FDA says Juul ‘ignored the law’ and warns it may take action – gpgmail


The Food and Drug Administration has put vaping giant Juul on notice with a pair of letters calling the company out for misleading statements about its products and ongoing targeting of teens. It is demanding written answers to a boatload of pertinent questions and expects Juul to respond within two weeks or risk “even more aggressive action” by regulators.

The specific claims being disputed by the FDA have to do with Juul positioning itself as a smoking cessation product. Now, it may be obvious anecdotally that vaping is a good way to wean yourself off smoking. But unlike nicotine patches and other products, there isn’t a lot of documentation on the complete risk associated with vaping — and with several people dead of vape lung, there would seem to be some worth considering.

“Companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said Acting FDA Commissioner Ned Sharpless in a news release. “Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”

Juul was reportedly directly targeting social media channels frequented by young people and, “despite commitments JUUL has made to address this epidemic, JUUL products continue to represent a significant proportion of the overall use of ENDS products by children. Some of this youth use appears to have been a direct result of JUUL’s product design and promotional activities and outreach efforts.”

In a recent Congressional hearing about the risk of “electronic nicotine delivery systems,” or ENDS, evidence was presented that a Juul representative told students that the company’s products were “much safer than cigarettes,” “totally safe,” and that the “FDA was about to come out and say it was 99% safer than cigarettes… very soon.”

Representations like these were apparently made far and wide, among students certainly and also among native American communities. They aren’t the kind of statements you can just say — tobacco cessation products are regulated, essentially medical products, and the FDA looks at them closely. Claims have to be documented and evaluated.

Juul seems to have been walking very close to the line in its public statements, and it’s likely that the company very carefully crafted these messages to convince people that its devices are good alternatives to smoking while not making any claims that would expose it to FDA attention. But they appear to have stepped over that line now and again and provoked exactly the kind of scrutiny they’d rather avoid.

“We request that you provide any and all scientific evidence and data, including consumer perception studies, if any, related to whether or not each statement and representation explicitly or implicitly conveys that JUUL products pose less risk, are less harmful, present reduced exposure, or are safer than other tobacco products,” the FDA told Juul.

Furthermore it asked Juul to explain why it uses a 5 percent nicotine concentration in its products, which could increase the likelihood of addiction, and why the company uses nicotine salts, a substance that reduces harshness and allows greater nicotine concentrations.

Likely independent of the ongoing investigation into lung problems seemingly caused by vaping, the FDA also requested “Aerosol particle size analysis of aerosol formed from your device,” “experimental design and data on pK studies from your device, your e-liquid, and combusted cigarettes,” comparisons between free nicotine and nicotine salt delivery, and “How the design and performance of your device and/or e-liquid, including the level, formulation, and delivery specifications of nicotine, affect lung deposition as related to the use and addictive potential of the product.”

In other words, tell us why you designed your product to be extra addictive and attractive to non-smokers, and whether this was in spite of knowing the substances created caused lung damage.

In a statement, Juul said that it was “reviewing the letters and will fully cooperate.”


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Juul introduces new POS standards to restrict sales to minors – gpgmail


Juul Labs, the e-cigarette behemoth partially owned by Altria, has today announced a new POS age-verification system that it will require all Juul retailers to comply with by May 2021.

The Retail Access Control Standards program, or RACS for short, raises the standard for age-restricted POS systems, automatically locking the POS each time a Juul product is scanned until a valid, adult ID is scanned. The system also looks for bulk purchases (four four-count packs of Juul Pods is the legal limit for a single transaction) and locks when the fifth Juul Pod pack is scanned, automatically removing the fifth pack from the customer’s cart.

Thus far, more than 50 retail chains, which represents 40,000 outlets, have committed to switching over to RACS, with 7,000 stores in the process of switching now and 15,000 to have implemented the technology by 2019’s end. The deadline for switching over to the RACS system is May 2021, at which point Juul will only sell its products to RACS-compliant retailers.

