The Food and Drug Administration on May 23 updated its import alert, which includes a "red list" of manufacturers, distributors and brands of vapor products that may be detained “without physical examination," the agency said.
The alert authorizes U.S. Customs and Border Protection (CBP) to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products, including cigarettes, electronic cigarettes, cigars and hookah tobacco.
The Federal Food, Drug and Cosmetic Act requires premarket review for any “new tobacco product,” which means any tobacco product that was not commercially marketed in the United States as of Feb. 15, 2007, or any modification of a tobacco product where the modified product was commercially marketed in the United States after Feb. 15, 2007, the agency said.
“Divisions may detain, without physical examination, the tobacco products identified on the red list of this import alert. If the division is not sure whether a tobacco product is the same product as one identified on the red list, the division should consult with the Center for Tobacco Products (CTP). CTP concurrence is required to add a product to the Red List,” the agency said.
The National Association of Tobacco Outlets, Inc. (NATO) said that just because a brand is identified “does not necessarily mean that all SKUs in that brand family have been cited in an FDA administrative or enforcement action.” NATO added that all retailers should check with their suppliers on the status of each individual product.
The full list of products now includes Chinese manufacturers and distributors as well as United States importers and distributors, which can be found here.
In an effort to step up its enforcement actions against unauthorized e-cigarettes, the FDA on Thursday said it is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for the sale of unauthorized Elf Bar e-cigarettes. The FDA said it is seeking a penalty amount of $20,678 from each retailer.
To date the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products that may be lawfully marketed and sold in the United States. Information on tobacco products that may be legally marketed in the United States is available in the agency’s new Searchable Tobacco Products Database.
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