IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA

https://www.courtlistener.com/docket/15760912/1/zlab-sa-v-juul-inc/

ZLAB S.A., SS GROUP HOLDINGS & SHENZEN YIBO TECH. CO.,
Plaintiffs,
v.
JUUL LABS, INC.,
Defendant.
Case No. ____________
PLAINTIFFS’ COMPLAINT AND DEMAND FOR JURY TRIAL

DEMAND FOR JURY TRIAL

Found this on the internet. Ziip files a lawsuit against JUUL Labs. I find this very interesting and well hidden from retail.

Will be interesting to follow.

Altria and Philip Morris International Considering Merger

Altria and Philip Morris International Considering Merger

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Altria and Philip Morris International Considering Merger

Two of the world’s biggest tobacco companies are considering merging. A recent press release from Altria revealed that the company was in discussions with Philip Morris International regarding a potential all-stock, merger of equals. If completed, the merger would reunite the two companies that split back in 2008.

Altria and Philip Morris International separated back in 2008 in an effort to better focus on domestic and international markets. If the reunification goes through, the new company would have an estimated market value of more than $200 billion according to Reuters. News of the possible merger sent Philip Morris International stock prices down by 5 percent while shares of Altria increased by 9 percent. Prior to this news, Altria’s outstanding stock was valued at roughly $88 million while Philip Morris International’s market value stood at around $121 billion.

Analysts have predicted a merger and reunification of the companies would occur, partly due to the many changes impacting the tobacco industry. Cigarette sales are on the decline in the U.S., forcing both companies to look for alternatives and at reduced harm as a possible new profit center. Philip Morris International has received approval from the U.S. Food and Drug Administration to sell and market its heat-not-burn device iQOS in the U.S. Altria has invested $12.8 billion in e-cigarette manufacturer JUUL, giving it a 35 percent stake in the largest U.S. e-cigarette manufacturer. In 2018, Philip Morris International generated $79.82 billion in revenue while Altria reported revenue of $25.36 billion.

The press release from Altria on the merger talks cautioned that for now, the merger was just being discussed. “There can be no assurance that if an agreement is reached, that a transaction will be completed,” it is stated in the press release from Altria. “Any transaction would be subject to the approval of the two companies’ boards and shareholders, and regulators, as well as other conditions. Altria intends to make no further comment regarding the discussions unless and until it is appropriate to do so.”

You can read the full press release here. For all the latest news from Altria, visit altria.com

NO SURPRISE HERE AS THIS HAS BEEN A TOPIC OF CONVERSATION THE LAST TWO WEEKS. WHAT ARE YOUR THOUGHTS?

Vapor Technology Association Files Lawsuit Against FDA over PMTA Process

Vapor Technology Association Files Lawsuit Against FDA over PMTA Process

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Vapor Technology Association Files Lawsuit Against FDA over PMTA Process

The Vapor Technology Association (VTA), a leading U.S. non-profit industry trade association representing the industry-leading manufacturers of vapor devices, e-liquids, flavorings and components and retailers of these products, has filed a lawsuit against the U.S. Food and Drug Administration over its premarket tobacco application (PMTA) process.

The VTA teamed up with Vapor Stockroom (VSR) to file the lawsuit against the FDA in federal court. In question is the PMTA process and what exactly will be required of vapor manufacturers to file these applications. Recently, the PMTA deadline was moved up to May 2020 [read more here] and while the lawsuit was filed by the VTA in regards to its potential negative impact on the vapor industry, the PMTA process and deadline will also impact other covered tobacco products, including the premium cigar industry.

The VTA wants the FDA to clearly define and publish guidance on the specific requirements of the PMTA process. The lawsuit also is seeking to stop the FDA from enforcing its May 2020 deadline for PMTAs and from actions to be taken against those companies that do not file an application in time to meet this deadline. The VTA reports that there are the May 2020 deadline makes it nearly impossible for many small and mid-sized vapor businesses to file an PMTA in time, especially with the process being unclear and without proper guidance from the FDA. The organization is calling for a more reasonable deadline to be set for PMTAs after proper guidance has been published for more time to be provided for the many tests and studies to be conducted that are required by the FDA.

