HPHC Market Map Study for US Machine-Made Cigars Part 1 Physical - - PowerPoint PPT Presentation

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HPHC Market Map Study for US Machine-Made Cigars Part 1 Physical - - PowerPoint PPT Presentation

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HPHC Market Map Study for US Machine-Made Cigars Part 1 Physical Properties, Filler, and Smoke HPHC variability Karl A. Wagner, Lara L. Baker, Michael J. Morton, Raquel M. Olegario, Jennifer H. Sm ith Tobacco Science Research Conference

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SLIDE 1

Karl A. Wagner, Lara L. Baker, Michael J. Morton, Raquel M. Olegario, Jennifer H. Sm ith Tobacco Science Research Conference

  • Sept. 15 - 18, 2019

HPHC Market Map Study for US Machine-Made Cigars – Part 1 Physical Properties, Filler, and Smoke HPHC variability

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 1

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SLIDE 2

Study Overview

  • Part 1: market map overview
  • Discuss the inherent variability of cigars
  • Describe the products
  • Present physical properties and abbreviated HPHCs for filler and smoke1 under

CORESTA, ISO and Intense smoking regimes

  • Compare the physical properties and HPHC variability of cigars and cigarettes
  • Part 2: predictive models 2
  • Compare variability and yields of the three different smoking regimes
  • Examine correlations of TPM, tar, and CO to smoke constituent yields and effect on

market mapping prediction intervals

  • Examine cigar filler manufacturing variability

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 2

  • 1. Guidance for Industry, Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act (March 2012).

  • 2. TSRC Presentation #62, HPHC Market Map Study for US Machine Made Cigars – Part 2 Predictive Models, Michael Morton.
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SLIDE 3

Cigar Regulatory Landscape

  • In May 2016, FDA issued final rule to deem other tobacco products
  • Regulates cigars, pipe tobacco, e-cigarettes and other tobacco products, including

dissolvables, gels, and hookah tobacco 1

  • Maryland Federal District Court 2
  • Ordered FDA to set May 11, 2020, as the deadline for submission of applications for newly

deemed tobacco products

  • FDA has not published an HPHC list for cigars or specified a smoking regime(s)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 3

  • 1. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking

Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (May 10, 2016).

  • 2. American Academy of Pediatrics v. FDA, No. PWG-18-883, 2019 U.S. Dist. Westlaw 3067492 (D. Md. July 7, 2019).
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SLIDE 4

Comparison of Sources of HPHC Variability

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 4

Cigarettes

  • Uniform product category
  • Extensive testing experience
  • Standardized methods
  • Extensive interlaboratory testing
  • Well characterized reference

products

  • Diverse product category
  • Limited testing experience
  • Few smoke standardized methods
  • Limited interlaboratory testing
  • Reference products recently

introduced

Analytical Process

  • More sophisticated equipment
  • Often blend over multiple crops
  • Wrapped in paper
  • Less sophisticated equipment
  • Often blend from single crop
  • Wrapped in tobacco or tobacco

sheet

Manufacturing Process

Cigars

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SLIDE 5

Cigar Selection

  • 24 US machine-made cigars
  • Selection based on:

− Market share − Style (untipped, filter tip, plastic tip, wood tip) − Wide range of flavor characteristics

  • Includes 9 manufacturers
  • ~38 % market share for cigarillos
  • ~11 % market share for filter tips
  • Dimensions and properties
  • Diameter: 7.8 mm – 16 mm
  • Length: 95 mm – 158 mm
  • Weight: 1.1 g – 8.0 g
  • 13 Untipped, 3 filter tip, 8 plastic / wood tipped

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 5

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SLIDE 6

Market Map - Machine Made Cigars

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 6

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SLIDE 7

Smoking Regimes

CORESTA CRM #64 1 ISO 3308 Intense ISO 20778

Puff volume (ml) 20 35 55 Puff frequency (sec) 40 60 30 Puff duration (sec) 1.5 2 2 Vent blocking (%) none none 100

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 7

20 40 60 80 8 10 12 14 16 18 20 22

Puff Volume (ml) Cigar Diameter (mm)

For cigars > 12 mm diameter: puff volume = (0.139) (dia2)

  • CORESTA Recommended Method No. 64 - Routine Analytical Cigar-Smoking Machine -

Specifications, Definitions and Standard Conditions

  • ISO 3308:2012, Cigarettes. Routine analytical cigarette-smoking machine — Definitions

and standard conditions

  • ISO 20778:2018, Cigarettes. Routine analytical cigarette smoking machine. Definitions

and standard conditions with an intense smoking regime

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SLIDE 8

Abbreviated HPHC List for Cigarettes1

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 8

Cigarette Smoke Roll-your-own Tobacco and Cigarette Filler Nicotine, Carbon Monoxide Nicotine Ammonia Ammonia NNK, NNN NNN, NNK Formaldehyde, Acetaldehyde, Acrolein, Crotonaldehyde Arsenic, Cadmium Benzo[a]pyrene 1-Aminonaphthalene, 2-Aminonaphthalene, 4-Aminobiphenyl 1,3-Butadiene, Acrylonitrile, Benzene, Isoprene, Toluene

  • 1. Guidance for Industry, Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco

Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act (March 2012).

