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Wednesday, September 22, 2021

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HomeFDAFDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

FDA Warns Firm with Over 15 Million Products Listed with FDA to Remove Unauthorized E-Cigarette Products from Market

“Today, the FDA issued a warning letter to a company with over 15 million tobacco products listed with the FDA, including many flavored e-liquids, for illegally marketing electronic nicotine delivery system (ENDS) products without authorization. This action demonstrates the agency’s ongoing commitment toward ensuring that marketed tobacco products are in compliance with the law to better protect youth and public health.

“The warning letter is the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. The FDA wants all tobacco product manufacturers and retailers to know that we continue to watch the marketplace very closely and will hold companies accountable for breaking the law. 

“The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency – especially those products with a likelihood of youth use or initiation.”

Additional Information:

  • Today, the U.S. Food and Drug Administration issued a warning letter to Visible Vapors LLC—a company based in Pennsylvania that manufactures and operates a website selling electronic nicotine delivery system (ENDS) products, including e-cigarettes and e-liquids—advising them that marketing these new tobacco products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S. The firm did not submit any premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline.
  • Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-cigarettes and e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. 
  • While the warning letter issued today cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanutbutter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with the FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement. 
  • In line with the agency’s enforcement priorities, after Sept. 9, 2020, the FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a product application.
  • From January through June 2021, the FDA issued a total of 131 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications for such products by the Sept. 9 deadline.

Additional Resources:

 

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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