NASCO Products LLC – FDA EIR, Jul 7, 2016

An FDA inspection of NASCO Products, LLC, a cigarette manufacturer in Mocksville, NC, occurred on July 6-7, 2016, under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. The inspection, directed by the Center for Tobacco Products (CTP), primarily focused on manufacturing, advertising, and labeling practices. While no major sanitation deficiencies were found and no Form FDA 483 (Inspectional Observations) was issued, the inspection revealed several key issues. Notably, the firm continued to use a statement in print advertising for its "Red Sun" brand, implying a "corporate mission to reduce the harm caused by smoking," despite a previous commitment to remove a similar statement from social media. This claim was found within their "extremely nicotine" marketing campaign, which also asserted "highest nicotine content of any cigarette sold in America," requiring substantiation from the company. Additionally, the inspection identified a lack of a formal, documented employee training program and the absence of a written recall procedure for tobacco products. Management committed to discussing the removal of the misleading "reduce harm" statement from all advertising and agreed to inform the FDA in writing of their decision. Physical samples of Red Sun and Red Sun Bold Cold Menthol cigarettes were collected for laboratory analysis. The firm, through its attorney, declined to sign a Form FDA 463a Affidavit.