This revised deadline only applies to business owners who were already manufacturing their products before the 8th of August this year, when the deeming rule came into effect. Therefore for these specific manufacturers the cut off date to register will be the 30th June 2017, whilst for all other companies where manufacturing began on the 8th of last August or after, the cut of date remains the 31st December this year, hence the latter should register immediately if they have not done so.
The current guidance says that any change that would be solely affecting a product’s label would not require an SE application to be submitted, as the product would not be considered a “new tobacco product”. Additionally it was agreed that changes to product quantity would create a “new tobacco product” and hence approval would be required. Specifically for these circumstances, the FDA has created a special process known as the Product Quantity Change SE Application.
Is the FDA loosening its grip?
The extension of the application deadline brings a wave of relief to the vaping industry, as did the withdrawal of the Refuse to Accept Procedures for Premarket Tobacco Product Submissions directive last month. Is the FDA starting to review it’s harsh regulations due to external pressure? At this point one can only speculate, however with the pressures imposed by members of the incoming administration it looks like the situation may be perhaps changing to favour the industry and its consumers.