Democratic lawmakers asked the Supreme Court on Sept. 4 to overturn a lower court ruling that blocks the Food and Drug Administration (FDA) from rejecting certain types of e-cigarettes, warning that the ruling threatens to undermine public health.
In an amicus brief filed with the nation’s highest court, the group of 16 lawmakers asked that the decision by the Fifth U.S. Circuit Court of Appeals be reversed and marketing denial orders that were issued to the companies be reinstated.
The lawmakers, led by Rep. Frank Pallone Jr. (D-N.J.), ranking member of the House Energy and Commerce Committee; Senate Majority Whip Dick Durbin (D-Ill.), chair of the Senate Judiciary Committee; and Sen. Jeff Merkley (D-Ore.), argued that the lower court’s decision poses serious health risks, particularly to children, and that the FDA reached a “carefully reasoned conclusion” in not allowing the products on the market.
That decision struck down the agency’s rejections of applications from two e-cigarette manufacturers: Triton Distribution and Vapetasia LLC.
In its ruling, the Fifth Circuit found that the FDA acted “arbitrarily and capriciously” and in violation of a federal law called the Administrative Procedure Act by rejecting applications filed by the e-cigarette liquid makers in 2020.
The applications were for products with flavors such as sour grape, pink lemonade, and creme brulee, and names including “Jimmy the Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
In its January ruling, the court said the FDA gave the vape companies “detailed instructions for what information federal regulators needed to approve e-cigarette products,” creating a “false promise” that their products could potentially satisfy the agency’s requirements.
The companies said they spent “untold millions” to provide what the FDA required but the agency ”turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice,” the court said.
At the time, the agency argued that it had rejected the product’s marketing applications because the two companies failed to show that the possible benefits for adult smokers outweighed the risk of harm to youth.
The court, however, found that the FDA did not consider plans by the companies to prevent underage access and use of the products.
In their filing with the Supreme Court, the lawmakers argued that the Fifth Circuit’s decision threatens to undermine the public health successes of the 2009 Family Smoking Prevention and Tobacco Control Act as well as its future efficacy. Under the law, e-cigarette manufacturers must prove to the FDA that a tobacco product is “appropriate for the protection of public health” before it is sold in the United States.
They argue that the 2009 law—which brought about sweeping changes in the federal oversight of the tobacco market—was passed after Congress recognized that soaring tobacco use by children presented a “pediatric disease of considerable proportions” that results in new generations of tobacco-dependent children and adults.
“In the fifteen years since the passage of the Act, the authority of the Food and Drug Administration (FDA) ‘to address issues of particular concern ... especially the use of tobacco by young people’ has remained ‘flexible,’ allowing FDA to respond to evolving challenges in the marketplace,” the lawmakers wrote in the brief.
Lawmakers Warn of ‘Devastating Consequences’
The most notable change, the lawmakers said, has been the widespread adoption of e-cigarettes.“FDA has utilized its regulatory and enforcement authorities to address the health threat posed by e-cigarettes, and has done so in a manner consistent with Congressional intent as expressed in the Act,” they wrote.
Until the Fifth Circuit’s decision, judicial oversight of the agency’s authority has been “generally consistent” and has allowed the FDA to “exercise its statutory authority efficiently and correctly,” the lawmakers wrote.
Now, however, the Fifth Circuit has “set aside FDA’s carefully reasoned conclusion that certain sweet and fruity flavored tobacco products ... are not appropriate to protect the public health because they are more likely to appeal to youth consumers than they are to help current adult tobacco users quit,” they wrote.
The lawmakers said allowing the lower court’s ruling to remain in place would also result in the FDA wasting valuable resources reevaluating the companies’ product applications in “a less efficient, more resource-intensive manner before reaching the same result and once again denying the applications.”
“The key to reducing tobacco-related deaths is preventing youth tobacco use, and FDA’s authority to oversee e-cigarette products, including by denying authorization to sell specific products, is a foundational intervention in doing so,” they wrote. “The Fifth Circuit’s decision flies directly in the face of that authority and threatens to undermine both the Act’s success to date and future federal oversight of tobacco, dragging federal regulation of e-cigarettes backward and imperiling countless American youth.”
Concluding their filing, the lawmakers said that affirming the Fifth Circuit’s decision on any basis would be “diametrically opposed to the intent of Congress in passing the Act” and would have “devastating consequences for the American health system and individual Americans.”
The Epoch Times reached out to Triton Distribution and Vapetasia LLC for comment but received no reply by publication time.
