FDA EIR - Santa Fe Natural Tobacco Company - Tobaccoville - April 15, 2015

An FDA surveillance inspection of Santa Fe Natural Tobacco Company, Inc. in Oxford, NC, was conducted from April 14-15, 2015. The inspection, performed under the authority of Public Law 111-31 (Tobacco Control Act), Chapter IX of the FD&C Act, and 21 CFR 1140, focused on the manufacturing of Natural American Spirit brand cigarettes and roll-your-own tobacco. Areas reviewed included raw material receipt and storage, finished product handling, product listing, written procedures, training materials, packaging, labeling, and advertising requirements. Crucially, the inspection revealed no objectionable conditions, and therefore, no FDA Form 483 was issued. The company's management was highly cooperative, providing all requested information and expressing a commitment to comply with current and future FDA regulations. Although specific Tobacco Product Manufacturing Practices (TPMP) had not yet been promulgated by the FDA, the agency's Regulatory Counsel advised Santa Fe Natural Tobacco Company to review Section 906(e)(1) of the Act and consider general principles from current Good Manufacturing Practices (cGMPs) in other FDA-regulated sectors, such as Foods (21 CFR Part 110), Drugs (21 CFR Parts 210, 211), and Medical Devices (21 CFR Part 820). The company was also directed to the Center for Tobacco Products (CTP) website for the latest guidance.