With e-cigarettes—especially fruity-flavored ones that taste, for example, like peach soda—fueling youth tobacco use today, the Litigation Center of the American Medical Association and State Medical Societies and others are urging a federal appeals court to uphold a decision that stops companies from marketing these products.
In an effort to protect public health, the Food and Drug Administration (FDA) denied flavored e-cigarette makers their request to market certain products. Under the Family Smoking Prevention and Tobacco Control Act, the FDA must approve marketing plans before companies can go forward with them. The companies must demonstrate, among other things, that marketing the product would be “appropriate for the protection of public health.”
E-cigarette companies sought review of the FDA’s decision, claiming the administration didn’t consider certain evidence they submitted about the products’ potential public health benefits, such as reduced harm compared to smoking and marketing plans to curb youth uptake of vaping. They also claim, among other things, that the FDA essentially put a ban on marketing these products without a formal rulemaking process.
In their amicus brief, the AMA Litigation Center, the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, the Louisiana State Medical Society and five other national and state public health and community organizations said the FDA followed the law and that the decision to not allow the marketing to move forward was the right one for public health.
The brief tells the court that the FDA’s review focused on the two competing factors that the Tobacco Control Act directs them to consider, namely the likelihood that the product will:
- Help existing tobacco users stop using tobacco products.
- Lead nontobacco users, including youth, to begin using such products.
The “FDA found overwhelming evidence that Petitioners’ flavored e-cigarettes, including menthol, are highly attractive to youth—to a much greater degree than tobacco-flavored products—and pose serious risks of addiction and other health harms, particularly to young people,” the AMA Litigation Center and others said in the amicus brief they filed in the case, Breeze Smoke LLC v. Food & Drug Administration.
In addition, the brief says, the “FDA found the scientific literature to be conflicting on whether flavored products are more effective than tobacco-flavored e-cigarettes in helping adult smokers to stop smoking” and said it was “entirely reasonable” for the FDA to ask the companies to submit “robust countervailing evidence of the benefit of their flavored products versus tobacco-flavored products in aiding smokers to stop smoking.”
Youth prevention essential
Using tobacco products continues to be the leading cause of preventable deaths in the U.S., with nearly a half million deaths a year tied to tobacco use. Preventing smoking among adolescents is key to bringing that number down.
Citing the Technical Project Lead Review the FDA issued to one of the companies, the brief from the AMA Litigation Center and others notes that “use of tobacco products, no matter what type is almost always started and established during adolescence when the developing brain is most vulnerable to nicotine addictions.”
The statistics show that almost 90% of adult daily smokers started smoking by 18, yet those who reach 26 without ever using cigarettes will most likely never become daily smokers.
Other substantial evidence shows that e-cigarette use increases the risk of youth and young adults ever using combusted tobacco cigarettes.
While the companies tell the 5th U.S. Circuit Court that they are taking issue with the “targeted review” the FDA used to determine if their applications included “evidence that is capable of showing a sufficient benefit to adult smokers that could outweigh the known and substantial risk to youth,” the AMA Litigation Center and others noted that focusing on that evidence meets the public health standard that the Tobacco Control Act established.
“Absent such evidence, FDA is statutorily required to deny an application,” the brief says.
Flavored e-cigs especially appealing
The most recent National Youth Tobacco Survey shows that more than 2.5 million youth—including 14.1% of high schoolers—reported currently using e-cigarettes. The survey further shows that 85.5% of high-school e-cigarette users and 81.5% of middle-school users reported using a flavored product.
On top of that, more than 70% of current youth e-cigarette users reported using e-cigarettes because of those flavors. And more than 93% of youth users reported that their first e-cigarette product was flavored, higher than the 54.9% of e-cigarette users 25 or older who reported that.
Because the appeal to youth is so high and general literature about whether flavored products helped smokers stop smoking was inconclusive, it was reasonable for the FDA to ask companies for robust evidence to support that claim, the brief says. The consumer-use surveys that companies summitted were not sufficient and, contrary to the companies’ “characterization, FDA did not deny these applications ‘based on the alleged absence of a few selected data points.’”
Find out more about the cases in which the AMA Litigation Center is providing assistance and learn about the Litigation Center’s case-selection criteria.
