{start}
The FDA’s Assault on Vaping: Devastating Consequences for Public Health and Economy
Introduction
The FDA’s aggressive stance on vaping has had dire consequences, impacting both public health and the economy. By denying millions of adults access to low-risk vaping products that aid in smoking cessation, the FDA is compromising the health of individuals who rely on these alternatives. Moreover, the stringent regulations have resulted in the destruction of thousands of jobs and billions of dollars in income, causing significant harm to ordinary Americans. In this article, we delve into the FDA’s flawed authorization process, its detrimental effects on small businesses, and the flourishing of the black market as a result of these regulations.
The PMTA Pathway Nightmare
The FDA’s authorization process for e-cigarettes, known as the Premarket Tobacco Application (PMTA) pathway, is intended to ensure that vaping products cater to adult smokers without attracting non-smokers, particularly children. However, the PMTA pathway presents significant challenges for applicants. Submitting an application to the FDA’s Center for Tobacco Products (CTP) can be an arduous process, often taking years and costing millions of dollars. Obtaining authorization from the agency has become nearly impossible. Out of the nearly seven million vaping products that manufacturers have submitted PMTAs for, the FDA has only approved 23 tobacco-flavored e-cigarette liquids and devices, indicating an excessively strict regulatory approach.
Artificially High Standards and CTP’s Inconsistent Policies
Evidence suggests that the FDA set artificially high standards for PMTAs after the submission of millions of applications in 2020. Internal agency documents have revealed instances where the CTP leadership overruled its scientific reviewers who were ready to grant marketing authorization for some flavored vaping products. The flawed regulatory efforts of the CTP have faced criticism from two federal appeals courts, which have accused the agency of acting arbitrarily and lacking procedural soundness. The US House Oversight Committee is currently investigating the CTP, citing confusion, inefficiency, litigation, and suspicions of political interference stemming from the center’s erratic policies.
FDA’s Impact on US Small Businesses
To gain insight into the adverse effects of the FDA’s vaping prohibition on American businesses and their employees, we turn to an interview conducted by the American Vapor Manufacturers (AVM) with Darrell Suriff, the CEO of Pastel Cartel, a prominent Texas-based company that sells the popular Esco Bar brand of disposable vapes. Suriff’s story highlights the FDA’s role in creating a black market while attempting to control illegally imported disposable vapes. The FDA’s actions have not only harmed the independent vaping industry and its customers but have also given rise to an illicit market.
The Anti-Flavor Crusade
In 2019, the Trump Administration announced plans to ban all flavored vaping products, with a few exceptions for disposables. However, the real issue lies not in the disposable exemption but in the flavor ban itself, orchestrated by Mitch Zeller, the former director of the CTP. Zeller was also involved in the FDA’s decision to ban over six million vaping products in 2021. Internal reports from the CTP reveal that 75 percent of adult users vape flavored products. By banning these flavors, the FDA unintentionally created a demand that fueled the growth of the black market. Claims that the migration to disposables is solely an industry response to youth-focused product removal are unfounded. Disposable manufacturers like Suriff have been operating for years and have stringent policies in place to prevent underage sales.
Confiscated Products and Regulatory Missteps
The FDA’s actions extend beyond banning certain products to the confiscation of imported vaping items. In May, the agency placed an import alert on several popular brands of disposable vapes, including Esco Bar, allowing inspectors to seize these products as illegal tobacco imports until their lawfulness is proven. The US Customs seized nearly $14 million worth of Suriff’s products imported from his Chinese factory and subsequently fined him $1.4 million for violating the ban. However, the products had been shipped before the import alert took effect. The confiscation had severe consequences, as a portion of the shipment was intended for independent lab testing required for the PMTA process. This import alert caused delays, resulting in significant financial losses and additional fees for Suriff.
Battling Bureaucracy and Economic Fallout
Another FDA misstep occurred when the agency refused to accept Suriff’s PMTA in December 2022, primarily because it lacked an updated form that the FDA had introduced just eight days earlier. The company hired to assist with the application was unaware of the change, leading to its rejection. Consequently, the FDA issued a Refuse-to-Accept (RTA) notice, making the shipping and sale of Esco Bars illegal. Suriff attempted to obtain more information by filing a Freedom of Information Act (FOIA) request but was asked to pay $5,000 for the documents. The financial toll of combating the federal bureaucracy has been overwhelming, with Suriff estimating that he has spent $1 million on legal fees in a single year. The import ban forced Pastel Cartel to shut down a large factory, laying off hundreds of employees both in China and the United States.
The Flourishing Black Market
Despite the FDA’s crackdown, unauthorized vapes continue to flood the US market. The agency claims to have taken swift action to curb the sale of illegal disposable e-cigarette products, but it primarily targets compliant companies like Pastel Cartel, which voluntarily provide details about their operations through the PMTA process. Instead of effectively intercepting all imported vaping products at the border and releasing shipments from companies that have submitted PMTAs, the FDA’s approach perpetuates the thriving black market. Suriff has actively cooperated with federal regulators, reporting numerous instances of websites illegally selling disposables and notifying the agency of imported products disguised as “USB chargers.” However, the FDA has not adequately addressed these issues, leaving businesses like Suriff’s to bear the brunt of the consequences.
