FDA Approves Vuse Solo

Posted by Robert Taney on Nov 12, 2021

Vuse Solo: First PMTA Approval

The FDA has issued Marketing Granted Orders (MGOs) for the Vuse Solo and their Original Tobacco cartridge flavor. Both the first and second generation designs of their Original Tobacco flavored cartridge were approved. Manufactured by RJ Reynolds (now a subsidiary of British American Tobacco), the Vuse Solo is a first-generation cig-a-like and typically sold in convenience stores and gas stations.

In an ominous development, ten flavored Vuse Solo cartridges received Marketing Denial Orders (MDOs). Announced on the FDA website, the refusal to authorize flavors other than tobacco is a grim development. The fate of the menthol flavored Solo cartridges is currently unknown.

It is unclear if the rejection of the flavored cartridges is an indication that the FDA will only approve tobacco flavored nicotine vaping products during the Premarket Tobacco Product Application process (PMTA) or if the federal ban on flavored vape pods, which also covered first generation cig-a-likes which use prefilled carts such as the Vuse Solo, influenced the decision. Vuse Solo cartridge flavors have been off the market since January 2020 due to the federal ban, with only menthol and tobacco currently being sold in the US.

As the only vape product currently approved by the FDA, apart from the separate iQOS technology, it is worth reviewing the Vuse Solo. It is piece of vaping history. The Vuse Solo is a time capsule of vaping’s humble origins, in the days before vape mods, vape pods and nicotine salts.

Countless vapers have embraced newer and superior hardware. Anyone who started vaping after 2015 has probably never even tried a cig-a-like such as the Vuse Solo. As the review below will demonstrate, hopefully the approval of the Vuse Solo is not a harbinger of what will be left on the market when the PMTA process is done shaking out.

PMTA Process

The actual PMTA process merits its own deep-dive and the final verdict on the future of independent vaping industry remains in the balance. The ability of legal age adults to access the nicotine vape juice flavors they prefer is currently being determined by the FDA.

The PMTA application process consists of multiple steps through which the FDA reviews vaping products. Their goal is to assess the public health impact of new tobacco products. Vapes, which they refer to as Electronic Nicotine Delivery Systems (ENDs), fall under this umbrella.

PMTA’s design mirrors the early statements of former-FDA commissioner Scott Gottlieb. Gottlieb stated repeatedly that it would be a net benefit if all combustible cigarette smokers switched to vaping. But confronted by an increase in teenage vaping, he struck out in all directions before realizing too late that a single device (Juul) and single flavor (Mint) made up the bulk of the underage market.

PMTAs are essentially an application filed for every product vape juice flavor and vaping device. Don’t be deceived by this dry language. It is a huge deal, deciding the fate of adult access, individual products, and the industry as a whole.

UK versus PMTA

It is sad to compare the what is going on in the United States to the United Kingdom’s compassionate and science-based approach to vaping. In the UK, e-cigs are endorsed by their National Health Service. With skin in the game as a national health provider, they only adopt measures that work and are cost effective. Any modality found lacking on either count is not covered. A whole gamut of alternative medicines, homeopathy and supplements have gotten the axe.

The UK hosts a website titled and Using E-Cigarettes to Stop Smoking and has begun a process through which vaping products can be prescribed by doctor. This is no small deal as it will allow prescription drug coverage for vaping products. We covered the UK’s prescription vape initiative in a previous feature.

Big Tobacco’s Advantage

Big Tobacco manufactured products such as the Vuse Solo seemed to have a head start when it came to navigating the PMTA process. Backed by the money of British American Tobacco, which obtained RJ Reynolds in 2017, the Solo is also an older piece of technology.

Altria’s partnership with Juul, a device whose popularity with minors was the catalyst for widespread vaping crackdowns, gives them a similar advantage. Big Tobacco companies have the legal firepower and funding to survive. Moreover, they still sell combustible cigarettes. Their bottom line is not harmed if the flavors most popular with adult vapers are barred from the market and adult vapers are funneled back onto their legacy products.

Regulatory Capture

Another factor to consider: Big Tobacco manufactured vape products are sold almost exclusively at brick-and-mortar convenience store locations. They materially benefited from the passing of the PACT Act. That they are also in line to benefit from the PMTA process is hard to file as a coincidence.