“FDA’s constantly shifting regulatory process is wholly unreasonable, unfair and unlawful,” commented Tony Abboud, executive director of the VTA. “The Agency has failed to provide advance notice or an opportunity for public comment as required by the Administrative Procedure Act. Grossly accelerating the deadlines and then repeatedly changing the already onerous requirements is unacceptable under any regulatory regime, but this is especially true for vapor products when FDA itself warns that ‘it is likely that there would be a mass market exit of ENDS products’ that ‘could adversely affect the public health.’”

Abboud went on to say that no business should be expected to have conducted the tests required by the PMTA requirement without proper guidance. While the FDA did publish a guidance document for vapor manufacturers to follow for the PMTA process back in June 2019 [read more here], the earlier deadline leaves many companies scrambling to conduct all the necessary tests necessary to file the PMTA. Many questions about the process and its requirements, however, have gone left unanswered and to comply will require more resources than some companies have available to them. This is why Vapor Stockroom, a manufacturer based in Lexington, Kentucky, also joined in on the lawsuit.

“Our company complied with every regulation imposed by FDA and invested in our business while waiting for FDA to deliver on all of the promised PMTA rules, guidance and standards,” commented Tony Florence, President of Vapor Stockroom, LLC. “We never thought that FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business. It’s a devastating one-two punch to small businesses all over the country.”

Abboud warns of the devastating impact the PMTA process could have on many businesses if the FDA isn’t challenged. The VTA an VSR are being represented by Thompson Hine LLP and the case is titled Vapor Technology Association, et al. vs. Food & Drug Administration. The filing can be viewed here.

For all the latest news from the Vapor Technology Association, visit vaportechnology.org

So what are your thoughts on this development?

Menthol May Boost Cigarettes’ Addictive Properties: Study

https://www.medicinenet.com/script/main/art.asp?articlekey=171918

Menthol May Boost Cigarettes’ Addictive Properties: Study

HealthDay Reporter

TUESDAY, July 23 (HealthDay News) — The mint flavoring in menthol cigarettes makes it easier for young people to start smoking and harder for smokers to quit, U.S. health officials said Tuesday.

In a review of existing research, the U.S. Food and Drug Administration said that, although there’s little evidence that menthol cigarettes are more or less dangerous than non-menthol cigarettes, findings suggest that “menthol use is likely associated with increased smoking initiation by youth and young adults.”

Studies also indicate that “menthol in cigarettes is likely associated with greater addiction [because] menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking,” the review said.

Evidence suggests that menthol’s “cooling and anesthetic properties” can make cigarette smoke taste less harsh, so it’s “likely that menthol cigarettes pose a public health risk above that seen with non-menthol cigarettes,” the agency said.

The FDA said it was posting the review to gather “all comments, data, research and other information” in the next 60 days “to determine what, if any, regulatory action with respect to menthol in cigarettes is appropriate.”

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA regulatory authority over the tobacco industry.

“Menthol cigarettes raise critical public health questions,” FDA Commissioner Dr. Margaret Hamburg said in an agency news release. “The FDA is committed to a science-based approach that addresses the public health issues raised by menthol cigarettes, and public input will help us make more informed decisions about how best to tackle this important issue moving forward.”

The menthol in cigarettes has been a controversial ingredient for years.

Also Tuesday, a just-published study suggested that menthol’s interactions in the brain may play a role in its appeal to smokers.

If that’s true, menthol could contribute to nicotine addiction, said review author Nadine Kabbani, a neuroscientist and assistant professor at George Mason University in Falls Church, Va. If that’s the case, she said, “then it’s important for regulatory bodies to consider the implications of menthol on public health.”

Earlier this month, Joseph Califano Jr., a former health, education and welfare secretary in the Jimmy Carter administration, and Louis Sullivan, a health and human services secretary in the George H.W. Bush administration, called in The New York Times for menthol to be banned as a cigarette flavoring. “Menthol flavorings not only lure children to start smoking, but they also make it harder for menthol smokers to quit,” they wrote.

Menthol, a derivative from the peppermint plant, may be best known as an ingredient in medicines such as cough drops. But many smokers are familiar with its use in cigarettes. According to the American Legacy Foundation, which advocates against tobacco use and wants a ban on menthol cigarettes, its effects include “covering up the tobacco taste and reducing the throat irritation associated with smoking, particularly among first-time users.”

The foundation said young and black smokers are especially drawn to menthol cigarettes.

“Studies have failed to provide unequivocal evidence that menthol plays a significant role in smoking initiation, addiction to nicotine or cessation,” said Dr. Brad Rodu, a professor of medicine and the endowed chairman of tobacco harm reduction research at the University of Louisville.

