Juul, the e-cigarette, has scored a big win as the Food and Drug Administration rescinded its marketing ban on the product on Thursday.
Two years ago, the government ordered Juul Labs to remove its e-cigarettes and vaping products from stores and online shops. The products remained on the shelves pending an appeal.
The company claimed that its products could be used to stop smoking cigarettes – and came during a massive rise in the use of e-cigarettes.
The FDA blocked Juul’s application after a two-year review, finding the documents “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law.”
The FDA has now announced that it would be rescinding the action due to new case law and the agency’s review of information that had been provided by the the company. The move does not indicate whether the marketing applications are likely to be authorized or denied, the agency said in a news release.
The application is currently under pending status. Agency regulations limit what officials can say regarding pending applications.
The review does not change the fact that all e-cigarette products are required to have FDA authorization to be legally marketed, the agency said.
In response to the update, Juul Labs stated they “appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.
“We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health.”
Congress had previously given the FDA the authority to regulate the manufacturing and distribution of tobacco products. E-cigarette companies were then required to submit their products for reapproval but were able to keep selling e-cigarettes in the meantime.
