It seems people are vaping marijuana products (that's been around with their own vapers for a while, not sure how they are using them in a JUUL) and that's a leading cause of the problem. My point is that while we should do everything possible to prevent kids from using them, banning them for adults will drive people back to tobacco cigarettes which does much more damage (to health, air ducts, furniture, fire hazards, etc). Of course best is not doing any nicotine product, but in these stressful days it's not easy to do. I hope we don't see blanket bans when some players like JUUL are making efforts like not selling flavors in stores and changing up marketing.
Philip Morris has its own coming out soon and is FDA approved:
FDA clears iQOS, Philip Morris International's device that ...
https://www.cnbc.com/2019/04/30/fda-cle ... bacco.html
Of course there need to be regulations, there are lots of companies making knock off pods for JUUL... Juul Pods | Vapor4Life is a huge distributor of nic salt pods: https://www.vapor4life.com › vape-pods › juul-podsThe FDA just cleared a new tobacco product. Here’s what it is
PUBLISHED TUE, APR 30 2019 4:12 PM EDT UPDATED TUE, APR 30 2019 4:33 PM EDT
Angelica LaVito @ANGELICALAVITO
The FDA cleared iQOS, Philip Morris International’s device to heat tobacco.
Altria will sell iQOS in the U.S., with plans to introduce it in Atlanta this summer.
Philip Morris International won authorization from the Food and Drug Administration to sell iQOS, a device that heats tobacco rather than burning it, in the U.S.
Here’s what you need to know.
What are heat-not-burn tobacco products?
As the name suggests, the device heats tobacco but doesn’t burn it. Igniting tobacco causes it to undergo a chemical process that emits toxins in cigarettes.
Unlike e-cigarettes, which use nicotine-laced liquid, heat-not-burn products use real tobacco. Tobacco sticks are warmed to a temperature that’s high enough to release an aerosol but not hot enough to cause combustion. This process may significantly reduce risk compared with smoking while satisfying users’ nicotine cravings.
Philip Morris has already launched iQOS in more than 40 markets around the world. Rivals British American Tobacco and Japan Tobacco also sell heat-not-burn products internationally.
Is iQOS safe?
PMI says iQOS is not risk-free, rather it’s less risky than conventional cigarettes.
The company stresses quitting smoking is the best way to reduce risk and that iQOS is meant for adult smokers who want to continue using tobacco, not kids or non-smokers. PMI has found exclusively using iQOS significantly lowers users’ risk of harm than if they were to continue smoking cigarettes.
″...[T]hrough the FDA’s scientific evaluation of the company’s applications, peer-reviewed published literature and other sources, the agency found that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke,” the FDA said in a statement.
Still, public health groups aren’t sold. American Lung Association CEO Harold Wimmer in a statement said the organization is “deeply concerned about the health impacts of this new product.”
The FDA is still reviewing PMI’s application that if approved would allow it to market iQOS as being safer than cigarettes.
When might I see iQOS on shelves?
Altria plans to start selling iQOS in Atlanta this summer. There, Altria will open an iQOS store and numerous mobile stores. Heatsticks, Marlboro-branded tobacco sticks that are used with the iQOS device, will be available in about 500 retail stores, including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway and other retailers, Altria said.
The company will take the insights from Atlanta and scale iQOS “quickly and efficiently,” CEO Howard Willard said in a statement.
Press release from the FDA:
https://www.fda.gov/news-events/press-a ... each-youthFDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing
For Immediate Release: September 09, 2019
Today, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA’s ongoing investigation related to JUUL.
“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” said Acting FDA Commissioner Ned Sharpless, M.D. “In addition, we’re troubled about several issues related to JUUL’s outreach and marketing practices that came to light in a recent Congressional hearing. We will continue to scrutinize tobacco product marketing and take action as appropriate to ensure that the public is not misled into believing a certain product has been proven less risky or less harmful. We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren’t being marketed or sold to kids. We’ve also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we’ll take even more aggressive action.”
As stated in the warning letter, the FDA has determined that JUUL has marketed its products as modified risk tobacco products without an appropriate FDA order in effect. JUUL’s labeling, advertising, and/or other activities directed to consumers represent, or would be reasonably expected to result in consumers believing, that the products 1) present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; 2) contain a reduced level of a substance or present a reduced exposure to a substance; and/or 3) do not contain or are free of a substance or substances.
The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:
JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
JUUL was “totally safe.”
A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
“FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”
Additionally, a “Letter from the CEO” that appeared on JUUL’s website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child, states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
The FDA has requested that JUUL provide a written response within 15 working days describing its corrective actions and its plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), including its plan to prevent the same or similar violations. Failure to ensure compliance with FD&C Act may result in the FDA initiating further action, including, but not limited to, civil money penalties, seizure, and/or injunction.
