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The United States Food and Drug Administration (FDA) ordered the recall of Juul Labs Inc. and denied marketing authorization for its vaping devices and pods. This comes after various speculations from sources close to the administration.
In a statement, the FDA said that the company must stop selling and distributing its products and will have to recall products currently on the US market. Retailers should contact the company with questions about products in their inventory.
FDA Commissioner Robert M. Califf said the company’s products make up a significant portion of all items available on the market and many have played a disproportionate role in the rise of youth vaping.
“Today’s action is a further step forward in the FDA’s commitment to ensure that all electronic nicotine delivery system and e-cigarette products currently marketed to consumers meet our public health standards,” he said.
The FDA determined that the Company’s Premarket Tobacco Applications ‘Lacked Sufficient Evidence’ regarding the toxicological profile of the products to demonstrate that their marketing would be appropriate for the protection of public health.
Among the findings found in the company’s study were insufficient and conflicting data on genotoxicity and leaching of potentially harmful chemicals from the company’s proprietary e-liquid pods.
Until now The FDA has received no clinical information suggesting an immediate danger associated with the use of the Juul device., potential toxicological hazards or potential harm. The administration recommended not to modify or add substances to tobacco products.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by law, but the onus of proving that a product meets those standards ultimately rests on the shoulders of the company.” said the acting director of the FDA’s Center for Tobacco Products.
“Juul had the opportunity to provide evidence showing that the marketing of its products meets those standards. Nevertheless, the company failed to provide that evidence and instead left us with important questions. Without the data necessary to determine the relevant health risks, the FDA is issuing these marketing denial orders,” he said.
Juul products on the market include the vaping device and four types of Juulpods: Virginia tobacco-flavored pods with 5% and 3% nicotine strengths and menthol-flavored pods with 5% and 5% nicotine strengths. 3%.
The FDA’s announcement comes amid another investigation into more infant deaths due to consumption of Abbott-brand formula. To read the story click here.
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