Which Products Are FDA Authorized?

Only a small number of nicotine products have been authorized by the FDA. Authorization means these products have passed scientific review and can be legally marketed in the U.S. They are safer than cigarettes, but it does not mean they are safe.

Over 85% of tobacco products sold in the USA are not authorized for sale. They may contain unknown chemicals and have not been tested. Here is a link to the FDA searchable tobacco products data base.

The FDA has authorized a limited set of products in the following categories:

• E-Cigarettes and Vaping Devices

  • Products from Vuse Solo (R.J. Reynolds), Logic, NJOY, and JUUL have FDA authorization.

  • JUUL device, Virginia Tobacco JUULpods (3% and 5%), and Menthol JUULpods (3% and 5%).

  • All authorized vape products are “closed systems” — meaning they use pre-filled cartridges or pods.

• Heat-Not-Burn Devices

  • IQOS (Philip Morris) heats tobacco without burning it.

  • Devices like IQOS 3 and IQOS 2.4 are authorized for sale.

• Smokeless Tobacco

  • Includes products like General Snus and Zyn (Swedish Match), On!Plus (Helix)

  • These products are placed between the gum and lip or dissolved in the mouth.

• Non-Nicotine Products Are Designed to Avoid FDA Oversight

  • Link to FDA position

  • They have not been authorized

  ⚠️ Flavored vaping products that appeal to youth have not been authorized.
  The FDA continues to deny applications for products that could increase youth nicotine use. The one exception is Juul Menthol.
  
  What Role Do Flavors Play?

  • Flavors are controversial—but for many adults, they play a role in switching away from cigarettes.
    → Learn how flavors fit into nicotine options

Note: The majority of nicotine products sold in vape shops or online do not yet have FDA authorization. The FDA oversees all tobacco products. Cigarettes, pipe tobacco, and cigar brands marketed before 2007 were given presumptive authorization. Any new product containing nicotine must be reviewed.

Dr. Anselm’s perspective: If you chose a nicotine product to help with quitting or harm reduction, always use FDA-authorized products.