Still, it’s clear that menthol cigarettes are popular. Is it just a matter of personal preference? Kabbani, who has studied menthol cigarettes herself, examined the potential role of another factor — menthol’s impact in the brain — in her new review.

She wrote that new research suggests that menthol affects how cells in the brain go about the business of processing nicotine, an addictive ingredient in tobacco. Specifically, she said, the presence of menthol appears to affect the ability of nicotine to bind with “receptors” in cells.

“This is a very important scientific discovery because if menthol does alter the actions of nicotine on its target receptor in the brain, then it is very likely to contribute to nicotine addiction,” she said. “Additional studies are now necessary to test this.”

What’s next? Future research in mice can offer insight into the effects of menthol in cigarettes on pleasure in the brain, Kabbani wrote in her review. And, she wrote, research into genetic variations could offer insight into why some people are more prone to addiction to menthol cigarettes.

Rodu, the University of Louisville tobacco researcher, said the evidence doesn’t support banning menthol, especially in light of two recent studies that found that the risk of lung cancer is actually lower among those who smoke menthol cigarettes compared to smokers of other cigarettes.

The review appeared online July 23 in the journal Frontiers in Pharmacology.

MedicalNews
Copyright © 2013 HealthDay. All rights reserved.

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SOURCES: Nadine Kabbani, Ph.D., neuroscientist and assistant professor, George Mason University, Fairfax, Va.; Brad Rodu, D.D.S., professor, medicine, and endowed chair, Tobacco Harm Reduction Research, University of Louisville, Kentucky; American Legacy Foundation website; July 23, 2013, evidence review, U.S. Food and Drug Administration; July 23, 2013, Frontiers in Pharmacology, online; July 2, 2013, The New York Times

What are your thoughts on this article?

Ohio (finally) gets with the hemp program

House panel claims Juul deliberately targeted children, teens

 

https://thehill.com/policy/healthcare/454839-house-investigation-finds-juul-deliberately-targeted-children

House panel claims Juul deliberately targeted children, teens

The company “deployed a sophisticated program to enter schools and convey its messaging directly to teenage children,” the House Oversight and Reform subcommittee claimed.

The remarks were laid out in a memo detailing the results of an investigation launched by the House panel last month. The investigation, unveiled during a hearing with Juul executives and summarized in the subsequent memo, is based on approximately 55,000 nonpublic documents that the company gave to the subcommittee and the Massachusetts attorney general.

In one instance, the investigation found documents showing that Juul operated a division that paid schools at least $10,000 to let Juul representatives have access to students during class, summer school and weekend programs for kids caught vaping in school.

The intent was to demonstrate that Juul can be an alternative to traditional cigarettes and to demonstrate how Juul is different from Big Tobacco companies.

In another example, the committee found that Juul paid $134,000 to set up a five-week summer camp for 80 children at a Baltimore charter school from grades 3 through 12.

Internal Juul emails showed company officials said they were aware their strategies to reach kids both in and outside of school were “eerily similar” to those used by large cigarette makers.

During the hearing, Juul Chief Administrative Officer Ashley Gould said the company discontinued the program in 2018 after learning about the similarities to the anti-smoking campaigns used by tobacco companies.

Juul co-founder James Monsees tried to distance himself from Big Tobacco, even though Juul is now partially owned by Altria, the parent company of Philip Morris International, which makes Marlboro cigarettes.

Democrats at the hearing blamed Juul for the massive spike in youth vaping, which federal officials have called a public health “epidemic.”

Monsees told lawmakers he never wanted the product to be used by minors.

“We never wanted any non-nicotine user, and certainly nobody underage, to ever use Juul products,” Monsees said, while acknowledging that the data show otherwise. “Our company has no higher priority than fighting” underage use.

Monsees emphasized that Juul is meant to be an alternative for adult smokers. He said that unlike tobacco companies, “we embrace appropriate regulation.”

Juul has been on the front lines of advocating to raise the age to purchase tobacco to 21.

“Put simply, Juul Labs isn’t Big Tobacco,” Monsees said.

Monsees noted that Juul has taken steps to make sure that young people are not using its product. The company has removed its flavored pods from retail stores, beefed up its age-verification processes for purchasing online and shut down its Facebook and Instagram accounts.The hearing, which was the second in two days, marked the first time Juul executives have been called to testify before Congress about the youth vaping epidemic.

