tobacco

The Family Smoking Prevention and Control Act (Tobacco Control Act or TCA) of 2009 and the subsequent Deeming Rule of 2016  gave the United States (U.S.) Food and Drug Administration (FDA) the authority to regulate all tobacco products and nicotine derived tobacco products to protect the public health and reduce tobacco use by minors. Deemed tobacco products are e-cigarettes and other electronic nicotine delivery systems (ENDS), cigars, pipe and hookah tobacco, nicotine gel, and dissolvable nicotine products. The Consolidated Appropriations Act of 2022, further extended the jurisdiction of the FDA and application of the TCA to all products containing nicotine from any source.

All tobacco products must be approved for marketing in the U.S. by the FDA. Tobacco products may be:

• Grandfathered for marketing if they were commercially marketed in the U.S. prior to February 15, 2007;
• Substantially equivalent to a grandfathered tobacco product as demonstrated through a Substantial Equivalence (SE) application to the FDA; or
• New tobacco products, those not commercially marketed in the U.S. prior to February 15, 2007, that receive a marketing granting order (MGO) through a Premarket Tobacco Application (PMTA) submission to the FDA.

Section 902 and 906(e)(1) of the Food, Drug, and Cosmetic Act (FDCA), which was added with the passage of the TCA, states that a tobacco product is considered adulterated if the methods used in, and the facilities and controls used for, the manufacture, preproduction design validation (including a process to assess the performance of a tobacco product), packing, and storage of a tobacco product do not conform to Current Good Manufacturing Practices (cGMPs). Tobacco product cGMPs, that will be referred to as Tobacco Product Manufacturing Practices (TPMPs), have not yet been promulgated by the FDA, but they are a foundational rule that the Center for Tobacco Products (CTP) is working on. Although TPMPs will eventually more specifically, detail tobacco cGMP requirements, compliance to general cGMPs is already a TCA requirement. 

A cGMP quality management system (QMS) must, therefore be in place at all tobacco facilities to consistently manufacture, package, label, hold, distribute, and test tobacco products and ensure the FDA approved finished product specification has been met. The QMS is the formal, documented system that dictates all controlled processes and procedures to obtain and consistently maintain product quality and regulatory compliance. This cGMP QMS will be assessed upon an FDA on-site inspection, Remote Regulatory Assessment (RRA), Remote Interactive Evaluation (RIE), or Pre-Approval Inspection (PAI) for new tobacco products.

TLC Regulatory and Laboratory Consulting can provide assistance to clients with the development, improvement, and implementation of a cGMP QMS, and all preparation efforts for an FDA assessment and communications thereof.