Table 1
Study design and batch designations.
| Batch designation Study phase | A | B1, B2, B3 a | C | D | E | F | G | H |
|---|---|---|---|---|---|---|---|---|
| Phase 1 | Week 1 | Week 1 | Week 1 | |||||
| Short-term | shift 1 | shift 2 | shift 3 | |||||
| Phase 2 | Year 1 | Year 1 | Year 1 | Year 1 | ||||
| Medium-term | quarter 1 | quarter 2 | quarter 3 | quarter 4 | ||||
| Phase 3 | Year 1 | Year 2 | Year 3 | |||||
| Long-term |
Table 2
Sample descriptions.
| Sample code | Blend | ~Non-intense “tar” | Comment |
|---|---|---|---|
| 1 | American | 10 mg | – |
| 2 | American | 3 mg | Charcoal filter |
| 3 | Virginia | 10 mg | – |
| 4 | American | 10 mg | – |
| 5 a | NA | NA | Withdrawn |
| 6 | American | 14 mg | – |
| 7 | American | 1 mg | – |
| 8 | Virginia | 8 mg | – |
| 9 | American | 7 mg | |
| 10 (3R4F) | American | 8 mg | Single batch study reference |
| 11 (1R6F) | American | 8 mg | Informational |
Table 3
Relative range (%) among time point for each product sample for select parameters and constituents.
| Sample | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Timepoint | 1 | 2 | 3 | 4 | 6 | 7 | 8 | 9 | 3R4F | |
| Physical parameters | ||||||||||
| Cigarette weight as-is (mg/cig) | Short | 0.8% | 0.6% | 0.2% | 0.9% | 0.2% | 0.3% | 0.3% | 0.6% | NCa |
| Medium | 1.3%* | 1.7%* | 1.2%* | 1.4%* | NC | 1.6%* | 0.9%* | 2.6%* | 0.2% | |
| Long | 3.4%* | 0.3% | 0.4% | 1.9%* | 0.7% | 3.2%* | 3.8% | 1.1% | 0.4% | |
| Filter tip ventilation (%) | Short | 3.4%* | 6.0%* | 0.1% | 8.4%* | 0.9% | 19.7%* | 1.3% | 0.9% | NC |
| Medium | 1.8%* | 8%* | 0.4%* | 8.2%* | NC | 27.1%* | 5.5%* | 5.0%* | 2.4% | |
| Long | 10.4%* | 8.6% | 0.1% | 9.0%* | 2.8% | 14.0%* | 0.7% | 1.2% | 6.6% | |
| Tobacco constituents | ||||||||||
| NNN (ng/g) | Short | 1.4% | 7.4% | 11.9% | 3.1% | 3.0% | 6.5% | 14.7%* | 27.1%* | 3.8% |
| Medium | 41.9%* | 31.4%* | 51%* | 14.6%* | 29.4%* | 34.5%* | 30.5%* | 81.5%* | 2.8% | |
| Long | 34.0%* | 31.5%* | NCS b | 2.3% | 13.8%* | 28.1%* | NCS | 57.2%* | 3.2% | |
| NNK (ng/g) | Short | 8.1% | 24.7%* | 8.1% | 12.6%* | 10.3% | 2.0% | 15.4%* | 32.9%* | 3.3% |
| Medium | 62.1%* | 53.5%* | 47.4%* | 7.5% | 37.8%* | 33.9%* | 28.2%* | 58.9%* | 9.2% | |
| Long | 34.7%* | 20.9% | NCS | 6.4% | 36.0% | 21.4% | NCS | 54.4% | 8.9%* | |
| Nicotine (μg/g) | Short | 2.2%* | 1.0% | 4.8%* | 3.1%* | 1.0% | 4.8%* | 2.1%* | 3.9%* | 0.4% |
| Medium | 9.8%* | 13.8%* | 4.1%* | 3.7%* | 5.2%* | 5.2%* | 3.9%* | 8.6%* | 1.7%* | |
| Long | 8.3%* | 5.6%* | 14.0%* | 2.5%* | 2.8%* | 4.4%* | 0.3% | 7.6%* | 0.1% | |
| Ammonia (μg/g) | Short | 6.7%* | 7.5%* | 9.4%* | 6.7%* | 1.5% | 0.9% | 34.4%* | 12.8%* | 3.1% |
| Medium | 11.6%* | 15.0%* | 63.7%* | 8.6%* | 21.1%* | 11.0%* | 66.5%* | 10.3%* | 4.8%* | |
| Long | 12.5%* | 2.1% | NCS | 24.6%* | 10.6%* | 10.4%* | NCS | 17.2%* | 1.0% | |
| Smoke constituent – Non-intense regime | ||||||||||
| Ammonia (μg/cig) | Short | 0.9% | < LOQ | 2.3% | 8.3% | 2.6% | < LOQ | 8.7% | 2.1% | 5.3% |
| Medium | 18.8%* | < LOQ | 5.5% | 5.0% | 28.3%* | < LOQ | 17.7% | 19.2% | 6.0% | |
