An Evaluation of the Variability of HPHCs in Cigars as compared to Cigarettes

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1 An Evaluation of the Variability of HPHCs in Cigars as compared to Cigarettes Presented by: Karl A. Wagner, Ph.D. Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 1

2 Sources of Variability Cigarettes Cigars Analytical Process Manufacturing Process Extensive testing experience Standardized methods Proficiency testing Reference products Uniform product category More sophisticated equipment Typically blend over multiple crop years Wrapped in paper Limited testing experience Few standardized methods Limited proficiency testing No reference products Diverse product category Less sophisticated equipment Typically blend from single crop Wrapped in tobacco Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 2

3 Cigar Market Diversity Machine-made Corona Plastic Tip Wood Tip untipped Filter Tip Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 3

4 The Continuum of Short-term Testing Variability Cigarette and Cigar Filler Less Variability Cigarettes Machine Made Cigars Premium Hand Rolled Cigars More Variability Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 4

5 Overview of ALCS Internal Studies Smoke Collection - Smoke traps (Commercial and ALCS designs) - Smoking regime variability (CORESTA, ISO, HC) Physical Properties - Resistance to draw (RTD), weights, and relationship to TNCO yield Comparison of Cigar and Cigarette HPHC Variability Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 5

6 Smoke Collection Examples of Analytical Testing Variability: How Testing Infrastructure Impacts Results Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 6

7 TPM (mg/cigar) Testing Reliability Data generated at ISO contract laboratory CORESTA Smoking Regime (20 cc / 1.5 sec / 40 sec) Commercial (CORESTA) smoke trap Total Particulate Matter (TPM) Product ID Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 7

8 Poster Presentation - STPOST 06 Blake, T., et al., The Challenges of Machine Smoking the Diverse Cigar Product Category Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 8

TPM (%RSD) 1 2 3 4 5 6 7 8 9 TPM Variability - ALCS vs CORESTA Smoke Traps 60% 50% 40% 30% 20% 10% 0% ALCS Smoke Trap Coresta Smoke Trap CORESTA Regime ISO Regime HC Regime 1 2 3 4 5 6 7

9 TPM (%RSD) TPM Variability - ALCS vs CORESTA Smoke Traps 60% 50% 40% 30% 20% 10% 0% ALCS Smoke Trap Coresta Smoke Trap CORESTA Regime ISO Regime HC Regime Product TPM is less variable with the ALCS smoke trap Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 9

10 Average % RSD All Brands Average % RSD All Brands Overall Variability Average %RSD Across All Brands 35% 30% CORESTA Smoke Trap CORESTA ISO HCI 35% 30% ALCS Smoke Trap CORESTA ISO HCI 25% 25% 20% 15% 10% 5% 0% TPM Nicotine Tar CO 20% 15% 10% 5% 0% TPM Nicotine Tar CO Reduced variability for the ALCS smoke trap Consistent variability across all three smoking regimes Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 10

11 Physical Properties Examples of How Manufacturing Variability Impacts Analytical Results Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 11

12 RTD (mm Water) Resistance to draw (RTD) Machine-made cigar sorted by RTD (n=258) Replicate Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 12

13 RTD (mm Water) Cigar Weight (g) Cigar RTD and Weight Machine-made cigar sorted by RTD (n=258) RTD open Weight Replicate Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 13

14 RTD (mm Water) Cigar Weight vs RTD Machine-made cigar (n=258) y = x R² = Cigar Weight (g) Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 14

15 RTD Cigarettes and Cigars 100 replicates per product Cigarettes (10 products, 1 manufacturer) Machine-made Cigars (77 products, 6 manufacturers) Hand-made Cigars (10 products, 6 manufacturers) Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 15

16 Weight Cigarettes and Cigars 100 replicates per product Cigarettes (10 products, 1 manufacturer) Machine-made Cigars (77 products, 6 manufacturers) Hand-made Cigars (10 products, 6 manufacturers) Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 16

17 Relative Weight Cigarettes and Cigars 100 replicates per product Cigarettes (10 products, 1 manufacturer) Machine-made Cigars (77 products, 6 manufacturers) Hand-made Cigars (10 products, 6 manufacturers) Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 17

18 Effect of RTD (Weight) on TNCO Yields 1 2 Randomly select 60 untipped machine-made cigars Determine RTD and weight and sort by RTD 3 4 Select 20 cigars that evenly cover the measured RTD range Determine TNCO As RTD and weight increased: - Increase: puff count, CO - Decrease: TPM, nicotine, water, and tar Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 18

19 TPM (mg/ cigar) Nicotine (mg/cigar) RTD (mm water) CO (mg/ cigar) Effect of RTD (Weight) on TNCO Yield Cigar Weight vs RTD y = x R² = Cigar Weight (g) RTD vs TPM y = x R² = RTD (mm water) RTD vs Carbon Monoxide y = x R² = RTD (mm Water) RTD vs Nicotine y = x R² = RTD (mm Water) Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 19

20 Comparison of Cigarette and Cigar HPHC Variability Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 20

21 TPM Variability Across All Brands 55 data points per product 146 cigarette products, 86 cigar products Cigarette ISO regime Cigarette HC regime Cigar CORESTA regime, ALCS smoke trap Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 21

22 Relative TPM Variability Across All Brands 55 data points per product 146 cigarette products, 86 cigar products Cigarette ISO regime Cigarette HC regime Cigar CORESTA regime, ALCS smoke trap Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 22

23 Average % RSD (across all products) Short-term Variability - Smoke 146 cigarette products, 86 cigar products, 7 replicates per brand (TNCO = 20) 30% 25% 20% Cigarette - ISO Cigarette - HC Cigar - CORESTA 15% 10% 5% 0% Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 23

24 Average % RSD (across all products) Short-term Variability Tobacco Aliquots were taken from 100 g ground sample composites 86 cigarette products, 90 cigar products, 7 replicates per brand 30% 25% Cigar Filler, Wrapper, Binder Cigarette Filler 20% 15% 10% 5% 0% Ammonia Arsenic Cadmium NNK NNN Nicotine Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 24

25 Key Takeaways Cigars are a more diverse product category than cigarettes More variability is expected with cigar smoke testing than with cigarette smoke testing - Analytical testing - Manufacturing process Tobacco HPHCs show less variability than smoke HPHCs and may be useful for comparative purposes Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 25

26 Considerations The commercial cigar smoke trap is not as robust as the cigarette smoke trap and may be a significant source of variability and result in lower yields In the cigar analytical testing space, opportunities exist for: - Creation of standardized methods - Establishing proficiency testing - Creation of reference products Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 26

27 Contributing Authors Lara L. Baker, Tammy L. Blake, Anthony P. Brown, Matt S. Melvin, Michael J. Morton, Yezdi B. Pithawalla, Jennifer H. Smith Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 27

28 Altria Client Services Regulatory Sciences Karl Wagner October 9, CORESTA - ST02 28

Higher yield product smoking, are there yield errors inherent when using a mechanical smoking machine?

Higher yield product smoking, are there yield errors inherent when using a mechanical smoking machine? Authors Tim Mason: Cerulean, Rockingham drive, Linford wood East, Milton Keynes, United Kingdom. Ian