The company recognizes that overhauling a POS can be costly and difficult, and is offering $100 million+ in incentives to retailers who switch over. For retailers with newer POS systems, the switch might only require a software update, while others may need to update their hardware, as well.

Now, the system isn’t foolproof. After an ID is scanned, all personal information is automatically deleted from the system, which means that bad actors/unauthorized resellers could amass a bulk amount of Juul products by visiting various stores or returning to the same store multiple times.

However, this is likely just the beginning for the RACS program, which for the first time gives Juul much more control around how their products move through the market, ultimately limiting the opportunity for Juul products to end up in the hands of minors.

Alongside the introduction of RACS, Juul is also expanding the Track & Trace program it piloted in April in the Houston area.

Track and Trace allows teachers, parents, law enforcement and otherwise responsible adults to log the serial number of confiscated Juul devices, giving Juul the information it needs to track that device through the supply chain and identify the store where it was sold.

Using Juul’s secret shopper program, the company can then specifically target those stores and shut down the illegal sale of Juul devices to minors.

Today, Track and Trace is expanding nationwide in the U.S.

While these are major steps in combating underage use of Juul products, the company itself admits that it believes youth vaping numbers will continue to rise.

From the release:

It is our expectation that this year’s survey, unfortunately, will likely show continued growth in youth use of vapor products in the U.S. If this turns out to be the case, it will be due in part to the fact that:

  • When this year’s NYTS data was collected, T21 laws were being passed in a dozen states but had not been implemented
  • Little to no category-wide actions have been taken as FDA is finalizing its guidance that, once implemented, should impose additional restrictions on the sale and marketing of certain flavored vapor products — actions that we voluntarily imposed on ourselves last November

In November 2018, Juul announced its Youth Prevention Plan ahead of the FDA’s crackdown on e-cig products. It included the ban of flavored Juul pod sales in convenience stores and other Juul-approved retailers, limiting the sale of non-tobacco and non-menthol flavored pods to its online storefront. Juul says this represented 50 percent of its revenue at the time. The company also took down its Facebook and Instagram pages, and revamped its Twitter to ditch any promotional or marketing content from the platform.

Still, even with the many steps the company has taken to limit youth use of the product, one of Juul’s biggest obstacles is the sale of counterfeit and infringing products, which may include dangerous and/or unknown chemicals. The company hired former Apple employee Adrian Punderson to help lead the fight against counterfeits in February.

As of December 2018, Juul was reportedly valued at $38 billion, estimated to own more than 70 percent of the e-cig market.


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Vape lung has claimed its first victim, and the CDC is investigating – gpgmail


A person has died from what the Centers for Disease Control and Prevention speculate is a vaping-related condition. Nearly 200 other cases of varying severeness have been reported nationwide, described by the CDC as “severe unexplained respiratory systems after reported vaping or e-cigarette use.”

No information was provided about the deceased other than that they were an adult living in Illinois, and that they had died of some sort of pulmonary illness exacerbated or caused by vaping or e-cigarette use. Others affected in that state have been between 17-38 and mostly men, the CDC doctor added on a press call earlier today.

As little is known for sure about this growing problem, the team was hesitant to go beyond saying there was good reason to believe that these cases were all vaping-related, although they differ in some particulars. They have ruled out infectious disease.

The CDC’s acting deputy for non-infectious diseases, Dr Ileana Arias, explained on the call after expressing their condolences:

CDC is currently providing consultations to state health departments about a cluster of pulmonary illnesses having to do with vaping or e-cigarette use… While some cases appear to be similar and linked to e-cigarette product use, more information is needed to determine what is causing the illnesses.

In many cases patients report a gradual start of symptoms, including breathing difficulty, shortness of breath and/or hospitalization before the cases. Some have reported gastrointestinal illnesses as well… no specific product has been identified in all cases nor has any product been conclusively linked to the illnesses

Even though cases appear similar, it isn’t clear if these cases have a common cause or if they are different diseases with similar presentations.

An FDA representative on the call said that his agency is also looking into this, specifically whether these are products that fall under its authority. It’s possible they were imported, for example, or sold under the table.

