FDA extends comment deadline by a month; 30,000+ sent so far

Written by || 21 June, 2014 || Regulatory news analysis |

USPS 300x180The U.S. Food and Drug Administration (FDA) has extended the period for industry and public comments on its proposed e-cigarette regulations by 30 days, to 8th August.

The deadline for responses was originally 9th July, but – as widely expected – both the contentiousness of the issues, and the unusually large number of questions on which the agency is seeking input, have reportedly led to it already receiving nearly 34,000 comments in less then a month.

With the rate likely to accelerate, that figure suggests that feedback on the so-called “deeming regulations” for e-cigarettes (and other tobacco products which the FDA does not currently regulate) could eventually be on a similar scale to its 2013 consultation on menthol-flavoured cigarettes, which received around 200,000 responses over 120 days.

The FDA, which in its announcement of the extension called regulating e-cigarettes “a very high priority”, could still allow yet further time for comments.

Details of how to respond to the agency’s proposals can be found here.

What This Means: An extension was foreseen by many and means little in itself; the numerous questions asked by the agency have inevitably attracted many who believe they have the answers. It is also worth noting that the consultation covers complex regulations on cigars as well as e-cigs, and they seemed from early figures to have accounted for a large share of the replies.

The positive news, for every side of the e-cigarette regulation debate, is that this does indicate the FDA is serious about hearing all views on its proposals.

– Barnaby Page ECigIntelligence staff

Photo: Ray Bouknight