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Lawmakers Say Puff Bar Used Pandemic to Market to Teens

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June 2, 2020

House lawmakers asked the Food and Drug Administration this week to ban Puff Bar, the fast-growing e-cigarette that has quickly replaced Juul as the vape of choice among young people.

The disposable devices come in more than 20 flavors, among them piña colada, pink lemonade, watermelon and a mysterious blend called O.M.G. Although the Trump administration banned fruit, mint and dessert flavors in refillable cartridge-based e-cigarettes like Juul earlier this year, it carved out an exemption for brands that are used once and thrown away.

Puff Bar, which launched last year, has been the key beneficiary of the loophole. It has built on its early success by adding a line of flavor pods called Puff Krush that are compatible with the Juul device, upsetting that company, whose own business has sunk since it restricted sales in the United States to tobacco and menthol varieties last fall. Based on data used only for tracked channels, which include convenience stores and some other retailers but not online sales or vape shops, Puff Bar sales have consistently been over $3 million a week since April, with volumes now over 300,000 sticks per week.

“Puff Bar is quickly becoming the new Juul,” Rep. Raja Krishnamoorthi, Democrat of Illinois, wrote in a letter to the F.D.A. on Monday. Mr. Krishnamoorthi, the chairman of the House Subcommittee on Economic and Consumer Policy, accused the e-cigarette company of exploiting the coronavirus to sell its products to schoolchildren.

To make his case, the lawmaker included a copy of a Puff Bar advertisement featuring a photograph of a bedroom, with the words: “We know that the inside-vibes have been … quite a challenge. Stay sane with Puff Bar this solo-break. We know you’ll love it. It’s the perfect escape from the back-to-back zoom calls, parental texts and WFH stress.”

Mr. Krishnamoorthi said that “this advertisement is designed to convince children home from school to vape in their rooms without their parents noticing.”

A second advertisement included in the complaint features an attractive young woman wearing a tight T-shirt and spewing big clouds of vapor. The same picture was used in a separate advertisement that suggested vaping a Puff Bar as a way to relax over spring break.

Todd Eric Gallinger, a lawyer who represented a company called Cool Clouds Distribution in a trademark application for the Puff logo, did not return a call seeking comment. The Puff Bar website does not list the names of any of the company’s executives. Indeed, since it began, the provenance of the Los Angeles-based business has been a secret. Its website states: “Who makes Puff Bar? Everyone wants to know the mastermind team behind the latest craze in the world of electronic cigarettes. Where did the Puff Bar team come from and where do they plan to go from here?”

Wherever it is, the company isn’t telling. The only details revealed indicate that the product is made in China and the flavors are developed in Malaysia.

But the company has not been under the radar. Tobacco-control advocates, including educators, organizations like Parents Against Vaping E-cigarettes and others, have been concerned about Puff Bar since it turned up in schools late last fall. Robin Koval, the chief executive and president of Truth Initiative, which seeks an end to tobacco use, said she supports a Puff Bar ban.

“It is an outrage that during a pandemic that attacks the lungs, Puff Bar is freely targeting our nation’s youth, putting their lives at even greater risk,” Ms. Koval said. “These egregious ads from Puff Bar are the latest example.”

In a recent online survey of 364 current vapers, ages 15 through 24, the Truth Initiative found that 57 percent were worried that vaping put them at risk of serious illness from the coronavirus, and slightly more than half wanted to quit.

The F.D.A. declined to discuss Puff Bar. Still, in an email, Mitchell Zeller, the director of the agency’s Center for Tobacco Products, wrote that the agency intended to take action against any electronic nicotine product “if it is targeted to youths, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent minors’ access.”

When the F.D.A. started regulating e-cigarettes, it permitted the continued sale of products that were on the market as of Aug. 8, 2016, pending agency review. Since Puff Bar was introduced after that date, the agency does generally have the authority to remove it, despite the fact that the product is disposable and even if the agency cannot prove the company is targeting youths. The exception would be if Puff Bar had already been on the market before the 2016 deadline, under a different name, or sold by another company.

In recent weeks, the agency has blocked the importing of two e-cigarette products from China: EonSmoke, which sold disposable e-cigarettes in a number of flavors before shutting down, and RELX, available in flavors including Drunk in Mexico, Naked in Iceland and Mango.

Sheila Kaplan is a prize-winning investigative reporter who covers the Food and Drug Administration, the tobacco industry and the intersection of money, medicine and politics. @bySheilaKaplan

PTAF’s statement on the FDA’s approval of Philip Morris to Market IQOS Heated Cigarette as Modified Risk Tobacco Product

In approving Philip Morris product, IQOS, the FDA has once again demonstrated that it is not the appropriate agency to regulate nicotine and tobacco products. FDA’s Center for Tobacco Products (CTP) has ignored its own scientific guidelines and the advice of public health experts around the country. In addition, Philip Morris has marketed IQOS in other countries in ways that clearly appeal to kids. The inexcusable mistakes that triggered the teen vaping epidemic and the appalling fumble of flavor regulation reverberate in this decision. FDA is constructed to work with manufacturers to bring healthful nutrition, therapeutics, and devices to the public. It is entirely unprepared to deal with an industry rooted in deception and deadly addiction. One of the first and most important public health actions of a new administration and congress should be to remove the CTP from the FDA and expeditiously replace its leadership.

Are smokers protected from COVID-19?

Over the years, public health campaigns have highlighted the dangers to health associated with smoking cigarettes and actively sought to discourage the practice.

Current data from the Office of National Statistics (ONS) from 2018 suggests that around 7.2 million adults smoke cigarettes which is a 5% decrease since 2011.1 While there several health benefits that accrue from smoking cessation, recent press reports seem to suggest that smokers are somehow protected from COVID-19.

