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FDA extends registration deadline for some firms by six months

deeming regulations news package - manufacturers 900x540The U.S. Food and Drug Administration (FDA) has given a last-minute extension to some manufacturers of vapour products, allowing them an extra six months to register their companies and products as required by the deeming regulations.

The revised deadline applies only to manufacturers who were already making their products as of 8th August this year, when the deeming regulations came into effect – a group which includes vape stores that mix their own-liquid.

It had originally been 31st December this year, but they will now have until 30th June 2017 to register.

But companies which began manufacturing on or after 8th August must still register immediately.

The federal agency says it “is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date”.

Separately, the FDA has also updated its guidance on the substantial equivalence (SE) process, one of several routes by which tobacco products can be submitted for approval by it.

The guidance now reflects a court decision in the District of Columbia (DC) that any modification only affecting a product’s label would not require an SE application to be submitted. The product would not be treated as a “new tobacco product” and therefore could simply be sold with the altered label.

The court agreed with the FDA that changes to product quantity would create a “new tobacco product” and still require approval. For these circumstances, the FDA has created a special process known as the Product Quantity Change SE Application, which it says requires less information than most SE applications and can be reviewed more quickly.

What This Means: The extension of the registration deadline will be welcomed by an industry that was starting to panic. But for readers of Beltway tea leaves, at least, the interesting question is whether it indicates a willingness on the FDA’s part to ease the burden on business, or concern about its own capacity to process registrations if they all arrived before the New Year.

– ECigIntelligence staff

Graphic: Carl Gamble

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