FDA Authorizes Vuse Devices: Solo & Alto (Timeline + What It Means)

It’s official: the U.S. Food & Drug Administration (FDA) has authorized multiple Vuse products through the PMTA pathway first Vuse Solo in October 2021, then Vuse Alto in July 2024. Below we explain what’s authorized, what isn’t, and how to choose between Vuse Solo and Vuse Alto for your needs.

What exactly did the FDA authorize?

• Vuse Solo (Oct 12, 2021):
  Authorized products: Vuse Solo Power Unit and two tobacco-flavor cartridges. Menthol not authorized for Solo.
  Shop Solo: Vuse Solo Power Unit • Solo Original Tobacco 4.8% cartridges • Solo Menthol 4.8% cartridges (menthol flavor is sold where legal but is not FDA-authorized).
• Vuse Alto (July 18, 2024):
  Authorized products: Vuse Alto device and six tobacco pods—Golden Tobacco and Rich Tobacco in 1.8%, 2.4%, 5.0%. Menthol not authorized.
  Shop Alto: Alto Power Unit (Silver) • Alto Power Unit (Rose Gold) • Alto Power Unit (Red) • Alto Pods 5% Golden Tobacco • Alto Pods 1.8% Golden Tobacco.

Want the flavor differences? See Golden Tobacco vs. Rich Tobacco.

Why were hundreds of other applications denied?

Since 2021, the FDA has denied large numbers of flavored products that didn’t demonstrate a net benefit for adult smokers relative to risks to youth. That’s why the authorizations above are limited to tobacco flavors.

Solo vs Alto: which Vuse is right for you?

• Vuse Solo: simple draw-activated device. Start here if you want a classic cig-a-like. Shop Solo or grab the Solo Power Unit. 
• Vuse Alto: compact pod system with multiple nicotine strengths. Browse Alto devices/pods or go straight to Alto 5% Golden Tobacco pods. Curious about puff counts? Here’s how many puffs are in a Vuse pod.

Related reads

• Your Vuse vape user guide
• Your guide to selecting the best Vuse device
• Vape showdown: Vuse vs blu vs JUUL 

FAQs

1. Which Vuse products are FDA-authorized?
   Vuse Solo (device + two tobacco cartridges) and Vuse Alto (device + six tobacco pods: Golden Tobacco & Rich Tobacco in 1.8%, 2.4%, 5.0%).
2. Are any Vuse menthol pods authorized?
   No. As of the July 18, 2024 decision, only tobacco flavors for Vuse were authorized.
3. Why are so many flavored vapes denied?
   The FDA requires robust evidence that benefits to adult smokers outweigh risks to youth; many flavored products didn’t meet that bar.

Editor’s note: Updated November 12, 2025 to reflect FDA decisions through 2024 and add shopping links.

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