FDA EIR - NASCO Products LLC - April 26, 2019

An FDA inspection of NASCO Products LLC, a tobacco product manufacturer in Mocksville, NC, was conducted from April 23-26, 2019. The inspection, performed under the authority of the Family Smoking Prevention and Tobacco Control Act, verified information and data submitted in Premarket Tobacco Applications (PMTAs) for 22nd Century Group, Inc.'s Very Low Nicotine (VLN™) cigarettes. Although no formal Inspectional Observations (Form FDA 483) were issued, several areas were discussed for improvement. These included ensuring manufacturing practices and quality assurance measurements for VLN™ cigarettes consistently aligned with PMTA descriptions. Additionally, product packaging and labels must accurately reflect commercially distributed items, with consumer complaint contact information reviewed. Management was also advised on the importance of developing comprehensive written Corrective Action and Preventative Action (CAPA) procedures, conducting a complete Hazard Analysis for VLN™ products, implementing statistically sound finished product sampling plans, formally validating manufacturing equipment, and standardizing nicotine testing methods by external laboratories. NASCO Products LLC acknowledged its responsibilities under the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act.