FDA Cracks Down on Nicotine Products: No Enforcement Discretion

March 26, 2023

In a letter received by VTA on February 2, 2023, Director King of the CTP clarified the FDA's stance on enforcement discretion for TDN and NTN products. The letter stated that TDN and NTN products are being treated equally, and that the FDA has not been using enforcement discretion for either type of product. All products containing TDN or NTN are considered illegal and cannot be sold without PMTA authorization.

This marks a change from the FDA's previous position, in which it acknowledged the use of enforcement discretion. However, CTP now states that all illegally marketed TDN and NTN products are subject to FDA enforcement, including seizure, civil money penalties, or injunctions. There is no broad policy of enforcement discretion for TDN or NTN products that lack PMTA authorization.

The timing of CTP's letter coincides with pressure from VTA and Senator Richard Durbin and other senators, who criticized the FDA's exercise of enforcement discretion and demanded that it end. CTP's letter makes it clear that there is no enforcement discretion preference for TDN over NTN products, and that all nicotine-containing products on the market without PMTA authorization are illegal.