Cut and pasted:
Provision Applicable Newly Deemed Products Effective
Date Retailers Man-
ufacturers Importers Dis-
tributors
*Registration of establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product and product listings
Finished tobacco products9
December 31, 2016
X Manufacturers
X
10 Importers:
9. Note that while that the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), FDA intends to limit enforcement of the registration and product listing requirements to newly regulated finished tobacco products at this time.
10. Only to the extent the importer repackages or otherwise changes the container, wrapper, or labeling of any tobacco product package.
11. Note that while that the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), FDA intends to limit enforcement of the ingredient listing requirements to newly regulated finished tobacco products at this time.
12. FDA considers “small-scale tobacco product manufacturers” to be a manufacturer of any regulated tobacco product with 150 employees or fewer and annual total revenues of $5,000,000 or less.
13. Note that while that the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), FDA intends to limit enforcement of the HPHC reporting requirements to newly regulated finished tobacco products at this time.
14. Note that while that the deeming rule extends FDA’s tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), FDA intends to limit enforcement of the tobacco health document submission requirements to newly regulated finished tobacco products at this time.
15. FDA considers “small-scale tobacco product manufacturers” to be a manufacturer of any regulated tobacco product with 150 employees or fewer and annual total revenues of $5,000,000 or less.