FDA is still working through thousands of PMTAs


The US Food and Drug Administration (FDA) has admitted that it is still working through thousands of Premarket Tobacco Product Applications (PMTAs) that were submitted in September.

The FDA has has received applications from brands all over the world, some of which have submitted hundreds of products for assessment.

The regulator said that it remains committed to releasing a list of the approved tobacco products to the public which will help retailers know which products can be sold legally on the US market.

The FDA’s Center for Tobacco Products Director, Mitch Zeller, said that the assessing the applications is an:

“Extremely labor-intensive manual exercise of unpacking every single application.

“But we have lots of people working on this, and we absolutely intend to provide such list.”

Submission Criteria

Brands submitting a product must satisfy a list of strict criteria, including that it is beneficial to wider public health and not just former smokers who may use the product.

The FDA will also assess whether a product could lead never-smokers to using tobacco and whether the product is made in a clean, safe environment.

Considerations

Zeller commented on how the FDA is organising the lists of the applications.

He revealed that they are considering giving priority to companies that submitted products on time, regardless of their size. 

Zeller said that one of the FDA’s goals is to ‘transform the marketplace for these unauthorised products into a regulated marketplace’.

“[The] principle that we came up with is to devote a certain percentage of the reviewing resources to those products that have, or are having, the greatest impact on public health, either positive or negative, simply by virtue of share of market.”

Mitch Zeller, FDA

Learn more: Why Industry Must Unite to Get UK Vape Shops Reopened Without Delay

Story source: CSP Magazine

Image Source: CDC on Unsplash



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