  • All testing was conducted at ISO 17025 accredited laboratories
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SLIDE 9

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 9

Cigar and Cigarette Physical Properties

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SLIDE 10

RTD – Cigars and Cigarettes

24 cigar products (220 reps each) and 10 cigarette products (100 reps each)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 10

The cigars and cigarettes were commercially available in 2018 and 2017, respectively

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SLIDE 11

Weight – Cigars and Cigarettes

24 cigar products (220 reps each) and 10 cigarette products (100 reps each)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 11

The cigars and cigarettes were commercially available in 2018 and 2017, respectively

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SLIDE 12

Relative Weight – Cigars and Cigarettes

24 cigar products (220 reps each) and 10 cigarette products (100 reps each)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 12

The cigars and cigarettes were commercially available in 2018 and 2017 respectively

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SLIDE 13

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 13

Cigar and Cigarette HPHC Yields and Variability

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SLIDE 14

TPM Variability Across Categories and Regimes

24 cigar products (42 reps each) and 25 cigarette products (55 reps each)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 14

The cigars and cigarettes were commercially available in 2018 and 2012, respectively

  • CORESTA Cigars
  • ISO Cigars
  • Intense Cigars
  • ISO Cigarettes ●Intense Cigarettes
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SLIDE 15

Relative TPM Variability Across Categories and Regimes

24 cigar products (42 reps each) and 25 cigarette products (55 reps each)

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 15

The cigars and cigarettes were commercially available in 2018 and 2012, respectively

  • CORESTA Cigars
  • ISO Cigars
  • Intense Cigars
  • ISO Cigarettes ●Intense Cigarettes
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SLIDE 16

Short-term Variability – Smoke

24 cigar products, 146 cigarette products, 7 replicates per brand

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 16

5 10 15 20 25

Average % RSD (across all products)

Cigar CORESTA Cigar ISO Cigar Intense Cigarette ISO Cigarette Intense

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SLIDE 17

Short-term Variability – Filler

24 cigar products, 146 cigarette products, 7 replicates per brand

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 17

5 10 15 20 25

Avergae % RSD (across all products)

Ground Cigars Cigarette Filler

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SLIDE 18

NNK – Ground Cigar

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 18

500 1000 1500 2000 2500 3000 3500 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

NNK (ng/g)

Product

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SLIDE 19

NNK – Cigar Smoke Yields

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 19

500 1000 1500 2000 2500 3000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

NNK (ng/cigar)

Product CORESTA ISO Intense

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SLIDE 20

Nicotine – Ground Cigar

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 20

5 10 15 20 25 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Nicotine (mg/g)

Product

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SLIDE 21

Nicotine – Cigar Smoke Yields

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 21

2 4 6 8 10 12 14 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Nicotine (mg/cigar)

Product CORESTA ISO Intense

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SLIDE 22

Key Takeaways

  • Cigars are a more diverse product category than cigarettes
  • Cigar physical properties and smoke yields are significantly more

variable than cigarettes

  • Cigar filler HPHCs show significantly less variability than cigar smoke

HPHCs and may be useful for comparative purposes

  • In the cigar analytical testing space, opportunities exist for:
  • Creation of standardized methods for smoke HPHCs
  • Establishing proficiency testing
  • Characterization of the University of Kentucky cigar reference products

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 22

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SLIDE 23

Key Takeaways

  • Cigars are a more diverse product category than cigarettes
  • Cigar physical properties and smoke yields are significantly more

variable than cigarettes

  • Cigar filler HPHCs show significantly less variability than cigar smoke

HPHCs and may be useful for comparative purposes

  • In the cigar analytical testing space, opportunities exist for:
  • Creation of standardized methods
  • Establishing proficiency testing
  • Characterization of reference products

Karl A. Wagner | Regulatory Sciences | Altria Client Services | TSRC Sept 15-18th 2019 | FINAL 23

www.altria.com/ ALCS-Science