Table 1 to Paragraph (c)(3)(iii)
Tobacco product category | Tobacco product subcategory | Product properties |
(A) Cigarettes | (1) Filtered | -Package type (e.g., hard pack, soft pack, clam shell). |
-Product quantity (e.g., 20 cigarettes, 25 cigarettes). | ||
-Length (e.g., 89.1 millimeters (mm), 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Ventilation (e.g., none, 10.0%, 25.0%). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Non-filtered | -Package type (e.g., hard pack, soft pack, clam shell). | |
-Product quantity (e.g., 20 cigarettes, 25 cigarettes). | ||
-Length (e.g., 89.1 mm, 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
- Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Other | -Package type (e.g., hard pack, soft pack, clam shell). | |
-Product quantity (e.g., 20 cigarettes, 25 cigarettes). | ||
-Length (e.g., 89.1 mm, 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Ventilation (e.g., none, 10.0%, 25.0%). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(B) Roll-Your-Own Tobacco Products | (1) Roll-Your-Own Tobacco Filler | -Package type (e.g., bag, pouch). |
-Product quantity (e.g., 20.1 grams [g], 16.0 ounces [oz.]). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Rolling Paper | -Package type (e.g., box, booklet). | |
-Product quantity (e.g., 50 sheets, 200 papers). | ||
-Length (e.g., 79.1 mm, 100.0 mm, 110.2 mm). | ||
-Width (e.g., 28.1 mm, 33.0 mm, 45.2 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Cigarette Tube, Filtered | -Package type (e.g., bag, box). | |
-Product quantity (e.g., 100 tubes, 200 tubes). | ||
-Length (e.g., 89.1 mm, 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Ventilation (e.g., none, 10.0%, 25.0%). | ||
-Characterizing flavor(s) (e.g., none, menthol, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) Cigarette Tube, Non-filtered | -Package type (e.g., bag, box). | |
-Product quantity (e.g., 100 tubes, 200 tubes). | ||
-Length (e.g., 89.1 mm, 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) Filter | -Package type (e.g., bag, box). | |
-Product quantity (e.g., 100 filters, 200 filters). | ||
-Length (e.g., 8.0 mm, 12.1 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(6) Paper Tip | -Package type (e.g., bag, box). | |
-Product quantity (e.g., 200 tips, 275 tips). | ||
-Length (e.g., 12.0 mm, 15.1 mm). | ||
-Width (e.g., 27.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(7) Other | -Package type (e.g., bag, box). | |
-Product quantity (e.g., 200 tips, 100 filters, 200 tubes. | ||
-Characterizing flavor(s) (e.g., none, menthol, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(C) Smokeless Tobacco Products | (1) Moist Snuff, Loose | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). |
-Product quantity (e.g., 20.0 g, 2.1 oz.). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable, e.g., fine cut, long cut, straight cut). | ||
(2) Moist Snuff, Portioned | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 22.5 g, 20.0 g). | ||
-Portion count (e.g., 15 pouches, 20 pieces). | ||
-Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece). | ||
-Portion length (e.g., 15.0 mm, 20.1 mm). | ||
-Portion width (e.g., 10.0 mm, 15.1 mm). | ||
-Portion thickness (e.g., 5.0 mm, 7.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Snus, Loose | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 20.0 g, 2.1 oz.). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) Snus, Portioned | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 22.5 g, 20.0 g). | ||
-Portion count (e.g., 15 pouches, 20 pieces). | ||
-Portion mass (e.g., 1.5 g/pouch, 1.0 g/piece). | ||
-Portion length (e.g., 15.0 mm, 20.1 mm). | ||
-Portion width (e.g., 10.0 mm, 15.1 mm). | ||
-Portion thickness (e.g., 5.0 mm, 7.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) Dry Snuff, Loose | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 20.0 g, 2.1 oz.). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(6) Dissolvable | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 22.5 g, 20.0 g) -Portion count (e.g., 15 sticks, 20 pieces). | ||
-Portion mass (e.g., 1.5 g/strip, 1.0 g/piece). | ||
-Portion length (e.g., 10.0 mm, 15.1 mm). | ||
-Portion width (e.g., 5.0 mm, 8.1 mm). | ||
-Portion thickness (e.g., 3.0 mm, 4.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(7) Chewing Tobacco, Loose | -Package type (e.g., bag, pouch, wrapped). | |
-Product quantity (e.g., 20.0 g, 3.1 oz). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(8) Chewing Tobacco, Portioned | -Package type (e.g., plastic can with metal lid, plastic can with plastic lid). | |
-Product quantity (e.g., 22.5 g, 20.0 g) -Portion count (e.g., 10 bits). | ||
-Portion mass (e.g., 2.1 g/bit). | ||
-Portion length (e.g., 8.0 mm, 10.1 mm). | ||
