FDA Blocks Flavored E-Cigarettes, Sparking Legal Fight Over Risks to Minors

The FDA blocked the approval of flavored e-cigarettes, causing controversy amongst the Supreme Court and manufacturers with petitions citing the agency’s failure to follow proper legal procedures when rejecting the applications. This led to a lawsuit from multiple e-cigarette manufacturers who claim the FDA unfairly changed its requirements without enough warning.¹

Colored e-cigarettes | Image Credit: © iama_sing - stock.adobe.com

"FDA switched its position on what studies were required to show that the products have benefits to existing smokers that offset risks to youth,” said Eric Heyer, an attorney representing the manufacturers Triton Distribution and Vapetasia.¹

The FDA began the regulation of cigarettes in the 1990s, driving rates of underage smoking to 2%. However, the rise of e-cigarettes, or vapes, has filled the gap left behind by decreasing rates of cigarette use. This is largely driven by the misconception that e-cigarettes do not have the same contaminants and carcinogens found in traditional tobacco cigarettes. Many individuals, as a result, have transitioned to use of e-cigarettes as an alternative or as a tool for smoking cessation.^2,3

E-cigarettes, according to American Heart Association, are not safer than cigarettes and are made with many harmful substances including nicotine, which can impact learning, memory, and attention in developing adolescents. Additionally, these products often contain diacetyl, which has been linked to serious lung disease. Despite these risks, use continues to increase amongst adults, particularly adolescents, raising the concern that smoking may be “re-normalized” and decades of global efforts to reduce smoking could be undermined.³

In 2023, more than 2.1 million adolescents self-reported use of e-cigarettes, including 10% of high school students, of which 26.3% use the product daily. Experts and health care providers have continuously raised concerns about the marketing of flavored e-cigarettes, claiming they are more appealing to minors. Under a 2009 federal law, the FDA is required to control the use of tobacco and nicotine products used by adolescents. Over the years, the agency has repeatedly barred the marketing and distribution of various flavored e-cigarettes over concerns of risks to public health.²

Since the FDAs denial of approval for e-cigarette products, multiple companies have spoken out against the decision, claiming the agency unfairly disregarded arguments that flavored e-cigarette products help adults quit smoking tradition cigarettes without the risk to adolescents. Additionally, they claim the FDA changed its requirements in the middle of the approval process, leaving manufacturers without a sufficient warning. Despite this, the FDA remains firm in its position about the risk of flavored e-cigarettes on public health.⁴

"That is their argument," said Curtis Gannon, a lawyer from the Biden administration representing the FDA. "But I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth."¹

Supreme Court justices Elena Kagan, Ketanji Brown Jackson, and Brett Kavanaugh support the FDAs decision, citing little surprise over the denial of approval for flavored e-cigarette products.¹

"I guess I'm not really seeing what the surprise is here, or what the change is here," said Kagan. "There's just not a lot of mystery here about what FDA was doing. You might disagree with that, because you think that, in fact, the world of 40-year-olds really wants to do blueberry vaping, but you can't say that FDA hasn't told you all about what it's thinking in this respect."¹

Despite the confirmed dangers of these products, they remain widely available to consumers. Should the supreme court side with the FDA, e-cigarette manufacturers maintain the opportunity to reapply for approval. However, it can be speculated that the FDA will continue its stance that flavored e-cigarette products pose a significant public health risk to minors.

REFERENCES

1. Supreme court divided over fda block on kid-friendly flavored vapes. ABC News. December 2, 2024, Accessed December 3, 2024. https://abcnews.go.com/Politics/supreme-court-weighs-fda-block-kid-friendly-flavored/story?id=116232703

2. FDA battles vaping industry at the supreme court. NPR. December 2, 2024. Accessed December 3, 2024. https://www.npr.org/2024/12/02/nx-s1-5205471/fda-vaping-supreme-court

3. Is vaping better than smoking. American Heart Association. January 5, 2024. Accessed December 3, 2024. https://www.heart.org/en/healthy-living/healthy-lifestyle/quit-smoking-tobacco/is-vaping-safer-than-smoking

4. Supreme court grapples with FDA's refusal to approve flavored vapes. NBC News. December 2, 2024. Accessed December 3, 2024. https://www.nbcnews.com/politics/supreme-court/supreme-court-hears-fight-fdas-refusal-approve-flavored-vapes-rcna182018