Tobacco FDA Compliance Consulting Services
At FDA Compliance Group, our FDA consultants have worked for the FDA or have extensive experience in the tobacco and nicotine products industry. We can help you reach and maintain full FDA compliance with all applicable tobacco regulations and requirements.
FDA Authority Over Tobacco and Nicotine Products
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 marketed in the United States must have appropriate FDA authorization. Depending on the product, this may involve tobacco products being:
- Grandfathered for marketing if they were commercially marketed in the United States prior to February 15, 2007
- Substantially equivalent to a grandfathered tobacco product as demonstrated through a Substantial Equivalence (SE) application to the FDA
- New tobacco products, those not commercially marketed in the United States prior to February 15, 2007, that receive a marketing granting order (MGO) through a Premarket Tobacco Application (PMTA) submission to the FDA
Tobacco Product Manufacturing Practices and cGMP QMS
Section 902 and 906(e)(1) of the Food, Drug, and Cosmetic Act (FDCA), which was added with the passage of the Tobacco Control Act, 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).
For tobacco, these cGMPs are referred to as Tobacco Product Manufacturing Practices (TPMPs). The proposed TPMPs were published in the Federal Register with the Notice of Proposed RuleMaking (NPRM) on March 10, 2023. The FDA has proposed TPMP regulations using an “umbrella” approach in 21 CFR 1120 for finished and bulk tobacco products.
A cGMP quality management system (QMS) must be in place for compliance with the proposed TPMPs. The QMS is the formal, documented system that defines controlled processes and procedures so you can obtain and consistently maintain product quality and regulatory compliance. This cGMP QMS will be assessed upon an FDA onsite inspection, Remote Regulatory Assessment (RRA), Remote Interactive Evaluation (RIE), or Pre-Approval Inspection (PAI) for new tobacco products.
FDA Compliance Group can help you build, upgrade, and maintain a cGMP QMS that aligns with TPMP expectations and supports your FDA tobacco compliance checks and inspections.
GMP, HACCP, and Tobacco Quality Systems
We can assess your manufacturing, quality, and laboratory systems and provide guidance on developing or enhancing a quality system that is appropriate for tobacco and nicotine product regulation. This includes GMP and HACCP aligned processes, documented controls for raw materials and finished products, and monitoring systems that support consistent, compliant production.
FDA Tobacco Inspections and Warning Letters
We help you fully prepare for FDA tobacco inspections, from pre audit readiness to onsite support during the inspection. If you receive an FDA Form 483 or FDA Warning Letter, we can help you analyze the findings and craft robust written responses. Strong, timely responses to 483s and Warning Letters can often prevent further regulatory action.
FDA Imports and Detention for Tobacco Products
Our consultants can assist with FDA import compliance for tobacco and nicotine products. This includes reviewing your import operations, documentation, and labeling, and providing guidance if products are detained or subject to automatic detention.
Pre-Production Design Controls
We provide training in design controls, with emphasis on pre-production design validation, so you can begin design and development with FDA terminology and regulations in mind. This helps you establish clear specifications, design reviews, and change controls that support both TPMP compliance and marketing authorization requirements.
Nonclinical Studies and Laboratory Operations
We can assist you with the development of nonclinical studies, both in vivo and in vitro, including CRO selection, trial evaluations, study monitoring training, and complete training on applicable FDA requirements. We audit onsite and contract laboratories for compliance with FDA expectations for current good manufacturing practices and TPMP related controls, so your laboratory and testing procedures are aligned with the specific FDA requirements for tobacco products.
For more information on FDA consulting services for tobacco and nicotine products, or to schedule a consultation, please contact FDA Compliance Group.