| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-154 |
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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). The HPHC constituents tested are determine by the sponsor. The examples illustrated here are for informational purposes only and are used to illustrate how data on constituents may be represented.
| Example |
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| Include Page |
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| SDTM Example.Product HPHC Cigarette Testing |
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| SDTM Example.Product HPHC Cigarette Testing |
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This example illustrates HPHC testing and vaping
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-243 |
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regimens for an ENDS product.| Example |
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| Include Page |
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| SDTM Example.Product HPHC ENDS Testing |
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| SDTM Example.Product HPHC ENDS Testing |
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Reference:
US Food and Drug Administration. Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established List. April 2012. Accessed October 16, 2023. https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/