An e-vape liquid company in California has scored brief levity from the FDA.
THOUSAND OAKS, Calif. — The Humble Juice Co., an e-liquid maker based north of Los Angeles, announced recently that the US Food and Drug Administration (FDA) has reportedly rescinded a marketing denial order (MDO) which the agency issued on September 15, 2021. The company’s flavored e-cigarette products were the subject of the MDO during the PMTA process.
Tobacco Reporter indicates that Humble filed a petition in October with the US Cort of Appeals for the Ninth Circuit.
The petition challenged the US FDA’s decisions to place the MDO on their products. Humble indicates that they removed the legal filing after the rescission letter was issued.
“FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Daniel Clark, the chief executive officer of Humble, in a statement. “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,” Clark added in the press statement.
FDA’s rescission letter states that Humble’s PMTA requires much more 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 adds that the change was due to what the FDA characterizes as “unusual circumstances” and it “has no intention of initiating an enforcement action” against any of Humble’s flavored e-liquid products with pending PMTAs.
“A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health,” states FDA’s Center for Tobacco Products. “In order to reach such a decision and to authorize marketing, FDA considers…among other things: Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers.”
This includes “whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available; and
Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available.”