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.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Malaysia's Perak State Plans to Implement E-Cigarette Ban in October, Health Department Accelerates Drafting of Policy Document
Malaysia's Perak State Plans to Implement E-Cigarette Ban in October, Health Department Accelerates Drafting of Policy Document
Malaysia's Perak state government plans to enforce a statewide ban on e-cigarettes in October to improve public health.
Jun.23 by 2FIRSTS.ai
Pahang State in Malaysia Announces Total Ban on E-Cigarettes, Plans Gradual Phase-Out of Sales
Pahang State in Malaysia Announces Total Ban on E-Cigarettes, Plans Gradual Phase-Out of Sales
The Pahang state government in Malaysia has banned the use of e-cigarettes and vaping devices statewide, effective immediately. The ban was approved on May 14 and endorsed by Sultan Abdullah. Local authorities will enforce the ban, and sellers are advised to gradually reduce their inventory.
Jun.12 by 2FIRSTS.ai
E-cigarette Ban in UK Prompts Concerns Over Illegal Market Influx
E-cigarette Ban in UK Prompts Concerns Over Illegal Market Influx
Over 600,000 UK e-cigarette users unaware of upcoming ban on disposable products, experts warn of influx of illegal alternatives.
May.28 by 2FIRSTS.ai
2Firsts Insight | UK Distributors Rush to Stockpile and Launch Emergency Promotions Ahead of Disposable Vape Ban
2Firsts Insight | UK Distributors Rush to Stockpile and Launch Emergency Promotions Ahead of Disposable Vape Ban
Starting June 1, 2025, the UK will implement a comprehensive ban on the sale of disposable vapes. 2Firsts has observed that vape distributor websites in the UK—such as VapeSourcing, VAPE CLUB, and Vape UK—are urging consumers to stock up while actively promoting alternative products like pod systems and open-system vapes. These platforms have also released user guides to help consumers transition smoothly.
May.21 by 2FIRSTS.ai
2Firsts Insight | DOJO Launches Own E-Liquid Brand, Set to Hit Shelves in Germany
2Firsts Insight | DOJO Launches Own E-Liquid Brand, Set to Hit Shelves in Germany
The e-cigarette brand DOJO has unveiled DOJOLIQ, its self-developed e-liquid line co-created with the VAPORESSO team. The product comes in 10ml bottles and features 10 flavors, primarily fruit-based. It is now listed on several German online vape retail platforms and will be available for purchase soon.
Jun.10 by 2FIRSTS.ai
Arkansas Passes PMTA Registration Bill, First State to Ban Personal Possession of Illegal E-Cigarettes
Arkansas Passes PMTA Registration Bill, First State to Ban Personal Possession of Illegal E-Cigarettes
Arkansas has become the 12th US state to pass a PMTA registration bill, and the first to ban personal possession of non-compliant e-cigarettes. The law, backed by traditional tobacco firms, includes some exemptions for open-system products but leaves questions over bottled e-liquids. The new rules will take effect in November 2025, with penalties for retailers, manufacturers, and wholesalers who violate the law.
May.08 by 2FIRSTS.ai