In accordance with the Tobacco Control Act, the US FDA acts as the regulating authority for all items that meet the definition of a “tobacco product”, including newly-developed products such as electronic nicotine delivery systems (ENDS, such as e-cigarettes). Recently issued guidance has extended the deadlines for submission of premarket tobacco applications (PMTA) by four years. PMTAs for most ENDS which were on the market on 8th August 2016 must now be submitted by 8th August 2022.

US Food and Drug Administration (FDA) (2017). Extension of certain tobacco product compliance deadlines related to the final deeming rule. Guidance for industry (revised). August 2017.

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf

 

The above items were taken from the September 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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