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TOBA-154 - Getting issue details... STATUS Harmful and potentially harmful constituents (HPHC) are a subset of tobacco product constituents which may cause direct and indirect harm to product users. These compounds may be found in the tobacco product, tobacco smoke, or aerosol. (https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list).   

Example

Tobacco product HPHC testing results are represented in the PT domain. This example illustrates HPHC testing and smoking regimens for a cigarette product. The example assumes testing at a single time point, not serial testing over multiple timepoints as in stability studies. See Section 3.1.4, Stability Studies, for more information and examples illustrating how to represent those data.

This example only shows test results for each constituent for 1 replicate of 1 sample of 1 product that was tested (PTREPNUM = 1 for all records). Details of the sampling and testing plan, including the number of samples of the products tested, are determined by the applicant or by regulatory requirement.  Applicants would likely have multiple product samples tested in multiple replicates, and those would be distinguished in the dataset by values of PTREPNUM being set to 1 through n, where n = the number of replicates being performed.

Note the use of the PTXFN (external file name) to indicate that the lab methodology was submitted as separate documentation.

Rows 1-17:

Show HPHC testing performed in smoke produced by a smoking machine from the tobacco product identified in SPTOBID (CIG01a). Note of the use of SPDEVID as the device identifier for the smoking machine and the use of PTREFID to identify the smoking regimen (non-intense regimen). PTSPEC=SMOKE to indicate the specimen type is smoke.

Row 18:Shows 1 analyte was tested with a different smoking regimen (PTREFID=INTENSE REGIMEN) using the same smoking machine.
Row 19:Shows 1 analyte was tested in the tobacco filler (PTSPEC). Thus SPDEVID and PTREFID are null.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTXFNPTNAMPTSPECPTREPNUMPTDTC
1TOB07PTCIG01aPUFFMASTER3K1NON-INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC522ug/cigarette522522ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE12022-09-30
2TOB07PTCIG01aPUFFMASTER3K2NON-INTENSE REGIMENACROLEINAcroleinHPHC TESTINGHPHC43ug/cigarette4343ug/cigaretteTL002_V3.6.pdfTPT LABCOSMOKE12022-09-30
3TOB07PTCIG01aPUFFMASTER3K3NON-INTENSE REGIMENACRYNTRLAcrylonitrileHPHC TESTINGHPHC7ug/cigarette77ug/cigaretteTL006_V6.pdfTPT LABCOSMOKE12022-09-30
4TOB07PTCIG01aPUFFMASTER3K4NON-INTENSE REGIMENABP44-AminobiphenylHPHC TESTINGHPHC1.2ng/cigarette1.21.2ng/cigaretteTL008_V3.pdfTPT LABCOSMOKE12022-09-30
5TOB07PTCIG01aPUFFMASTER3K5NON-INTENSE REGIMENAMNPHTH11-AminonaphthaleneHPHC TESTINGHPHC14ng/cigarette1414ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE12022-09-30
6TOB07PTCIG01aPUFFMASTER3K6NON-INTENSE REGIMENAMNPHTH22-AminonaphthaleneHPHC TESTINGHPHC8ng/cigarette88ng/cigaretteTL003_V1.4.pdfTPT LABCOSMOKE12022-09-30
7TOB07PTCIG01aPUFFMASTER3K7NON-INTENSE REGIMENAMMONIAAmmoniaHPHC TESTINGHPHC9ug/cigarette99ug/cigaretteTL020_V4.pdfTPT LABCOSMOKE12022-09-30
8TOB07PTCIG01aPUFFMASTER3K8NON-INTENSE REGIMENBENZENEBenzeneHPHC TESTINGHPHC33ug/cigarette3333ug/cigaretteTL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
9TOB07PTCIG01aPUFFMASTER3K9NON-INTENSE REGIMENBZAPYRBenzo[a]pyreneHPHC TESTINGHPHC6.8ng/cigarette6.86.8ng/cigaretteTL017_V1.1.pdfTPT LABCOSMOKE12022-09-30
10TOB07PTCIG01aPUFFMASTER3K10NON-INTENSE REGIMENCMONOXCarbon MonoxideHPHC TESTINGHPHC10.1mg/cigarette10.110.1mg/cigaretteTL019_V3.pdfTPT LABCOSMOKE12022-09-30
11TOB07PTCIG01aPUFFMASTER3K11NON-INTENSE REGIMENCROTNALDCrotonaldehydeHPHC TESTINGHPHC11ug/cigarette1111ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE12022-09-30
12TOB07PTCIG01aPUFFMASTER3K12NON-INTENSE REGIMENFORMALDFormaldehydeHPHC TESTINGHPHC27ug/cigarette2727ug/cigaretteTL001_V5.pdfTPT LABCOSMOKE12022-09-30
13TOB07PTCIG01aPUFFMASTER3K13NON-INTENSE REGIMENISOPRENEIsopreneHPHC TESTINGHPHC320ug/cigarette320320ug/cigaretteTL041_V1.pdfTPT LABCOSMOKE12022-09-30
14TOB07PTCIG01aPUFFMASTER3K14NON-INTENSE REGIMENNICOTINENicotineHPHC TESTINGHPHC0.721mg/cigarette0.7210.721mg/cigaretteTL007_V2.1.pdfTPT LABCOSMOKE12022-09-30
15TOB07PTCIG01aPUFFMASTER3K15NON-INTENSE REGIMENNNKNicotine-Derived Nitrosamine KetoneHPHC TESTINGHPHC71ng/cigarette7171ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
16TOB07PTCIG01aPUFFMASTER3K16NON-INTENSE REGIMENNNNN-NitrosonornicotineHPHC TESTINGHPHC85ng/cigarette8585ng/cigaretteTL026_V12.2.pdfTPT LABCOSMOKE12022-09-30
17TOB07PTCIG01aPUFFMASTER3K17NON-INTENSE REGIMENTOLUENETolueneHPHC TESTINGHPHC53ug/cigarette5353ug/cigaretteTL011_V3.3.pdfTPT LABCOSMOKE12022-09-30
18TOB07PTCIG01aPUFFMASTER3K18INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC1552ug/cigarette15521552ug/cigaretteTL009_V4.3.pdfTPT LABCOSMOKE12022-09-30
19TOB07PTCIG01a
19
AMMONIAAmmoniaHPHC TESTINGHPHC956ug/g956956ug/cigaretteTL016_V1.2.pdfTPT LABCOTOBACCO FILLER12022-09-30
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The identifying characteristics of the smoking machine are represented in the Device Identifiers reference dataset. DI is the source of the applicant-defined device ID variable (SPDEVID) used in the PT dataset to indicate the smoking machine used to perform the smoking regimen.

