HPHCs, Other Constituents, and Smoking / Vaping Regimens

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

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	PTSEQ	PTREFID	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTXFN	PTNAM	PTSPEC	PTREPNUM	PTDTC
1	TOB07	PT	CIG01a	PUFFMASTER3K	1	NON-INTENSE REGIMEN	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	522	ug/cigarette	522	522	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
2	TOB07	PT	CIG01a	PUFFMASTER3K	2	NON-INTENSE REGIMEN	ACROLEIN	Acrolein	HPHC TESTING	HPHC	43	ug/cigarette	43	43	ug/cigarette	TL002_V3.6.pdf	TPT LABCO	SMOKE	1	2022-09-30
3	TOB07	PT	CIG01a	PUFFMASTER3K	3	NON-INTENSE REGIMEN	ACRYNTRL	Acrylonitrile	HPHC TESTING	HPHC	7	ug/cigarette	7	7	ug/cigarette	TL006_V6.pdf	TPT LABCO	SMOKE	1	2022-09-30
4	TOB07	PT	CIG01a	PUFFMASTER3K	4	NON-INTENSE REGIMEN	ABP4	4-Aminobiphenyl	HPHC TESTING	HPHC	1.2	ng/cigarette	1.2	1.2	ng/cigarette	TL008_V3.pdf	TPT LABCO	SMOKE	1	2022-09-30
5	TOB07	PT	CIG01a	PUFFMASTER3K	5	NON-INTENSE REGIMEN	AMNPHTH1	1-Aminonaphthalene	HPHC TESTING	HPHC	14	ng/cigarette	14	14	ng/cigarette	TL003_V1.4.pdf	TPT LABCO	SMOKE	1	2022-09-30
6	TOB07	PT	CIG01a	PUFFMASTER3K	6	NON-INTENSE REGIMEN	AMNPHTH2	2-Aminonaphthalene	HPHC TESTING	HPHC	8	ng/cigarette	8	8	ng/cigarette	TL003_V1.4.pdf	TPT LABCO	SMOKE	1	2022-09-30
7	TOB07	PT	CIG01a	PUFFMASTER3K	7	NON-INTENSE REGIMEN	AMMONIA	Ammonia	HPHC TESTING	HPHC	9	ug/cigarette	9	9	ug/cigarette	TL020_V4.pdf	TPT LABCO	SMOKE	1	2022-09-30
8	TOB07	PT	CIG01a	PUFFMASTER3K	8	NON-INTENSE REGIMEN	BENZENE	Benzene	HPHC TESTING	HPHC	33	ug/cigarette	33	33	ug/cigarette	TL017_V1.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
9	TOB07	PT	CIG01a	PUFFMASTER3K	9	NON-INTENSE REGIMEN	BZAPYR	Benzo[a]pyrene	HPHC TESTING	HPHC	6.8	ng/cigarette	6.8	6.8	ng/cigarette	TL017_V1.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
10	TOB07	PT	CIG01a	PUFFMASTER3K	10	NON-INTENSE REGIMEN	CMONOX	Carbon Monoxide	HPHC TESTING	HPHC	10.1	mg/cigarette	10.1	10.1	mg/cigarette	TL019_V3.pdf	TPT LABCO	SMOKE	1	2022-09-30
11	TOB07	PT	CIG01a	PUFFMASTER3K	11	NON-INTENSE REGIMEN	CROTNALD	Crotonaldehyde	HPHC TESTING	HPHC	11	ug/cigarette	11	11	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
12	TOB07	PT	CIG01a	PUFFMASTER3K	12	NON-INTENSE REGIMEN	FORMALD	Formaldehyde	HPHC TESTING	HPHC	27	ug/cigarette	27	27	ug/cigarette	TL001_V5.pdf	TPT LABCO	SMOKE	1	2022-09-30
13	TOB07	PT	CIG01a	PUFFMASTER3K	13	NON-INTENSE REGIMEN	ISOPRENE	Isoprene	HPHC TESTING	HPHC	320	ug/cigarette	320	320	ug/cigarette	TL041_V1.pdf	TPT LABCO	SMOKE	1	2022-09-30
14	TOB07	PT	CIG01a	PUFFMASTER3K	14	NON-INTENSE REGIMEN	NICOTINE	Nicotine	HPHC TESTING	HPHC	0.721	mg/cigarette	0.721	0.721	mg/cigarette	TL007_V2.1.pdf	TPT LABCO	SMOKE	1	2022-09-30
15	TOB07	PT	CIG01a	PUFFMASTER3K	15	NON-INTENSE REGIMEN	NNK	Nicotine-Derived Nitrosamine Ketone	HPHC TESTING	HPHC	71	ng/cigarette	71	71	ng/cigarette	TL026_V12.2.pdf	TPT LABCO	SMOKE	1	2022-09-30
16	TOB07	PT	CIG01a	PUFFMASTER3K	16	NON-INTENSE REGIMEN	NNN	N-Nitrosonornicotine	HPHC TESTING	HPHC	85	ng/cigarette	85	85	ng/cigarette	TL026_V12.2.pdf	TPT LABCO	SMOKE	1	2022-09-30
17	TOB07	PT	CIG01a	PUFFMASTER3K	17	NON-INTENSE REGIMEN	TOLUENE	Toluene	HPHC TESTING	HPHC	53	ug/cigarette	53	53	ug/cigarette	TL011_V3.3.pdf	TPT LABCO	SMOKE	1	2022-09-30
18	TOB07	PT	CIG01a	PUFFMASTER3K	18	INTENSE REGIMEN	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	1552	ug/cigarette	1552	1552	ug/cigarette	TL009_V4.3.pdf	TPT LABCO	SMOKE	1	2022-09-30
19	TOB07	PT	CIG01a		19		AMMONIA	Ammonia	HPHC TESTING	HPHC	956	ug/g	956	956	ug/cigarette	TL016_V1.2.pdf	TPT LABCO	TOBACCO FILLER	1	2022-09-30

