XXII In December of 2018, the Company submitted Modified Risk Tobacco Product (MRTP) and related PMT applications to the FDA for the Company’s VLNC cigarettes. Together, these important applications seek the FDA’s authorization to commercialize the Company’s VLN™ cigarettes and to communicate to consumers that VLN™ cigarettes contain at least 95% less nicotine as compared to the 100 leading cigarette brands in the United States.
The FDA’s inspection was a highly anticipated component of the third phase of the FDA’s four phase review process for the PMT application. The FDA’s stated goal for the inspection was “to verify the information and data contained in the [PMT] application.” As such, the FDA inspectors witnessed production of 22nd Century’s proprietary VLN™ cigarettes. In addition, FDA inspectors reviewed 22nd Century’s raw material receiving and storage procedures, quality control processes, manufacturing equipment and systems, tobacco processing methods, and finished-products analyses procedures.
Concurrent with the FDA’s review process for 22nd Century’s MRTP and PMT applications, the FDA is pursuing a proposed rule that, when finalized and effective, would limit the amount of nicotine in all cigarettes sold in the United States to “minimally-addictive or non-addictive levels.
22nd Century’s proposed VLN™ cigarettes – with a target concentration of 0.5 mg nicotine per gram tobacco – fall squarely within the nicotine range that public health officials anticipate will be mandated by the FDA, and that will simultaneously enable the WHO to advance its global nicotine reduction agenda. For these reasons, when 22nd Century’s proprietary VLNC cigarettes achieve MRTP status, they could serve as a powerful tool and precedent in support of the FDA’s broader national nicotine reduction mandate.
