Advertisement
Advertise with us
sidenav

FDA Issues First Authorization for a Vaping Product

Advertisement
Advertise with us

The FDA has issued its first marketing authorization for a vaping product. Marketing Granted Orders (MGOs) for the first generation-style Vuse Solo e-cigarette and two tobacco-flavored replacement cartridges were published on the FDA Center for Tobacco Products website Tuesday afternoon.

Along with the authorizations, the FDA announced it has issued Marketing Denial Orders (MDOs) for 10 Vuse Solo refill cartridges in flavors other than tobacco—even more evidence that the agency has no intention of authorizing any flavored products except possibly menthol. It’s unknown if the FDA denied the PMTA for the Vuse menthol-flavored refill.

Premarket Tobacco Applications (PMTAs) for the Vuse Solo and refill cartridges in several flavorswere submitted to the FDA in October 2019. The manufacturer of the Vuse brand is RJ Reynolds Vapor Company—a division of Reynolds American Inc., which is a subsidiary of British American Tobacco.

The Vuse Solo is a so-called cigalike—a small stick battery that uses prefilled, disposable cartomizers. The product resembles a cigarette, although the Solo battery is silver in color, and the cartridges are black. Vuse Solo cartridges use nicotine salt-based e-liquid, and are available only in 4.8 percent (48 mg/mL) nicotine strength.

The device is very low in power, and requires a high nicotine strength to provide a reasonable satisfying hit for users. It is considered less effective as a product for transitioning smokers than pod-based devices like the Vuse Alto, JUUL and NJOY Ace.

The Vuse Solo was among the first products to be submitted for review, but it is an extremely cautious choice by the FDA. Among mass market vaping products, cigalikes like the Solo are the least popular in 2021. The FDA probably chose the Solo to be the first authorized product to assess the reaction from the tobacco control and medical organizations that the agency always seeks to please.

Advertisement
Advertise with us
Latest Reviews
Article preview image
Freemax REXA PRO & REXA SMART Review: Too Smart?

The Freemax REXA PRO and REXA SMART are highly advanced pod vapes, offering seemingly endless features, beautiful touchscreens, and new DUOMAX pods.

Wed Jul 30 2025
Article preview image
OXVA XLIM Pro 2 DNA Review: A Match Made in Heaven!

The OXVA XLIM Pro 2 DNA is powered by a custom-made Evolv DNA chipset, offering a Replay function and dry hit protection. Read our review to find out more.

Fri Jul 18 2025
Article preview image
SKE Bar Review: A Reusable Crystal Bar!

The SKE Bar is a 2 mL replaceable pod vape with a 500 mAh battery, a 1.2-ohm mesh coil, and 35 flavors to choose from in 2% nicotine.

Mon Jul 7 2025
Advertisement
Advertise with us
Latest Learn
vaping taxes
Vaping Taxes in the United States and Around the World

Because of declining cigarette sales, state governments in the U.S. and countries around the world are looking to vapor products as a new source of tax revenue.

Thu Jul 31 2025
How Old Do You Have to Be to Vape?
How Old Do You Have to Be to Vape?

The legal age to buy e-cigarettes and other vaping products varies around the world. The United States recently changed the legal minimum sales age to 21.

Tue Jul 1 2025
Where vaping is banned or restricted
Vape Bans: E-Cigarette Restrictions in the U.S. and Worldwide

A list of vaping product flavor bans and online sales bans in the United States, and sales and possession bans in other countries.

Fri Jul 4 2025
About Authors
Jim McDonald
843 posts

Smokers created vaping for themselves without help from the tobacco industry or anti-tobacco crusaders, and I believe vapers and the vaping industry have the right to continue innovating to give everyone who wants to use nicotine access to safe and attractive non-combustible options. My goal is to provide clear, honest information about vaping and the challenges nicotine consumers face from lawmakers, regulators, and brokers of disinformation. You can find me on Twitter @whycherrywhy

See author’s profile
Vaping360.com strives to be the world's most trusted resource for vapers and smokers. We take pride in our editorial integrity, accuracy, and the honesty of our writers.
Read more about us

Rely on Our Expertise

At Vaping360, we take pride in our deep expertise and years of experience in the vaping industry. Our dedicated team of professionals is committed to leveraging their extensive knowledge to meet your needs and exceed your expectations.

Authenticity

Genuine insights backed by thorough and exhaustive research and testing.

Reliability

Consistent, accurate information from the vaping industry experts.

Empowerment

Transparent and reliable content for confident and informed decision-making.

About us

Our mission is clear: to help people who smoke transition to low-risk alternatives and contribute to a smoke-free world. With each article we publish and each review we conduct, we're working towards this goal.

about-us-banner
product preview