The U.S. Supreme Court upheld the FDA’s decision to deny two e-cigarette companies the right to sell flavored e-cigarette products, finding that the FDA followed the legal process.
Key points:
1. The U.S. Supreme Court upheld the FDA’s decision to deny Triton Distribution and Vapetasia, two e-cigarette companies, the ability to sell flavored e-cigarette products, finding that the FDA followed the legal process under the Administrative Procedure Act.
2. The ruling emphasizes protecting youth from the risk of nicotine addiction posed by flavored e-cigarettes and supports the FDA’s measures to protect youth health.
3. The court confirmed that the FDA did not use regulatory standards and scientific evidence in evaluating the application, despite e-cigarette companies’ claims that their products had harm reduction potential for traditional smokers.
According to Reuters on April 3, the US Supreme Court strongly upheld the US Food and Drug Administration’s (FDA) decision to refuse to allow two e-cigarette companies to sell flavored e-cigarette products that regulators deemed to pose a risk to youth health.
Justice Samuel Alito wrote the unanimous decision that overturned the lower court’s decision. Lower courts had previously held that the FDA did not follow the legal process under the Administrative Procedure Act when it denied applications by two companies, Triton Distribution and Vapetasia, to sell nicotine-containing products.
The e-cigarette companies argued that the FDA used regulatory standards in evaluating their applications that did not match the published guidelines the companies relied on. In his ruling, Alito noted that “interested parties may have assumed that the agency would apply a more lenient evidentiary standard than in the denial order that FDA ultimately issued.” Alito said,
- “Ultimately, we cannot say that the FDA improperly changed its position on scientific evidence and other guidelines.”
The ruling does not address the harmfulness of FDA’s failure to consider its program to restrict access and use of its products by minors and orders the lower court to reevaluate the issue under a different legal standard.
The campaign group Tobacco-Free Kids praised the Supreme Court’s decision, saying it “should encourage the FDA to maintain its current regulatory direction.” “Today’s ruling is an important victory for the health of America’s children and efforts to protect them from flavored e-cigarettes that are contributing to the youth nicotine addiction crisis,” the group said in a statement.
In a 2016 law under President Barack Obama, the FDA considered e-cigarettes to be tobacco products subject to review under the Tobacco Control Act of 2009.
Over the years, the FDA has approved just 34 flavored e-cigarettes, all in tobacco or menthol flavors, and the agency insists it is not banning flavored e-cigarette products altogether. Although illegal, a variety of flavored e-cigarette products are readily available. To gain regulatory approval, e-cigarette companies must demonstrate that their products are “appropriate to protect public health,” meaning that any health benefits – such as helping traditional cigarette smokers switch to e-cigarettes, which are generally less harmful – must outweigh the risks of bringing a new product to market.
Eric Heyer, a lawyer for e-cigarette companies, expressed disappointment with the court’s ruling. “Triton and Vapetasia continue to believe in the harm reduction potential of their products for smokers.”
Triton Distribution and Vapetasia filed for FDA approval in 2020 for their products, which include flavors like sour grape, pink lemonade and creme brulee, and names like “Jimmy The Juice Man Peachy Strawberry” and “Suicide Bunny Mother’s Milk and Cookies.” The products have been criticized for being designed to appeal to minors, and the FDA has rejected applications for more than a million flavored e-cigarette products, including Triton and Vapetasia.
During arguments in the case on Dec. 2, Justice Department lawyers representing the FDA said the companies were aware throughout the application process of the agency’s concerns about flavors that appeal to teens and the harmful nature of nicotine on the developing brain.
Hill hinted during the debate that President Donald Trump’s administration could change the U.S. position on flavored vape products. Despite supporting a ban on flavored e-cigarette products during his first term, he pledged to “save e-cigarettes” during his presidential campaign.
In 2020, the FDA found that nearly one in five high school students and nearly one in 20 middle school students used e-cigarettes in 2020, making e-cigarettes “the most widely used tobacco product among adolescents.” Triton and Vapetasia petitioned the New Orleans-based 5th Circuit Court of Appeals in 2021 to review the FDA’s denial of their application, and the 5th Circuit’s full bench ruled 10-6 that the FDA violated the Administrative Procedure Act and acted arbitrarily and capriciously, and seven other federal appeals courts sided with the FDA in similar cases.
