The SE Report must include a comparison of the characteristics of the new tobacco product to the predicate tobacco product. Where test data is submitted, the testing information must include the test protocols, quantitative acceptance criteria, and test results (including means and variances, data sets, and a summary of the results). Comparison testing must be conducted on a sufficient sample size and on test samples that reflect the finished tobacco product composition and design. The SE report must state whether the same test methods were used for the new tobacco product and the predicate product, and if the methods differed, an explanation as to how the results of the different test methods can be compared. The SE report must identify national and international standards used to test the new and predicate tobacco products and explain any deviations from the standard, or state that no standards were used for the testing. The SE report must include the following:
Table 1 to § 1107.19(a)(1)
Provide Target Specification With Upper and Lower Range Limits for: |
-Cigarette length (mm). |
-Cigarette circumference or diameter (mm). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (mm or cuts per inch (CPI)). |
-Filter ventilation (%). |
-Tipping paper length (mm). |
-Cigarette paper base paper porosity (CORESTA unit (CU)) or permeability. |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigarette paper band width (mm). |
-Cigarette paper band space (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))). |
-Filter length (mm). |
-Filter pressure drop (mm H2O). |
Table 2 to § 1107.19(a)(1)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tobacco filler mass (mg). |
-Tobacco moisture (%) or oven volatiles (%). |
-Filter ventilation (%). |
-Tobacco cut size (mm or CPI). |
-Cigarette paper base paper porosity (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)). |
-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., DPF, total denier (g/9000m), and filter density (g/cm3))). |
-Filter pressure drop (mm H2O). |
Table 3 to § 1107.19(a)(2)
Provide Target Specification With Upper and Lower Range Limits for: |
Portioned Smokeless Tobacco Products: |
-Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
-Tobacco moisture (%). |
-Portion length (mm). |
-Portion width (mm). |
-Portion mass (mg). |
-Pouch material thickness (mm) (if applicable). |
-Pouch material porosity or permeability (CU or L/m2/s) (if applicable). |
-Pouch material basis weight (g/m2). (if applicable). |
-Nicotine dissolution rate (%/min) (if applicable). |
Non-portioned Smokeless Tobacco Products: |
-Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
-Tobacco moisture (%). |
Table 4 to § 1107.19(a)(2)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
Portioned Smokeless Tobacco Products: |
-Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
-Tobacco moisture (%). |
-Portion mass (mg). |
-Pouch material porosity or permeability (CU or L/m2/s). |
-Pouch material basis weight (g/m2). |
-Nicotine dissolution rate (%/min) (if applicable). |
Non-portioned Smokeless Tobacco Products: |
-Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). |
-Tobacco moisture (%). |
Table 5 to § 1107.19(a)(3)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Paper length (mm). |
-Paper width (mm). |
-Mass per paper (mg). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity or permeability (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigarette paper band width (mm) (if applicable). |
-Cigarette paper band space (mm) (if applicable). |
Table 6 to § 1107.19(a)(3)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Mass per paper (mg). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity or permeability (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
Table 7 to § 1107.19(a)(4)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tube length (mm). |
-Tube circumference or diameter (mm). |
-Tube mass (mg). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigarette paper band width (mm) (if applicable). |
-Cigarette paper band space (mm) (if applicable). |
Table 8 to § 1107.19(a)(4)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tube mass (mg). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)). |
Table 9 to § 1107.19(a)(5)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tube length (mm). |
-Tube circumference or diameter (mm). |
-Tube mass (mg). |
-Tipping paper length (mm). |
