Revised Harmful and Potentially Harmful Constituents Reporting Compliance Deadline

Today, FDA has revised the "Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule" guidance and the related Small Entity Compliance Guide, "FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements." This revision extends the Harmful and Potentially Harmful Constituents (HPHCs) reporting compliance date to a date that is six months after the publication date of a final guidance regarding HPHC reporting under section 904(a)(3) and nine months after that publication date for small tobacco product manufacturers. For products entering the market after the publication date of the final guidance regarding HPHC reporting under section 904(a)(3), manufacturers must report on HPHCs 90 days prior to marketing the products.
 
In the preamble to the final deeming rule, FDA indicated that it intends to issue guidance regarding HPHC reporting (and later a testing and reporting regulation under section 915) with enough time for manufacturers to report, given the three-year compliance period. At this time, FDA has not published a final HPHC reporting guidance and as a result, we are providing a revised compliance date based on when a final HPHC reporting guidance is issued.

 

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