-Portion width (e.g., 6.0 mm, 8.1 mm). | ||
-Portion thickness (e.g., 5.1 mm, 7.0 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(9) Other | -Package type (e.g., bag, box, can). | |
-Product quantity (e.g., 20.1 g, 22.5 g, 3.0 oz.). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen, tobacco). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(D) Electronic Nicotine Delivery System (ENDS) (Also referred to as vapes) | (1) E-Liquid, Open | -Package type (e.g., bottle, box, pod). |
-Product quantity (e.g., 1 bottle, 5 bottles). | ||
-E-liquid volume (e.g., 0.5 milliliters [ml]), 2.0 ml, 5.1 ml). | ||
-Nicotine concentration (e.g., 0 milligrams/milliliter [mg/ml], 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/bottle). | ||
-Propylene glycol (PG)/vegetable glycerin (VG) ratio (e.g., not applicable [N/A], 0/100, 50/50, 100/0). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) E-Liquid, Closed | -Package type (e.g., cartridge, pod). | |
-Product quantity (e.g., 1 cartridge, 5 cartridges). | ||
-E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). | ||
-Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 2.0 mg/bottle). | ||
-PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) E-Cigarette, Closed | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes). | ||
-Length (e.g., 100.0 mm, 120.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.0 mm). | ||
-Wattage (e.g., 100 watts [W], 200 W). | ||
-Battery capacity (e.g., 100 milliampere hours [mAh], 200 mAh). | ||
-E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). | ||
-Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette). | ||
-PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(4) E-Cigarette, Open | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes). | ||
-Length (e.g., 100.0 mm, 120.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.0 mm). | ||
-E-liquid volume (e.g., 0.5 ml, 2.0 ml, 5.1 ml). | ||
-Wattage (e.g., 100 W, 200 W). | ||
-Battery capacity (e.g., 100 mAh, 200 mAh). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) ENDS Component | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g.,1 coil). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(6) ENDS Other | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g., 1 e-cigarette, 5 bottles). | ||
-Characterizing flavor(s) (e.g., none, cherry, wintergreen, tobacco, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(E) Cigars | (1) Cigar, Filtered Sheet-Wrapped | -Package type (e.g., hard pack, soft pack, clam shell). |
-Product quantity (e.g., 20 filtered cigars, 25 filtered cigars). | ||
-Length (e.g., 89.1 mm, 100.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Ventilation (e.g., none, 0%, 10.0%, 25.0%). | ||
-Characterizing flavor (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Cigar, Unfiltered Sheet-Wrapped | -Package type (e.g., box, film sleeve). | |
-Product quantity (e.g., 1 cigar, 5 cigarillos). | ||
-Length (e.g., 100.1 mm, 140.0 mm). | ||
-Diameter (e.g., 8.0 mm, 10.1 mm). | ||
-Tip (e.g., none, wood tips, plastic tips). | ||
-Characterizing flavor (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Cigar, Unfiltered Leaf-Wrapped | -Package type (e.g., box, film, sleeve, none). | |
-Product quantity (e.g., 1 cigar, 5 cigars). | ||
-Length (e.g., 150.1 mm, 200.0 mm). | ||
-Diameter (e.g., 8.0 mm, 10.1 mm). | ||
-Wrapper material (e.g., burley tobacco leaf, Connecticut shade grown tobacco leaf). | ||
-Characterizing flavor (e.g., none, whiskey). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) Cigar Component | -Package type (e.g., box, booklet). | |
-Product quantity (e.g., 10 wrappers, 20 leaves). | ||
-Characterizing flavor (e.g., none, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) Cigar Tobacco Filler | -Package type (e.g., bag, pouch). | |
-Product quantity (e.g., 20.0 g, 16.1 oz.). | ||
-Characterizing flavor (e.g., none, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(6) Other | -Package type (e.g., box, booklet). | |
-Product quantity (e.g., 1 cigar, 5 cigars, 20 leaves, 16 g). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(F) Pipe Tobacco Products | (1) Pipe | -Package type (e.g., box, none). |
-Product quantity (e.g., 1 pipe). | ||
-Length (e.g., 200.0 mm, 300.1 mm). | ||
-Diameter (e.g., 25.1 mm). | ||
-Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Pipe Tobacco Filler | -Package type (e.g., bag, none). | |
-Product quantity (e.g., 20.0 g, 16.1 oz). | ||
-Tobacco cut style (e.g., standard cut, such as shag cut, bugler cut, loose cut, etc., or a pressed cut, such as flake, cube cut, roll cake, etc., or a mixture). | ||
-Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Pipe Component | -Package type (e.g., box, bag, none). | |
-Product quantity (e.g., 1 bowl, 1 stem, 100 filters). | ||