Politicians continue to pressure the FDA to make PMTA decisions they consider favorable. Their goal is a nearly total ban on vaping devices. This lobbying crosses a line set by the Supreme Court case Pillsbury v. The Federal Trade Commission.

Depending how the PMTA process plays out, it is beginning to look like textbook regulatory capture. Regulatory capture is a theory that often plays out in practice in the United States. It occurs when government agencies are dominated by the largest stakeholders in the industries they are meant to regulate. Public interest takes a backseat.

Undue Influence

Blurring the line between oversight and undue influence, the fact free agenda of anti-vaping activists seems tireless because their coffers are bottomless. Funded by $160 million of Michael Bloomberg’s money, the imbalance between vapers and those who view the activity as alien and disreputable, is always evident. The wealthiest Americans ceased smoking long ago, and nicotine consumption or addiction simply is not on their radar.

To suggest total abstinence is the only solution for any other risky behavior would get you laughed out of the room in the social circles dead set on vaping’s destruction. Yet this puritanical gold standard is pursued relentlessly in the case of nicotine. Even after vaping demolished nicotine replacement therapy as a cessation method in a New England Journal of Medicine Study, it is still promoted as the only viable alternative to combustible cigarettes.

Perhaps it is unwitting, but anti-vaping activists are setting the stage for regulatory capture and for a vaping market dominated entirely by Big Tobacco companies.

Attacks on flavored vapes by lobbyists, politicians and the media nearly resulted in the banning of all flavored vapes outright and Juul Mint being allowed to stay on the market.

A last second reprieve was granted when the federal flavor ban was shifted to target prefilled pods and cartridges, and mint was added to the list of characterizing flavors.

The max-VG juices that Senators like Romney and Durbin love to wheel out in press conferences are not even a rounding error when compared to what kids are actually vaping. Loud, noisy, thirsty, and large box mods, which generate profuse odor and vapor, are literally the least likely way for a teenager to consume nicotine.

Today, with Tobacco 21 taking hold and teen vaping declining, the opponents of vaping show no willingness to take their foot off throat of the industry. Revelations that the vaping heart disease study was falsified, and the outbreak of lung ailments in the fall of 2019 were could be traced entirely to THC cartridges using vitamin E acetate have made nary a dent in their god-like certainty that vaping is bad. The CDC National Youth Tobacco Survey confirmed two years ago that flavors were not the cause of the teen vaping epidemic.

Kure has no interest in selling to minors and uses cutting edge age verification software. There are plenty of legal age adult smokers and vapers out there. Our goal is to provide them with the products that best fit their needs. The PMTA process and PACT Act are making this increasingly difficult, but we are in it for the long haul.

Vuse Solo Review

Launched in 2013, the Vuse Solo is a basic cig-a-like. It is draw-activated and uses snap and go cartridges that hold 0.5ml of e-juice. The Vuse Solo uses a simple USB charger that is proprietary, much like the Vuse Alto and Juul. There is no cross compatibility with other mini-USB cables.

Measuring 10mm x 120mm, it is longer than a combustible cigarette but approximately the same diameter. It weighs a mere 15 grams, which makes it possible for the strong lipped to operate it hands free like an actual cigarette. The Vuse Solo was designed for ease of use. Charge it and snap on a cartridge. Nothing else is required. Button pushing, coil swapping, bottle squeezing, and wattage adjusting are not required.

Vaping the Vuse Solo

The Vuse Solo was designed with combustible cigarette smokers in mind and attempts to mirror the smoking process as much as possible. It has a tight draw meant to mimic a filtered combustible cigarette.

Unfortunately, the Vuse Solo really works best with small puffs of under two seconds. Despite design changes midstream, both the first and second generation Vuse Solo cartridges have a hard time handling longer inhales.

Anything over two seconds puts you in danger of a dry hit. The ramp up speed is also a bit slow. The Vuse Solo does not use the juice filled cotton polyfill design found in modern disposable vapes or the eGo cartomizers of its era. It has a digital vapor delivery processor and a cotton entwined vape coil. Ignoring their marketing copy, the result isn’t terrible but not earth shattering.