Conclusion
The FDA’s assault on vaping has had catastrophic implications for public health and the economy. The PMTA pathway, while intended to ensure safety and appeal to adult smokers, has become an insurmountable obstacle for manufacturers. The FDA’s high standards, arbitrary decision-making, and inconsistent policies have come under scrutiny from federal appeals courts and investigative committees. American small businesses, such as Pastel Cartel, have suffered immense losses, with layoffs and factory closures becoming inevitable. The FDA’s missteps and failures have unintentionally fueled the growth of a black market, undermining the very objectives it aimed to achieve. It is essential for regulatory agencies to consider the unintended consequences of their actions and collaborate with industry experts to develop effective policies that prioritize public health and economic stability.
https://reusable-disposable-vape.jimdosite.com/
https://detailsdisposable.weebly.com/
https://informationofdisposablevapes.blogspot.com/
https://sites.google.com/view/infodisposablevapes/home
https://hospitable-gull-dz180q.mystrikingly.com/
https://www.awkwardzombie.com/forum/viewtopic.php?f=2&t=296253&p=1547562#p1547562
https://www.crypto-city.com/forum/thread/9086/benefits-of-disposable-vapes/
https://play.teleporthq.io/workspaces/my-workspace-1li014
http://xn--80aajajavo3ag2a3c5b.xn--p1ai/portfolio/popular-vape-specific-cases/
http://xn--80aajajavo3ag2a3c5b.xn--p1ai/2022/11/09/popular-vape-specific-cases/
https://www.atoallinks.com/2022/recommends-4-vape-products/
https://www.atoallinks.com/2022/differences-between-e-cigarettes-and-real-cigarettes/
https://0xbt.net/profile/vapecig
https://0xbt.net/blog/view/12311873/popular-vape-specific-cases
https://alwilayah.net/blog/index.php?userid=336334
https://alwilayah.net/blog/index.php?userid=336334
https://pdr-studio.ru/?option=com_k2&view=itemlist&task=user&id=479686
https://forumias.com/post/detail/Comparing-the-Top-Disposable-Vape-Brands-1677144786
https://forumias.com/post/detail/The-Pros-and-Cons-of-Disposable-Vapes-1677145442
https://americanwomenorg.com/vapecig
https://americanwomenorg.com/post/310
https://americanwomenorg.com/read-blog/151
https://americanwomenorg.com/read-blog/159
https://americanwomenorg.com/read-blog/162
https://post.news/article/2LEaViAHmWCshqIrv9M5L6kwhtb
https://the-dots.com/projects/i-want-to-enjoy-vape-in-a-box-856430
https://www.scoop.it/topic/vape-by-ecigatornew-gmail-com
https://www.sympla.com.br/produtor/vapecig
https://story.kakao.com/moonswamp/AOiFDYhMl60
https://story.kakao.com/moonswamp/eDHzsrMnM7A
https://www.instapaper.com/p/11453051
https://ctftime.org/team/213786
https://start.me/p/L1qjg8/startpage
https://disqus.com/by/ecigatornew/about/
https://vapecig.helpsite.com/articles/99694-what-is-a-vape
https://community.geosociety.org/gbgm/directory/profile?UserKey=d518f376-4ec8-49db-8ce5-a262dd744d38
https://dlaz.com.ua/uncategorized/types-of-e-cigarettes.html
http://www.im-creator.com/free/vapecig/vape_factory
https://community.convertkit.com/user/vapecig
FAQs
Q1: What is the PMTA pathway?
The PMTA pathway is the FDA’s authorization process for e-cigarettes. It is designed to ensure that vaping products appeal to adult smokers without attracting non-smokers, particularly children.
Q2: How many vaping products have been authorized by the FDA?
Out of nearly seven million vaping products that manufacturers have submitted PMTAs for, the FDA has only authorized 23 tobacco-flavored e-cigarette liquids and devices.
Q3: What impact has the FDA’s vaping prohibition had on small businesses?
The FDA’s vaping prohibition has had a devastating impact on small businesses, leading to the destruction of thousands of jobs and billions of dollars in income.
Q4: Why has the FDA’s flavor ban been criticized?
The FDA’s flavor ban has been criticized for inadvertently creating a black market and causing harm to the independent vaping industry and its customers. The ban led to a demand for flavored products that fueled the growth of illegal alternatives.
Q5: How has the FDA’s regulatory approach affected public health?
By restricting access to low-risk vaping products, the FDA has inadvertently pushed some individuals towards black-market vapes or back to smoking combustible cigarettes, compromising public health and undermining harm reduction efforts.