-Characterizing flavor(s) (e.g., none, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) Other | -Package type (e.g., bag, box, none). | |
-Product quantity (e.g., 1 pipe, 1 bowl, 1 stem, 100 filters). | ||
-Characterizing flavor(s) (e.g., none, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product. | ||
(G) Waterpipe Tobacco Products | (1) Waterpipe | -Package type (e.g., box, none). |
-Product quantity (e.g., 1 waterpipe). | ||
-Height (e.g., 200.0 mm, 500.1 mm). | ||
-Width (e.g., 100.1 mm, 300.0 mm). | ||
-Diameter (e.g., 100.1 mm, 300.0 mm)-Number of hoses (e.g., 1, 2, 4). | ||
-Characterizing flavor(s) (e.g., none). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Waterpipe Tobacco Filler | -Package type (e.g., bag, pouch). | |
-Product quantity (e.g., 20.0 g, 16.1 oz.). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, apple). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) Waterpipe Heat Source | -Package type (e.g., box, film sleeve, bag, none). | |
-Product quantity (e.g., 150.0 g, 680.0 g). | ||
-Portion count (e.g., 20 fingers, 10 discs, 1 base). | ||
-Portion mass (e.g., 15.0 g/finger, 10.0g/brick). | ||
-Portion length (e.g., 40.0 mm, 100.0 mm). | ||
-Portion width (e.g., 10.0 mm, 40.0 mm). | ||
-Portion thickness (e.g., 10.0 mm, 40.0 mm). | ||
-Source of energy (e.g., charcoal, battery, electrical). | ||
-Characterizing flavor(s) (e.g., none, menthol, apple). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) Waterpipe Component | -Package type (e.g., bag, box, none). | |
-Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces). | ||
-Characterizing flavor(s) (e.g., none, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) Waterpipe Other | -Package type (e.g., bag, box, none). | |
-Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces). | ||
-Characterizing flavor(s) (e.g., none, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(H) Heated Tobacco Products (HTP) | (1) Closed HTP | -Package type (e.g., box, none, plastic clamshell). |
-Product quantity (e.g., 1 device, 1 HTP). | ||
-Length (e.g., 100.0 mm, 120.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Wattage (e.g., 100 W, 200 W). | ||
-Battery capacity (e.g., 100 mAh, 200 mAh). | ||
-Characterizing flavor(s) (e.g., none). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(2) Open HTP | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g., 1 device, 1 HTP). | ||
-Length (e.g., 100.0 mm, 120.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Wattage (e.g., 100 W, 200 W). | ||
-Battery capacity (e.g., 100 mAh, 200 mAh). | ||
-Characterizing flavor(s) (e.g., none). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(3) HTP Consumable | -Package type (e.g., hard pack, soft pack, plastic clamshell). | |
-Product quantity (e.g., 20 sticks, 25 cartridges). | ||
-Length (e.g., 60.0 mm, 82.0 mm). | ||
-Diameter (e.g., 6.0 mm, 8.1 mm). | ||
-Ventilation (e.g., none, 10.0%, 25.0%). | ||
-Characterizing flavor(s) (e.g., none, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(4) HTP Component | -Package type (e.g., box, none, plastic clamshell). | |
-Product quantity (e.g., 1 mouthpiece, 1 spacer). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(5) Other | -Package type (e.g., box, bag, plastic clamshell, none). | |
-Product quantity (e.g., 1 base, 5 capsules). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). | ||
(I) Other | (1) Other | -Package type (e.g., box, bag, plastic clamshell, none). |
-Product quantity (e.g., 1 base, 5 capsules). | ||
-Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry). | ||
-Additional properties needed to uniquely identify the tobacco product (if applicable). |
Table 2 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Cigarettes
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Cigarette length (mm). | . Tobacco filler mass (mg). |
. Cigarette circumference or diameter (mm). | . Tobacco rod density (g/cm3). |
. Tobacco filler mass (mg). | . Tobacco cut size (mm or CPI). |
. Tobacco rod density (g/cm3). | . Tobacco moisture or oven volatiles (%). |
. Tobacco cut size (mm or CPI). | . Cigarette paper base paper porosity (permeability) (CU). |
. Tobacco moisture or oven volatiles (%). | . Cigarette paper band porosity or permeability (CU) or Cigarette paper band diffusivity (cm2/s). |
. Cigarette paper length (mm). | . Filter pressure drop (mm H2O). |
. Cigarette paper base paper porosity (permeability) (CU). | |
. Cigarette paper band porosity (permeability) (CU) [alternatively, band diffusivity (cm2/s)] (if applicable). | . Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament, total denier, and filter density)). |
. Cigarette paper band width (mm). | . Filter ventilation (%). |
. Cigarette paper band space (mm). | |
