E-Vapour (EVAP) Sub-Group 2017 Report. Kitzbühel, Austria October 10, 2017

Transcription

1 E-Vapour (EVAP) Sub-Group 2017 Report Kitzbühel, Austria October 10, 2017

2 History Evolution o 2014, formation of E-cigarette TF o 2016, TF activities completed; formation of E-vapor product SG 2

3 E-Vapour Products SG Membership SG Coordinator o Charles Garner - RAISC SG Secretary o Gene Gillman Enthalpy Analytical SG membership o 50 people US, EU, Asia o E-Vapour Product Companies, Suppliers, Contract Labs, Regulatory Agencies, Academia, Others,... 3

4 E-Vapour Product Sub-Group Scope: 1) To identify areas of scientific research and conduct studies that will characterize liquids, e-vapour product emissions, and device properties and performance 2) To develop and publish methods and guides 3) To organize and conduct periodic proficiency/collaborative studies of identified constituents in liquids and/or e-vapour product aerosol 4

5 Accomplishments Technical Guidelines 1) No Sample Handling and Sample Collection of E-Cigarettes and E-Vapour Generating Products -- Published on CORESTA Website November on

6 Accomplishments Technical Reports 1) Preliminary Proficiency Study for Analysis of Nicotine, Glycerin, PG, and Water in e-cigarette aerosol To be published on CORESTA Website by October ) 2015 Collaborative Study for Determination of Glycerin, Propylene Glycol, Water and Nicotine in Collected Aerosol of E-Cigarettes Was published on CORESTA Website on March

7 Accomplishments CORESTA Recommended Methods (CRMs) 1) CRM 81 Routine Analytical Method for E-cigarette Aerosol Generation & Collection Was published on CORESTA Website on June ) CRM 84 - Determination of Glycerin, Propylene Glycol, Water, and Nicotine in the Aerosol of E-Cigarettes by Gas Chromatographic Analysis Was published on CORESTA Website on March

8 Presentations Global Tobacco and Nicotine Forum in Warsaw Poland June Presented on our 2015 Collaborative Study for Measuring Nicotine, Glycerin, PG, and Water for e-vapour products. 8

9 E-Vapour Sub-Group Active NWIPs Project No. Activity Leader Time 127 Carbonyls in e-liquids Melvin Proposed criteria have been circulated in SG that are being discussed and revised for criteria that should be considered when selecting an Intense Vaping Regime Walele Sinclair Garner Aerosol Collection Strategies for E-Cigarette Technologies Technical Guide Davis/Joza 2017 (Under revision by SG) 088 Comparison of Puffing Parameters Peer-Reviewed Publication EVAP SG

10 Highlights of CRM84 CRM84 specifies technical requirements for the analysis of glycerin, propylene glycol, nicotine, and water in trapped e-cigarette aerosol Puffing parameters to collect e-cigarette aerosol o Puff Volume (55 cc), puff duration (3 sec), puff interval (30 sec), puff profile (square wave) Test atmosphere variability o Temperature ± 2 C o Relative Humidity ± 5 % 10

11 Method Summary Collection Aerosol collection by CORESTA CRM 81 55mL puff, 3s duration, 2x/min, square profile Humidity controlled to ± 5% Temperature controlled to ± 2 C Sample Prep Pad extraction with Propan-2-ol, 20mL and mechanical shaking Analysis GC-TCD for water GC-FID for other analytes DB-ALC1 30m x 0,32mm x 1,8µm 11

12 Carbonyl Method Active NWIP

13 List of Carbonyls Formaldehyde Acetaldehyde Acrolein Crotonaldehyde Propionaldehyde Butyraldehyde MEK Diacetyl Acetyl Propionyl Acetoin Acetone 13

14 Carbonyl Method Study Coordinator - Matt Melvin Statistical Analysis - Mike Morton Method Selection from LC/MS, GC/MS, & HPLC End of November 2016 Approved Study Protocol Phase I (January 2017) & Phase II (Fall 2017) Phase I Liquid (May 2017) Phase II Emissions (Fall 2017) Liquid manufacturers & (16) Laboratories volunteered 14