“We must trace the origins that led to this epidemic, expose the health risks associated with vaping, and hold accountable anyone and everyone who knowingly put children in harm’s way,” Krishnamoorthi said.

Juul went into a ninth-grade classroom and called its device ‘totally safe,’ teens testify

Story from CNN Health

https://www.google.com/amp/s/amp.cnn.com/cnn/2019/07/25/health/juul-reps-in-classroom-teen-testimony/index.html

(CNN)A Juul representative repeatedly told a ninth-grade classroom that the company’s e-cigarette was “totally safe” before showing underage students the device, according to two teenagers who testified under oath to Congress on Wednesday.

The comments came at the first of two hearings organized by the House Oversight Subcommittee on Economic and Consumer Policy to “examine [Juul’s] responsibility for the youth nicotine addiction epidemic.” Company executives, including Juul’s co-founder, will testifyon Thursday.
One of the teens who testified on Wednesday, 17-year-old Caleb Mintz, said a Juul representative spoke to his class as part a “mental health [and] addiction seminar” where teachers were asked to leave the room.
The representative mentioned his connection to Juul, Mintz said, and the comments on e-cigarette safety were met with a “sigh of relief” among his classmates who were already vaping.

‘Very disturbing behavior, to say the least’

In a statement, Juul said the presentation was part of a “short-lived Education and Youth Prevention Program which was ended in September 2018 after its purpose — to educate youth on the dangers of nicotine addiction — was clearly misconstrued.”
But experts say that Juul itself contributed to epidemic-levels of vaping among teens, in part by raising nicotine levels and triggering an “arms race” of the addictive chemical.
“I believe the presenter was sending mixed messages by saying Juul was ‘totally safe’ and following up every totally safe statement with ‘but we don’t want you as customers,’ ” said Mintz. “I believe that the presenter was playing on the rebellious side of teens,” he added, “where when teens are told not to do something, they are more likely to do it.”
Mintz’s friend, 16-year-old Phillip Fuhrman, testified that he was addicted to Juul at the time of the incident, which occurred in April 2018. The two boys spoke with the Juul representative after the presentation concluded, they said, and Mintz asked what he should do if he had a friend addicted to nicotine.
Democratic Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee, asked Fuhrman, “When Caleb [Mintz] asked the presenter what he should do if he had a friend that was addicted to nicotine, was Caleb referring to you?”
“He was,” Fuhrman testified. “Since Caleb was not specific on what kind of nicotine he was addicted to, whether it was an e-cigarette or cigarettes, the speaker thought that he was talking about cigarettes, and he said that he should mention Juul to his friend.”
The product was “a safer alternative than smoking cigarettes and it would be better for the kid to use that,” the Juul representative allegedly said, according to Fuhrman. “He didn’t use it but he did take it out and show it to us,” Fuhrman added.
Krishnamoorthi sighed before calling the company’s actions “very disturbing behavior, to say the least.” He summarized the testimony, saying “a person connected to Juul pulled out a Juul device to demonstrate its safety to teenagers and then lied about the product being quote-unquote totally safe.”
The Juul representative also “mentioned that the FDA was about to come out and say that Juul was 99% safer than cigarettes, and he said that that would happen very soon, and that it was in FDA approval while the talk was going on,” according to Fuhrman.
In the year since the incident, Juul has not received FDA approval as a smoking cessation device.

‘Under the guise of education’

Phillip’s mother, Dorian Fuhrman, testified that after her son started to vape, he “changed kind of overnight. He started spending a lot of time in his room in the dark. He became moody. We had a very contentious relationship.”
She worked with Mintz’s mother, Meredith Berkman, to start a group called Parents Against Vaping E-cigarettes after the classroom incident.
Berkman testified that “Juul sent a representative to talk to our kids about its product under the guise of education.” She said an outside group had organized the presentation at her son’s school, but “the school had no idea that the outside group had brought a Juul representative into the school.”
She said she believes the outside group “was naive, definitely, but in good faith.” Berkman said she called the group and a staffer answered the phone. Berkman testified that the staffer, when asked about the presentation, said she had been researching anti-Juul education and came across the name of Juul employee listed online as the company’s youth prevention coordinator.
When reached by the staffer, the Juul employee said she had “the perfect person” and sent the Juul representative into the school, according to Berkman.

