“To help manufacturers navigate the PMTA process, FDA has finalized a guidance on how to complete it as correctly, efficiently, and cost-effectively as possible. Prior to finalizing this guidance, FDA had issued a draft guidance for ENDS manufacturers in May 2016. While the final version is very similar to the draft, there are a few significant changes that are important to know before submitting a PMTA. These changes have been primarily made to further explain the types of information that may help FDA determine if marketing a proposed new tobacco product would be appropriate for the protection of public health.”
ARTICLE LINK:
Marketing ENDS as New Tobacco Products: A Guide for Manufacturers
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