FDA Meets Court Deadline – But Fails to Address Major E-cigarette Makers

This week, the FDA met a court-imposed deadline to review and decide on pre-market tobacco product applications, including all e-cigarettes and a majority of candy-flavored cigars. The agency issued decision letters to hundreds of companies, covering nearly 6.5 million unique tobacco products, but did not issue decision letters on products from major e-cigarette makers like Juul, Njoy, Puffbar and others. The FDA also did not provide any summary statements on which classes of products were approved and which were rejected. In statements to the public about their decision, the FDA implied they were unable to be more transparent about their decisions due to product confidentiality concerns, saying, “FDA understands that the public may be interested in the specific names of the currently marketed products subject to the negative decisions. However, before releasing this information, FDA needs to ensure the Agency is not releasing the applicant’s commercial confidential information. Given the large number of products involved, sharing this information requires additional time and resources. Accordingly, FDA is actively exploring options related to this issue.”

“How the FDA could fail to make a decision on Juul products is beyond me,” said ATS Tobacco Action Committee Chair Michelle Eakin, PhD.  “Juul has the largest share of the e-cigarette market, and its products were a primary driver in the sky-rocketing rise in youth e-cigarette use. The FDA has delayed long enough. Until the agency addresses Juul, Puffbar and other companies that are driving the youth e-cigarette market, it is failing to do its job.”

The ATS will continue to demand that the FDA issue and implement an effective regulatory strategy to reduce youth tobacco use – including e-cigarettes— and reduce overall tobacco dependency in the U.S.