15 Carbonyl Timeline Date December 31, 2016 January 13, 2017 January 20, 2017 January 27, 2017 End January to February 17, 2017 February March 31, 2017 April 1, 2017 April 2017 May 2017 Activity Participants select initial method. Distribute draft protocol, method, and data reporting sheet Laboratories state their intention to participate and order supplies Distribute final protocol, method, and data reporting sheet Participants order and receive the samples Laboratories conduct the study Laboratories submit results by this date Statistical evaluation and preparation of results Discuss results at 2017 Spring EVAP meeting 15

16 Participating Laboratories Participating Laboratories Essentra Scientific Labstat International ULC Lauterbach & Associates ASL Analytic Service Laboratory GmbH R.J. Reynolds Tobacco Zhengzhou Tobacco Research Institute of CNTC JTI UK Global Laboratory Services Altria Client Services Shanghai New Tobacco Products Research Institute of CNTC Laboratoire National de Métrologie et D'essais KT&G Research Institute JTI Oekolab Enthalpy Analytical Inc RDU Swisher International, Inc. JAPAN TOBACCO INC. Enthalpy Analytical Inc. RVA 17 laboratories from 8 countries agreed to participate Received 10 datasets 16

17 Carbonyl Method Technical Report circulated to SG R values between 18% to >200% Follow-up stability study on the test samples found that carbonyl compounds are not stable when added to e-liquids It is not possible to evaluate method performance using a collaborative study using shared samples 17

18 % From Time Zero Stability of carbonyls in e-liquids Days Acetoin Acetone 2-Butanone Acetaldehyde Propionaldehyde Butyraldehyde Diacetyl Formaldehyde Pentanedione Crotonaldehyde Acrolein 18

19 Intense Vaping Regime(s)

20 Intense Vaping Regime Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems Lines Evaluating new tobacco products under a range of conditions, including both non-intense (e.g., lower levels of exposure and lower volumes of aerosol generated) and intense (e.g., higher levels of exposure and higher volumes of aerosol generated), enables FDA to understand the likely range of delivery of emissions 20

21 Intense Vaping Regime Scientific justification for an intensive vaping regime will be determined based on the following factors: 1. Vaping topography data 2. Learnings from existing data assessing different vaping parameters 3. Technical constraints of vaping devices and smoking machines 21

22 Intense Vaping Regime Vaping Topography: Mean puff durations did not exceed 6 seconds 22

23 Intense Vaping Regime Vaping Topography: Majority of inter-puff intervals below 30 seconds 23

24 Intense Vaping Regime Vaping Topography: Mean puff volumes ranged approx ml 24

25 Intense Vaping Regime Learnings from existing data assessing vaping parameters o o Puff duration is the major factor impacting e-cigarette delivery Puff volume has minimal to no impact on e-cigarette delivery Technical constraints of vaping devices and smoking machines o o o Number of issues reported for some products using a bell shape puff profile Device failure issues reported for some products if the flow rate was not sufficient for device activation (no known issues with CRM81 flow rate of 18.3 ml/s = 55 ml / 3 seconds) Smoke machine modifications may be required for puff volumes >70 ml and inter-puff intervals <30 seconds 25

26 Intense Vaping Regime Should the group recommend an intense regime, or provide guidance on how to choose one? Is the inter-puff interval (30 seconds) appropriate? Should this be specified in the document, or provide guidance on how to select one? Is the puff duration (5 seconds) appropriate? Should this be specified in the document, or provide guidance on how to select one? Is the puff volume (95 ml) appropriate or needed? Should this be specified in the document, or provide guidance on how to select one? 26

27 Next Steps Update during meeting. Carbonyls in e-liquid Complete Tech Report At this time we will not draft a CRM. Aerosol results will be used to support a CRM. Carbonyls in aerosol-lead Melvin Group supports collaborative study More work is need to better define the study samples Small group to test devices and follow-up with the group. 27

28 Next Steps Update during meeting. Metals: Lead Joza and Colton Proficiency study with in-house methods Follow-up to group once the timeline is set and protocol drafted Stability indicating compounds: Walele, Dull, Miller, Joza and Davis First step: Guidance document on conduct of a stability study Follow-up at the next meeting to define next steps. 28

29 Questions?