‘Human guinea pigs for the Juul experiment’

Later in Wednesday’s hearing, Rep. Rashida Tlaib, a Democrat, told Berkman that “as a mother, I can sense your frustration. … I just want you to know you have the truth on your side. And just be stronger for that.”
Democratic Rep. Ayanna Pressley later echoed those comments, telling Berkman that “we thank you for your fierceness and your advocacy.”
“If we don’t take action now,” Berkman said in the hearing, “we face an entire generation of kids addicted to nicotine, who are human guinea pigs for the Juul experiment overall.”
Also at the hearing was public health analyst Rae O’Leary, who represented the Cheyenne River Sioux Tribe. She said Juul “targeted American Indians by exploiting tribal sovereignty, which will eventually negatively impact American Indian youth.”
She recounted a visit by Juul representatives earlier this year in which they offered the tribal council a “switching program” and free starter kits as part of an implied harm reduction effort and public health study. The tribe was “unfairly exploited,” O’Leary said.
Republican Rep. Michael Cloud said at the hearing that e-cigarettes may have a role in smoking cessation, but said “we do need to be clear about one thing. No one wants kids to use tobacco, no one wants kids vaping, and no one wants vaping companies to target children with advertisements.”
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Pressley said that “many of Juul’s tactics seem to be right out of the Big Tobacco playbook,” pointing out that for decades, tobacco companies targeted black communities, especially with menthol cigarettes.
“It’s extremely disturbing,” she said. “We’ve been here before. We don’t need a bunch of studies. The only studies we need are the millions of casualties that are behind us and that we run the risk of seeing ahead of us.”

Facebook and Instagram Updates Policy to Restrict Tobacco Content

Facebook and Instagram Updates Policy to Restrict Tobacco Content

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Facebook and Instagram Updates Policy to Restrict Tobacco Content

If you’re a tobacco manufacturer, retailer or consumer, be aware–Facebook and Instagram is changing its policies to make it harder to promote and post certain content related to tobacco products going forward.

On Wednesday, CNN broke the news that Facebook was unveiling a new policy that would prohibit all private sales, trades, transfers and gifting of tobacco and alcohol products on Facebook and Instagram. Social media platforms and their promotion of tobacco-related content has been under scrutiny in recent months, mostly brought on by the growing concern over the popularity of e-cigarettes and vaping and its impact on minors and teenagers [read more here]. This year, health advocacy groups have focused on social media and its role in promoting tobacco use. Health groups have pushed for various social media platforms to update their policies to directly impact tobacco content on their sites, making it less visible and thus less appealing to potential under-aged users [read more here]. YouTube has updated its policy to demonetize tobacco-related users and content [read more here] and the FDA and FTC recently cracked down on and sent warning letters about social media influencers promoting e-cigarette and vapor products without the proper warning statements [read more here].

Now, Facebook and Instagram are also updating their policies which will have an impact on not just tobacco businesses but consumers as well. Facebook, a social media company that also owns Instagram, places new, stricter limits on tobacco related content as it makes it harder for companies to use its social media accounts to sell, trade, transfer or gift tobacco products. Another change that will tobacco businesses on social media is that going forward, brands that post content related to the sale or transfer of these products will have to restrict their pages and content to those 18 years or older. The new policy applies to any Facebook group created to sell tobacco products (and alcohol products) and according to a spokesperson’s response to a CNN report, the social network is currently reaching out to group administrators to alert them of the changes. Failure to follow the new policy will lead to group and page removals.

This new policy is an extension of a policy that’s already in place that prohibits the sale of tobacco and alcohol products in Facebook Marketplace but this is the first time Facebook has made moves to extend its ban to organic content, typically generated by private users and not just businesses. Facebook, and several other social media platforms, already prohibits any tobacco-related content from being promoted on its platform, and on Instagram, through paid advertising. Facebook has said that it will “use a combination of technology, human review and reports from our community to find and remove any content that violates these policies.”

The policy also targets social media influencers, who are often used by companies to help promote a product through some sort of payment or barter through their personal accounts. Under the new policy, influencers that are paid to promote products that contain nicotine will still be allowed to post content that relates to tobacco and vapor products–for now. These posts will not have to be age restricted but Facebook is looking at updating its influencer policy and is working with industry and regulatory bodies on potential revisions.

WOW THEY ARE AT IT AGAIN! WHAT ARE YOUR THOUGHTS?