STATEMENT FROM THE VAPOR TECHNOLOGY ASSOCIATION IN RESPONSE TO THE FIFTH CIRCUIT COURT OF APPEALS OPINION IN WAGES AND WHITE LION INVESTMENTS, LLC (DBA TRITON DISTRIBUTION) V. U.S. FOOD & DRUG ADMINISTRATION:

The following statement is attributable to Tony Abboud, executive director of the Vapor Technology Association:

“The en banc opinion of the United States Court of Appeals for the Fifth Circuit that was released last Wednesday is nothing less than a blistering indictment of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for its intentional misleading of the U.S. e-cigarette industry and unlawful manipulation of its own pre-market tobacco application (PMTA) regulatory process. To use the language of the court, “Over several years, the Food and Drug Administration (“FDA”) sent manufacturers of flavored e-cigarette products on a wild goose chase,” in search of an approval that the FDA admitted in court it was never, ever, going to grant.

“The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes “save lives”. The court also emphasized the dramatic and abrupt “FDA flip-flop” which led to the implementation of what the court called a “de facto ban” on flavored e-cigarette products in the U.S. This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been towards e-cigarette products and the consumers that use them. As the court stated, “No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people.”

“The ruling by the Fifth Circuit’s en banc panel makes the recent release of the CTP five-year strategic plan – a case study in bureaucratic posturing – essentially null and void.  Nothing in the strategic plan demonstrates that the FDA acknowledges its past and recurring failings or, to the extent that it does, has any commitment to using its enormous regulatory power to authorize less harmful flavored e-cigarette products to save lives.  Worse, the strategic plan completely failed to address the central criticism of the Reagan-Udall Foundation that the FDA has failed to explain what evidence it demands to authorize e-cigarettes as “appropriate for the protection of public health” or otherwise explain how the agency is even interpreting or applying that legal standard.  And worst of all, the strategic plan reveals that FDA has no plan or intent to speak factually to the American public about the benefits of switching from smoking to vaping at any time in the near future.

“Compared to the diametrically opposite approach taken in England – where the government has authorized more than a million flavored e-cigarette products, is telling smokers to use e-cigarettes to quit smoking, and is giving away e-cigarette starter kits to one million of its smokers as part of its ‘Swap to Stop’ program designed to end smoking by 2030 – the U.S. FDA is locked in an anti-scientific ideologically prohibitionist mentality which will ensure that millions of Americans will continue to suffer from smoking related diseases and die from cigarette smoking every year.

“The Vapor Technology Association renews its call for FDA and specifically CTP to reverse course, follow the law, and restore scientific primacy and integrity to its regulatory process by rapidly reviewing and approving the pending flavored e-cigarette PMTAs in accordance with this latest demand by the Fifth Circuit.”

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About VTA

The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.

Also Read FDA’s Center for Tobacco Products Must Reverse Course to Quickly Reduce Smoking Harms

Leading Vape Trade Association Raises Concerns Over Continued Political Interference at the Center for Tobacco Policy 

WASHINGTON, FEBRUARY 24, 2023 –  Following the FDA’s response to the
Reagan-Udall Foundation’s critical report, Vapor Technology Association Executive Director Tony Abboud released the following statement:

“The FDA’s response to the Reagan-Udall Report highlights deep, structural problems with the CTP leadership and its operations. The agency’s response does not give any confidence that the biggest problem – the ongoing interference in the scientific process by political officials will ultimately be addressed – particularly since CTP continued this practice after the Reagan-Udall Foundation report was issued.”

“Tellingly, CTP has acknowledged that it operates with no long-term strategic plan yet at the same time turns around and asks for more money both in the form taxpayer funded appropriations as well as $100M in ‘user fees’. Under no circumstances should Congress consider appropriating even more money to an agency bureaucracy that operates with a such a concerning lack of transparency and without a long-term strategic plan in place.”

“To be clear, the request for user fee funding would require passage of a new federal excise tax that ultimately will be passed on to consumers in violation of President Biden’s pledge of no new taxes. According to the FDA, every single manufacturer is selling illegal products (because FDA has only authorized a handful of e-cigarettes). Yet, FDA has no concern about government imposing and collecting new taxes on illegal products to fund their bureaucracy.”

