FDA requests federal court extend premarket application deadline on e-cigarettes to September – Winston-Salem Journal

FDA requests federal court extend premarket application deadline on e-cigarettes to September – Winston-Salem Journal

Tobacco manufacturers may gain a 120-day extension for filing premarket applications with the FDA for electronic cigarettes and other next-generation products.

The current application deadline is May 12, set in a federal court-mandated order, for manufacturers to be included in a 12-month review process by the Food and Drug Administration. It includes makers of nicotine liquids.

The FDA said Tuesday it filed a legal motion Monday requesting an extension to Sept. 9. It’s the same federal court in Maryland that mandated the May 12 deadline.

If the extension to Sept. 9 is established, the 12-month review process would commence at that point.

The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as those factors compare with traditional cigarettes.

If e-liquid manufacturers don’t apply, their products would be deemed as illegal to sell.

However,
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