FDA

The US Food and Drug Administration (FDA) regulates the manufacture, import, packaging, labelling, advertising, promotion sale and distribution of electronic nicotine delivery systems (ENDS) so it plays a key role in the US e-cigarette industry.

Keep up to date with the latest developments at the ECigIntelligence FDA hub, where we keep all of our briefings and reports on the FDA and its regulation of e-cigarettes.

The Food and Drug Administration is responsible for protecting the public health by regulating tobacco products and reducing tobacco use by minors.
Before any product the FDA defines as tobacco – which includes ENDS – can be marketed in the US, the manufacturer has to submit a premarket tobacco product application (PMTA) to the FDA. The application needs to show that placing the product on the market would be “appropriate for the protection of the public health”.

This application is then reviewed by the FDA and either approved or rejected. The FDA has been cracking down on all vaping products that are not PMTA approved and issuing warning letters to manufacturers that are not compliant with regulations.

However, now there is a new administration in the White House and it’s yet to be seen what impact that Biden will have on the FDA’s stance towards ENDS. And how long will the FDA take to look through the thousands of PMTA applications that it has received?

Watch this space for further details.