Companies which launched products between 23rd June 2009 and 31st December 2009 will be the first needing to submit electronically all documentation of health, toxicological, behavioural or physiological effects of their products.
They will have until 8th February 2017, six months after the effective date of the FDA deeming regulations, to provide their documents. Small manufacturers will have an additional six months.
Other manufacturers do not have to submit their documentation yet, as a new ECigIntelligence report explains, but the FDA requires that they be retained for collection later.
What This Means: Because hardly any e-cigs were on the market or even in development in 2009, few companies will be required to take any action immediately. However, all health documents created after that year must be preserved, as the FDA is planning to collect them in the future – and if they are not submitted when asked for, that will constitute a violation of the law.
– David Palacios ECigIntelligence staff
Graphic: Carl Gamble