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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.

The FDA Issues PMTAs for Several NJOY Ace Products

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The FDA has been reckless in issuing MDOs without presenting relevant evidence to back up its decisions.The FDA has just granted NJOY LLC marketing...

The FDA Issues Marketing Denial Orders For The Myblu Vaping Device 

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Previous articles have reported that the FDA has been reckless in issuing MDOs without presenting relevant evidence to back up its decisions. The first...

US Judge Rules That Altria Can Keep Its Stake in Juul

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This court decision came at a time when Juul still awaits the FDA’s verdict about their PMTAs.Among the multiple lawsuits thrown at Juul/Altria, in...

Court Allows Four Vape Companies to Resume Sales of PMTA-Rejected Products

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The FDA had not anticipated such a large number of applications, and has therefore found ways to dismiss them without reviewing them. Bidi Vapor,...

Lawsuit Against the FDA Could Impact the Vaping Industry’s Future

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PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without...

Major US Vape Retailer Closes Its Doors Due to Unrealistic FDA...

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Like many vape businesses, the brand is finding it impossible to meet the FDA’s unrealistic regulatory requirements.AVAIL Vapor LLC’s specialized brick-and-mortar shops and website,...

Uncovered FDA Memos Reveal Murky Strategy to Reject PMTAs

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Despite shifting the PMTA deadline back and forth numerous times, leaving the smaller vape companies unprepared, over 500 businesses (most of which are small)...

Humble Juice MDO Rescinded by the FDA

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An e-vape liquid company in California has scored brief levity from the FDA. THOUSAND OAKS, Calif. — The Humble Juice Co., an e-liquid maker based...

FDA Revokes Marketing Denial Orders for Humble’s Flavoured E-liquids

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The MDOs for Humble Juice Co., were issued on September 15th, for the brands flavoured e-liquids with pending PMTAs. In response to this, Humble...

FDA Approves PMTA Of Discontinued Altria Product

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A new product is approved under the FDA PMTAs. The only catch is this: it's not marketed in the US anymore. SILVER SPRING, Md. —...