Further, the agency sent an additional letter to JUUL that notes that 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.
The letter outlines several additional issues of concern, including statements and representations made as part of JUUL’s “Make the Switch” campaign and JUUL’s “Switching Program” presentation to the Cheyenne River Sioux Tribe, such as:
“‘[JUUL is] a smart, really well thought-out alternative to smoking.’ Make the switch.”
“I think [JUUL is] an amazing invention…I don’t know how we lived without that. The alternative for adult smokers.”
“Elimination of combustible cigarettes is crucial to reduce risk of harm”
“Improve the lives of the world’s one billion adult smokers”
The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes. The FDA is requesting documents and information about these practices, including any and all scientific evidence or data, such as consumer perception studies, related to whether these statements and representations explicitly or implicitly convey that JUUL products pose less risk, are less harmful, present reduced exposure, are safer than other tobacco products or that the products are smoking cessation products.
The FDA is also asking JUUL to explain why it uses nicotine salts, which was described at the Congressional hearing as masking the harshness of nicotine. The agency further asks JUUL why it uses a nicotine concentration of 5% in its products, which the agency is concerned could potentially increase their addictiveness. The FDA is requesting documents and information on, among other things, JUUL’s use of nicotine salts in its e-liquids and the concentration of nicotine in its products.
The FDA has requested that JUUL provide the requested documents and information to the agency within 30 days of the date of the letter.
The agency previously requested documents from JUUL Labs in April 2018 to examine the reportedly high rates of youth use and the youth appeal of JUUL products. The FDA has also conducted an unannounced inspection of JUUL’s corporate headquarters. Additionally, the agency has conducted inspections of several of JUUL’s contract manufacturing facilities to determine compliance with all applicable FDA laws and regulatory requirements.
As part of the agency’s Youth Tobacco Prevention Plan, the FDA continues work on all fronts to tackle the troubling epidemic of youth e-cigarette use through all available regulatory tools. This includes taking action against manufacturers and retailers who illegally market or sell these products to minors, investigating counterfeit e-cigarette products, educating youth about the dangers of e-cigarettes, and implementing the policies necessary to keep them out of the hands of America’s kids.
Separately, the FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state and local public health partners to investigate the recent respiratory illnesses associated with vaping as quickly as possible and the agency is committed to taking appropriate actions as the facts emerge.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Meanwhile in Congress:
https://www.politico.com/story/2019/09/ ... es-1722637Vaping-related disease spurs calls for tighter rules in Congress
By SARAH OWERMOHLE and RACHEL ROUBEIN 09/10/2019 08:14 PM EDT
Lawmakers are seizing on the outbreak of a vaping-related illness to push for more aggressive regulation of the young but fast-growing e-cigarette industry. Democrats and increasing numbers of Republicans want age restrictions, flavor bans, and marketing crackdowns. They want the FDA to move faster to investigate and regulate e-cigarettes, touted by the industry as a way to reduce harm from traditional cigarette smoking but which has also led to what the FDA calls an “epidemic” of youth vaping of nicotine.
Health authorities haven’t fully untangled what’s causing the respiratory disease, which has potentially affected more than 450 and killed six. Public health officials across 33 states have linked many of the cases to vaped forms of marijuana and its component CBD — both of which are in legal but in regulatory limbo. Counterfeit or black market nicotine vapes may also have a role — and legal vapes haven’t been totally ruled out, but they aren’t dominating the public health investigation into the illness.
Yet anti-tobacco lawmakers and children’s health advocates are using the moment to demand more regulation of e-cigarettes, including industry powerhouse Juul. They want to go further than Senate Majority Leader Mitch McConnell’s bill, which would raise the age for buying all tobacco to 21. And they want consistent national standards, not a state-by-state patchwork as some areas of the country plow ahead on flavor bans.
McConnell, who is pushing the bill alongside Virginia Democrat Tim Kaine, hasn’t spoken about his bill in public in months, and his office Tuesday referred to his earlier statements about doing “everything we can to keep these harmful products out of high schools and out of youth culture." The McConnell-Kaine bill is part of a broader health care cost bill, including drug prices and “surprise” medical bills, that’s passed the Senate HELP committee but does not appear likely to come to the floor quickly.
Senate Finance ranking member Ron Wyden (D-Ore.) also proposed just last week that the committee advance legislation to tax e-cigarettes at the same rate as traditional cigarettes to remove the “on-ramp” for kids, he told POLITICO. Many Republicans are still lined up with McConnell, wanting to raise the purchase age but leaving the rest to states and the FDA. Some, like Indiana Sen. Todd Young, who has sponsored legislation to raise the legal age to 21, say they’re open to tougher measures. Sen. Mitt Romney of Utah, urged the FDA to pull e-cigarette products off the market.