. Filter length (mm). | |
. Filter pressure drop (mm H2O). | |
. Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament, total denier, and filter density)). | |
. Tipping paper length (mm). | |
. Filter ventilation (%). |
Table 3 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Portioned and Nonportioned Smokeless Tobacco Products
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
Portioned Smokeless Tobacco Products | |
. Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). | . Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
. Tobacco moisture (%). | . Tobacco moisture (%). |
. Portion length (mm). | . Portion mass (mg). |
. Portion width (mm). | . Pouch material basis weight (g/m2) (if applicable). |
. Portion mass (mg). | . Pouch material porosity (CU) (permeability) (L/m2/s). |
. Portion material thickness (mm) (if applicable). | . Nicotine dissolution rate (%/min). |
. Pouch material basis weight (g/m2) (if applicable). | |
. Pouch material porosity (permeability) (CU or L/m2/s) (if applicable). | |
. Nicotine dissolution rate (%/min). | |
Nonportioned Smokeless Tobacco Products | |
. Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron) | . Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
. Tobacco moisture (%) | . Tobacco moisture (%). |
Table 4 to Paragraph (i)(2)(ii)-Required Design Parameter Information for RYO Tobacco Rolling Papers
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Roll-your-own (RYO) paper length (mm). | . RYO mass per paper (mg). |
. RYO paper width (mm). | . RYO paper base paper basis weight (g/m2). |
. RYO mass per paper (mg). | . RYO paper base paper porosity (permeability) (CU). |
. RYO paper base paper basis weight (g/m2). | . RYO paper band porosity (permeability) (CU) or [alternatively, RYO paper band diffusivity (cm2/s)] (if applicable). |
. RYO paper base paper porosity (permeability) (CU). | |
. RYO paper band porosity (permeability) (CU) or [alternatively, RYO paper band diffusivity (cm2/s)] (if applicable). | |
. RYO paper band width (mm) (if applicable). | |
. RYO paper band space (mm) (if applicable). |
Table 5 to Paragraph (i)(2)(ii)-Required Design Parameter Information for RYO Tobacco Tubes
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tube mass (mg). | . Tube mass (mg). |
. Tube length (mm). | . Tube paper base paper basis weight (g/m2). |
. Tube circumference or diameter (mm). | . Tube paper base paper porosity (permeability) (CU). |
. Tube paper width (mm). | . Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm2/s) (if applicable). |
. Tube paper base paper basis weight (g/m2). | |
. Tube paper base paper porosity (permeability) (CU). | |
. Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm2/s) (if applicable). | |
. Tube paper band width (mm) (if applicable). | |
. Tube paper band space (mm) (if applicable). |
Table 6 to Paragraph (i)(2)(ii)-Required Design Parameter Information for RYO Tobacco Filtered Tubes
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tube mass (mg). | . Tube paper base paper basis weight (g/m2). |
. Tube length (mm). | . Tube paper base paper porosity (permeability) (CU). |
. Tube circumference or diameter (mm). | . Tube mass (mg). |
. Tube paper length (mm). | . Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm2/s) (if applicable). |
. Nonfilter tube length (mm). | . Filter pressure drop (mm H2O). |
. Tube paper width (mm). | . Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm3))). |
. Tube paper base paper basis weight (g/m2). | . Filter ventilation (%). |
. Tube paper base paper porosity (permeability) (CU). | |
. Tube paper band porosity (permeability) (CU) (if applicable) or Tube paper band diffusivity (cm2/s) (if applicable). | |
. Tube paper band width (mm) (if applicable). | |
. Tube paper band space (mm) (if applicable). | |
. Filter length (mm). | |
. Filter pressure drop (mm H2O). | |
. Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged (e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm3))). | |
. Tipping paper length (mm). | |
. Filter ventilation (%). |
Table 7 to Paragraph (i)(2)(ii)-Required Design Parameter Information for RYO Tobacco
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tobacco cut size (mm or CPI). | . Tobacco cut size (mm or CPI). |
. Tobacco moisture or oven volatiles (%). | . Tobacco moisture or oven volatiles (%). |
Table 8 to Paragraph (i)(2)(ii)-Required Design Parameter Information for RYO Tobacco Paper Tips
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. RYO paper tip length (mm). | . RYO paper base paper basis weight (g/m2). |
. RYO paper tip width (mm). | . RYO paper porosity (permeability) (CU). |
. RYO paper tip mass (mg). | . RYO paper tip ventilation (%). |
. RYO paper base paper basis weight (g/m2). | |
