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A barrier against reducing the risks of smoking

The acronym PMTA stands for Premarket Tobacco Applications. It is the sales licence all vape manufacturers must obtain before they can sell their products in the United States.

From 9 September 2020, any vaping product that was not on sale before 8 August 2016, and that has not been authorised by the US Food & Drug Administration (FDA) through a PMTA, can no longer be offered to American vapers.

The problem is that the cost of a PMTA can run into millions of dollars, which is a budget most small independent vape companies simply do not have.

Vape makers line up to defend FDA’s enforcement guidance

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The lawsuit brought by public health groups against the U.S. Food and Drug Administration (FDA) over its May 2026 enforcement guidance is turning into...

FDA moves to replace its 2021 PMTA rule

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In a short statement published on its website, the agency says it intends to evaluate changes to the framework "including through initiation of new...

Challenging the Obsession About Youth Uptake, Data Show That US Tobacco...

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For years, tobacco harm reduction experts have highlighted that nicotine policy should follow one simple principle: people smoke for nicotine, but they die from...

Clickbait Obsession: Makary’s FDA Exit Revealed Media’s Preference for Political Theater...

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After being criticised for the insurmountable PMTA process for years, the FDA recently relaxed enforcement on some unauthorised vaping products and approved the first...

The FDA Announces it Will Ease Vape Enforcement. Is This a...

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The FDA’s latest guidance on vaping regulation marks a major change in the American nicotine debate. This shift is based more on practical regulation...

The FDA Announces PMTA Approval For Vuse Alto Tobacco-Flavoured E-Cigarette Pods

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The FDA emphasized that while the approval means that these products are considered "appropriate for the protection of public health," this does not mean...

The FDA is Blasted For The Way It’s Handling (And Not...

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U.S. Senators have criticized top health and law enforcement officials over the surge of illegal electronic cigarettes in the U.S., saying that the multibillion-dollar...

Juul’s Next-Gen Device Is A Sign of Progress

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Juul Labs is back with a new closed-system pod device that it calls a solution to address a variety of issues, like youth uptake...