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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

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	Smoking Machine
2	TOB07	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme
3	TOB07	DI	PUFFMASTER3K	3	TRADENAM	Trade Name	PuffMaster 3000

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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

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	NON-INTENSE REGIMEN		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	NON-INTENSE REGIMEN		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	NON-INTENSE REGIMEN		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	NON-INTENSE REGIMEN		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	NON-INTENSE REGIMEN		PUFFNUM	Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	NON-INTENSE REGIMEN		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	NON-INTENSE REGIMEN		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	NON-INTENSE REGIMEN	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	NON-INTENSE REGIMEN	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	TOB07	DU	PUFFMASTER3K	1	INTENSE REGIMEN		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	TOB07	DU	PUFFMASTER3K	2	INTENSE REGIMEN		PUFFDUR	Puff Duration	2.25	sec	2.25	2.25	sec
12	TOB07	DU	PUFFMASTER3K	3	INTENSE REGIMEN		PUFFINT	Puff Interval	3	PUFF/min	3	3	PUFF/min
13	TOB07	DU	PUFFMASTER3K	4	INTENSE REGIMEN		PUFFBLCK	Puff Block	30	%	30	30	%
14	TOB07	DU	PUFFMASTER3K	5	INTENSE REGIMEN		PUFFNUM	Number of Puffs	100	PUFF	100	100	PUFF
15	TOB07	DU	PUFFMASTER3K	6	INTENSE REGIMEN		PUFFVOL	Puff Volume	20	mL	20	20	mL
16	TOB07	DU	PUFFMASTER3K	7	INTENSE REGIMEN		PUFFRNG	Puff Range	50-150		50-150
17	TOB07	DU	PUFFMASTER3K	8	INTENSE REGIMEN	2	PUFFPAUS	Puff Pause	30	s	30	30	s
18	TOB07	DU	PUFFMASTER3K	9	INTENSE REGIMEN	2	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF

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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

Row	STUDYID	DOMAIN	SPTOBID	SPDEVID	PTSEQ	PTREFID	PTTESTCD	PTTEST	PTCAT	PTSCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTSPEC	PTREPNUM	PTDTC
1	TOB08	PT	ENDS02a		1		ACTALD	Acetaldehyde	HPHC TESTING	HPHC	7.9	µg/mL	7.9	7.9	µg/mL	E-LIQUID	1	2022-09-30
2	TOB08	PT	ENDS02a	PUFFMASTER3K	2	NON-INTENSE REGIMEN	NICOTINE	Nicotine	HPHC TESTING	HPHC	53.5	µg/puff	53.5	53.5	µg/puff	AEROSOL	1	2022-09-30
3	TOB08	PT	ENDS02a	PUFFMASTER3K	3	NON-INTENSE REGIMEN	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	34.7	ng/puff	34.7	34.7	ng/puff	AEROSOL	1	2022-09-30
4	TOB08	PT	ENDS02a	PUFFMASTER3K	4	NON-INTENSE REGIMEN	BNZOICAC	Benzoic Acid	HPHC TESTING	Other	43.3	µg/puff	43.3	43.3	µg/puff	AEROSOL	1	2022-09-30
5	TOB08	PT	ENDS02a	PUFFMASTER3K	5	INTENSE REGIMEN	NICOTINE	Nicotine	HPHC TESTING	HPHC	105	µg/puff	105	105	µg/puff	AEROSOL	2	2022-09-30
6	TOB08	PT	ENDS02a	PUFFMASTER3K	6	INTENSE REGIMEN	ACTALD	Acetaldehyde	HPHC TESTING	HPHC	43.5	ng/puff	43.5	43.5	ng/puff	AEROSOL	2	2022-09-30
7	TOB08	PT	ENDS02a	PUFFMASTER3K	7	INTENSE REGIMEN	BNZOICAC	Benzoic Acid	HPHC TESTING	Other	84.1	µg/puff	84.1	84.1	µg/puff	AEROSOL	2	2022-09-30

