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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.

Turning Point Brands PMTAs Under New Review

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The publicly traded Turning Point Brands says that the FDA has rescinded a previously issued Marketing Denial Order regarding its PMTA applications. LOUISVILLE, Ky. —...

The FDA Finalizes Two Rules for PMTAs

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These rules are meant to ensure that all future submissions contain the basic information needed to meet the relevant premarket requirements efficiently and effectively.The...

The FDA’s Bias Against The Vape Industry Emerges During The PMTA...

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The FDA has previously approved new tobacco products from three companies, for which it was happy to accept more general evidence than it currently...

Iowa AG Concerned Over FDA Denials

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A strong elected proponent for vaping's tobacco harm reduction role is very concerned about the Food and Drug Administration's move to deny over a...

ECigIntelligence: The Vape Brands Submitting The Highest Numbers of PMTAs

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US brand JD Nova Group is the company that submitted the most applications, at 4.68m submissions.After analysing a list published by the FDA in...

FDA Delays Juul Decision

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The FDA has recently announced that it has delayed a critical decision on the future of Juul electronic cigarettes. WASHINGTON — The US Food and...

The US FDA Moves Bantam PMTAs Into Formal Scientific Review

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Bantam is a manufacturer of artisanal flavours which are built from scratch using only high-quality ingredients. The brand is adamant about their quality and...

The US Vape Industry Grows Discouraged as The FDA Rejects Thousands...

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The first batch of rejections came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications...

The FDA Rejects PMTAs For Over 800 Flavoured Vaping Products

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Earlier in August the FDA announced that it would not review 4.5 million applications from the same company, JD Nova, as that they did...

Attorneys General Ask FDA To Decline Vaping PMTAs

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A coalition of 31 US state attorneys general is urging the Food and Drug Administration to deny several PMTA applications for flavored vaping products. WASHINGTON...