Understanding FDA-Authorized Nicotine Products

What “FDA Authorized” Really Means

If you’re trying to reduce harm from nicotine, you might look for products that are “FDA approved.” But here’s the catch: the FDA doesn’t approve tobacco products—including vapes or nicotine pouches—the way it approves medications or medical devices.

Instead, it authorizes some products for sale through a process called the Premarket Tobacco Product Application (PMTA). That means the FDA has reviewed scientific data and decided the product can be legally marketed because it meets a public health standard—not because it’s safe.

Understanding this difference can help you make smarter choices. Here's what you need to know:

• FDA authorization is not the same as FDA approval.

  • FDA approval (used for medications) means a product is proven safe and effective for its intended use.

  • Tobacco products are inherently harmful, so they can’t be FDA-approved.

• FDA authorization allows marketing under strict conditions.

  • It means the product met FDA’s standards for being “appropriate for the protection of public health.”

  • This includes evaluating both risks and benefits to the entire population — users and non-users.

• Only a small number of nicotine products have received FDA authorization.

  • As of now, only 33 electronic nicotine delivery system (ENDS) products have gone through the PMTA (Premarket Tobacco Product Application) process.

  • These include a few specific devices and e-liquids, like some Vuse, Logic, and IQOS products.

• The FDA continues to deny authorization for products that appeal to youth.

  • Most flavored e-liquids and many currently sold vape products do not have FDA marketing authorization.

• Even among authorized products, availability is limited.

  • Many of the 33 authorized products may not be easy to find.

  • Over 85% of vape products sold today have not been authorized by the FDA.

  Smokeless tobacco products have also received FDA authorization.   

  • These include specific products like Swedish Match’s General Snus and Zyn varieties.