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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.

Statement by FDA Chief on Agency’s Actions Related to Youth Vaping

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Earlier this month, a court case which had been brought about by anti-tobacco and health groups, after the FDA had announced the premarket tobacco...

FDA’s Acceptance of the Ten Month Deadline On E-Cig PMTA Applications...

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A federal judge in Maryland, U.S. District Judge Paul Grimm, ordered the U.S. Food and Drug Administration (FDA) to advance the regulation of e-cigarettes...

US E-Cig Manufacturers Given 10 Months to Submit PMTA

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Last March the FDA issued its much-anticipated guidelines with regards to new restrictions on vaping products. The draft had been released just weeks before...

FDA Finalizes PMTA Guidance for E-Cigarettes

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The new PMTA process includes reviewing a product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged...

Former FDA Chief About E-Cig Rules “We struck the wrong balance”

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Last March the FDA issued its much-anticipated guidelines with regards to new restrictions on vaping products. The draft had been released just weeks before...

The FDA was ordered to regulate e-cigs and vapes by a...

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In the latest challenge against vaping, the Food and Drug Administration (FDA) is being forced by a federal court to vacate previous industry guidance...

US FDA Approves Heat-Not-Burn Devices

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“Following a rigorous science-based review through the pre-market tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the US market...

FDA Moves PMTA Deadline from 2022 to 2021

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The draft guideline was released just weeks before Commissioner Scott Gottlieb’s set exit. This move was infact one of Gottlieb’s priorities following the backlash...

A Year After Announcing Tobacco Plan, No New NRT’s Yet Approved...

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A bit over a year ago, public health activists and vapers alike had breathed a sigh of relief, as the U.S. Food and Drug...

FDA Publishes Revised Ingredient Listing Guidance for Tobacco Products

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The vaping industry has been asking the FDA to exempt the devices from the Tobacco Control Act Section 904(a)(1) for years. Finally, just under...