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.

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
2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
2Firsts On-Site | CTIHK Showcases Nicotine Pouches, Heated Tobacco and Chinese Cigars at InterTabac 2026
At InterTabac 2026 in Dortmund, China Tobacco International (HK) Company Limited (CTIHK) is exhibiting across two separate booths in Hall 5 and Hall 4. Products observed by 2Firsts include heated tobacco products, nicotine pouches, Chinese cigars and tobacco leaf. Nicotine pouch products on display include TOOP, Shuangxi and Ashima.
Market
Sep.16
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
FDA Unifies Tobacco Registration and Product Listing Form Across Product Categories
The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.
FDA
Sep.30
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
China’s State Council has appointed Zhang Xiaotang as deputy director of the State Tobacco Monopoly Administration, with the regulator’s official website now listing him as a Party leadership group member and deputy director. Zhang previously led Hebei China Tobacco and earlier headed the STMA’s finance and audit department. His appointment follows the elevation earlier this year of former tax official Yao Laiying to head the STMA, adding another senior official with a strong fiscal or financial-management background to China Tobacco’s top leadership in 2026.
News
Sep.20
Special report|Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Special report|Indonesia's Vape Industry Has 200 Manufacturers and $1.7 Billion in Investment. Could a Regulatory Divide Derail Its Rise as the World's No. 2 Manufacturing Hub After Shenzhen?
Indonesia's Ministry of Industry said at a November 3, 2026, policy forum that the country has about 200 electronic cigarette companies, Rp31 trillion (approximately $1.71 billion) in cumulative industry investment and around 100,000 jobs across the supply chain. The National Narcotics Agency is seeking a comprehensive ban on vape use and circulation, while the industry ministry favors tighter import, product-standard and distribution controls. Indonesia exported approximately $518 million in vaping products in 2025, and Chinese manufacturers including Smoore, GEEKVAPE and Jinjia Group have established local operations. An international logistics specialist interviewed by 2Firsts said more Chinese vape companies began production in Indonesia from the second half of 2025, accompanied by increased shipments of manufacturing equipment and investment in logistics facilities. The regulatory debate comes as Indonesia expands its role in international vaping manufacturing.
Special Report
Nov.05
Product | Philip Morris Launches TEREA Bold Red and Bold Black in Germany With Level-10 Tobacco Intensity at €8 per Pack
Product | Philip Morris Launches TEREA Bold Red and Bold Black in Germany With Level-10 Tobacco Intensity at €8 per Pack
Philip Morris International (PMI) introduced TEREA Bold Red and Bold Black heated tobacco sticks in Germany in October 2026, both carrying a brand-rated tobacco-flavor intensity of 10, the highest level in the country's TEREA portfolio. Bold Red features leather and warm woody notes, while Bold Black combines woody and subtle floral notes. Both are sold in 20-stick packs at €8, approximately 2.6% above standard TEREA products. Germany's TEREA range now includes 11 flavor variants, alongside a separate 26-stick XL format priced at €10. IQOS Germany announced the new products on October 12, followed by a phased retail rollout from late October and an IQOS Club campaign running through December.
product
Nov.02