Prompted by company’s judicial petition to have MDO vacated, federal regulator’s action restores flavored e-liquid maker’s PMTA, allowing Humble Juice to continue marketing its product while status remains pending.
Electronic nicotine delivery system (ENDS) e-liquid maker Humble Juice Co. announced that the U.S. Food and Drug Administration (FDA) has rescinded the marketing denial order (MDO) issued Sept. 15, 2021, for Humble’s flavored e-liquid products with pending Premarket Tobacco Product Applications (PMTAs).
Humble had filed a petition in October with the U.S. Court of Appeals for the Ninth Circuit, challenging the FDA’s decision and seeking to have the MDO vacated. Following the receipt of the rescission letter, Humble withdrew its petition as FDA’s rescission of Humble’s MDO places the brand’s flavored e-liquids back into the PMTA review process and provides Humble with a pathway to market its products while its PMTAs are pending.
FDA’s rescission letter states that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”
The agency also stated that due to the unusual circumstances, it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs. Humble will continue to market its products while its application remains in the review process.
“FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”
Founded in 2015 by Clark, the Southern California-based company was born from a single idea: Hardworking, honest people can make high-quality vape e-juice at an affordable price. That humble goal has resulted in the brand’s demand both domestically and internationally, a robust e-commerce and retailer presence, and a thriving innovation pipeline.
Humble is committed to producing flavor-filled and compliant e-juice, and is currently undergoing the PMTA process with the FDA.
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November 13, 2021 at 02:07AM
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FDA Rescinds Denial Order After Humble Juice Challenge - Convenience Store Decisions
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