The Jones Labs Receives PMTA, MRTP Filing Letters

The Jones Labs announced it has received filing letters from the U.S. Food and Drug Administration (FDA) for both its premarket tobacco product application (PMTA) and its modified-risk tobacco product application (MRTP).

The Jones Labs pods
Credit: The Jones Labs

“The Jones product family is being evaluated for safety and efficacy as alternatives to combustible cigarettes and their comparable safety to smoking the Harmful or Potential Harmful Constituents (HPHCs) of combustible cigarettes,” a press release states. “As a leader of pre-August 8 [the FDA’s deadline for a product to be on the market to be eligible to remain on the market while going through the PMTA process] compliance, The Jones Labs registered with the FDA in July 2016 in preparation for Electronic Nicotine Delivery System regulations.”

The Jones Labs states that the potential of electronic drug-delivery systems remains at the core of its technology. “Due to our record of compliance with the Center for Tobacco Products (CTP), our products are eligible for enforcement discretion until our application process has been completed,” the release states.

The core technology of The Jones Labs submissions are based in “Buffered Aerosol Drug Delivery,” a review article published in the inaugural edition of the United Journal of Drug
Development and Industrial Pharmacy. “The technology submitted for review is being further
developed in parallel to address other cessation and medicine-assisted therapeutic needs in the market,” the review states. “With this unique drug-delivery platform technology they stand to disrupt the established order of all smoking and smokeless products, cannabis or tobacco.”

The Jones Labs offers universally compatible tobacco vapables as an alternative to
smoking combustible cigarettes, the release states. “With multiple present and future product offerings similar to The Jones Pods (www.thejonespod.com), we are developing Rise, by The Jones (www.risebythejones.com), a state-of-the-art smoking cessation platform that utilizes the core technology for replacement and cessation therapies across the board.”