The FDA bans Juul e-cigarettes after “insufficient” data on harmful chemicals

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After years of delays in regulation and litigation, the U.S. Food and Drug Administration (FDA) has finally called for the withdrawal of all e-cigarette products from leading company Juul in the United States. The FDA called the main reason for the action “insufficient and contradictory data” in toxicological studies provided by Juul.

The FDA’s move is the culmination of nearly a decade of regulatory battles over who should control e-cigarette products in the U.S. market. For several years, these products were completely unregulated and could end up on commercial shelves without safety oversight, until in 2016, the Tobacco Control Act was finally amended to allow the FDA to include modern smokeless tobacco products and e-cigarettes in its regulations. -legal sphere.

The initial amendment indicated that all e-cigarettes must complete an application to sell tobacco products before being sold in the United States. The first deadline for companies to meet these requirements was set for 2018, but in 2017 the FDA postponed this until August 2022 after claiming that companies needed extra time to conduct research and better complete their applications.

This extraordinary five-year delay led to a parade of lawsuits, initially from anti-tobacco groups seeking the FDA to move the deadline forward and then from e-cigarette lobby groups trying to reclaim any expedited time. At the same time, the deadline for applications is constantly changing, research began to build question safety of certain chemicals for e-cigarettes and in 2019 the Trump administration banned it a number of e-cigarettes without tobacco.

Now, after all these years of hesitation, the FDA has finally moved on to evaluating the application of the product from the leading e-cigarette manufacturer in the US Juul. An impressive comprehensive solution requires the immediate removal of all Juul products from commercial sale in the United States. In a strongly worded statement, the FDA stated that Juul’s application does not provide satisfactory evidence that its products are safe.

“After reviewing the company’s pre-sale tobacco products (PMTA), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that product marketing would be appropriate for public health,” the FDA said. explained in a statement. “In particular, some results of the company’s study have raised concerns due to inadequate and conflicting data – including on genotoxicity and potentially harmful chemicals leached from the company’s patented electronic liquid pods – that have not been properly reviewed and have not allowed the FDA to complete toxicological risk assessment of products listed in the company’s applications. “

The statement clearly states that there is currently no evidence of imminent danger from the use of Juul products. Instead, he emphasizes that the evidence provided by Juul to the FDA was insufficient to conclude that pods for e-liquids are safe.

Juul fast made a statement indicating that he will appeal the FDA’s decision by any available means, including appealing to the regulator in court. Juul believes it has provided the regulator with sufficient toxicological data, and the company notes that a recently assessed application was filed more than two years ago.

“We respectfully disagree with the FDA’s findings and decision and continue to believe that we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, Juul’s chief regulator. “In our applications, which we submitted more than two years ago, we believe that we have properly described the toxicological profile of JUUL products, including comparisons with flammable cigarettes and other vapor products, and we believe that these data together with evidence meet the statutory standard.” fitness for public health ”.

From October 2021 The FDA is slowly making its way through the millions of applications for tobacco products that have been filed in recent years. Within a few months the regulator approved some products for e-cigarettes for sale in the US, so this promotion aimed at Juul is certainly not the beginning of a total ban on all nicotine vaping products.

However, Juul is arguably the largest player in the multibillion-dollar e-cigarette market, and it is unlikely that this effective ban on one of the most popular vaping products in the country will pass without a significant fight. Robert Calif, the current FDA commissioner, believes the action is a reminder to all e-cigarette companies of the need to comply with health standards.

“Today’s action is a further step forward in fulfilling the FDA’s commitment to ensuring that all e-cigarettes and e-nicotine delivery products currently sold to consumers meet our health standards,” Calif said. “The agency has allocated significant resources to review the products of companies that occupy most of the U.S. market. We recognize that they make up a significant portion of the products available, and many of them have played a disproportionately large role in the growth of vaping youth. ”

Source: FDA



The FDA bans Juul e-cigarettes after “insufficient” data on harmful chemicals

Source link The FDA bans Juul e-cigarettes after “insufficient” data on harmful chemicals