In the House, Rep. Donna Shalala (D-Fla.) is in talks with Republicans about her broader bill with House Energy and Commerce Chairman Frank Pallone (D-N.J.). The legislation, which she believes will get a markup soon, would raise the tobacco purchasing age to 21, ban flavors and restrict advertising. And while there are 33 co-sponsors on the bill, just one — New York’s Pete King — is a Republican. But that was before the lung disease emerged, and Shalala now says, “We’ll get Republican votes on it.” “What we need to do is keep the focus on kids. [That’s how] we win the debate nationally with the American people,” she added.
Longtime vaping critic Sen. Dick Durbin (D-Ill.) has called on FDA acting Commissioner Ned Sharpless to act on the e-cigarette industry right now — or resign. Durbin has another meeting with Sharpless this week, he told POLITICO, just a few days after the FDA warned Juul against marketing its products as much safer than tobacco. "As of last week, they'd done nothing,” Durbin said of the FDA. “As of this week, they've done something at least confronting Juul with its health claims, which should have been done long ago.”
An Energy and Commerce subcommittee will hold a hearing this Sept. 25 on the vaping-related illness and e-cigarette regulation. Pallone and Oversight and Investigations subcommittee chair Rep. Diana DeGette (D-Colo.) said in a statement that they “are greatly concerned that e-cigarette products continue to be disseminated and used while consumers lack information” on their health impact.
The FDA released a statement late Tuesday saying it’s doing everything it can to get to the bottom of the illness, and protect young people. “We’re committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share,” it said. Cigarette smoking remains a leading cause of death and disease in the United States, and no tobacco product should be considered safe to use,” it added. Meanwhile, lawmakers on both sides of the aisle are questioning whether the FDA should step up regulation of the e-cigarette industry, where no products have gone through federal review yet. A federal court order this summer moved the FDA deadline to May 2020, but in the meantime, hundreds of vapes remain on the market in regulatory limbo.
The efforts to address teen vaping has bipartisan appeal in a Congress fiercely divided over health policy. Many lawmakers say the unregulated landscape of e-cigarettes — and scarce research on vaping’s purported benefits over smoking — is fueling a public health epidemic with no end in sight. “This has to be dealt with,” said Rep. Jan Schakowsky (D-Ill.), who represents the state with the first reported vaping-related death. “I would like to see these e-cigarettes absolutely banned, but part of the problem is, we know so little about what's actually in it.”
Critics argue that these bills would not touch what increasingly appears to be a key culprit in the outbreak: marijuana vapes, including THC-based products that give people a ‘high’ and recently legalized hemp-derived CBD, which has boomed in popularity and is in a regulatory void as FDA races to draw up regulations. Marijuana is still a touchy subject on the Hill, and legislation rescheduling pot — which would allow for more research and potentially let FDA set some regulatory ground rules — is less likely to head to President Donald Trump’s desk than broader tobacco bills. Many Democratic lawmakers are also hesitant to narrow in on marijuana vapes when the broader e-cigarette industry has been in their sights for months now.
Longtime proponents of marijuana legalization point to the current outbreak as an example of why federal action is needed. "We can’t continue to keep our heads in the sand on the federal level while this is happening at the state level,” said Sen. Cory Gardner (R-Colo). “This is all an argument for why we need to legalize and regulate. We need to have standards. We need to make sure people know what's going on,” said Rep. Earl Blumenauer (D-Ore.), a longtime proponent of marijuana legalization.
Several Democrats, including DeGette and Michigan Rep. Rashida Tlaib, drew parallels between the vaping industry’s strategies and cigarette companies’ moves when they were put under the spotlight in the 1990s. Tlaib pointed to Michigan Gov. Gretchen Whitmer’s recent order to temporarily ban e-cigarette flavors as evidence the federal government should take a stronger stance. “I think there’s been new momentum because parents are now starting to see this, that their children are targeted by these companies and their flavors,” she said. She compared e-cigarette makers responses’ to criticism — that they are helping smokers switch off more dangerous tobacco products — to “gaslighting.”
Anybody doing that in a school should be fired, no question. But adults have rights too and hopefully there will be a compromise. This is going to stir a lot of passion, next congressional hearings are end of the month and JUUL is working on responses to the FDA's inquiries. Yes to regulation, yes to advertising restrictions, but bans are taking the rights of adults away and pushing back to tobacco cigarettes, which everyone I know who uses them is really happy with the results (gums and patches didn't work at all, and a common side effect of Chantix is brain seizures!). So it's a balance.