Close to a dozen major health groups are lending support to a lawsuit charging the FDA with harming the health of children, teens, and young adults by delaying regulation of non-cigarette tobacco products.
The lawsuit, filed in March by the American Academy of Pediatrics and others, challenges the FDA's decision to delay regulation of the products indefinitely.
In an , the American Thoracic Society and 10 other health organizations argued that the FDA's inaction on premarket review required by the 2016 rule regulating the e-cigarettes, cigars, and hookah tobacco products is causing harm and will continue to cause harm to the nation's youth.
Manufacturers of products introduced after February 2007, which includes almost all e-cigarettes, would have been required to make their case to the FDA for staying on the market by no later than next month before the delay.
Manufacturers of cigars now have until 2021 and e-cigarette makers have until 2022 to file premarket review applications under the delay, and the FDA can take as long as it wants to review those applications.
The delay was announced by FDA Commissioner Scott Gottlieb last summer as part of a sweeping policy overhaul regarding tobacco regulation.
"That means e-cigarettes and flavored cigars that have become so popular with teens and young adults can potentially stay on the market indefinitely," American Thoracic Society Tobacco Action Committee co-chair Enid Neptune, MD, told 鶹ý.
Dennis Henigan, of the Campaign for Tobacco Free Kids, said the explosive growth of the Juul e-cigarette brand serves as a cautionary tale about the danger of delaying FDA regulation of e-cigarettes and little cigars, which are now far more popular among teens and young adults than traditional combustible cigarettes are.
In just 3 years on the market, Juul has become the best selling e-cigarette in the United States. While no official figures on sales to teens have been released, the brand has reportedly become so popular with adolescents and young adults that the FDA recently called out the manufacturer, demanding documents to help "better understand the reportedly high rates of youth use and the particular youth appeal of these products."
"There could not be a more dramatic demonstration of the public health consequences of the FDA's inaction than the growth of Juul," Henigan said. "The decision to suspend the public health review of e-cigarette products got us where we are today with this product."
"Had it not been for the decision to delay, the manufacturers of Juul and other e-cigarettes would have had to demonstrate that their products are appropriate for the protection of public health by next month (August, 2018). That is their burden. Since Juul delivers a very potent dose of nicotine and threatens to addict a whole new generation of kids, it is a burden I'm certain they can't meet."
In a 2016 report, the U.S. Surgeon General identified the dramatic growth in e-cigarette use among the nation's teens and young adults as a major public health concern, concluding that the evidence suggests that nicotine exposure can harm the developing brain.
And in a comprehensive review of the e-cigarette research published in January, the National Academy of Sciences concluded that evidence supports the conclusion that e-cigarette use in adolescence is associated with an increased risk for smoking combustible cigarettes.
"Every day these products remain on the market, more and more kids will be attracted to them," Henigan said. "By taking the FDA out of the game, the Commissioner has perpetuated a wild, wild west atmosphere toward e-cigarette development and marketing, which has led to the situation we now find ourselves in."