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.

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. — but it does not mean they are safe.

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

  • E-Cigarettes and Vaping Devices
    ◦ Products like Vuse Solo (R.J. Reynolds), Logic devices, and specific pods or e-liquids.
    ◦ 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).
    ◦ These products are placed between the gum and lip or dissolved in the mouth.

⚠️ 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.

Note: The majority of nicotine products sold in vape shops or online do not yet have FDA authorization.

Thinking About Quitting? Here’s What Helps

Quitting nicotine is hard—but there’s real help available.

If you’re thinking about quitting cigarettes, vapes, or other nicotine products, you don’t have to do it alone. The FDA has approved several medications that can double your chances of quitting for good—and many are available over the counter.

FDA-Approved Quit-Smoking Medicines:

  • Nicotine patches

  • Nicotine gum

  • Nicotine lozenges

  • Nicotine nasal spray (prescription)

  • Nicotine inhaler (prescription)

  • Varenicline (Chantix) (prescription)

  • Bupropion SR (Zyban) (prescription)

These medications are approved for adults who smoke cigarettes. If you use other tobacco products (like cigars, hookah, or e-cigarettes), talk with a doctor or the quitline about your options.

📞 Free Help Is Available

Call 1-800-QUIT-NOW for free coaching, resources, and local referrals.
You can also download the quitSTART app or text QUITNOW to 333888.

Multilingual support is available in Spanish, Chinese, Korean, and Vietnamese.