-Filter ventilation (%). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity or permeability (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigarette paper band width (mm) (if applicable). |
-Cigarette paper band space (mm) (if applicable). |
-Filter length (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., DPF, total denier (g/9000m), and filter density (g/cm3))). |
-Filter pressure drop (mm H2O). |
Table 10 to § 1107.19(a)(5)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tube mass (mg). |
-Filter ventilation (%). |
-Cigarette paper base paper basis weight (g/m2). |
-Cigarette paper base paper porosity or permeability (CU). |
-Cigarette paper band porosity or permeability (CU) (alternately, 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., DPF, total denier (g/9000m), and filter density (g/cm3))). |
-Filter pressure drop (mm H2O). |
Table 11 to § 1107.19(a)(6)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tobacco cut size (mm or CPI). |
-Tobacco moisture (%) or oven volatiles (%). |
Table 12 to § 1107.19(a)(6)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tobacco cut size (mm or CPI). |
-Tobacco moisture (%) or oven volatiles (%). |
Table 13 to § 1107.19(a)(7)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Cigar mass (mg). |
-Cigar wrapper basis weight (g/m2). |
-Cigar binder length (mm). |
-Cigar binder width (mm). |
-Cigar binder basis weight (g/m2). |
-Cigar length (mm). |
-Cigar overall diameter (mm). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
-Cigar wrapper porosity or permeability (CU). |
-Cigar wrapper length (mm). |
-Cigar wrapper width (mm). |
-Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar wrapper band width (mm) (if applicable). |
-Cigar wrapper band space (mm) (if applicable). |
-Tipping paper length (mm). |
-Cigar binder porosity or permeability (CU). |
-Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar binder band width (mm) (if applicable). |
-Cigar binder band space (mm) (if applicable). |
-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., DPF, total denier (g/9000m), and filter density(g/cm3))). |
-Filter pressure drop (mm H2O). |
-Filter length (mm). |
-Filter diameter (mm). |
-Filter ventilation (%). |
Table 14 to § 1107.19(a)(7)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Cigar mass (mg). |
-Puff count. |
-Cigar wrapper basis weight (g/m2). |
-Cigar wrapper porosity or permeability (CU). |
-Cigar binder porosity or permeability (CU). |
-Cigar binder basis weight (g/m2). |
-Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged (e.g., DPF, total denier (g/9000m), and filter density (g/cm3))). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco cut size (CPI or mm). |
-Tobacco moisture or oven volatiles (%). |
-Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar binder band width (mm) (if applicable). |
-Cigar binder band space (mm) (if applicable). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
-Filter ventilation (%). |
-Filter pressure drop (mm H2O). |
Table 15 to § 1107.19(a)(8)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Cigar length (mm). |
-Cigar mass (mg). |
-Cigar overall diameter (mm). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
-Cigar wrapper porosity or permeability (CU). |
-Cigar wrapper length (mm). |
-Cigar wrapper width (mm). |
-Cigar wrapper basis weight (g/m2). |
-Cigar binder porosity or permeability (CU). |
-Cigar binder width (mm) (if applicable). |
-Cigar binder basis weight (g/m2). |
-Cigar tip mass (mg) (if applicable). |
-Tip length (mm) (if applicable). |
-Tip inner diameter (mm) (if applicable). |
-Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (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 wrapper band width (mm) (if applicable). |
-Cigar wrapper band space (mm) (if applicable). |
Table 16 to § 1107.19(a)(8)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Puff count. |
-Cigar mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco cut size (CPI or mm). |
-Tobacco moisture or oven volatiles (%). |
-Tobacco filler mass (mg). |
-Cigar wrapper basis weight (g/m2). |
-Cigar wrapper porosity or permeability (CU). |
-Cigar binder width (mm) (if applicable). |
-Cigar binder basis weight (g/m2). |
-Cigar binder porosity or permeability (CU). |
-Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm2/s)) (if applicable). |
-Cigar tip mass (mg) (if applicable). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
