FDA Supplemental Guide Version 2.6 Now Available

Trade Update • Sept.26, 2025

Key Points

• FDA released draft version Supplemental Guide version 2.6 via CBP.gov.
• New tobacco import data rules start with warnings in November 2025 and rejections in February 2026.
• Intended Use Codes 100.000 and 210.000 clarified for personal imports across commodities.
• Product and compliance codes updated for tobacco and electronic nicotine delivery systems (ENDS).
• Food Facility Registration Exemption code B description updated in Appendix B.

The Food and Drug Administration (FDA) released draft version 2.6 of its Supplemental Guide (SG) for regulated product imports, with specific changes outlined in the business rule revisions. The update focuses mainly on tobacco goods, including electronic nicotine delivery systems (ENDS). The U.S. Customs and Border Protection (CBP) issued guidance to support the implementation of the 2.6 Supplemental Guide.

Meanwhile, a version 2.5.13 was released prior to the 2.6 draft, which includes the addition of Intended Use Code (IUC) 920.000 as a valid code for the tobacco program code (TOB). A supplemental CBP guidance was also issued on CBP.gov.

Updated Tobacco Import Validations & Timeline

The 2.6 version introduces new validations for tobacco product imports with a phased enforcement schedule:

• Warnings begin in the certification environment from November 2025.
• Warnings in production start on November 20-21, 2025.
• Hard rejections for non-compliance start February 21, 2026.

Updates on IUC for Imports

The guide clarifies the use of Intended Use Codes for imports to align with regulatory expectations:

• Intended Use Codes 100.000 and 210.000 are now aligned for personal import scenarios across all commodities.
• The guide specifies when IUCs are mandatory, conditional, or optional for different products.

Tobacco & ENDS Code and Compliance Updates

Key product code changes include:

• For tobacco consumer use products with processing code CSU, PIC Code A is required.
• Affirmation of Compliance (AofC) codes were revised to remove outdated codes and accept new qualifiers for nicotine concentration, flavor, and product IDs.
• These updates apply to both tobacco and electronic nicotine delivery system products.

Food Facility Registration Exemption Code Update

Appendix B updates the description of Food Facility Registration Exemption codes to clarify eligibility criteria for importers. Specifically, code B exempts private residences from registration under 21 CFR 1.227, while other codes define exemptions for facilities such as farms, restaurants, retail food establishments, fishing vessels, and non-bottled water establishments.

 For further details or questions, contact FDA ACE Support at ACE_Support@fda.hhs.gov.

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