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The U.S. Food and Drug Administration has issued a Do Not Sell Order (MDO) to Shenzhen Youme Information Technology Co. Ltd. for two Suorin brand e-cigarette products. Also issued his MDO of Fontem US, LLC for Blu PLUS+ branded e-cigarette products.
“Thorough scientific review of tobacco product applications is a key pillar of FDA’s comprehensive regulatory approach,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “It is the responsibility of the applicant to ensure that the application contains sufficient scientific evidence to meet the necessary public health standards required by law. was lacking.”
Companies may not sell or distribute these products in the United States. Otherwise, you risk FDA enforcement action. The companies may submit new applications for products covered by these MDOs, according to an agency press release.
The FDA has rejected Suorin Air refillable vaporizers and empty refillable cartridges in various colors. The FDA said Suorin Air’s empty cartridges allow consumers to fill the cartridges with separately purchased e-liquid.
“The application filed by Shenzhen Youme Information Technology Co. Ltd. lacked sufficient evidence of abuse liability, which is the ability to promote continued use of tobacco products and the development of dependence,” the release stated. ing.
SMOK recently rejected 22 products, including devices, pods, atomizers, and cartridges. This is the first time that the agency has strictly rejected one company’s hardware products all at once. According to the FDA, these products were rejected because they were submitted without specifying the specific e-liquid to be used in the device.
The rejected Blu PLUS+ product includes a battery and some pre-filled e-liquid pods.
- Blue PLUS+ battery
- blu PLUS+ Carolina Bold 2.0%
- Blue PLUS+ Classic Tobacco 1.2%
- Blue PLUS+ Classic Tobacco 2.4%
- blu PLUS+ Gold leaf 1.2%
- blu PLUS+ Gold leaf 2.4%
- blu PLUS+ Menthol 1.2%
- blu PLUS+ Menthol 2.4%
“Fontem US, LLC did not include sufficient ingredient information, hazardous and potentially harmful ingredient (HPHC) yields, and abuse liability information, among other deficiencies in the application,” the FDA said. I am.
“Furthermore, the applicant demonstrates that the new flavored product has the potential to provide benefits for adult smokers, in terms of complete switchover or a significant reduction in cigarette use, that outweigh the risks to youth. did not provide sufficient evidence.
FDA has also issued MDOs for additional blu PLUS+ products not listed above. To avoid disclosing sensitive commercial information, regulators only publish products that the FDA or the manufacturer confirms are currently on the market.
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