Information on the Tobacco industry
August 27th, 2019 — Current Issues, Electronic Cigarettes, General, Snus, Snuff & Alternative Products in US Markets
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.
August 27th, 2019 — Current Issues, For sale, General, Key International Business & Market Developments
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?
August 27th, 2019 — Current Issues, Electronic Cigarettes, Regulations: FDA etc., Science, Snus, Snuff & Alternative Products in US Markets, Tobacco Harm Reduction
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?
July 30th, 2019 — American Blend, Current Issues, Flavored Products, General, Making Tobacco Products Unpleasant, Preventing Youth Consumption, Regulations: FDA etc., Science, tobacco, Tobacco Harm Reduction
https://www.medicinenet.com/script/main/art.asp?articlekey=171918
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.
Copyright © 2013 HealthDay. All rights reserved.
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?
July 30th, 2019 — Current Issues, General, Regulations: FDA etc.
https://www.crainscleveland.com/jeremy-nobile-blog/ohio-finally-gets-hemp-program
Ohio Gov. Mike DeWine announced that he will sign Senate Bill 57 into law on Tuesday, July 30. The bill decriminalizes hemp, bringing Ohio in line with federal laws, which legitimized hemp and removed its Schedule I status with the 2018 Farm Bill. It also allows the Department of Agriculture to begin drafting rules to oversee a hemp program, including licensing hemp cultivators and processors.
The bill makes a distinction between hemp-derived CBD and marijuana, which state laws classified together in rules providing for the Medical Marijuana Control Program, creating mass confusion. So the new bill also legitimizes retail sales of CBD products.
The state failing to create a hemp program has meant plenty of missed rev here and blocked farmers from an industry for which they’ve been clamoring. The plant has a wide variety of applications and can be used in products from wellness items featuring CBD, which is isolated from the plant, to construction materials and clothing.
At least one Cleveland entrepreneur has been working on building a CBD plant in Nevada because of the lack of accommodating laws here.
According to the National Conference of State Legislatures, with Ohio jumping on the hemp boat, only 13 states (plus Washington D.C.) will lack a hemp program.
The passage now is critical because it should get the state moving on creating rules for a hemp program. The hope among farmers is that they can plant hemp next spring. After the bill gained momentum earlier this year, it seemed as if the legislature was going to wait on passing the bill until this fall, which would’ve hurt plans to plant hemp in time for next year’s growing season.
“The interest is definitely out there,” said Julie Doran, founder of the Ohio Hemp Farmers Cooperative, in a recent interview with Crain’s. “Farmers are looking for something new. And they’ve been getting madder and madder by the day because they felt like this was slipping away.”
The law’s passage, though, will have many effects. Once hemp rules are in place, farmers can get licensed and begin growing and even start exploring contracts for selling future harvests. Others will benefit from the CBD market, with some manufacturers preparing for significant growth of those items as the legal cloud over CBD in Ohio is lifted.
Meanwhile, in marijuana news, the Medical Marijuana Control Program has seen its first voluntary product recall.
The state has reported that Ohio’s Standard Wellness Co., a vertically integrated marijuana company that features dispensary arm The Forest Sandusky, has voluntarily recalled its “Standard Drops” after concerns of product quality were reported by patients.
The drops are a water-soluble tetrahydrocannabinol (THC) product. One bottle contains 110 milligrams of THC and sells for about $40. Refunds are being issued to people who have bought it. There are currently no reports of anyone getting sick or any other related health concerns.
A spokesperson for the Department of Commerce said the state is still reviewing exactly how many of those products were sold and how many are affected. It said that the products will no longer be available until the state completes an “investigation” into it, which includes re-testing existing items.
What exactly went wrong is not immediately clear. The state said the product in question did pass initial inspections, which were conducted by North Coast Labs.
According to the Cincinnati Enquirer, an employee at Standard Wellness apparently reported the product was congealing and turning opaque back in June, leading to instructions to refrigerate the product after opening.
Write us: Crain’s welcomes responses from readers. Letters should be as brief as possible and may be edited. Send letters to Crain’s Cleveland Business, 700 West. St. Clair Avenue, Suite 310, Cleveland, Ohio, 44113, or by emailing ClevEdit@crain.com. Please include your complete name and city from which you are writing, and a telephone number for fact-checking purposes.
July 26th, 2019 — Current Issues, Electronic Cigarettes, Flavored Products, Preventing Youth Consumption, Regulations: FDA etc., Snus, Snuff & Alternative Products in US Markets
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.
Subramanian (D-Ill.), chairman of the Oversight and Reform Subcommittee on Economic and Consumer Policy, who launched the investigation into the company’s marketing practices last month. Massachusetts Attorney General Maura Healey (D) is also investigating.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.
July 25th, 2019 — Current Issues, Making Tobacco Products Unpleasant, Preventing Youth Consumption, Regulations: FDA etc., Science, Snus, Snuff & Alternative Products in US Markets, tobacco
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.
Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
July 24th, 2019 — Current Issues, Electronic Cigarettes, Regulations: FDA etc., tobacco
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?
