Premium reports FAQs for FDA flavour regulations

FAQs for FDA flavour regulations


The rules and regulations around flavoured e-liquids are complex, and more importantly constantly changing. In January 2020, the US Food and Drug Administration (FDA) implemented further enforcement rules on a number of flavoured e-liquid products, however, there is still some confusion around which products they are, as well as what this actually means in practice. This report provides comprehensive and well-researched answers to some of the most frequently asked questions from those in the industry about both state and local implications, such as “are all flavours banned?” and “will flavoured products be able to get a PMTA?”

No. of pages: 9



1 Introduction
2 What is the FDA’s target?
3 Are flavours banned? Are all flavours included in the enforcement policy?
4 How can manufacturers ensure that they are effectively preventing minors from accessing their products?
5 How can manufacturers and distributors ensure ENDS are not targeting minors or not marketed in a way likely to promote use by minors?
6 Will flavoured products be able to get a PMTA?
7 Will the FDA ban menthol flavours?
8 State and local regulations – the impact
9 Can states regulate when the US federal government has done so?
10 So what happens to regulations currently in place or to proposals specifically regulating flavours?
11 Will states try to keep banning them?
12 What will happen if the FDA approves a PMTA for a product that has menthol and at the same time a state has banned menthol vapes? Wouldn’t the state be contradicting the marketing order by the FDA?
13 Other policy points for consideration