. RYO paper porosity (permeability) (CU). | |
. RYO paper tip ventilation (%). |
Table 9 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Filtered Sheet-Wrapped Cigars
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Cigar mass (mg). | . Cigar mass (mg). |
. Cigar wrapper basis weight (g/m2). | . Puff count. |
. Cigar binder length (mm). | . Cigar wrapper basis weight (g/m2). |
. Cigar binder width (mm). | . Cigar wrapper porosity (permeability) (CU). |
. Cigar binder basis weight (g/m2) | . Cigar binder porosity (permeability) (CU). |
. Cigar length (mm). | . Cigar binder basis weight (g/m2). |
. Cigar overall diameter (mm). | . Tobacco filler mass (mg). |
. Cigar minimum diameter (mm) if applicable. | . Tobacco rod density (g/cm3). |
. Cigar maximum diameter (mm) if applicable. | . Tobacco cut size (CPI or mm). |
. Tobacco filler mass (mg). | . Tobacco moisture or oven volatiles (%). |
. Tobacco rod density (g/cm3). | . Cigar wrapper band porosity (permeability) (CU) [alternatively, band diffusivity (cm2/s)](if applicable). |
. Tobacco cut size (CPI or mm). | . Cigar binder band porosity (permeability) (CU) [alternatively, band diffusivity (cm2/s)] (if applicable). |
. Tobacco moisture or oven volatiles (%). | . Cigar minimum diameter (mm) (if applicable). |
. Cigar wrapper porosity (permeability) (CU). | . Cigar maximum diameter (mm) (if applicable). |
. Cigar wrapper length (mm). | . Filter pressure drop (mm H2O). |
. Cigar wrapper width (mm). | . Filter efficiency (%) (if no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density (g/cm3)]}. |
. Cigar wrapper band porosity (permeability) (CU) (if applicable). | . Filter ventilation (%). |
. Cigar wrapper band width (mm) (if applicable). | |
. Cigar wrapper band space (mm) (if applicable). | |
. Cigar binder porosity (permeability) (CU). | |
. Cigar binder band porosity (permeability) (CU) (if applicable). | |
. Cigar binder band width (mm) (if applicable). | |
. Cigar binder band space (mm) (if applicable). | |
. Filter length (mm). | |
. Filter diameter (mm). | |
. Filter pressure drop (mm H2O). | |
. Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm3)]}. | |
. Tipping paper length (mm). | |
. Filter ventilation (%). |
Table 10 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Unfiltered Sheet-Wrapped Cigars
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Cigar mass (mg). | . Puff count. |
. Cigar length (mm). | . Cigar mass (mg). |
. Cigar overall diameter (mm). | . Tobacco rod density (g/cm3). |
. Cigar minimum diameter (mm) (if applicable). | . Tobacco cut size (CPI or mm). |
. Cigar maximum diameter (mm) (if applicable). | . Tobacco moisture or oven volatiles (%). |
. Tobacco rod density (g/cm3). | . Tobacco filler mass (mg). |
. Tobacco moisture or oven volatiles (%). | . Cigar minimum diameter (mm) (if applicable). |
. Tobacco cut size (CPI or mm). | . Cigar maximum diameter (mm) (if applicable). |
. Tobacco filler mass (mg). | . Cigar wrapper porosity (permeability) (CU). |
. Cigar wrapper porosity (permeability) (CU). | . Cigar wrapper basis weight (g/m2). |
. Cigar wrapper length (mm). | . Cigar binder basis weight (g/m2). |
. Cigar wrapper width (mm). | . Cigar binder porosity (permeability) (CU). |
. Cigar wrapper basis weight (g/m2). | . Cigar tip mass (mg) (if applicable). |
. Cigar binder porosity (permeability) (CU). | . Cigar wrapper band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). |
. Cigar binder width (mm) | . Cigar binder band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). |
. Cigar binder basis weight (g/m2). | |
. Cigar tip length (mm) (if applicable). | |
. Cigar tip inner diameter (mm) (if applicable). | |
. Cigar tip mass (mg) (if applicable). | |
. Cigar wrapper band space (mm) (if applicable). | |
. Cigar wrapper band width (mm) (if applicable). | |
. Cigar binder band width (mm) (if applicable). | |
. Cigar binder band space (mm) (if applicable). | |
. Cigar wrapper band porosity or permeability (CU) [alternately, band diffusivity (cm2/s)] (if applicable). | |
. Cigar binder band porosity (permeability) (CU) [alternately, band diffusivity (cm2/s)] (if applicable). |
Table 11 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Leaf-Wrapped Cigars
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Cigar mass (mg). | . Puff count. |
. Cigar length (mm). | . Cigar mass (mg). |
. Overall diameter (mm). | . Cigar minimum diameter (mm). |
. Cigar minimum diameter (mm). | . Cigar maximum diameter (mm). |
. Cigar maximum diameter (mm). | . Cigar wrapper basis weight (g/m2). |
. Tobacco moisture or oven volatiles (%). | . Cigar binder basis weight (g/m2). |
. Tobacco filler mass (mg). | . Tobacco filler mass (mg). |
. Tobacco rod density (g/cm3). | . Tobacco rod density (g/cm3). |
