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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Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic act: DRaFT GUIDaNCE

Policy

FDa (2012)

DEPaRTMENT OF hEaLTh aND hUMaN SERVICES Food and Drug administration [Docket No. FDa–2012–N–0143] harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke; Established List

Policy

FDa (2012)

DEPaRTMENT OF hEaLTh aND hUMaN SERVICES: Food and Drug administration [Docket No. FDa–2012–D–0049] Draft Guidance for Industry: Reporting harmful and Potentially harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic act; availability

Policy

FDa (2012)

Guidance for Industry - S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for human Use

Policy

FDa (2012)

Preliminary Scientific Evaluation of the Possible Public health Effects of Menthol Versus Nonmenthol Cigarettes

Population Clinical
Consumer Use
Flavor Appeal

FDa (2013)

"harmful and Potentially harmful Constituents" in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic act (Revised)

Policy

FDa (2016)

Meetings with Industry and Investigators on the Research and Development of Tobacco Products

Policy

FDa (2016)

Premarket Tobacco Product applications for Electronic Nicotine Delivery Systems - Guidance for Industry

Policy

FDa (2016)

Premarket Tobacco Product applications for Electronic Nicotine Delivery Systems - Guidance for Industry.

Policy

FDa (2019)

E-Cigarettes-a review of the evidence-harm versus harm reduction.

Population Clinical
Population Health Impact

Feeney (2022)