Santa Fe Natural Tobacco Company - Tobaccoville – FDA EIR, Feb 1, 2018

A comprehensive FDA inspection of Santa Fe Natural Tobacco Company, Inc. - Oxford took place from January 30 to February 1, 2018. This inspection was conducted under the authority of Public Law 111-31 (Tobacco Control Act), Chapter IX of the Federal Food, Drug, & Cosmetic Act (FD&C Act), and 21 CFR 1140. The primary focus addressed previous violations from an April 2015 inspection, which resulted in a Warning Letter issued on August 27, 2015. The main issue was the unauthorized use of "Additive-Free" and "Natural" descriptors on cigarette products without an appropriate FDA order as required by section 911(g) of the FD&C Act. During this latest inspection, the company demonstrated corrective actions by confirming the removal of these descriptors from all Natural American Spirit packaging and advertising, with cessation of distribution for non-compliant products by December 2017. All remaining problematic labeling materials were destroyed. No new objectionable conditions were identified, and an FDA 483 (Inspectional Observations) was not issued. Management was reminded of their ongoing responsibility to ensure all tobacco products comply with section 911 and other applicable FD&C Act provisions, including pre-market approval, to prevent future regulatory actions.