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.

South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's liquid-vape market is showing changes across raw-material imports, product types and sales channels after synthetic nicotine came under the Tobacco Business Act on April 24. Customs data show nicotine-analogue imports totaled 12,126 kilograms from April through August, while synthetic-nicotine imports over the same five months totaled 231,663 kilograms, just 39.3% of the amount imported in March alone. Physical liquid-vape stores tracked in Seoul and Gyeonggi Province fell 9.9%, unmanned outlets edged higher and online sales listings increased from 27,774 to 42,437. Government testing of 105 liquid inhalation products promoted as nicotine-free separately found nicotine in 13 and 6-methylnicotine in 12.
Sep.22
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
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
Altria’s USSTC Starts $250 Million Kentucky Expansion, Adding More Than 200 Jobs
U.S. Smokeless Tobacco Company, an Altria Group company, has broken ground on an approximately $250 million manufacturing expansion in Hopkinsville, Kentucky. The roughly 270,000-square-foot facility is expected to create more than 200 jobs and absorb processing, manufacturing and packaging operations currently split between Hopkinsville and Nashville, Tennessee. USSTC previously said production at its Nashville facility is expected to wind down by early 2028. The project forms part of Altria’s broader effort to modernize and consolidate its U.S. smokeless tobacco manufacturing network.
Sep.10
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
Product | BAT Expands VELO Travellers’ Collection With Mexico, Spain and Sweden Summer Edition Nicotine Pouches
British American Tobacco (BAT) Global Travel Retail has expanded the VELO Travellers’ Collection with three new Summer Editions: Mexico, Spain and Sweden. Inspired by destination themes, the new nicotine pouch variants are designed for global travel-retail channels. The launch further strengthens VELO’s positioning as a travel-retail exclusive product collection.
Aug.27
UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
UK Reform Party Proposes Cap of 1,000 Vape Shops Under Plan to Tighten Retail Controls
The UK Reform Party has proposed limiting the number of dedicated vape shops in the country to around 1,000 as part of a plan to tighten oversight of vape retail channels. The proposal was put forward by Reform UK deputy leader and MP Lee Anderson. The plan remains a political proposal and has not become UK government policy, with no detailed legislation, implementation timeline or allocation rules announced.
Aug.10