Table 17 to § 1107.19(a)(9)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Cigar length (mm). |
-Cigar mass (mg). |
-Overall diameter (mm). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
-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 18 to § 1107.19(a)(9)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Puff count. |
-Cigar mass (mg). |
-Tobacco filler mass (mg). |
-Tobacco rod density (g/cm3). |
-Tobacco cut size (CPI or mm). |
-Cigar wrapper basis weight (g/m2). |
-Cigar binder basis weight (g/m2). |
-Tobacco moisture or oven volatiles (%). |
-Cigar minimum diameter (mm) (if applicable). |
-Cigar maximum diameter (mm) (if applicable). |
Table 19 to § 1107.19(a)(10)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 20 to § 1107.19(a)(10)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 21 to § 1107.19(a)(11)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Cigar wrapper length (mm). |
-Cigar wrapper width (mm). |
-Cigar wrapper porosity (CU). |
-Cigar wrapper basis weight (g/m2). |
Table 22 to § 1107.19(a)(11)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Cigar wrapper length (mm). |
-Cigar wrapper width (mm). |
-Cigar wrapper basis weight (g/m2). |
Table 23 to § 1107.19(a)(12)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Bowl chamber outer diameter (mm). |
-Bowl chamber inner diameter (mm). |
-Draught hole diameter (mm). |
-Draught hole location. |
-Draught hole shape. |
-Bowl chamber hole shape. |
-Bowl chamber volume (cm3). |
-Stem length (mm). |
-Stem diameter (mm). |
-Shank length (mm). |
-Shank diameter (mm). |
-Draught hole area (mm2). |
-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 filter is unchanged (e.g., DPF, total denier (g/9000m), and filter density (g/cm3))). |
-Filter pressure drop (mm H2O). |
-Filter length (mm). |
Table 24 to § 1107.19(a)(12)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Bowl chamber volume (cm3). |
-Air flow through air valve (cc/min). |
-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 filter is unchanged (e.g., DPF, total denier (g/9000m), and filter density (g/cm3))). |
Table 25 to § 1107.19(a)(13)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 26 to § 1107.19(a)(13)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 27 to § 1107.19(a)(14)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Hose length (mm). |
-Hose internal diameter (mm). |
-Hose materials. |
-Stem length (mm). |
-Stem internal diameter (mm). |
-Base diameter (mm). |
-Base volume (cm3). |
-Base shape. |
-Pressure drop (mm H2O). |
-Water filter efficiency (%). |
-Hose air permeability (CU). |
-Head height (mm). |
-Head top diameter (mm). |
-Head bottom diameter (mm). |
-No. of holes. |
-Head volume (mm3). |
-Heating source type. |
-Head materials. |
Table 28 to § 1107.19(a)(14)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Hose length (mm). |
-Hose internal diameter (mm). |
-Stem length (mm). |
-Stem internal diameter (mm). |
-Base diameter (mm). |
-Base volume (cm3). |
-Pressure drop (mm H2O). |
-Water filter efficiency (%). |
-Head height (mm). |
-Head top diameter (mm). |
-Head bottom diameter (mm). |
-Head volume (mm3). |
Table 29 to § 1107.19(a)(15)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Heating element mass (mg). |
-Heating element density (g/cm3). |
-Heating element resistance (ohms) (if applicable). |
-No. of heating elements. |
-Heating element configuration. |
-Heating element diameter (gauge). |
-Battery current rating (mA) (if applicable). |
-Battery capacity (mAh) (if applicable). |
-Battery voltage operating range (volts) (if applicable). |
-Battery current operating range (amps) (if applicable). |
-Power delivery unit (PDU) voltage operating range (volts) (if applicable). |
-PDU current operating range (amps) (if applicable). |
-PDU wattage operating range (watts) (if applicable). |
-PDU temperature cut-off ( °C) (if applicable). |
Table 30 to § 1107.19(a)(15)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Heating element temperature range ( °C) (if applicable). |
-Heating element mass (mg). |
-Heating element density (g/cm3). |
-Heating element resistance (ohms) (if applicable). |
-Heating element diameter (gauge). |
-Battery current rating (mA) (if applicable). |
-Battery capacity (mAh) (if applicable). |
-Battery voltage operating range (volts) (if applicable). |
-Battery current operating range (amps) (if applicable). |