Vuse Solo and Nic Salts

The story of the Vuse Solo is the story of the biggest change to the vaping landscape. This is the advent of nicotine salts. As a device developed early last decade, the Vuse Solo uses freebase nicotine. The introduction of nic salts in general and the Juul pod kit in particular drove devices like the Vuse Solo off gas station shelves.

Veteran vapers had long ditched the cig-a-like for vape mods and larger cartomizer devices. Vape mods are the polar opposite of the cig-a-like. They use max-VG juices with lower nicotine but deliver a satisfying experience through far greater vapor production. Vape pods operate on similar premise to the Vuse Solo, but have better flavor, vapor production and are more satisfying.

Freebase Nicotine versus Salt Nic

The crucial difference between freebase and salt nic is that salt nic has a lower pH level. This means you can add more salt nicotine into an e-juice without making it too harsh to tolerate. Nic salts also cross the blood brain barrier more readily, increasing satisfaction according to studies conducted by Juul.

Nic salts are quite smooth at 5 percent nicotine strength. Freebase nicotine is outstanding for max-VG juices of 0.3, 0.6 and even 1.2 percent nicotine strength. But at 4.8 percent, freebase is not a satisfactory solution for a device as small and underpowered as the Vuse Solo.

On paper, there isn’t much to distinguish a 270mAh Juul battery and the 270mAh Vuse Solo. Holding 0.7ml of e-liquid, the capacity of a Juul is not that much greater. But newer vape pod designs are less prone to dry hits than a Vuse Solo.

Salt Nic Juice Was a Game Changer

The use of very strong freebase nicotine will always define the Vuse Solo. The harshness of a 4.8 percent strength freebase nicotine was promoted as a feature and not a bug back in 2013. It supposedly lent authenticity to the vaping experience. The original Blu E-Cigs also had a high nicotine strength using freebase nicotine.

The launch of Juul in 2015, and the subsequent explosion in popularity of bottled salt nic juices and refillable vape pod kits would have seemed to be the coup de grace on the cig-a-like Vuse Solo. The Vuse Solo was both harsher and less satisfying than rival vape pods. It is no accident that Vuse has since launched a nic salt vape pod in the Vuse Alto, a more powerful freebase device that uses less potent freebase nicotine in the Vuse Vibe and a new cig-a-like that with a much lower nicotine strength in the Vuse Ciro.

Refillable Vape Pod Kits

The combination of bottled salt nic juice and refillable vape pod kit also allows vapers to save a ton of money. You also have a wider selection of lower nicotine options, better flavors and less waste is generated. You can enjoy lower-nicotine freebase e-juices from a vape pod or salts that are more potent than the Vuse Solo.

What you cannot vape in a refillable vape pod kit is freebase nicotine with a strength of 4.8 percent. Even in the era of eGo style cartomizers, 3.6 percent was considered the absolute ceiling of human tolerance. High PG bottled e-juices like those found in the Vuse Solo have remain popular with some older vapers but none match it’s elevated nic strength. The only reason the Vuse Solo was able to be palatable was the low wattage and vapor production of the device.

The nicotine strength in the Vuse Solo is high, but the total amount of vapor generated is quite low. The net result is an entry level device that was middling at the time and thoroughly outshined by salt nic vape pod kits and disposable vapes in 2021.

Vuse Solo Flavors

The Vuse Solo will presumably be sold in only the Original Tobacco flavor moving forward, with an outside chance that Menthol will make it through the PMTA crucible. The defunct flavors barred in the 2020 federal flavor ban were Berry, Crema, Nectar, Melon, Mint, Chai, Tropical and Fusion. Fans of Mexican food will be happy to note that Crema was not a salty sour cream flavor. Another odd choice was the Menthol was the pure cold flavor and Mint was the tobacco and menthol blend. Some of these flavors were also available in the Vuse Vibe and were quite good on that platform.

Final Thoughts

As an almost obsolete design, perhaps it makes sense that the Vuse Solo was approved first in the PMTA process. It is a tolerable starter kit but anyone who switches to vaping will probably want an upgrade sooner rather than later. Let us hope that the PMTA process does not weed out these upgrades and that adult vapers will still have access to the flavors and devices they prefer next year.

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