. Tobacco cut size (CPI or mm). | . Tobacco cut size (CPI or mm). |
. Tobacco moisture or oven volatiles (%). | . Tobacco moisture or oven volatiles (%). |
. Cigar wrapper length (mm). | |
. Cigar wrapper width (mm). | |
. Cigar wrapper basis weight (g/m2). | |
. Cigar binder width (mm). | |
. Cigar binder basis weight (g/m2). |
Table 12 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Cigar Tobacco
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tobacco cut size (CPI or mm) | . Tobacco cut size (CPI or mm). |
. Tobacco moisture or oven volatiles (%) | . Tobacco moisture or oven volatiles (%). |
Table 13 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Cigar Wrappers
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Cigar wrapper length (mm). | . Cigar wrapper length (mm). |
. Cigar wrapper width (mm). | . Cigar wrapper width (mm). |
. Cigar wrapper basis weight (g/cm2). | . Cigar wrapper basis weight (g/cm2). |
Table 14 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Waterpipes
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Hose length (mm). | . Hose length (mm). |
. Hose materials. | . Hose internal diameter (mm). |
. Hose internal diameter (mm). | . Stem length (mm). |
. Stem length (mm). | . Stem internal diameter (mm). |
. Stem internal diameter (mm). | . Base diameter (mm). |
. Base diameter (mm). | . Base volume (cm3). |
. Base volume (cm3). | . Pressure drop (mm H2O). |
. Base shape. | . Water filter efficiency (%). |
. Pressure drop (mm H2O). | . Head height (mm). |
. Water filter efficiency (%). | . Head top diameter (mm). |
. Hose air permeability (CU). | . Head bottom diameter (mm). |
. Head height (mm). | . Head volume (mm3). |
. Head top diameter (mm). | |
. Head bottom diameter (mm). | |
. Number of holes. | |
. Head volume (mm3). | |
. Heating source type. | |
. Head materials. |
Table 15 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Waterpipe Tobacco
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tobacco cut size (CPI or mm). | . Tobacco cut size (CPI or mm). |
. Tobacco moisture or oven volatiles (%). | . Tobacco moisture or oven volatiles (%). |
Table 16 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Waterpipe Heating Sources
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Heating element temperature range ( °C). | . Heating element temperature range ( °C). |
. Heating element mass (mg). | . Heating element mass (mg). |
. Heating element density (g/cm3). | . Heating element density (g/cm3). |
. Heating element resistance (ohms) (if applicable). | . Heating element resistance (ohms) (if applicable). |
. Number of heating elements. | . Heating element diameter (gauge). |
. Heating element configuration. | . Battery current rating (mA) (if applicable). |
. Heating element diameter (gauge) (if applicable). | . Battery capacity (mAh) (if applicable). |
. Battery current rating (mA) (if applicable). | . Battery voltage operating range (volts) (if applicable). |
. Battery capacity (mAh) (if applicable) | . Battery current operating range (amps) (if applicable). |
. Battery voltage operating range (volts) (if applicable). | . Power delivery unit (PDU) temperature cut-off ( °C) (if applicable). |
. Battery current operating range (amps) (if applicable). | . Power delivery unit (PDU) voltage operating range (volts) (if applicable). |
. Power delivery unit (PDU) temperature cut-off ( °C) (if applicable). | . PDU current operating range (amps) (if applicable). |
. Power delivery unit (PDU) voltage operating range (volts) (if applicable). | . PDU wattage operating range (watts) (if applicable). |
. PDU current operating range (amps) (if applicable). | |
. PDU wattage operating range (watts) (if applicable). |
Table 17 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Waterpipe Foil
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Foil length (mm) (for square or rectangular shape foil). | . Foil length (mm) (for square or rectangular shape foil). |
. Foil width (mm) (for square or rectangular shape foil). | . Foil width (mm) (for square or rectangular shape foil). |
. Diameter (mm) (for circular shape foil). | . Diameter (mm) (for circular shape foil). |
. Foil thickness (mm). | . Foil thickness (mm). |
. Number of holes. | . Diameter of the holes (mm). |
. Diameter of the holes (mm). |
Table 18 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Waterpipe Head
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Head height (mm), | . Head height (mm). |
. Head top diameter (mm), | . Head top diameter (mm). |
. Head bottom diameter (mm), | . Head bottom diameter (mm). |
. Number of holes, | . Head volume (mm3). |
. Head volume (mm3), | |
. Head materials, |
Table 19 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Pipes
