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FDA extends registration deadline for some

The U.S. Food and Drug Administration, (FDA), is conceding a six month extension to some e-cig manufacturers to register their companies and products.

Diane Caruana

December 15, 2016

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.

Reasonable changes

Manufacturers who were already producing vaping products before the 8th of last August can register up to the 30th of June 2017, whilst all companies where manufacturing began on the 8th of last August or after, the cut of date remains the 31st December this year.

The FDA said that it “is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date”. The agency has also updated its guidance on the substantial equivalence (SE) process. Additionally, last month the agency also withdrew the directive which imposed restrictions with regards to the criteria needed for a vaping business to be eligible to apply for the required tobacco product application, (PMTA).

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.