The FDA has issued a Marketing Denial Order (MDO) for the myblu Menthol 2.4% e-cigarette product from Fontem US, LLC (myblu), a subsidiary of Imperial Tobacco (...
According to the official website of the US Food and Drug Administration (FDA), the FDA has issued a Marketing Denial Order (MDO) for myblu Menthol 2.4% of Fontem US, LLC (myblu), a subsidiary of Imperial Tobacco (ITG). The company must not market or sell the product in the United States or face enforcement action by the FDA. The company can resubmit a new application to address the deficiencies associated with the marketing denial order.
On April 28, 2020, Fontem US LLC (Fontem US), a subsidiary of Imperial Tobacco, submitted a Premarket Tobacco Product Application (PMTA) to the FDA seeking authorization to continue selling its various my blu e-cigarette products.
The FDA issued a marketing refusal order for Imperial Tobacco myblu, marketing and retail activities will be prohibited
Fontem US LLC (Fontem US) has submitted a premarket tobacco product application to the FDA
But in April 2022, the FDA also rejected myblu device kits and myblu Intense Tobacco Chill 2.5%, myblu Intense Tobacco Chill 4.0%, myblu Intense Tobacco 2.4%, myblu Intense Tobacco 3.6%, myblu Gold Leaf 1.2%, and myblu Gold Leaf 2.4% and other product applications.
This is the second time that myblu has received a marketing refusal order from the FDA since last year. Dr. Matthew Farrelly, director of the FDA's Office of Tobacco Products (CTP) Science, said:
"The application lacks scientific evidence to demonstrate that the positive public health effects of the product outweigh the known risks."
FDA evaluates premarket tobacco product applications (PMTAs) against public health criteria that consider a product's impact on the overall population, including benefits (such as a complete transition to the product or a substantial reduction in combustible cigarette use among adult smokers) and risks (such as teens start smoking)
Tobacco products subject to a Do Not Marketing Order (MDO) may not be sold, distributed, or marketed in the United States. In addition, such products are not allowed to enter or be transported into interstate commerce, and if the product is already on the market, it must be removed from the market or face FDA enforcement action.
To date, the FDA has received more than 26 million applications for "designated products" and has made decisions on 99 percent of them. The FDA has authorized the sale of 23 tobacco-flavored vaping products and devices, which are currently the only vaping products legally sold or distributed in the United States.
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