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Please add a row column to your dataset.

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

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	PUFFMASTER3K	1	DEVTYPE	Device Type	Smoking Machine
2	TOB07	DI	PUFFMASTER3K	2	MANUF	Manufacturer	Acme
3	TOB07	DI	PUFFMASTER3K	3	TRADENAM	Trade Name	PuffMaster 3000

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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

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUREFID	DUGRPID	DUTESTCD	DUTEST	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	PUFFMASTER3K	1	NON-INTENSE REGIMEN		PUFFPROF	Puff Profile	SQUARE		SQUARE
2	TOB07	DU	PUFFMASTER3K	2	NON-INTENSE REGIMEN		PUFFDUR	Puff Duration	1.25	sec	1.25	1.25	sec
3	TOB07	DU	PUFFMASTER3K	3	NON-INTENSE REGIMEN		PUFFINT	Puff Interval	7	PUFF/min	7	7	PUFF/min
4	TOB07	DU	PUFFMASTER3K	4	NON-INTENSE REGIMEN		PUFFBLCK	Puff Block	25	%	25	25	%
5	TOB07	DU	PUFFMASTER3K	5	NON-INTENSE REGIMEN		PUFFNUM	Number of Puffs	200	PUFF	200	200	PUFF
6	TOB07	DU	PUFFMASTER3K	6	NON-INTENSE REGIMEN		PUFFVOL	Puff Volume	10	mL	10	10	mL
7	TOB07	DU	PUFFMASTER3K	7	NON-INTENSE REGIMEN		PUFFRNG	Puff Range	100-200		100-200
8	TOB07	DU	PUFFMASTER3K	8	NON-INTENSE REGIMEN	1	PUFFPAUS	Puff Pause	60	s	60	60	s
9	TOB07	DU	PUFFMASTER3K	9	NON-INTENSE REGIMEN	1	PUFFPINT	Puff Pause Interval	10	PUFF	10	10	PUFF
10	TOB07	DU	PUFFMASTER3K	1	INTENSE REGIMEN		PUFFPROF	Puff Profile	SQUARE		SQUARE
11	TOB07	DU	PUFFMASTER3K	2	INTENSE REGIMEN		PUFFDUR	Puff Duration	3.25	sec	3.25	3.25	sec
12	TOB07	DU	PUFFMASTER3K	3	INTENSE REGIMEN		PUFFINT	Puff Interval	10	PUFF/min	10	10	PUFF/min
13	TOB07	DU	PUFFMASTER3K	4	INTENSE REGIMEN		PUFFBLCK	Puff Block	25	%	25	25	%
14	TOB07	DU	PUFFMASTER3K	5	INTENSE REGIMEN		PUFFNUM	Number of Puffs	300	PUFF	300	300	PUFF
15	TOB07	DU	PUFFMASTER3K	6	INTENSE REGIMEN		PUFFVOL	Puff Volume	25	mL	25	25	mL
16	TOB07	DU	PUFFMASTER3K	7	INTENSE REGIMEN		PUFFRNG	Puff Range	100-400		100-400
17	TOB07	DU	PUFFMASTER3K	8	INTENSE REGIMEN	2	PUFFPAUS	Puff Pause	10	s	10	10	s
18	TOB07	DU	PUFFMASTER3K	9	INTENSE REGIMEN	2	PUFFPINT	Puff Pause Interval	30	PUFF	30	30	PUFF

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HPHCs, Other Constituents, and Smoking / Vaping Regimens