FDA investigates whether dozens of electronic cigarette products are illegally marketed



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The Food and Drug Administration, in its latest effort to curb young people's vaping, is looking into whether dozens of e-cigarette products are sold illegally, the agency said Friday.

The FDA said it had asked 21 manufacturers and importers to specify if more than 40 products were on the market before August 8, 2016. Products introduced or modified after that date must be cleared by the FDA before they are released. to be put on sale.

If the FDA determines that the products are sold illegally, the companies risk fines, foreclosures or a court order to remove them from the market. Friday's decision is the agency's first major action to enforce the requirement for products introduced after August 2016 to receive prior approval from the agency, officials said.

Last month, Commissioner of the FDA Scott Gottlieb said the use of electronic cigarettes by young people had become an "epidemic" and that he had stepped up his enforcement actions against retailers . He also asked leading electronic cigarette manufacturers to submit detailed plans to reduce the use of minors and warned that the agency would consider a possible ban on flavored electronic cigarettes or a ban on online sales of cigarettes. Electronic cigarettes.

Public health groups have repeatedly urged the agency to take action against what they consider to be new products that have not yet been approved by the FDA. In a letter to Gottlieb in August, six health and tobacco control organizations said "manufacturers of electronic cigarette products have introduced new products at an alarming rate, totally defying the law, regardless FDA application "A vaping website says that so many new products have been introduced that it is difficult to track them.

The letter, which included the American Academy of Pediatrics and the Campaign for Tobacco-Free Kids, added that many of the new products seemed to be trying to capitalize on the success of Juul Labs, whose electronic cigarettes have grown in popularity. among young people. people.

Among the products examined by the FDA are Vuse Alto, manufactured by R.J. Reynolds Vapor Co .; Myblu starter kit from Fontem U.S .; and Rubi de Kandypens. The agency said Juul had not received a request for information because the FDA had recently conducted an unannounced inspection of the company's headquarters to find out more about its marketing practices.

A spokeswoman for Reynolds said the company had informed the FDA in May "that it would make VUSE Alto available nationally and that it was a refurbished and renowned version." a vapor-based product legally marketed in the United States as of August 8, 2016. "

The agency said that there could be situations in which an electronic cigarette product did not appear to be on the market as of August 8, 2016, but that it was actually available in the trade and in accordance with the law. For example, a product may have been available without being announced or publicly announced, or may have had a different name.

However, in cases where products are sold illegally, "we will act quickly when companies circumvent the law," Gottlieb said in a statement.

Read more:

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The FDA goes ahead with its "historic" plan to reduce nicotine in cigarettes

Judge maintains FDA can regulate e-cigarettes, just like conventional cigarettes

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