On Tuesday, the Food and Drug Administration (FDA) issued a press release stating that they have filed requests through the Department of Justice (DOJ) for permanent injunctions against six e-cigarette distributors.
This request, the release says, comes after multiple warnings and notices from the FDA informing the companies that the products they were distributing were not FDA approved and were in violation of the law. At this point, the FDA asserts that all six companies, Morin Enterprises Inc., Soul Vapor LLC, Super Vape’z LLC, Vapor Craft LLC, Lucky’s Convenience & Tobacco LLC, and Seditious Vapours have all been made fully aware of their failure to submit premarket applications for their products, and continue to knowingly break the law.
Some of these companies seem to be behaving in an intentionally difficult manner in an attempt to keep their production going. For example, in the complaint against Super Vape’z the FDA claims that after inspecting their facilities, they found hundreds of illegal products. The FDA sent a letter informing them of these violations, and cited a specific example of one of the violations. In response, Super Vape’z chose to only discontinue the one cited flavor despite the mention of over 700 products, and the assertion by the FDA that “the violations discussed in this letter do not necessarily constitute an exhaustive list.”.
Brian M. Boynton, the head of the Justice Department’s Civil Divisions, stated that “These cases are an important step in stopping the illegal sale of unauthorized electronic nicotine delivery system products. The Department of Justice will continue to work closely with FDA to stop the distribution of illegal, unauthorized tobacco products.”
Since the late 2010s, the e-cigarette market has been the subject of much speculation with the rise of their use amongst the American youth. One remedy was to ban the use of any flavored E-liquids, which vape company JUUL had made quite popular.
The FDA release states that “Between January 2021 through Sept. 9, 2022, the FDA issued nearly 300 warning letters, to firms that collectively have more than 17 million e-cigarettes listed with the agency, for failure to submit a timely premarket application.”
The release also warns that “It is illegal to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty.” In the case of these six companies, the DOJ requests that they be permanently restrained and enjoined from selling unlawful, misbranded products, and that these businesses have their facilities and records inspected.
