Trump administration is readying tighter regulations on e-cigarettes, including ban on flavorings – gpgmail


The Department of Health and Human Services and the Food and Drug Administration are readying tough new requirements on e-cigarettes — including a potential ban on flavorings for vaping products.

The FDA compliance policy would mean that all non-tobacco flavored e-cigarettes would have to be cleared by the FDA before they could be sold. The regulations could effectively remove flavored e-cigarette products from the market until they go through the testing required for FDA approval.

In August 2016, e-cigarette companies were required to file premarket tobacco product applications with the FDA over a two-year period. Those companies whose products have not received FDA approval are now considered to be marketed illegally, according to the HHS statement.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said Health and Human Services Secretary Alex Azar, in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Over the past year, the e-cigarette industry has faced a steady stream of criticism related to the health effects of vaping and the ways in which companies marketed their products to minors.

A new version of the National Youth Tobacco Survey shows the continued rise in rates of youth e-cigarette use, especially through non-tobacco flavors, according to the Department of Health and Human Services. More than 25% of high school students were e-cigarette users in 2019, and the bulk of those kids cited fruit and mint flavors as their pods of choice.

Earlier in September, the Centers for Disease Control issued a warning against vaping as several deadly instances of lung-related illnesses cropped up among vape users (although no solid link between the lung condition and vaping has been identified). As we reported at the time:

The first death was reported in late August in Indiana, but other suspected cases have turned fatal in Illinois, Minnesota, California and Oregon — as reported by The Washington Post, though the CDC said three are confirmed and one is under investigation. The number of reported cases has skyrocketed, though this is likely a consequence of better information coming from state health authorities and hospitals, rather than a sudden epidemic.

The FDA is now working on a compliance policy that will be announced in the coming weeks to address the flavored e-cigarette issue.”Once finalized, this compliance policy will serve as a powerful tool that the FDA can use to combat the troubling trend of youth e-cigarette use. We must act swiftly against flavored e-cigarette products that are especially attractive to children. Moreover, if we see a migration to tobacco-flavored products by kids, we will take additional steps to address youth use of these products,” said Acting FDA Commissioner Ned Sharpless, MD, in a statement.”Earlier this week, the FDA sent a warning letter to the leading e-cigarette company, Juul Labs. With a reported 70% of the U.S. e-cigarette market and more than $14 billion in financing, Juul is the largest private company operating in the vaping space.

The government’s mobilization efforts come just one day after former New York City mayor and billionaire philanthropist Mike Bloomberg announced a $160 million effort to combat youth vaping.

Blomberg actually called out the federal government in the announcement, saying:

The federal government has the responsibility to protect children from harm, but it has failed – so the rest of us are taking action. I look forward to partnering with advocates in cities and states across the country on legislative actions that protect our kids’ health. The decline in youth smoking is one of the great health victories of this century, and we can’t allow tobacco companies to reverse that progress.


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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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CDC says stop vaping as mystery lung condition spreads – gpgmail


Vape lung is spreading and the CDC is warning people not to use vaping products while they are investigating the cause. In a media briefing, the public health agency said that some 450 people are now thought to be affected, and as many as five have died.

The CDC’s incident manager for this issue, Dana Meaney Delman, summed up the situation as follows:

CDC, states, and other partners are actively investigating, but so far, no definitive cause has been established. No specific e-cigarette device or substance has been linked to all cases, and e-cigarette include a variety of chemical and additives; consumers may not know what these products contain.

Based on the clinical and laboratory evidence to date, we believe that a chemical exposure is likely associated with these illnesses. However, and I really want to stress this, more information is needed to determine which specific products or substances are involved

Reports earlier this week suggested that Vitamin E acetate, a byproduct of the vitamin complex formed during the vaporization process, may be to blame. Delman downplayed this, saying that although they are working with the labs that made that connection, nothing has been established as yet.

One trend worth noting, however, is that very few of the cases involve only nicotine products; Most of the afflicted users reported using THC exclusively or as well as nicotine. This could be the result of many factors, however, so take it with a grain of salt.

The first death was reported in late August in Indiana, but other suspected cases have turned fatal in Illinois, Minnesota, California, and Oregon — as reported by the Washington Post, though the CDC said three are confirmed and one is under investigation. The number of reported cases has skyrocketed, though this is likely a consequence of better information coming from state health authorities and hospitals, rather than a sudden epidemic.

In the meantime the only advice they have is to avoid e-cigarette and vape device usage, especially modified devices or homebrew material. The fact is no one really knows what chemicals are formed in the conditions created by these devices and some of them could be toxic.

While the investigation is ongoing, CDC has advised that individuals consider not using e-cigarettes because as of now, this is the primary means of preventing this type of severe lung disease. And of course e-cigarette use is never safe for youth, young adults, or pregnant women.

People who do use e-cigarette products should monitor themselves for symptoms (e.g., cough, shortness of breath, chest pain, nausea, vomiting, or others) and promptly seek medical attention for any health concerns. Regardless of the ongoing investigation, people who use e-cigarette products should not buy these products off the street and should not modify e-cigarette products or add any substances that are not intended by the manufacturer.

The CDC is working with numerous state authorities and the FDA to identify the cause of this malady, and will soon publish a report in the New England Journal of Medicine detailing the first 53 cases identified. This should help doctors and other health workers tell if they are dealing with a case of vape lung or something else.

Daniel Fox from WakeMed Hospitals in North Carolina characterized the condition as they had encountered it, with a preliminary diagnosis of “lipoid pneumonia”:

What we wanted to report and what we have seen has been a cluster of five cases that will be reported later today. Each of these cases featured a pulmonary illness in a relatively young person. Ranging in age from 18-35 from what we saw here in North Carolina. The symptoms that these patients were experiencing were being short of breath, having some GI or gastrointestinal symptoms of nausea and vomiting and fevers.

One of the things that was found in common with all of these cases is that all patients were using vaped substances in e-cigarettes. They all had abnormal chest x-rays and developed a need for a lot of oxygen.

All of our patients underwent evaluation, and after the clinical evaluation we found a certain type of pneumonia that was noninfectious. It’s called lipoid pneumonia. Basically, can be, it can occur when either oils or lipid-containing substances enter the lungs.

That is consistent with the Vitamin E acetate hypothesis, as that substance is oily and could enter the lungs mixed with the vapor and then stay there. But none of the doctors or experts on the call made that connection officially.

Some patients are being misdiagnosed as having bronchitis or a viral infection. If you are or anyone you know is getting sick and uses vaping products a lot, it’s worth mentioning this if you get checked out.

Delman concluded her briefing with an assurance that everything that can be done is being done:

Please know that CDC, FDA, state, and clinical partners are working hard to understand why people are getting sick. We will continue to share what we know and what we don’t know to help health departments, clinicians, and the public respond to this outbreak.

If you are concerned about your health or the health of a loved one who is using an e-cigarette product, contact your health care provider, or your local poison control center at 1-800-222-1222.


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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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