7 Daze LLC Appeals FDA Issuance of a Marketing Denial Order
ONTARIO, Calif., Oct. 12, 2021 /PRNewswire/ -- 7 Daze LLC, a leading premium e-liquid manufacturer, revealed today that it has filed an appeal in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Food and Drug Administration (FDA) in response to FDA's issuance of a marketing denial order (MDO) for Reds Appletm by 7 Dazetm products.
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).
"7 Daze stands behind the quality of its in-depth and detailed PMTAs, which demonstrates that 7 Daze products are APPH, following all available FDA guidance," said John Lau, president of 7 Daze. Consistent with this guidance, the PMTAs included comprehensive product testing with the world's leading laboratory, perception and intent studies including multiple secondary tobacco comparative studies, in-vivo and in-vitro toxicological data, and completed randomized clinical trials. Despite submitting rigorous scientific and data driven PMTAs, 7 Daze was issued a MDO on September 8th, 2021.
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.
About 7 Daze
7 Daze is a leading e-liquid manufacturer based in Southern California. It is committed to providing adult-smokers with an alternative to traditional tobacco products. Since 2013, the company's products have been trusted by adult smokers in over 100 countries worldwide.
For more information and documentation, visit https://7dazemfg.com/pages/pmta/
Media Contact:
John Lau
866-447-3293
[email protected]
SOURCE 7 Daze LLC
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