Last month we told you about a ruling in federal court in an e-cigarette lawsuit where the American Academy of Pediatrics (AAP), the Campaign for Tobacco Free Kids, and a number of other health groups were suing the Food and Drug Administration (FDA). Back in May, Judge Paul W. Grimm ruled that the Food and Drug Administration (FDA) was to begin reviewing thousands of e-cigarette products currently on the market within 30 days. In his ruling, Grimm called the FDA’s delay in reviewing vaping products, “so extreme as to amount to an abdication if its statutory responsibilities.” The lawsuit was filed in federal court in Maryland in 2018. The FDA has the right to appeal the decision, and we’re certain that’s coming.
This week Soupwire learned that the American Academy of Pediatrics, who are the plaintiffs in the e-cigarette lawsuit, filed a proposed remedial order seeking an “appropriate remedy” asking Judge Grimm to order the FDA to move the FDA’s (Pre-Market Tobacco Application) PMTA deadline to 120 days — a mere four months from the judge’s order. This speeds up the timeline dramatically for every vaping company in the U.S. (and by “dramatically”, we mean, by two whole years), not to mention the FDA — who would have to review thousands and thousands of products in the space of a few months. The proposed order, if signed off on by judge Grimm, would also require the FDA to give a status report every 90 days.
E-liquids and E-cigarettes introduced prior to August 8, 2016 would likely not be affected by this lawsuit or the judge’s final ruling unless they have filed for a PMTA (Pre-Market Tobacco Application) due to a change in packaging, ingredients, etc. after August 8, 2016.
Attorney Gregory Conley, President of the American Vaping Association, told Soupwire, “The AAP is a prohibitionist group and that fact is reflected in their proposed order. With the exception of large tobacco companies and perhaps JUUL, no company is prepared to file a PMTA in the timeframe they propose. Tens of thousands of products that are being used today to help smokers and ex-smokers improve their health will be removed from the market if AAP gets their way. The FDA has still not released final guidance on what should be in a PMTA for a vapor product, so any company attempting to file an application will be completely at the mercy of the FDA and their frequently changing standards.”
The FDA has until June 12, 2019 to respond to the AAP’s proposed order, as well as the right to file an appeal.
Soupwire will continue to follow this case and bring you the latest vaping news.