The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act.

This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The official document is scheduled to be published on 01/09/2017 and will be applicable 30 days later, on 09/02/2017.

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Kathleen O'Connor
Kathleen O'Connor
7 years ago

In my first pass reading this thing, vaping will be deemed a combo device.

Even if the mftr. makes no theraputic claims, the FDA can use any info they see fit (like our vaping advocacy!) to force the item to fall under medical device/Modified Risk Tobacco Product.

Page 69: “A manufacturer’s making a modified risk claim
for a specific tobacco product renders the product an MRTP, which can be marketed only afterthe manufacturer substantiates any modified risk claims in an MRTP application and after FDA determines that the product meets the statutory standard. Additionally, if a manufacturer intends that its product be used for cessation, it can submit an NDA, Abbreviated New Drug Application (ANDA), Premarket Approval Application (PMA), or premarket notification submission so that FDA can determine whether the product meets the statutory standard and can approve the application or clear the submission, if appropriate.”