-Power delivery unit (PDU) voltage operating range (volts) (if applicable). |
-PDU current operating range (amps) (if applicable). |
-PDU wattage operating range (watts) (if applicable). |
-PDU temperature cut-off ( °C) (if applicable). |
Table 31 to § 1107.19(a)(16)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Head height (mm). |
-Head top diameter (mm). |
-Head bottom diameter (mm). |
-No. of holes. |
-Head volume (mm3). |
-Head materials. |
Table 32 to § 1107.19(a)(16)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Head height (mm). |
-Head top diameter (mm). |
-Head bottom diameter (mm). |
-Head volume (mm3). |
Table 33 to § 1107.19(a)(17)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Length (mm) (for square or rectangular shape foil). |
-Width (mm) (for square or rectangular shape foil). |
-Diameter (mm) (for circular shape foil). |
-Foil thickness (mm). |
-No. of holes. |
-Diameter of the holes (mm). |
Table 34 to § 1107.19(a)(17)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Length (mm) (for square or rectangular shape foil). |
-Width (mm) (for square or rectangular shape foil). |
-Diameter (mm) (for circular shape foil). |
-Foil thickness (mm). |
-Diameter of the holes (mm). |
Table 35 to § 1107.19(a)(18)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 36 to § 1107.19(a)(18)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Tobacco moisture or oven volatiles (%). |
-Tobacco cut size (CPI or mm). |
Table 37 to § 1107.19(a)(19)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Draw resistance (mm H2O). |
-Puff count (for full tank/cartridge). |
-Atomizer tank/cartridge volume (mL). |
-No. of heating elements (e.g., coil). |
-Heating element diameter (gauge). |
-Heating element length (mm). |
-Heating element resistance (Ohms). |
-Heating element temperature range ( °C). |
-Heating element configuration (target only). |
-Battery voltage operating range (V). |
-Battery current operating range (mA). |
-Battery capacity (mAh). |
-Battery nominal voltage (V). |
-Battery current rating (mA). |
-Battery charging temperature limits ( °C). |
-Battery discharge temperature limits ( °C). |
-Battery end of discharge voltage (V). |
-Battery maximum charging current (mA). |
-Battery maximum discharging current (mA). |
-Battery upper limits charging voltage (V). |
-Power Delivery Unit (PDU) voltage operating range (V). |
-PDU current operating range (mA). |
-PDU wattage operating range (watts). |
-PDU temperature cut-off ( °C) (if applicable). |
-PDU current cut-off (mA) (if applicable). |
-Airflow rate (L/min) (if applicable). |
-Ventilation (%). |
-Inhaled aerosol temperature ( °C). |
Table 38 to § 1107.19(a)(19)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Draw resistance (mm H2O). |
-Puff count (for full tank/cartridge). |
-Atomizer tank/cartridge volume (mL). |
-Heating element diameter (gauge). |
-Heating element resistance (Ohms). |
-Heating element temperature range ( °C). |
-Battery voltage operating range (V). |
-Battery current operating range (mA). |
-PDU voltage operating range (V). |
-PDU current operating range (mA). |
-PDU wattage operating range (watts). |
-PDU current cut-off (mA) (if applicable). |
-Inhaled aerosol temperature ( °C). |
-PDU temperature cut-off ( °C) (if applicable). |
-Battery capacity (mAh). |
-Battery nominal voltage (V). |
-Battery current rating (mA). |
-Heating element length (mm). |
-Battery charging temperature limits ( °C). |
-Battery discharge temperature limits ( °C). |
-Battery maximum charging current (mA). |
-Battery maximum discharging current (mA). |
-Battery upper limits charging voltage (V). |
-Airflow rate (L/min) (if applicable). |
-Ventilation (%). |
Table 39 to § 1107.19(a)(20)
Provide Target Specifications With Upper and Lower Range Limits for: |
-E-liquid viscosity (at 20 °C). |
-E-liquid volume (ml). |
-Particle number concentration (#/cm3). |
-Count median diameter (nm). |
-PM2.5 ([MICRO]g/m3). |
Table 40 to § 1107.19(a)(20)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-E-liquid viscosity (at 20 °C). |
-E-liquid volume (ml). |
-Particle number concentration (#/cm3). |
-Count median diameter (nm). |
-PM2.5 ([MICRO]g/m3). |
Table 41 to § 1107.19(a)(21)
Provide Target Specifications With Upper and Lower Range Limits for: |
-Overall Device: |
-Mass (mg). |
-Length (mm). |
-Width (mm). |
-Height (mm). |
-Diameter (mm). |
-Draw resistance (mm H2O). |
