US FDA denies more PMTAs a week before the final deadline – ‘more will follow’

The US Food and Drug Administration (FDA) has told ECigIntelligence that it has issued a number of “additional” marketing denial orders (MDOs) for flavoured e-cigarettes, denying their premarket tobacco product applications (PMTAs).

“The agency will continue to review other premarket tobacco applications for non-tobacco flavored ENDS to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth,” they said.

Although the agency did not confirm why it issued the latest MDOs, it suggested that it could be related to a lack of “sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth”.

“In the absence of this evidence, the agency intends to issue an MDO,” the spokesperson said.

They also warned that “more marketing decisions will follow”, but it remains unclear whether the FDA will allow any flavours other than tobacco and menthol to remain in the US market

Last week, the agency ruled out premarket tobacco product applications (PMTAs) for 55,000 flavoured e-cigarette products from one single manufacturer after concluding that on balance they posed a threat to public health.

 

What This Means: The latest denial orders come less a week before the FDA’s 9th September deadline by which the agency is required to have finalised its review of all the applications.

It is believed that there are still around 1.5m applications that have not yet received any notification whether or not the products can be marketed.

David Palacios ECigIntelligence staff

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