WASHINGTON, D.C. – On May 15, U.S. District Judge Paul W. Grimm ruled that the Food and Drug Administration (FDA) acted illegally when, in August 2017, it allowed e-cigarettes to remain on the market until 2022 before applying for FDA authorization (and also allowed products to stay on the market indefinitely during FDA review). Ruling in a lawsuit filed by our public health and medical organizations, Judge Grimm found that the FDA’s delay exceeded the agency’s legal authority and played a role in the skyrocketing youth use of e-cigarettes. The judge ordered our organizations (the plaintiffs) and the government (the defendant) to propose remedies to implement his ruling.
On May 29, our organizations filed a brief urging Judge Grimm to set a deadline of 120 days from his final order for manufacturers to submit applications for their products to stay on the market and to allow products that are the subject of applications to remain on the market for up to one year while the FDA considers the applications. We also urged the judge to order the FDA to report regularly to the Court on its implementation of these requirements.
Late Wednesday, the government filed its brief in which it asserted that the court has no authority to require the FDA to take specific actions and stated “the Court should simply remand to the FDA to permit it to choose a course of action consistent with the Court’s opinion.” The government’s brief also stated that “should the Court order premarket applications to be submitted by a date certain, it should set that deadline no sooner than 10 months from the date of its decision, along with a one-year period for FDA review.”
The government’s “trust us” approach is a recipe for even more delay in subjecting e-cigarettes to public health review. The delays to date have allowed e-cigarette manufacturers to sell products in a huge assortment of kid-friendly flavors and set the stage for the youth e-cigarette epidemic. Further delays are not justified from a legal standpoint, and they are harmful to our nation’s children and public health. As Judge Grimm recognized in his May 15 opinion, the FDA’s delay of product review deadlines gave manufacturers a “holiday from meeting the obligations of the law” and allowed manufacturers to “continue to advertise and sell products that are addictive and that target a youth market.”
Judge Grimm was absolutely right in stating that “manufacturers have long been on notice that they will have to file premarket approval applications… and if they have chosen to delay their preparation to do so, then any hardship occasioned by their now having to comply is of their own making.” In its latest brief, the government itself stated that, while the FDA delayed the product review deadlines, “manufacturers were not precluded from submitting applications earlier – in fact, the agency has repeatedly encouraged them to do so.” E-cigarette manufacturers have no one to blame but themselves if they are not ready to submit the required applications.
It is time for the FDA to stop making excuses and to meet its legal obligation to subject e-cigarettes to public health review. The FDA cannot and must not give e-cigarette manufacturers more time to keep addicting kids.
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.
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