FDA Will Fast-Track Some Nicotine Pouch Authorizations

The FDA Center for Tobacco Products is planning to fast-track marketing authorization for four brands of nicotine pouches, following pressure from the White House. 

The news was reported today by Reuters, which described the sped-up authorization plan as an FDA “pilot program.” Reuters says the program will be used to accelerate premarket tobacco application (PMTA) review for pouches sold by four publicly traded tobacco companies.

White House pressure for pouches, but not vapes

Reuters based its story on access to transcripts of recent FDA meetings where the changes in FDA direction were discussed. FDA officials told staff the new program was developed in response to pressure from leadership, including from the White House, according to Reuters.

Health and Human Services Secretary Robert F. Kennedy Jr.---whose department oversees the FDA---recently told an interviewer that nicotine pouches are the safest way to consume nicotine, and that “vapes are second.” He added that “we are fast-tracking approval” of some vapes. 

However, no vaping products are included in the pilot authorization program described by Reuters, despite Kennedy’s claim and President Donald Trump’s 2024 campaign promise to “save vaping.”

The products set to be fast-tracked are all produced by tobacco companies or affiliates: Zyn Ultra (Swedish Match/Philip Morris International), on! and on! PLUS (Helix Innovations/Altria Group), Velo mini (R.J. Reynolds), and Fre and Alp (Turning Point Brands). 

At least two of the companies chosen for the new sped-up authorization process have donated to President Trump’s campaign or inauguration, and Alp is part-owned by conservative commentator Tucker Carlson. (Kennedy has been spotted using Alp pouches.)

FDA Tobacco: not much happens, and it takes a long time 

So far, ZYN is the only nicotine pouch brand to receive FDA marketing authorization---a process that took nearly five years from PMTA submission (March 2020) to marketing granted order (MGO) this January.

Although the Tobacco Control Act---which serves as a charter for the Center for Tobacco Products (CTP)---requires the FDA to make an authorization decision within 180 days of a PMTA’s acceptance for review, the agency has never authorized a product in less than two years, and many applications remain in limbo five years or more after submission.

Altria vape subsidiary NJOY recently sued the agency for dragging its feet, and both Altria and R.J. Reynolds are now taking the unprecedented step of launching new products without prior FDA authorization and daring the confused and directionless CTP to stop them.

In the five years since the PMTA submission deadline, the FDA has granted marketing authorization to just eight e-liquid-based vaping devices, along with tobacco- or menthol-flavored refills for them. The agency has rejected PMTAs for millions of products, and has never authorized a bottled e-liquid, refillable device, or a vape in any flavor except tobacco and menthol.