Everyone involved is still in the information-gathering phase, as you can tell, but it’s apparently serious enough that they felt the need to make this announcement. Meanwhile they are asking doctors to report cases they suspect might be related.

“Right now states are leading their own specific epidemiologic investigations and we’re providing assistance as needed,” explained the CDC’s Dr. Josh Schier. “CDC is working on a system to collect, aggregate, and analyze data at the national level to better characterize this illness.”

As the mechanism is unknown, it’s unclear what the actual danger is. Is it some byproduct of the nicotine cartidges, or THC ones? Is it the vapor itself? Is it only at certain temperatures or concentrations? Is it directly affecting the lungs or entering the bloodstream? No one knows yet — all they’ve seen is an sudden uptick in respiratory or pulmonary issues where the sufferer also uses vaping products.

The CDC’s Dr Brian King went into a bit more detail on the possibilities, explaining that while no specific chemical can be said to be the problem, that’s more for a want of study, not a want of potentially harmful chemicals.

“We do know that e-cigarettes do not emit a harmless aerosol,” he explained. “There’s a variety of harmful ingredients identified, including things like ultrafine particulates, heavy metals like lead and cancer causing chemicals. And flavoring used in e-cigarettes to give it a buttery flavor, diacetyl, it’s been related to severe respiratory illness.”

“We haven’t specifically linked any of those specific ingredients to the current cases but we know that e-cigarette aerosol is not harmless,” King concluded.

He also suggested, in response to a question why we were suddenly seeing lots of these cases, that the problems have been occurring all this time but only recently have hospitals and other organizations done the due diligence as far as linking them to e-cigarette use.

Few studies have been done on vaping’s potential health effects, and none on long-term effects, since the devices only recently gained popularity — well ahead of the possibility of regulation and years-long studies.

Research published just last month from Yale found that Juul vape pens produced chemicals not listed on the package, some of which are known to be irritants.

“People often assume that these e-liquids are a final product once they are mixed. But the reactions create new molecules in the e-liquids, and it doesn’t just happen in e-liquids from small vape shops, but also in those from the biggest manufacturers in the U.S.,” said Yale’s Hanno Erythropel in a news release. I asked Juul for comment at the time and received no response.

That vaping works as a way to quit smoking — which we know is absolutely disastrous to your health — seems clear. But it remains to be seen exactly how much less of a risk vaping offers.

If you use vaping products and have been experiencing coughing, shortness of breath, fatigue, or chest pain, tell your doctor.


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The scientist behind Juul launches a Juul alternative for China – gpgmail


The chemist who helped create the magic sauce behind Juul, Xing Chenyue, unveiled the product of her new startup Myst Labs this week after two years of development: electronic cigarette alternatives designed for China’s 350 million smokers, the world’s biggest smoking population.

This new contender makes for a potentially heated battlefield given that Juul will reportedly enter China soon. gpgmail has reached out to Juul about its expansion, but has not heard back at the time of writing.

Pax Labs — the company that spun out Juul in 2017 — was a 20-person team when Xing joined as one of its first scientists in 2013. During her nearly three-year post at what would become America’s largest vaping company, Xing helped invent nicotine salts, the compounds that made Juul an instant hit. The patented technology inspired a raft of followers because it allows high levels of nicotine to be inhaled more easily and with less irritation, according to the U.S. Centers for Disease Control and Prevention.

Xing left Juul when the company made a foray into marijuana vaporizers, a move that didn’t particularly interest the scientist, a non-smoker whose ambition is to “help smokers meet their nicotine needs whilst reducing the harmful substances they consume,” Xing told gpgmail in a phone interview.

Myst says it spends about 20% of its money raised on research and development. / Photo: Myst Labs

The China-born scientist took up a project management role at publicly-traded pharmaceutical company Dermia before eventually returning to cigarettes research by starting Myst Labs, which she co-founded in 2017 with Thomas Yao, a venture capitalist she had met over a decade ago at Fudan University in Shanghai.