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Bowl chamber cover outer diameter (mm). | . Bowl chamber volume (cm3). |
. Bowl chamber cover inner diameter (mm). | . Pipe pressure drop (mm H2O). |
. Draught hole diameter (mm). | . Air flow through air valve (cc/min). |
. Screen (if applicable). | . Airway volume (cm3). |
. Draught hole shape. | . Filter pressure drop (mm H2O). |
. Draught hole location. | . Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm3)]}. |
. Bowl chamber hole shape. | |
. Bowl chamber volume (cm3) | |
. Airway volume (cm3) | |
. Stem length (mm). | |
. Stem diameter (mm). | |
. Shank length (mm). | |
. Shank diameter (mm). | |
. Draught hole dimension. | |
. Pressure drop through air valve (mm H2O). | |
. Air flow through air valve (cc/min). | |
. Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm3)]}. | |
. Filter pressure drop (mm H2O). | |
. Filter length (mm). |
Table 20 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Pipe Tobacco
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Tobacco cut size (CPI or mm). | . Tobacco cut size (CPI or mm). |
. Tobacco moisture or oven volatiles (%). | . Tobacco moisture or oven volatiles (%). |
Table 21 to Paragraph (i)(2)(ii)-Required Design Parameter Information for ENDS
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Draw resistance (mm H2O). | |
. Puff count (for full tank/cartridge). | . Draw resistance (mm H2O). |
. Atomizer tank/cartridge volume (mL). | . Puff count (for full tank/cartridge). |
. Number of heating elements (e.g., coil). | . Atomizer tank/cartridge volume (mL). |
. Heating Element diameter (gauge). | . Heating Element diameter (gauge). |
. Heating Element length (mm). | . Heating Element resistance (Ohms). |
. Heating Element resistance (Ohms). | . Heating Element temperature range ( °C). |
. Heating Element temperature range ( °C). | . Battery voltage operating range (V). |
. Heating Element configuration (target only). | . Battery current operating range (mA). |
. Battery voltage operating range (V). | . PDU voltage operating range (V). |
. Battery current operating range (mA). | . PDU current operating range (mA). |
. Battery Capacity (mAh). | . PDU wattage operating range (watts). |
. Battery Nominal Voltage (V). | . PDU Current cut-off (mA) (if applicable). |
. Battery Current rating (mA). | . PDU temperature cut-off ( °C) (if applicable). |
. Battery charging temperature limits ( °C). | . Battery Capacity (mAh). |
. Battery discharge temperature limits ( °C). | . Battery Nominal Voltage (V). |
. Battery end of discharge voltage (V). | . Battery Current rating (mA). |
. Battery maximum charging current (mA). | . Battery charging temperature limits ( °C). |
. Battery maximum discharging current (mA). | . Battery discharge temperature limits ( °C). |
. Battery upper limits charging voltage (V). | . Battery maximum charging current (mA). |
. Power Delivery Unit (PDU) voltage operating range (V). | . Battery maximum discharging current (mA). |
. PDU current operating range (mA). | . Battery upper limits charging voltage (V). |
. PDU wattage operating range (watts). | . Inhaled aerosol temperature ( °C). |
. PDU temperature cut-off ( °C) (if applicable). | . Airflow rate (L/min) (if applicable). |
. Airflow rate (L/min) (if applicable). | . Ventilation (%). |
. PDU Current cut-off (mA) (if applicable). | |
. PDU Temperature cut-off ( °C) (if applicable). | |
. Inhaled aerosol temperature ( °C). | |
. Ventilation (%). |
Table 22 to Paragraph (i)(2)(ii)-Required Design Parameter Information for E-liquids
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. E-liquid viscosity (at 20 °C). | . E-liquid viscosity (at 20 °C). |
. E-liquid volume (ml). | . E-liquid volume (ml). |
. Particle number concentration (#/cm3). | . Particle number concentration (#/cm3). |
. Count median diameter (nm). | . Count median diameter (nm). |
. PM2.5 ([MICRO]g/m3). | . PM2.5 ([MICRO]g/m3). |
Table 23 to Paragraph (i)(2)(ii)-Required Design Parameter Information for Heated Tobacco Products (HTP)
Provide target specification with upper and lower range limits for: | Provide test data (include test protocols, quantitative acceptance criteria, data sets, and a summary of the results) for: |
. Overall Product. | . Overall Product. |
o Mass (mg). | o Draw resistance (mm H2O). |
o Length (mm). | o Puff count (for full tank/cartridge). |
o Width (mm). | o Product volume (mL). |
o Height (mm). | o Airflow rate (L/min) (if applicable). |
o Diameter (mm). | o Ventilation (%). |
o Draw resistance (mm H20). | o Operational Temperature ( °C). |
o Puff Count (for full tank/cartridge). | o Temperature sensor (if applicable). |
o Puff volume (mL). | o Material wrapper length (mm) (if applicable). |
o Product volume (mL). | o Material wrapper width (mm) (if applicable). |
