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FDA seized more than 700000 US dollars worth of e-cigarette products and warned 10 companies that did not submit PMTA

2021/03/02|Industry news

Recently, the U.S. Food and Drug Administration (FDA) continues to give priority to the enforcement of e-cigarette market, especially the enforcement of non-conforming e-cigarette products and their related companies that have not submitted PMTA applications.

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FDA, customs and Border Protection Bureau (CBP) jointly seized e-cigarette products worth more than 700000 US dollars

On January 13, it was learned from the US Food and Drug Administration (FDA) website that the agency announced that in cooperation with us customs and Border Protection (CBP) officials at Dallas Fort Worth International Airport, it seized 33681 e-cigarettes, involving a value of $719453.

It is understood that in December last year, U.S. Customs and border protection seized 42 batches of goods transported from China to counties in Texas. These include disposable flavored e-cigarette products, including puff XXL and puff flow.

Mitch Zeller, director of the FDA's tobacco product center, said the FDA continues to give priority to enforcement of e-cigarette products, especially those that are most attractive and accessible to young people. We are very concerned about the popularity of these products among young people. The seizure showed manufacturers, retailers and importers of tobacco products that the FDA is paying close attention to the market and will hold companies responsible for violating tobacco laws and regulations.

In addition, CBP's trade enforcement task attaches great importance to the interception of illegal products that may harm U.S. consumers. In fiscal year 2020, CBP seized 93590 e-cigarettes that did not comply with U.S. federal regulations. "Many counterfeit, unauthorized or unauthorized products are likely to be produced in unregulated facilities, and their unverified ingredients pose a serious threat to the health of consumers." "Research shows that when these counterfeit and unauthorized products fall into the hands of children, the situation is particularly alarming," Timothy lemox, port director of CBP, said in a statement. We will continue to take every opportunity to work with our FDA partners to intercept and seize products that threaten US consumers. "

Ten e-cigarette companies received warning letters from FDA because they have not yet submitted PMTA

On January 15, it was learned from the official website of the US Food and Drug Administration (FDA) that the agency has issued warning letters to 10 companies that produce and sell e-cigarettes (especially e-cigarette liquid) online, warning them that it is illegal to sell these products without pre-sale authorization, because these companies have not submitted PMTA (pre marketing tobacco product application) before the deadline of September 9, 2020 .

According to the court order, applications for pre marketing review of certain identified new tobacco products, including electronic cigarette oil, as of August 8, 2016, must be submitted to FDA by September 9, 2020. Prior to this deadline, the FDA usually intends to postpone implementation for up to one year until FDA reviews the application, unless the FDA takes negative action on the application.

According to the press release released by FDA, the 10 companies receiving the warning letters are little house vapes LLC, Castle Rock vapor LLC, dropsmoke Inc, perfection vapes Inc, CLS trading LLC D / B / a vape dudes HQ, session Supply Co., coastal E-liquid laboratory / GC vapers LLC, Dr. crimmy LLC D / b / a Dr. crimmy's v-liquid, CMM capital LLC D / B / a ETX Vape、 E-Cig Barn LLC。 The FDA requires companies that receive warning letters to respond within 15 working days, detailing how they intend to address the issues raised by the agency.

"The pre market application process ensures that many new tobacco products, including tobacco products, will be subject to rigorous scientific evaluation by the FDA," FDA Commissioner Stephen M. Hahn said in a statement "Scientific review of new products is a key part of our mission to protect the public, especially children, from the dangers of tobacco use. In addition to the important pre-sales scientific review, we are also committed to giving priority to offenders by selling unauthorized products, which is our way of protecting public health. "

Mitch Zeller, director of FDA's tobacco product center, said: "these warning letters are the result of ongoing monitoring of violations of tobacco laws and regulations and Internet surveillance. We want to make it clear to all tobacco manufacturers and retailers that the FDA will pay close attention to the market and will hold companies responsible for violations of the law. "

It is reported that the FDA plans to release a list of products that the agency has received its application for, but before providing such a list, the FDA is verifying some information about these products to make the release of the list comply with the federal disclosure law.

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