As Myst began to take form, Juul was on course to reach its whopping $38 billion valuation even while it was under fire for luring teenagers into vaping. Meanwhile in China, vaping had just begun to catch on. Research from Soochow Securities (in Chinese) shows that China, despite being the world’s biggest producer of vaping devices, accounts for merely 6% of the world’s e-cig market. Xing wanted to seize the opportunity and this time, she’s in control over what comes out of the lab.

“We certainly want to reach the same level of society-wide impact in China as Juul does in the U.S. We hope Myst can leave a positive mark on Chinese smokers,” said Xing. “Myst can slowly transform the way people smoke and gradually reduce the level of their nicotine intake.”

Myst’s first product, dubbed the P1 series, is a 399 yuan ($58) flash-drive-shaped device that comes with a nicotine level of 3% or 5% and sports a retractable cigarette holder for hygiene and a “click” sound that mimics a lighter. Myst will ship in China through online and offline channels and said it plans to sell in international markets down the road. Its price point is comparable to Juul’s pricing in the U.S.

Myst does not market itself as a smoking cessation tool because to do so would require approval from China’s drug regulator. Rather, the startup bills itself as a “new type of cigarette substitute for adult smokers.” It has avoided using images of young, cool-looking models, the style of campaigns that backfired on Juul. To verify customers’ age, Myst applies facial recognition, an increasingly ubiquitous technology in China where people scan their face to pay for things or access certain entertainment services such as video games and live videos.

myst 4

Myst says its products are priced and marketed to target ‘adult smokers,’ not young people. / Photo: Myst Labs

That positioning also allows the company to potentially evade stepping on the toes of China’s powerful cigarette monopoly, which provides the government with handsome sums of tax revenues.

From Silicon Valley to Shenzhen

Myst deploys about half of its 20-person team to conduct research and development in Silicon Valley. The rest of the company mainly works out of Shenzhen, the electronics manufacturing hub that also produces the majority of the world’s vaporizers.

“We are combining Silicon Valley research and China’s supply chain, a strategy that sets us apart from most vaporizers on the market,” Yao, who heads up business development at Myst, told gpgmail.

He compared China’s vaping craze to what happened to smartphones between 2010 and 2011 when copycats of incumbents crowded the market in a gold rush. Countless knockoffs of Juul and other established brands now flood the market. Companies with various degrees of development capabilities have also mushroomed — at least 20 Chinese e-cig startups have received venture investment in the last seven months.

As with the smartphone market that’s now dominated by a small rank of players, Yao believed the bad apples in vaping will eventually be weeded out. “This [counterfaiting] happens whenever China experiences a technological breakthrough. Chinese brands get eliminated at a rate to which no other country can compare. Perhaps a lot of [e-cig] companies will go out of business by the end of this year.” A sector reshuffle will result in part from government regulation, which can arrive in China anytime soon.

myst 5

Myst co-founder Thomas Yao introduced his co-founder and the company’s chief scientist Xing Chenyue, a former scientist at Juul. / Photo: Myst Labs

Xing believes Myst’s edge lies in the quality of its products. According to Yao, the company spends about 20% of the money raised on R&D.

Yao declined to disclose how much the company has banked but said it has sufficient funds in the coffer and that “money isn’t an issue” because he has personally invested in Myst. Yao had previously picked some winners by backing mobility unicorn Lime and India’s wallet leader Paytm in their early days.

The co-founder has also brought to the table key personnel for the business, including Myst’s chief executive officer Daniel Chen, who previously managed Hong Kong-listed robotics firm Super Robotics; chief operation officer Martin Liu, former CEO of Blackberry China; head of product Yingqun Cao, a former product manager at Google Home and Juul; and lastly head of design Jiandong Hao, previously a design director at global design firm IDEO.

The pool of talent is reflective of Myst’s vision to digitize smoking, which can manifest in the form of a connected vaporizer that tracks users’ health conditions just like a smart wristband does. Myst’s current generation of products does not yet enable the futuristic scenario, but Yao maintained that digitization is key to smoking.

“For smokers, vaporizers could become the second most used electronic devices after smartphones,” he said.


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