o Airflow rate (L/min) (if applicable). | o Material wrapper basis weight (g/m2) (if applicable). |
o Ventilation (%). | o Material porosity (permeability) (CU) (if applicable). |
o Operational Temperature ( °C). | . Heating element. |
o Temperature sensor (if applicable). | o Heating Element diameter (gauge). |
o Material wrapper length (mm) (if applicable). | o Heating Element resistance (Ohms). |
o Material wrapper width (mm) (if applicable). | o Heating Element temperature range ( °C). |
o Material wrapper basis weight (g/m2) (if applicable). | . E-liquid. |
o Material porosity (permeability) (CU) (if applicable). | o E-liquid viscosity (at 20 °C). |
. Heating element. | o E-liquid volume (ml). |
o Heating element source/type/approach (electrical, carbon, aerosol, etc.). | . Tobacco (if applicable). |
o Heating element temperature range ( °C). | o Tobacco moisture (%). |
o Heating element operational temperature ( °C). | o Tobacco cut size (CPI or mm). |
o Heating element maximum temperature (boost temperature) ( °C). | o Tobacco density (g/cm3) |
o Heating element material. | . Battery. |
o Heating element Configuration (i.e., the shape and design of the heating element. If the heating element is a coil, it is the shape and arrangement of the coil. If the heating element is a novel design, provide the configuration and its design targets.). | |
o Heating element length (mm). | |
o Heating element mass (mg). | |
o Heating element location. | |
o Number of heating elements (e.g., coil) (dimensionless). | o Battery voltage operating range (V). |
o Heating Element diameter (gauge) (if applicable). | o Battery current operating range (mA). |
o Heating Element resistance (Ohms) (if applicable). | o PDU voltage operating range (V). |
. Tobacco/E-liquid. | o PDU current operating range (mA) PCO wattage operating range (W). |
o Tobacco mass (mg) (if applicable). | |
o Tobacco density (g/cm3) (if applicable). | o PDU Current cut-off (mA) (if applicable). |
o Tobacco moisture or oven volatiles (%) (if applicable). | o PDU temperature cut-off ( °C). |
o Tobacco cut size (CPI or mm) (if applicable). | o Battery Capacity (mAh). |
o E-liquid volume (mL) (if applicable). | o Battery Nominal Voltage (V). |
o E-liquid viscosity (at 20 °C) (if applicable). | o Battery Current rating (mA). |
. Battery (if applicable). | o Battery charging temperature limits ( °C). |
o Battery capacity (mA). | o Battery discharge temperature limits ( °C). |
o Battery Voltage Operating Range (V) or Wattage (W). | o Battery maximum charging current (mA). |
o Battery Current Charging range (amps). | o Battery maximum discharging current (mA). |
o Battery Nominal Voltage (V). | o Battery upper limits charging voltage (V). |
o Battery Current rating (mA). | . Aerosol. |
o Battery charging temperature limits ( °C). | |
o Battery discharge temperature limits ( °C). | |
o Battery end of discharge voltage (V). | o Inhaled aerosol temperature ( °C). |
o Battery maximum charging current (mA). | o Aerosol Particle number concentration (#/cm3). |
o Battery maximum discharging current (mA). | o Count median diameter (nm). |
o Battery upper limits charging voltage (V). | o PM2.5 ([MICRO]g/m3). |
o Power Delivery Unit (PDU) voltage operating range (V). | . Filter (if applicable). |
o PDU current operating range (mA). | o Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm3)]}. |
o PDU wattage operating range (watts). | o Filter ventilation (%). |
o PDU temperature cut-off ( °C) (if applicable) | o Filter pressure drop (mm H2O). |
o PDU Current cut-off (mA) (if applicable). | |
. Aerosol. | |
o Inhaled aerosol temperature ( °C). | |
o Aerosol Particle number concentration (#/cm3). | |
o Count median diameter (nm). | |
o PM2.5 ([MICRO]g/m3). | |
. Filter (if applicable). | |
o Filter efficiency (%) {If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged [e.g., denier per filament (DPF), total denier (g/9000m), and filter density(g/cm3)]}. | |
o Filter pressure drop (mm H2O). | |
o Filter length (mm). | |
o Filter diameter (mm). | |
o Filter ventilation (%). |
"I (name of responsible official) on behalf of the applicant, (applicant name), hereby certify that the applicant will maintain all records to substantiate the accuracy of this application for the period of time required in 21 CFR 1114.45 and ensure that such records remain readily available to FDA upon request. I certify that this information and the accompanying submission are true and correct, that no material fact has been omitted, and that I am authorized to submit this on the applicant's behalf. I understand that under section 1001 of title 18 of the United States Code anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal penalties."
21 C.F.R. §1114.7