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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 US FDA Sends Permanent Injunctions to Six Small Vape Manufacturers

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Many smaller vape businesses could not afford the very costly and overwhelming PMTA process.The companies are E-Cig Crib in Minnesota, Soul Vapor in West...

The US FDA Issues First PMTA Denial For a Menthol-Flavoured Vape...

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The FDA said that the applicant didn't prove that its menthol products are more likely to help adult smokers quit more than non-flavoured products....

US Court of Appeals Rules That Recent FDA-Issued MDO’s Are Arbitrary...

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The FDA was not justified in ignoring parts of applications by vape companies, just because it decided they were not relevant.Bidi Vapor, Diamond Vapor,...

FDA Warns Synthetic Nicotine Manufacturers But Bypasses Full Ban

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Following a March 15th legislation, the FDA has been granted the authority to regulate tobacco products containing nicotine from any source, which has led...

New FDA Commissioner Urged To Complete PMTA Process

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Earlier this year, Attorneys General from 31 states signed a joint letter asking then FDA acting commissioner Janet Woodcock, to deny PMTAs for vaping...

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...
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