FDA Policy/General

FDA Vaping Enforcement Priorities Guidance

David McFarland

— 1 min read
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FDA has published a guidance, Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization, indicating that for ENDS products without agency authorization, FDA intends to prioritize enforcement against: 

  •          any flavored, cartridge-based ENDS product (other than tobacco- or menthol-flavored ENDS product);
  •          all other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
  •          any ENDS product that is targeted to minors or whose marketing is likely to promote the use of ENDS by minors.

FDA also says it intends to prioritize the enforcement of any ENDS product that is offered for sale after 5/12 and for which the manufacturer has not submitted a PMA (or after a negative action by FDA on a timely submitted application).

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