FDA illegally delayed action on e-cigarettes
A federal judge has ruled that the Food and Drug Administration (FDA) acted illegally when it delayed a required review of the public health impact of e-cigarettes – a delay that allowed the products to stay on the market until 2022. Cigar makers were given until 2021.
In what health experts are calling a major victory for children’s and teen’s health, U.S. District Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ruled that the FDA had exceeded its legal authority in giving e-cigarette manufacturers more time to sell their products before applying for FDA authorization.
Candy flavors, young users
The ruling results from a lawsuit filed by Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative and individual pediatricians that challenged the FDA’s decision. The lawsuit argued the FDA’s decision was unlawful, and put kids at special risk because of the many flavored e-cigarettes – including candy, fruit, mint and menthol - that they say are designed to appeal to young consumers.
Judge Grimm concluded that the FDA’s delay gave “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”
“Instead of addressing public health concerns associated with tobacco use by minors and others, the August 2017 Guidance [which delayed the product review requirement] exacerbates the situation by stating, in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market … at a time when minors’ use of tobacco products like e-cigarettes is at an epidemic level and rising,” Judge Grimm wrote.
Five more years to get more addicted to nicotine
“Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved – results entirely contrary to the express purpose of the Tobacco Control Act,” Judge Grimm continued.
The judge noted that e-cigarette makers have been aware of the regulatory requirements for some time.
“Manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports, and exemption requests, and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making.”
About the lawsuit
The lawsuit was filed on March 27, 2018, by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual pediatricians.
The health groups are being represented by the legal staff of the Campaign for Tobacco-Free Kids, lawyers at Democracy Forward Foundation and the law firm of Brown, Goldstein & Levy.