| Long | 14.7% | 8.8% | NCS | 7.4% | 21.5% | < LOQ | NCS | 7.5% | 9.2% | |
| Acetaldehyde (μg/cig) | Short | 5.0% | 9.5% | 2.4% | 6.5% | 6.9%* | 51.1%* | 5.1% | 7.4% | 6.8% |
| Medium | 11.3% | 11.4% | 6.5% | 9.3%* | 3.2% | 67.3%* | 3.9% | 13.2%* | 11.6%* | |
| Long | 12.4%* | 7.0% | 0.5% | 5.7% | 3.6% | 21.6% | 0.7% | 2.5% | 3.3% | |
| Total HCN (μg/cig) | Short | 5.8% | 8.5% | 2.9% | 15.9%* | 17.9%* | < LOQ | 15.7%* | 16.5% | 4.5% |
| Medium | 15.9%* | 22.9% | 8.0% | 8.1% | 9.4%* | < LOQ | 30.1%* | 16.4%* | 7.7% | |
| Long | 20.5%* | 31.0% | NCS | 13.3% | 15.3% | < LOQ | NCS | 6.0% | 12.1% | |
| 4-Aminobiphenyl (ng/cig) | Short | 3.2% | 5.5%* | 3.6% | 2.8% | 2.0% | 17.6%* | 4.9% | 1.1% | 4.5% |
| Medium | 4.5% | 2.4% | 4.5% | 6.5% | 6.4%* | 51.3%* | 20.1%* | 5.3% | 5.4% | |
| Long | 7.4% | 6.4% | NCS | 11.4%* | 2.6% | 16.9%* | NCS | 5.2% | 3.9% | |
| BaP (ng/cig) | Short | 2.2% | 3.0% | 1.7% | 0.3% | 1.9% | 4.2% | 2.2% | 2.6% | 1.1% |
| Medium | 4.1% | 3.6% | 2.3% | 4.0% | 6.1%* | 10.4% | 2.2% | 4.3% | 1.6% | |
| Long | 8.1% | 6.9% | 3.9% | NC | 6.3% | 29.9%* | 7.5% | 3.5% | 1.7% | |
| NNN (ng/cig) | Short | 13.4% | 14.3%* | 9.7% | 4.0% | 11.3% | 27.1%* | 15.6% | 13.1% | 2.9% |
| Medium | 36.9%* | 11.9% | 21.9% | 5.7% | 8.4% | 54.9%* | 51.3%* | 44.7%* | 16.5% | |
| Long | 33.1%* | 51.7%* | NCS | 0.7% | 12.4% | 25%* | NCS | 45.9%* | 10.8% | |
| NNK (ng/cig) | Short | 18.0% | 14.1%* | 8.2% | 8.0% | 9.9% | 40.2%* | 12.0% | 26.8% | 4.0% |
| Medium | 44.6%* | 31.7% | 25.1% | 11.6%* | 17.6% | 62.9%* | 34.4% | 36%* | 12.6% | |
| Long | 28.1%* | 47.7%* | NCS | 3.4% | 12.2% | 34.0% | NCS | 32.9%* | 12.7%* | |
| Benzene (μg/cig) | Short | 6.4% | 16.2%* | 2.8% | 3.9% | 2.9% | 23%* | 3.7% | 4.4% | 1.3% |
| Medium | 13%* | 19%* | 6.2% | 6.2% | 7.7% | 81.8%* | 11.5%* | 9.0% | 10.6%* | |
| Long | 14.5%* | 8.7%* | NCS | 0.3% | 1.7% | 28.1%* | NCS | 6.5% | 4.1% | |
| Smoke constituent - Intense regime | ||||||||||
| Ammonia (μg/cig) | Short | 10.6% | 9.9% | 0.8% | 1.1% | 7.2% | 3.7% | 13.4%* | 5.9% | 7.2% |
| Medium | 19.0% | 47.6% | 22.8% | 12.8% | 30.5%* | 7.3% | 45.2%* | 15.2% | 14.1% | |
| Long | 1.6% | 9%* | NCS | 1.9% | 22.9%* | 11.0% | NCS | 3.0% | 7.7% | |
| Acetaldehyde (μg/cig) | Short | 1.7% | 2.6% | 3.5% | 3.3% | 1.8% | 2.7% | 4.9% | 3.0% | 1.4% |
| Medium | 2.7% | 5.5% | 6.0% | 4.9% | 8.9%* | 6.7% | 6.9% | 4.7% | 3.5% | |
| Long | 2.4% | 3.8% | 1.0% | 2.9% | 9.4%* | 3.9% | 10.8%* | 0.5% | 0.4% | |
| Total HCN (μg/cig) | Short | 5.8% | 5.2% | 7.4% | 1.4% | 9.6% | 4.2% | 1.2% | 13.6% | 4.7% |
| Medium | 6.1% | 15.6%* | 9.2% | 2.9% | 9.5% | 8.9% | 19.2%* | 15.8%* | 7.5% | |
| Long | 13.4%* | 10.5%* | NCS | 10.8% | 9.4% | 4.7% | NCS | 13.0% | 2.8% | |
| 4-Aminobiphenyl (ng/cig) | Short | 3.9% | 3.2% | 2.0% | 4.8% | 0.7% | 0.4% | 1.7% | 4.7% | 2.4% |
| Medium | 10.9% | 14.3%* | 4.7% | 4.1% | 8.8%* | 5.2% | 17.3%* | 5.1% | 4.6% | |
| Long | 10.5% | 9.2% | NCS | 6.8%* | 13.7% | 9.6%* | NCS | 4.9% | 7.2% | |
| BaP (ng/cig) | Short | 2.2% | 2.9% | 2.8% | 2.1% | 1.8% | 0.4% | 3.8% | 3.1% | 2.3% |