-Puff count (for full tank/cartridge). |
-Puff volume (mL). |
-Product volume (mL). |
-Airflow rate (L/min) (if applicable). |
-Ventilation (%). |
-Operational temperature ( °C). |
-Temperature sensor (if applicable). |
-Material wrapper length (mm) (if applicable). |
-Material wrapper width (mm) (if applicable). |
-Material wrapper basis weight (g/m2) (if applicable). |
-Material porosity or permeability (CU) (if applicable). |
-Heating element: |
-Heating element source/type/approach (electrical, carbon, aerosol, etc.). |
-Heating element temperature range ( °C). |
-Heating element operational temperature ( °C). |
-Heating element maximum temperature (boost temperature) ( °C). |
-Heating element material. |
-Heating element configuration. |
-Heating element length (mm). |
-Heating element mass (mg). |
-Heating element location. |
-No. of heating elements (e.g., coil). |
-Heating element diameter (gauge) (if applicable). |
-Heating element resistance (Ohms) (if applicable). |
-Tobacco/E-liquid: |
-Tobacco mass (mg) (if applicable). |
-Tobacco density (g/cm3) (if applicable). |
-Tobacco moisture or oven volatiles (%) (if applicable). |
-Tobacco cut size (CPI or mm) (if applicable). |
-E-liquid volume (mL) (if applicable). |
-E-liquid viscosity (at 20 °C) (if applicable). |
-Battery (if applicable): |
-Battery capacity (mAh). |
-Battery voltage operating range (V) or wattage (W). |
-Battery current charging range (amps). |
-Battery nominal voltage (V). |
-Battery current rating (mA). |
-Battery charging temperature limits ( °C). |
-Battery discharge temperature limits ( °C). |
-Battery end of discharge voltage (V). |
-Battery maximum charging current (mA). |
-Battery maximum discharging current (mA). |
-Battery upper limits charging voltage (V). |
-Power Delivery Unit (PDU) voltage operating range (V). |
-PDU current operating range (mA). |
-PDU wattage operating range (watts). |
-PDU temperature cut-off ( °C) (if applicable). |
-PDU current cut-off (mA) (if applicable). |
-Aerosol: |
-Inhaled aerosol temperature ( °C). |
-Aerosol particle number concentration (#/cm3). |
-Count median diameter (nm). |
-PM2.5 ([MICRO]g/m3). |
-Filter (if applicable): |
-Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged (e.g., DPF, total denier (g/9000m), and filter density(g/cm3))). |
-Filter pressure drop (mm H2O). |
-Filter length (mm). |
-Filter diameter (mm). |
-Filter ventilation (%). |
Table 42 to § 1107.19(a)(21)
Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: |
-Overall device: |
-Draw resistance (mm H2O). |
-Puff count (for full tank/cartridge) (dimensionless). |
-Product volume (mL). |
-Airflow rate (L/min) (if applicable). |
-Ventilation (%). |
-Operational temperature ( °C). |
-Temperature sensor (if applicable). |
-Material wrapper length (mm) (if applicable). |
-Material wrapper width (mm) (if applicable). |
-Material wrapper basis weight (g/m2) (if applicable). |
-Material porosity or permeability (CU) (if applicable). |
-Heating element: |
-Heating element diameter (gauge) (if applicable). |
-Heating element resistance (Ohms) (if applicable). |
-Heating element temperature range ( °C). |
-E-liquid: |
-E-liquid viscosity (at 20 °C) (if applicable). |
-E-liquid volume (ml) (if applicable). |
-Tobacco: |
-Tobacco moisture or oven volatiles (%) (if applicable). |
-Tobacco cut size (CPI or mm) (if applicable). |
-Tobacco density (g/cm3) (if applicable). |
-Battery: |
-Battery voltage operating range (V) or wattage (W). |
-Battery current operating range (mA). |
-PDU voltage operating range (V). |
-PDU current operating range (mA). |
-PDU wattage operating range (watts). |
-PDU current cut-off (mA) (if applicable). |
-PDU temperature cut-off ( °C) (if applicable). |
-Battery capacity (mAh). |
-Battery nominal voltage (V). |
-Battery current rating (mA). |
-Battery charging temperature limits ( °C). |
-Battery discharge temperature limits ( °C). |
-Battery maximum charging current (mA). |
-Battery maximum discharging current (mA). |
-Battery upper limits charging voltage (V). |
-Aerosol: |
-Inhaled aerosol temperature ( °C). |
-Aerosol particle number concentration (#/cm3). |
-Count median diameter (nm). |
-PM2.5 ([MICRO]g/m3). |
-Filter (if applicable): |
-Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged (e.g., DPF, total denier (g/9000m), and filter density(g/cm3))). |
-Filter ventilation (%). |
-Filter pressure drop (mm H2O). |
21 C.F.R. §1107.19