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7 Daze LLC Appeals FDA Issuance of a Marketing Denial Order

October 12, 2021 2 min read 0 Comments

7 Daze LLC Appeals FDA Issuance of a Marketing Denial Order

What happened?

7 Daze's PMTAs included comprehensive product testing with the world's leading laboratories, 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.

Why this matters.

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).

What happens now?

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.

As a result, we at 7 Daze have filed a 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.

For additional information, visit About the PMTA.

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