updated Oct 11, 2021
7 Daze™ has been one of the leading e-liquid manufacturers in the industry since its inception in 2014. With our unparalleled quality of flavors and customer satisfaction, we’ve developed a paramount reputation among users around the globe.
We earnestly strive to manufacture tobacco alternatives for adult smokers while placing considerable emphasis on anti-vaping practices in minors, and we continue to grow on that commitment. 7 Daze™ operates closely within FDA guidelines and maintains a strict adherence to all federal, state, and local regulations.
All manufacturers of electronic nicotine delivery systems (ENDS) were required to submit a Premarket Tobacco Application (PMTA) to the FDA by the September 9th, 2020 deadline to continue selling ENDS products in the United States. Following a PMTA submission, manufacturers were allowed to market its products with a grace period of a year while the FDA evaluated the scientific studies and data presented in the applications submitted to ensure that the products are appropriate for the protection of the public health (APPH).
While 7 Daze™ remains committed to regulatory compliance and the premarket review process, the company respectfully submits that the MDO is defective and unlawful on multiple grounds, including that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, procedurally and substantively flawed, and otherwise not in accordance with law.
7 Daze’s filing request that the Court vacate or modify the order, in whole or in part; provide interim relief to stay the order, restore the status quo, and ensure that 7 Daze may continue to market its products subject to the order; and otherwise provide all appropriate relief to which 7 Daze™ may be entitled.
You may view the documentation of our appeal here: