Abstract: Product changes are an integral part of quality improvement and innovation, whether it is for design improvement, supply chain constraints, product standard compliance or business requirements. Navigating the regulatory landscape when product changes are needed is a challenge when changes may potentially result in the product being considered a new tobacco product in the context of PMTA. Section 910(a)(1)(B) of the FD&C Act states that new tobacco products include those that are new because they have been rendered new through any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007.

The FDA has classified “minor” and “major” amendments in terms of their impact on the PMTA review process, but guidance is vague in terms of classification of changes themselves and how to report those changes. The FDA provides examples in the Premarket Tobacco Applications (PMTA) Final Rule, PMTA ENDS guidance and the proposed Tobacco Product Manufacturing Practice rule (TPMP). The aim of this poster is to propose a systematic classification of the changes, establish how to address change requests, change assessment and change order via Good Change Control Practices and how it should be reported to the FDA.

The approach presented below is based on multiple FDA guidance documents and regulations on product changes and when to report to the FDA that have been implemented across regulated industries:

• FDA Medical Device Guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device

• FDA ANDA/NDA Guidance: Changes to an Approved NDA or ANDA

• FDA PMTA Final Rule: Premarket Tobacco Products Applications and Record keeping Requirements.

• FDA Proposed TPMP requirements


Lise Fraissinet, Lillian Ortega, Chris Woodruff, Randy Freund, Bryan Burd, Kevin Burd

Affiliations: Chemular, Inc, Hudson, MI, USA