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Enforcement Actions Against Illegally Marketed Tobacco Products

On January 2, 2020, FDA announced the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed tobacco products on the market without premarket authorization. Specifically, the agency is now prioritizing enforcement against the following groups of unauthorized ENDS products: 

  1. Any flavored, cartridge-based ENDS (other than tobacco or menthol flavored) 
  2. All other ENDS products for which the manufacturer has failed to take adequate measures to prevent underage access 
  3. Any ENDS product that is targeted to youth or likely to promote use by youth. 

Under this policy, companies that do not cease manufacture, distribution and sale of these unauthorized tobacco products risk FDA taking regulatory action, ranging from warning letters to injunction, seizure, and/or civil money penalty actions.

The following entities have been the subject of FDA Warning Letters for offering for sale tobacco products that require, and do not have, marketing authorization after FDA implemented this enforcement policy: 

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