The U.S. Food and Drug Administration (FDA) has issued warning letters to eight online retailers and one manufacturer for allegedly selling unauthorized flavored, disposable e-cigarettes. The warning letters cite several brands popular among youth, as well as products featuring the names or images of celebrities.
Violations of the Federal Food, Drug, and Cosmetic Act
The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States without obtaining the required marketing authorization from the FDA, violating the Federal Food, Drug, and Cosmetic Act. The FDA has cautioned the firms to address any similar violations and take prompt action to comply with the law, as failure to do so may result in additional enforcement actions, such as injunctions, seizures, and/or civil money penalties.
FDA’s Commitment to Enforcement and Collaboration
The FDA remains committed to enforcing the law and working with federal enforcement partners to address unauthorized tobacco products in the United States. To date, the agency has issued more than 700 warning letters to firms for manufacturing, selling, and/or distributing unauthorized new tobacco products, over 800 warning letters to retailers for selling unauthorized tobacco products, and filed civil money penalty complaints against more than 83 manufacturers and more than 175 retailers for distribution and/or sale of unauthorized tobacco products.
Limited Number of Authorized E-Cigarette Products
As of December 19, the FDA has authorized only 34 e-cigarette products and devices. The agency provides a printable one-page flyer listing all authorized e-cigarette products to assist retailers in determining which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement action.
As a vaping industry professional, it is crucial to stay informed about the regulatory landscape and ensure compliance with all applicable laws and regulations. Manufacturers and retailers should carefully review the list of authorized e-cigarette products and take immediate action to remove any unauthorized products from their inventory. By working collaboratively with the FDA and other regulatory agencies, the vaping industry can demonstrate its commitment to responsible marketing and sales practices, while helping to prevent youth access to these products.
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