At TMAs 103rd Annual Meeting held on Tuesday, April 10, 2018, Dr. Zeller confirmed that FDA is actively working on a number of priorities that he called “Foundational Rules and Guidances”. This includes the issuing of the Tobacco Product Manufacturing Practice (TPMP) Rule which is required by Section 906(e) of the Tobacco Control Act addressing Good Manufacturing Practice (GMP) Requirements, which the FDA now calls TPMPs. Mr. Zeller made it clear that the FDA is “hard at work” on this rule.
When asked about when the industry can expect this Foundational Rule and Guidance for TPMPs to be issued by the FDA, Mr. Zeller declined to comment on a specific timeline, however, he did stress that the rule, along with the other foundational rules and guidance, is a priority for CTP. FDA is actively working on these and is committed to issuing the TPMP rule as soon as possible.
The tobacco industry should begin prioritizing manufacturing and quality processes assessments to begin preparing for and implementing quality systems, manufacturing controls, documentation, and SOPs. Based on Mr. Zeller’s presentation, the impending issuance of Tobacco TPMPs in conjunction with FDA’s new priorities indicates this preparation should begin sooner rather than later.
Posted in FDA and USDA Regulatory Update, Tobacco.