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How Has the PMTA Guidance Changed Since its First Release?

In May 2016, the US Food and Drug Administration (FDA) initiated planned requirements for e-liquid and tobacco chemicals testing. Premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) are required to be submitted for every flavor at every nicotine strength, with supporting pre-clinical and clinical safety data. In June 2019, the FDA released an updated guidance for the submission of PMTA authorizations.