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The agency also recently sent letters to JUUL Labs and several other companies requiring them to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of their products. The FDA is currently investigating whether manufacturers introduced certain e-cigarette products to the market after Aug. The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products. I believe certain flavors are one of the principal drivers of the youth appeal of these products. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. However, the retailers receiving the warning letters today are still advertising and selling the violative products.
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The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products. In total, the FDA has conducted , retail inspections, issued 77, warning letters to retailers for violating the law and initiated approximately 18, civil money penalty cases, as of Sept. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency. The FDA is stepping up those efforts indefinitely. However, the retailers receiving the warning letters today are still advertising and selling the violative products. Investigating whether manufacturers of certain e-cigarette products may be marketing new products that were not on the market as of Aug.
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The FDA also continues to conduct checks of retail establishments that sell tobacco products to ensure compliance with federal laws. The agency also has issued more than No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from selling tobacco products for specified periods of time. These products were the subject of agency action in May and, subsequently, are no longer being sold with the offending labeling and advertising by the companies that received the May warning letters. The agency will continue to monitor and take action against companies that sell tobacco products that might mislead a young child into thinking the product is appropriate for them to consume as food. The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law.
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