VTA Statement: 5th Circuit En Banc Opinion Rebukes FDA “De Facto Ban on Flavored E-Cigarettes”
Published on January 8, 2024
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.”
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.