FDA Rescinds Humble Juice Co.’s MDO

Flavored e-liquid products can continue to be sold while PMTA is under review
Humble Juice Co.

THOUSAND OAKS, Calif. — The U.S. Food and Drug Administration (FDA) rescinded a marketing denial order (MDO) issued for Humble Juice Co.’s flavored e-liquid products with pending premarket tobacco product applications (PMTAs). This is the latest of several MDOs the FDA has issued and later rescinded.

Humble Juice, Thousand Oaks, Calif., received the MDO on Sept. 15 and in October filed a petition with the U.S. Court of Appeals for the Ninth Circuit challenging the FDA’s decision and seeking to have the MDO vacated. Humble withdrew its petition as the FDA’s rescission of the MDO puts the brand’s flavored e-liquids back into the PMTA review process, the company said.

The FDA’s rescission letter said that upon further review, it identified information in Humble Juice’s PMTA that requires additional evaluation, and that it has no intention of initiating an enforcement action against Humble Juice’s flavored e-liquid products with pending PMTAs.

“FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” Humble Juice CEO Daniel Clark said. “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.”

In October 2020, Humble said it submitted PMTAs for 84 e-liquid products in various flavors, nicotine levels and sizes.

Retailers can download an Excel sheet of the latest MDO’s on the FDA’s website.  Notes on this sheet show the FDA has recently rescinded, partially rescinded or stayed MDO decisions for at least a dozen tobacco manufacturers.

Turning Point Brands, Louisville, Ky., was one of those companies. All Turning Point Brands’ proprietary vapor products, including its Solace branded e-liquids, will continue to be marketed while its PMTAs remain under review.

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