FDA: hundreds of thousands of PMTA applications will speed up the audit process


The U.S. Food and Drug Administration (FDA) will submit a pre marketing tobacco product application (PMTA) on September 9, foreign media vaporvoice reported. So far, all powerful tobacco companies have submitted PMTA for the electronic nicotine delivery system (ends). Only a small number of e-cigarette manufacturers publicly announced that their PMTA had been accepted by the FDA. Available vapor, e-alternative solutions, Charlie’s chalk dust and prism are just a few companies that have publicly announced applications for PMTA.

In less than a week’s time, the steam industry may undergo earth shaking changes, thousands of enterprises may close down, and millions of products may be taken off the shelves.

The FDA has stated that retail stores will not have a grace period, and electronic cigarettes that do not submit applications will be removed from the shelves by the product arrival date. This confuses e-cigarette shopkeepers, who want to know in advance what products are available for sale. As a result, a number of retailers wrote to the FDA on August 25, urging the FDA to publish a list of companies that submitted PMTA.

A week later, the FDA announced that it would break the tradition of announcing successful applications in advance. But when the list will be released remains a question mark.

In an August 31 press release, Mitch Zeller, director of the FDA’s Center for tobacco products, said the FDA plans to release a list of products deemed new to the market as of August 8, 2016, subject to the September 9 deadline. “Before we do this, however, we need to ensure that any release of such information complies with federal disclosure laws and regulations, as only certain types of product information in the application can be legally disclosed,” Zeller wrote.

The FDA also said it expected many pmtas and a one-year review schedule could be exceeded. Zeller acknowledged that there are “more than one million identified products” currently on the market with regulators.

“Even if only a few of these products have been submitted, considering that this will be an unprecedented number and several orders of magnitude higher than any of the agency’s experiences, the FDA is unlikely to review all of these applications in a one-year review period,” Zeller wrote. Based on the number of new applications we received before the deadline, ranging from hundreds of thousands to millions, we may not be able to complete the review of all tobacco product applications within one year by September 9, 2020. “

In order to stop losses as much as possible, the electronic cigarette Technology Association (VTA) recommends that retailers ask manufacturers for specific information on whether their products are included in the PMTA. Many distributors have said they intend to buy back any products that retailers cannot sell.

Tony Abboud, VTA’s executive director, said: “each manufacturer may have different ways to provide you with evidence that their products have been submitted to the PMTA, including a revised version of their cover letter or proof submitted through the electronic declaration portal. Although the FDA does not conduct a personal inspection at present, it is likely to recover soon after the covid-19 restriction is lifted. Therefore, if inspections are resumed before the FDA publishes a list of products that have been filed with pmtas, you can avoid potential contact by obtaining existing documentation from your manufacturer about the products on your shelves. “

In the short term, however, it may be difficult for the FDA to regulate retailers. In March, due to covid-19, the FDA temporarily postponed the compliance inspection and e-cigarette factory inspection. This suspension of individual retail law enforcement activities may continue until the covid-19 restriction begins to be lifted. However, the FDA said it plans to continue monitoring social media, industry-related websites and publications and issue warning letters when needed.

It should also be noted that in February this year, the FDA outlined and reiterated its enforcement priorities. The food and Drug Administration said it would focus on enforcement of end products based on seasoning cartridges; all other end products that manufacturers failed or failed to take appropriate measures to prevent exposure or use by minors; any end products targeted at minors or likely to facilitate their use; and manufacturers that did not submit PMTA by the deadline.

Zeller believes that the most important thing for manufacturers is to submit the PMTA on time. The FDA announced that if there are any deficiencies in the PMTA, the agency will address them in writing. “Although we expect high-quality and complete applications to be submitted by September 9, if we do find a defect, the FDA is likely to issue a defect letter asking the company to respond within 90 days,” Zeller wrote. This will give companies an opportunity to address these issues, rather than simply rejecting applications.

The U.S. Food and Drug Administration said it would also invest as much resources as possible in this case to help speed up the PMTA review process and ensure that all applications will be treated equally.

“As always, the FDA intends to allocate FDA resources fairly, to review applications from small and large manufacturers and importers, and applications received through different channels,” Zeller said. In addition, we intend to maximize the use of resources and review most products in the shortest possible time. To this end, we are improving our review process to shorten the overall review time. “



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