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000
$warningHtml
Details of the smoking regimen performed by the smoking machine are represented as device in-use properties (such as settings) of the smoking machine. They are linked to the HPHC testing results in PT by matching values of PTREFID/DUREFID.
Rows 1-9:Show the parameters of the non-intense smoking regimen.
Rows 8-9:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 60 seconds every 10 puffs.
Rows 10-18:Show the parameters of the intense smoking regimen.
Rows 17-18:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this smoking regimen pauses for 30 seconds every 10 puffs.

du.xpt

du.xpt

Row

STUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1NON-INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2NON-INTENSE REGIMEN

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3NON-INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

4

TOB07

DUPUFFMASTER3K4NON-INTENSE REGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5NON-INTENSE REGIMEN

PUFFNUM

Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6NON-INTENSE REGIMEN
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7NON-INTENSE REGIMEN
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8NON-INTENSE REGIMEN1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9NON-INTENSE REGIMEN1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10

TOB07

DUPUFFMASTER3K1INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

11

TOB07

DUPUFFMASTER3K2INTENSE REGIMEN

PUFFDUR

Puff Duration

2.25

sec

2.25

2.25

sec

12

TOB07

DUPUFFMASTER3K3INTENSE REGIMEN

PUFFINT

Puff Interval

3

PUFF/min

3

3

PUFF/min

13

TOB07

DUPUFFMASTER3K4INTENSE REGIMEN

PUFFBLCK

Puff Block

30

%

30

30

%

14

TOB07

DUPUFFMASTER3K5INTENSE REGIMEN
PUFFNUMNumber of Puffs

100

PUFF

100

100

PUFF

15

TOB07

DUPUFFMASTER3K6INTENSE REGIMEN
PUFFVOLPuff Volume

20

mL

20

20

mL

16

TOB07

DUPUFFMASTER3K7INTENSE REGIMEN
PUFFRNGPuff Range

50-150


50-150



17

TOB07

DUPUFFMASTER3K8INTENSE REGIMEN2PUFFPAUSPuff Pause

30

s

30

30

s

18TOB07DUPUFFMASTER3K9INTENSE REGIMEN2PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

This example illustrates HPHC testing and vaping TOBA-243 - Getting issue details... STATUS regimens for an ENDS product.

Example

Tobacco product HPHC testing results are represented in the PT domain. This example shows HPHC testing with an ENDS device. HPHC testing is conducted on samples of the product of interest, and (if applicable) samples of comparison products. Each product tested would have its own unique applicant-defined value for SPTOBID to identify the product. 

Row 1:Shows the HPHC testing performed for acetaldehyde from a sample of e-Liquid (as indicated by PTSPEC=E-LIQUID).
Rows 2-4:Show the HPHC testing performed for 3 analytes from aerosol produced using the non-intense regimen on a smoking machine. PTSPEC=AEROSOL, SPDEVID indicates the smoking machine used to produce the aerosol, and PTREFID indicates the vaping regimen.
Rows 5-7:Show the HPHC testing performed for 3 analytes using the intense regimen on the same smoking machine (PTREFID=INTENSE REGIMEN).

