Deployments Related to U.S. Food and Drug Administration (FDA) Supplemental Guide, DRAFT Version 2.6 are Scheduled for November 20 and 21, 2025

This is a reminder regarding the next two deployments related to "FDA Supplemental Guide, version 2.6", announced in CSMS #66347264.
Refer to the attachment for a visual of the scheduled FDA changes.
The following changes with a WARNINGS severity will be deployed to Production on November 20, 2025. 
 * PG01 and PG02 records – Add validation for consumer use products. PIC CODE in Product Code must be ‘A’ if Processing Code is ‘CSU 
 * PG01 and PG06 records – Enhance validations for US goods returned. IUC 920.000 must have Source Type Code ‘39’ and Country Code of ‘US’ OR ‘PR.’ 
 * PG23 record – Update Tobacco Submission Tracking (TST) Number Affirmation of Compliance qualifier syntax 
The following changes with a REJECT severity will be deployed to CBP’s Certification environment on November 21, 2025.
 * PG01 and PG02 records – Add validation for consumer use products. PIC CODE in Product Code must be ‘A’ if Processing Code is ‘CSU 
 * PG01 and PG06 records – Enhance validations for US goods returned. IUC 920.000 must have Source Type Code ‘39’ and Country Code of ‘US’ OR ‘PR.’ 
 * PG23 record – Update Tobacco Submission Tracking (TST) Number Affirmation of Compliance qualifier syntax 
 * PG01 – Enforce Intended Use Code (IUC) requirements for all processing codes 
 * PG07 – Trade Name only required for Processing Code CSU (Consumer Use) 
 * PG23 – No longer accept the following Affirmation of Compliance Codes: ‘SE’ (Substantially Equivalent), ‘EXE’ (Exemption from Substantial Equivalence), and ‘PMT’ (Premarket Tobacco Application) 
 * PG23 – Accept new Affirmation of Compliance Codes with qualifier: ‘FLV’ (flavor), ‘NIC’ (nicotine concentration), ‘PID’ (product identification number) 
The U.S. Food and Drug Administration (FDA) Supplemental Guide (SG) draft version 2.6 is posted in the ‘Draft Chapters: Future Capabilities’ [ https://links-1.govdelivery.com/CL0/https:%2F%2Fwww.cbp.gov%2Ftrade%2Face%2Fcatair/1/0100019982929852-0ff1b06f-7fc0-4ec5-8cbe-3a6fd233e3ef-000000/2-YXZyyLcTg6s28kFaqby8PNmvi0gp92ArFH0_AoJBY=424 ]section of CBP.gov
For questions about the changes to SG 2.6 contact FDA ACE Support: ACE_Support@fda.hhs.gov
Related message: CSMS # 66347264
 * FDA ACE Supplemental Guide version two point six Business Rule Revisions (1).pdf [ https://content.govdelivery.com/attachments/USDHSCBP/2025/11/17/file_attachments/3463914/FDA%20ACE%20Supplemental%20Guide%20version%20two%20point%20six%20Business%20Rule%20Revisions%20%281%29.pdf ]