“Unfortunately, CTP currently operates with a de facto policy that denies market approval to any non-tobacco flavored vaping products. This goes against the preponderance of the scientific evidence, including CTP’s own internal documentation, that concluded flavored vaping products are effective tools to help adult smokers quit. Since 2010, when e-cigarettes became widely available in the US, we have seen adults who smoke drop by a remarkable 62 percent. Flavored e-cigarettes should be a key part of the Administration’s cancer moonshot. Unfortunately, CTP seems determined to drive smokers to the riskiest of all nicotine devices – combustible cigarettes – and, while the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine containing product.”

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to innovating and selling high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.

MEDIA CONTACT
press@vaportechnology.org

Leading Vapor Trade Group Urges FDA to Adopt Reforms to Protect Sanctity of Scientific Process 

WASHINGTON, December 20, 2022 (Newswire.com) – Following the Reagan Udall Foundation release of their final report reviewing the operations of FDA’s tobacco program, the Vapor Technology Association, through its Executive Director Tony Abboud, released the following statement: 

“The Reagan-Udall Foundation’s independent review of FDA’s tobacco program has uncovered systemic problems inside the Center for Tobacco Products that allowed political decisions to override the science-based recommendations of FDA professional staff concerning the authorization of vaping products that would provide safer alternatives for adult smokers looking to quit combustible cigarettes.  

“The Reagan-Udall review was requested by FDA Commissioner Califf to address problems with the Center for Tobacco Products (CTP) programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. Their observations included the following:

• CTP has no strategic plan and must create one that identifies the Center’s strategic objectives and plots an operational roadmap to achieve them.
• CTP must resolve how to weigh the public health benefits of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms to youth who use ENDS.
• CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health standard.
• CTP struggles to function as a regulator due to some of its own policy choices.
• CTP faces significant challenges in clearing policies through the career and political infrastructure.
• CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.
• CTP has not been transparent regarding its failure to clear the market of illegal products.
• CTP’s current goals and priorities are unclear in communication and practice.

“The Vapor Technology Association has raised concerns for years about the opaque and questionable operations of the CTP. Reagan-Udall’s review highlights a shifting and arbitrary decision-making process, untethered from science due to political or external pressures, that has damaged the marketplace for safer vaping products, impaired the FDA’s credibility, undermined the FDA’s mission of harm reduction by denying millions of American smokers truthful information and authorized products. We are pleased to see many of the recommendations VTA provided to the Reagan-Udall Foundation reflected in the Foundation’s report.

“The fact that CTP has continued to issue major decisions despite deficiencies highlighted by Reagan-Udall is highly questionable. VTA agrees that ‘CTP must invest the time, now…to create and implement a Strategic Plan’ and that ‘the path to resolving many of the Center’s current challenges starts with establishing the scientific and policy framework to make clear and timely product decisions.’ For that reason, the FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary,” said Tony Abboud.

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners. Source: Vapor Technology Association

First, the “substantial effect on the Nation’s economy” created by the sale of tobacco products is of great significance. The passage of the TCA in 2009 led to the creation of a new, independent distribution chain of companies, including manufacturers, distributors, suppliers, and retailers, that has steadily grown outside of the traditional tobacco products industry, offering their customers non-combustible nicotine vapor products as alternatives to smoking cigarettes. According to a new economic impact report (prepared by John Dunham & Associates), the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy.

This industry would be devastated by unrestricted flavor bans, given its unique and substantial reliance on the sale of flavored vapor products to adult consumers. Importantly, the potential shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent (FTE) jobs, the loss of $5,258,906,715 in wages and benefits, and the loss of $16,449,776,269 to the U.S. economy makes the issue before the Court incredibly important. In the state of California, where the majority of e-liquid manufacturers of the independent vapor products industry are based, losses would total approximately 6,925 FTE jobs, paying $445,565,776 in wages and benefits, and the economic output of the California economy would be diminished by $1,497,332,882 if flavored vapor products could not be sold. 

Second, since the passage of the L.A. County Ordinance – leading tobacco-control scientists have challenged the notion of banning flavored e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes. Instead of blanket bans, these tobacco-control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products.

Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the TCA and would overrule the FDA’s decision-making for products deemed appropriate for the protection of public health, is not only unlawful, but is dangerous from a public health perspective, in VTA’s view.

ABOUT VTA
The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.