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDSPDEVIDPTSEQPTREFIDPTTESTCDPTTESTPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTSPECPTREPNUMPTDTC
1TOB08PTENDS02a
1
ACTALDAcetaldehydeHPHC TESTINGHPHC7.9µg/mL7.97.9µg/mLE-LIQUID12022-09-30
2TOB08PTENDS02aPUFFMASTER3K2NON-INTENSE REGIMENNICOTINENicotineHPHC TESTINGHPHC53.5µg/puff53.553.5µg/puffAEROSOL12022-09-30
3TOB08PTENDS02aPUFFMASTER3K3NON-INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC34.7ng/puff34.734.7ng/puffAEROSOL12022-09-30
4TOB08PTENDS02aPUFFMASTER3K4NON-INTENSE REGIMENBNZOICACBenzoic AcidHPHC TESTINGOther43.3µg/puff43.343.3µg/puffAEROSOL12022-09-30
5TOB08PTENDS02aPUFFMASTER3K5INTENSE REGIMENNICOTINENicotineHPHC TESTINGHPHC105µg/puff105105µg/puffAEROSOL22022-09-30
6TOB08PTENDS02aPUFFMASTER3K6INTENSE REGIMENACTALDAcetaldehydeHPHC TESTINGHPHC43.5ng/puff43.543.5ng/puffAEROSOL22022-09-30
7TOB08PTENDS02aPUFFMASTER3K7INTENSE REGIMENBNZOICACBenzoic AcidHPHC TESTINGOther84.1µg/puff84.184.1µg/puffAEROSOL22022-09-30
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The identifying characteristics of the smoking machine are represented in the DI reference dataset.

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB07DIPUFFMASTER3K1DEVTYPEDevice TypeSmoking Machine
2TOB07DIPUFFMASTER3K2MANUFManufacturerAcme
3TOB07DIPUFFMASTER3K3TRADENAMTrade NamePuffMaster 3000
$warningHtml
Details of the vaping regimen performed by the smoking machine are represented as device in-use properties, linked to the HPHC testing results in PT by matching values of PTREFID/DUREFID.
Rows 1-9:Show the parameters of the non-intense vaping regimen.
Rows 8-9:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this vaping regimen pauses for 60 seconds every 10 puffs.
Rows 10-18:Show the parameters of the intense vaping regimen.
Rows 17-18:Note the use of DUGRPID to group these records together to indicate that puff pause and puff pause interval are related records. Taken together, they indicate that this vaping regimen pauses for 30 seconds every 10 puffs.

du.xpt

du.xpt

RowSTUDYIDDOMAINSPDEVIDDUSEQDUREFIDDUGRPIDDUTESTCDDUTESTDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1

TOB07

DUPUFFMASTER3K1NON-INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

2

TOB07

DUPUFFMASTER3K2NON-INTENSE REGIMEN

PUFFDUR

Puff Duration

1.25

sec

1.25

1.25

sec

3

TOB07

DUPUFFMASTER3K3NON-INTENSE REGIMEN

PUFFINT

Puff Interval

7

PUFF/min

7

7

PUFF/min

4

TOB07

DUPUFFMASTER3K4NON-INTENSE REGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

5

TOB07

DUPUFFMASTER3K5NON-INTENSE REGIMEN

PUFFNUM

Number of Puffs

200

PUFF

200

200

PUFF

6

TOB07

DUPUFFMASTER3K6NON-INTENSE REGIMEN
PUFFVOLPuff Volume

10

mL

10

10

mL

7

TOB07

DUPUFFMASTER3K7NON-INTENSE REGIMEN
PUFFRNGPuff Range

100-200


100-200



8

TOB07

DUPUFFMASTER3K8NON-INTENSE REGIMEN1PUFFPAUSPuff Pause

60

s

60

60

s

9TOB07DUPUFFMASTER3K9NON-INTENSE REGIMEN1PUFFPINTPuff Pause Interval

10

PUFF

10

10

PUFF

10

TOB07

DUPUFFMASTER3K1INTENSE REGIMEN
PUFFPROFPuff ProfileSQUARE
SQUARE

11

TOB07

DUPUFFMASTER3K2INTENSE REGIMEN

PUFFDUR

Puff Duration

3.25

sec

3.25

3.25

sec

12

TOB07

DUPUFFMASTER3K3INTENSE REGIMEN

PUFFINT

Puff Interval

10

PUFF/min

10

10

PUFF/min

13

TOB07

DUPUFFMASTER3K4INTENSE REGIMEN

PUFFBLCK

Puff Block

25

%

25

25

%

14

TOB07

DUPUFFMASTER3K5INTENSE REGIMEN
PUFFNUMNumber of Puffs

300

PUFF

300

300

PUFF

15

TOB07

DUPUFFMASTER3K6INTENSE REGIMEN
PUFFVOLPuff Volume

25

mL

25

25

mL

16

TOB07

DUPUFFMASTER3K7INTENSE REGIMEN
PUFFRNGPuff Range

100-400


100-400



17

TOB07

DUPUFFMASTER3K8INTENSE REGIMEN2PUFFPAUSPuff Pause

10

s

10

10

s

18TOB07DUPUFFMASTER3K9INTENSE REGIMEN2PUFFPINTPuff Pause Interval

30

PUFF

30

30

PUFF

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.


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