| Medium | 3.7% | 3.6% | 7.2%* | 2.1% | 5.6% | 2.5% | 4.4% | 7.3% | 6.1%* | |
| Long | 5.4% | 5.4% | 2.5% | NC | 7.9% | 2.5% | 8.5% | 5.5% | 1.4% | |
| NNN (ng/cig) | Short | 1.2% | 17.3%* | 19.2%* | 18.9%* | 5.3% | 3.5% | 10.5% | 10.1% | 4.3% |
| Medium | 37.2%* | 26.6%* | 62.6%* | 4.6% | 20.9% | 23.7%* | 13.9% | 52.9%* | 10.3% | |
| Long | 22.9% | 52.9%* | NCS | 5.5% | 10.6% | 30.5%* | NCS | 40.6%* | 12.5% | |
| NNK (ng/cig) | Short | 6.6% | 2.3% | 14.8% | 9.2% | 11.1% | 15.8% | 21.3%* | 21.6%* | 5.7% |
| Medium | 34.5%* | 41.8%* | 18.7%* | 8.5% | 16.3% | 25.8%* | 33.6% | 26.2%* | 12.5% | |
| Long | 26.9% | 49.5%* | NCS | 6.6% | 25.4%* | 11.8% | NCS | 26.6%* | 12.0% | |
| Benzene (μg/cig) | Short | 5.0% | 2.3% | 8.5% | 3.4% | 6.2% | 4.7% | 10.5%* | 5.0% | 2.3% |
| Medium | 4.2% | 5.0% | 5.1% | 3.9% | 4.3% | 4.7% | 9.5%* | 7.0% | 2.4% | |
| Long | 3.7% | 5.1% | NCS | 2.3% | 1.5% | 1.3% | NCS | 3.2% | 4.9% | |
Table 4
Product 2 CO yields from non-intense smoking for long-term variability testing as an illustration of interactive effects among laboratories and of the magnitude of differences that may be expected from testing multiple batches of the same product in different laboratories using standardized methodology.
| Product 2 Non-intense CO (mg/cig) Phase 3 samples | Product range | Laboratory range | |||
|---|---|---|---|---|---|
| Batch | % | % | |||
| Lab | B3 | G | H | – | – |
| 1 | 4.41 | 4.11 | 4.64 | – | – |
| 4 | 3.85 | 3.70 | 3.87 | – | – |
| 5 | 3.56 | 3.64 | 3.48 | – | – |
| 6 | 4.70 | 4.59 | 4.87 | – | – |
| 7 | 3.92 | 3.75 | 4.44 | – | – |
| 8 | 4.00 | 3.75 | 4.43 | – | – |
| 9 | 3.62 | 3.16 | 3.92 | – | – |
| 10 | 3.53 | 3.70 | 3.50 | – | – |
| 11 | 4.14 | 4.02 | 4.66 | – | – |
| Average | 3.97 | 3.82 | 4.20 | 9.4 | 29.0 |
Figure 1
Tobacco NNN for Product 9 across all batches compared to repeat testing results for 3R4F across the same timeframes. Shaded regions represent repeat testing of the same batch. A, B1, C are samples collected within 1 week of production. Samples B2, D, E, and F are samples collected quarterly for 1 year. Samples B3, G, and H are samples collected annually for 3 years. 3R4F was one batch collected, shipped, and tested like the production samples. Percent values displayed are the spread in timepoint replicate averaged values to show relative variability of batches within a study phase.
Figure 2
Non-intense smoke BaP for product 1 across all batches compared to repeat testing results for 3R4F across the same timeframes. Shaded regions represent repeat testing of the same batch. A, B1, C are samples collected within 1 week of production. Samples B2, D, E, and F are samples collected quarterly for 1 year. Samples B3, G, and H are samples collected annually for 3 years. 3R4F was one batch collected, shipped, and tested like the production samples. Percent values displayed are the spread in timepoint replicate averaged values to show relative variability of batches within a study phase.