make these mistakes look like they're being taken seriously, Commissioner Califf announced a review of the Center for Tobacco Products (CTP). Commissioner Califf stated, "Every field is full of dedicated and talented people who work tirelessly on various scientific, policy, legal, and administrative activities. FDA employees should receive the best support so that they can fulfill their steadfast commitment to public health and to the American public we serve.


The audit will be carried out by a non-profit organization, the Reagan-Udall Foundation, in collaboration with unnamed experts to evaluate the processes and procedures, resources, and organizational structure of the food plan and CTP.


Is the Reagan-Udall Foundation reliable?


According to Filter, many people have expressed disappointment with the results of the self-audit announcement of the Reagan-Udall Foundation. "Many of the individuals investigating the foundation were handpicked from Reagan-Udall's board of directors, who are supporters of the safer nicotine zone," Filter reports. The foundation has not disclosed how many people participated in the audit, adding to the uncertainty around the issue. Notably, board members include Georges C. Benjamin, who is a proponent of prohibitionist organization Truth Initiative, and James E.K. Hildreth, a professor at Nashville's Meharry Medical College who has received millions of dollars in research grants from Juul.


According to a former employee of CTP interviewed by Filter, "I don't expect any major changes." It is currently unclear whether the Reagan-Udall Foundation will be a prohibitionist collaborator or a true partner to millions of adult smokers who are using e-cigarette products to quit smoking.


The US Food and Drug Administration (FDA) has been accused of failing to fulfill its regulatory authority to approve e-cigarette products that promote public health, without remorse. This is not due to an overloaded system or inadequate funding - the agency collects nearly $1 billion in user fees annually. "The FDA's bureaucrats have refused to take responsibility for this fact, which is the reality," added Amanda Wheeler, president of the American e-cigarette manufacturer.


Statement:


This article is compiled from third-party information and is provided for industry exchange and learning purposes only.


This article does not represent the views of 2FIRSTS and 2FIRSTS is unable to confirm the authenticity and accuracy of the article's content. The compilation of this article is solely for industry communication and research purposes.


Due to limitations in translation abilities, the compiled article may not accurately express the same message as the original text. Please refer to the original article for accuracy.


2FIRSTS fully aligns with the Chinese government's stance and statements regarding domestic issues, issues involving Hong Kong, Macau, and Taiwan, as well as 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.

Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
Ireland’s Vape Tax Raises €22 Million in Nine Months as Government Considers 2027 Budget Changes
According to Irish media outlets Highland Radio and BreakingNews.ie, the Irish government is considering whether to adjust vape tax policy in the 2027 Budget. The tax has generated about €22 million ($24 million) in revenue during its first nine months. While no increase has been confirmed, the revenue performance could influence future fiscal discussions. Any tax rise could increase product costs and potentially affect retail prices.
Aug.12
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
Product | VAPORESSO Launches PRIX MTL Pod, With NFC Version Linking Interchangeable Panels to On-Screen Animations
VAPORESSO introduced the PRIX MTL pod system in August 2026 in two versions, Filter and NFC. The Filter version allows users to switch between a conventional drip tip and a filter tip, while the NFC version links interchangeable panels to matching on-screen animations. PRIX features a 2,600mAh battery, a 5.5ml pod, a 0.87-inch TFT display and a maximum output of 40W, alongside Dual Mesh Impact Pods capable of operating at two resistance and power configurations. VAPORESSO's French website lists MSRP at $39.99 for the Filter version and $49.90 for the NFC version.
Market
Aug.24 by 2Firsts Perspectives
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
Earnings Analysis | CTIHK H1 2026 Revenue Falls 26.9% as Core Businesses Diverge and New Growth Drivers Remain to Be Proven
China Tobacco International (HK) reported a 26.9% revenue decline in H1 2026, while gross profit fell only 9.5%, revealing sharp divergence across its businesses. Tobacco leaf imports contracted, while leaf exports and Brazil operations expanded strongly. Cigarette exports faced China duty-free market transition, and new tobacco products remained small. Meanwhile, CTIHK continues to strengthen its role as an investment and financing platform, though major external deals have yet to emerge. 2Firsts examines what these shifts mean for its next growth drivers.
Capital Markets
Aug.24
Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow
Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow
French vaping company Kumulus Vape reported first-half 2026 revenue of €25.5 million, down 8.3% year over year, as its core B2B distribution business fell 11% to €21.6 million. B2C and store-network revenue rose 5.6% and 17.8%, respectively. Commercial margin increased to 26.3% from 21.7%, while net profit rose 24.1% to €0.8 million. The company attributed the profitability improvement to catalog optimization, logistics restructuring and the ramp-up of Labster, its in-house production unit for proprietary brands.
Market
Sep.17 by 2Firsts Perspectives
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Philip Morris Japan (PMJ) has expanded the ZYN by IQOS oral tobacco pouch portfolio in Japan with four new ZYN Strong products, adding a third intensity level alongside the existing Low and Medium ranges. The Strong series first entered selected duty-free channels in Japan on July 1, 2026, before expanding to IQOS stores, the ZYN Online Store and selected tobacco retailers from August 18. The expansion increases the Japanese ZYN by IQOS lineup from eight to 12 products.
Aug.20
Product | R.J. Reynolds Launches Four Flavored Vuse Pro Pods for Vuse Alto Devices in U.S.
Product | R.J. Reynolds Launches Four Flavored Vuse Pro Pods for Vuse Alto Devices in U.S.
R.J. Reynolds Vapor Company has introduced Vuse Pro prefilled pods in Peach, Berry, Watermelon and Fresh Mint in selected U.S. states. Vuse’s U.S. website says the pods are intended for use with existing Vuse Alto devices. Each contains 2.0 mL of e-liquid at 5.0% nicotine by weight, uses nicotine salts and is offered in two- and four-pod packs. Reynolds said the rollout includes mandatory ID scanning for every purchase, purchase limits, stronger retailer-accountability requirements and strict age-restricted marketing standards. The four pods have not received marketing authorization from the U.S. Food and Drug Administration.
Sep.10