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The U.S. Food and Drug Administration today issued marketing denial orders (MDOs) for JUUL Labs Inc. for all of its products currently marketed in the United States. As a result, the company should stop selling and distributing these products. Additionally, those currently on the US market must be removed, or risk enforcement action. Products include the Juul and four types of JuulPods: Virginia tobacco flavored pods with 5.0% and 3.0% nicotine concentrations and menthol flavored pods with 5.0% and 3.0% nicotine concentrations. Retailers should contact Jules with any questions about the products in their inventory.
“Today’s action represents further progress on the FDA’s commitment to ensuring that all e-cigarettes and e-nicotine delivery system products currently marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Resources for product reviews from companies that represent most of the US market. We recognize that these items make up a large part of the available products and many have played a disproportionate role in the increased prevalence of vaping for youth.”
These devices are only relevant to the commercial distribution, import, and retail sales of these products, and do not restrict the possession or use of an individual consumer—the US Food and Drug Administration cannot and will not require an individual consumer to possess or use Juul products or any other tobacco products.
After reviewing the company’s pre-marketing tobacco product applications (PMTAs), the Food and Drug Administration determined that the applications lacked sufficient evidence regarding the products’ toxicological profile to demonstrate that marketing of the products would be appropriate to protect public health. In particular, some of the company’s study findings have raised concerns due to insufficient and conflicting data — including genotoxicity and potentially harmful chemicals from the company’s proprietary e-liquid capsules — that have not been adequately processed and have prevented the Food and Drug Administration from completing. Assessment of the risks of products mentioned in the company’s applications.
To date, the US Food and Drug Administration has not received clinical information indicating a direct risk associated with the use of Juul or JuulPods. However, the MDOs released today reflect the FDA’s decision that there is insufficient evidence to assess the potential toxicological risks of using Juul products. There is also no way to know the potential harms from using authorized or unauthorized third party e-liquids with a Juul or using a JuulPod with a non-Juul device. The US Food and Drug Administration recommends not modifying or adding substances to tobacco products. Juul users are encouraged to report any unexpected health issues or product issues to the Food and Drug Administration through the Safety Reporting Portal and to seek medical attention when necessary.
said Michelle Mittal, acting director of the FDA’s Center for Tobacco Products. As with all manufacturers, Jules had the opportunity to provide evidence that the marketing of their products met these criteria. However, the company did not provide this guide and instead left us with important questions. Without the necessary data to identify relevant health risks, the Food and Drug Administration issues these marketing denial orders.”
No products subject to MDO may be offered for sale or distributed in the United States, or the U.S. Food and Drug Administration may take enforcement action.
In addition to ensuring Juul’s compliance with this requirement, as with unauthorized products in general, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without a legally required pre-marketing license are being marketed illegally and are subject to enforcement action.
As the FDA has stated in the past, unauthorized Electronic Nicotine Delivery System (ENDS) products for which there is no pending order, including for example, products that have MDO, are among our highest application priorities. Therefore, the FDA encourages retailers to discuss the products in their stockpile with their suppliers including the current status of a marketing application or marketing authorization for a particular tobacco product. Manufacturers will be the best source of that information and retailers should rely on manufacturers directly to inform decisions about which products to continue to sell.
There are many resources to help smokers who want to quit. Quitting all tobacco products is the best possible path to good health. Some existing JO users who will not be able to access JO products after this procedure or existing smokers who wish to transition away from cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the US Food and Drug Administration based on their potential benefit. Adult smokers.
To date, the US Food and Drug Administration has approved 23 ENDS products. Under the PMTA track, applicants must demonstrate to the agency, among other things, that permitting the marketing of the new tobacco product will be appropriate to protect public health.
The U.S. Food and Drug Administration (FDA) continues to work to complete its review of the remaining pending applications for products considered submitted by the September 9, 2020 deadline.
The Food and Drug Administration, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and veterinary medicines, vaccines, and other biological products for human use and medical devices. The agency is also responsible for the safety and security of our nation’s food, cosmetics, and dietary supplement supplies, products that emit electronic radiation, and for regulating tobacco products.
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