FDA UPDATE - Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule

The FDA has issued its latest guidance to the tobacco product industry, including Electronic Nicotine Delivery Systems (ENDS).

The guidance details the following deadline extensions:

(1) Revised compliance date for “Registration of establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product and product listings” to reflect the date extension found in the “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” guidance issued in September 2017

(2) Revised compliance date for “Tobacco health documents” to provide a six-month extension for tobacco product manufacturers and importers in areas impacted by recent natural disasters.

(3) Revised compliance date for submitting ingredients listing.  The date has been pushed back to the 8th of May 2018 or the 8th of November 2018 for small-scale manufacturers. 

Harmful and Potentially Harmful Constituents (HPHCs)

The latest guidance maintains the requirement to report Harmful and Potentially Harmful Constituents (HPHCs) for each product by November 8th 2019.

Please see the link below to the full guidance document.

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf

 

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Posted by Andrew Mooney | Nov 14, 2017 10:13:43 AM | Categories: News, PMTA

Andrew Mooney