Indeed, early reports from China on the clinical characteristics of patients admitted to hospital with COVID-19 found that the proportion of smokers was less than expected based on the estimated prevalence of smoking in the country which is 27.7%.2 For instance, in one study, the proportion of smokers was found to be considerably less than the average at 1.4%3 and while higher at 7% in another study,4 this was still lower than the average. Since these early reports from China, several other studies from different countries have also demonstrated that a lower than expected number of smokers have been hospitalized with COVID-19. In a study of those hospitalized with COVID-19 in New York, the prevalence of smokers was 5.1%5 which is less than half of the most recent estimate of the overall US smoking prevalence of 13.7%.6 Similarly, a retrospective analysis of 441 patients admitted to a hospital in northern Italy, found that less than 5% of patients were smokers, compared to an estimated age-adjusted prevalence of 14.9%.7 In a study of 340 patients in a French university hospital, it was found that 6.1% of patients were smokers compared to a population rate of 25.4%.8 Finally, in a yet to be peer-reviewed meta- analysis of available studies, Spanish researchers calculated that smokers were statistically less likely (odds ratio = 0.18, 95% CI 0.14 – 0.23) to be hospitalized for COVID-19.9

But are these observations simply a fluke or is there a plausible explanation that could account for the reduced incidence of COVID-19 among smokers?

One hypothesis proposes that it is nicotine which provides a degree of protection against the virus. This is based on an observation in 1990, that acute nicotine inhalation can increase both systolic and diastolic blood pressure and that this effect is mediated via an increase in angiotensin converting enzyme activity.10 In addition, other work has shown how the nicotine- induced rise in the level of ACE is also associated with a downregulation of the level of ACE- 211 which is now considered to be a functional receptor for COVID-19 entry into cells.12 Other work has shown that nicotine is able to activate nicotinic acetylcholine receptors on immune cells and that this effect leads to an inhibition of the release of pro-inflammatory cytokines and protects against acute inflammation in lung tissue.13 While this appears to represent a rationale for how nicotine may be protective against COVID-19, other and more recent work published as a research letter to the European Respiratory Journal,14 found that in both smokers and those with COPD, there was an increased airway expression of ACE-2. The authors concluded that this offered a possible explanation as to why those with COPD are at an increased risk of infection but the data effectively countered the potentially protective role of nicotine. In an effort to

untangle the association between smoking and COVID-19, an as yet non-peer reviewed analysis of 67 observational studies conducted in several different studies concluded that there is substantial uncertainty about the associations between smoking and COVID-19 outcomes.15 Moreover, an evidence review by Healthcare Improvement Scotland, also concluded that there is no significant association between smoking and severe disease.16 In contrast, the most recent meta-analysis of 19 peer-reviewed papers that included 11,590 patients concluded that smoking is a risk factor for the progression of COVID-19, with smokers having a higher odds of COVID- 19 progression.17

In summary and based on the available evidence, it seems unlikely that smoking offers some degree of protection from the effects of COVID-19. The ONS report1 shows that smoking rates are the lowest at 7.9% in those 65 years and over and it is possible that the lower incidence of infection among smokers, simply reflects the fact that fewer older people smoke rather than an intrinsic and protective effect among smokers. Until more definitive evidence emerges, it would seem prudent that current healthcare advice to stop smoking is continued rather than patients relying on a potentially spurious belief that somehow smoking will prevent them from becoming infected with COVID-19.

References

  1. Office for National Statistics. Adult smoking habits in the UK: 2018. www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/healthandlifeexpectancies/bulletins/ adultsmokinghabitsingreatbritain/2018 (accessed May 2020).
  2. Parascandola M, Xiao L. Tobacco and the lung cancer epidemic in China. Trans Lung Cancer Res 2019;8(S1):S21-S30.
  3. Zhang JJ et al. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy 2020; Feb 19.
  4. Huang C et al. Clinical features of patients infected with novel 2019 novel coronavirus in Wuhan, China. Lancet 2020;395:497-506.
  5. Goyal P et al. Clinical characteristics of Covid-19 in New York City. N Engl J Med 2020; Apr 17.
  6. Centers for Disease Control and Prevention. Smoking & Tobacco Use.www.cdc.gov/tobacco/data_statistics/fact_sheets/adult_data/cig_smoking/index.htm (accessed May 2020).
  7. Gaibazzi N et al. Smoking prevalence in low in symptomatic patients admitted for COVID-19. MedRxiv2020 doi.org/10.1101/2020.05.05.20092015
  8. Miyara M, Tubach F, Pourcher V et al. Low rate of daily active tobacco smoking in patients withsymptomatic COVID-19. Qeios 2020. www.qeios.com/read/WPP19W.4
  9. Gonzalez-Rubio J et al. What is happening with smokers and COVID-19? A systematic review and meta-analysis. Preprints 2020; doi: 10.20944/preprints202004.0540.v1.
  10. Calzado MCG et al. Tobacco and arterial pressure (II). The acute effects on the angiotensin-convertingenzyme. Ann Med Intern 1990;7(8):392-5.
  11. Oakes JM et al. Nicotine and the renin-angiostensin system. Am J Physiolo Regul Integ Comp Physiol2018;315(5):R895-R906.
  12. Kai H, Kai M. Interactions of coronavirus with ACE2, angiotensin II and RAS inhibitors-lessons fromavailable evidence and insights into COVID-19. Hyptertens Rev 2020; doi.org/10.1038/s41440-020-0455-8.
  13. Mabley J, Gordon S, Pacher P. Nicotine exerts and an anti-inflammatory effect in a murine model of acutelung injury. Inflammation 2011;34(4):231-7.
  14. Leung JM et al. ACE-2 expression in the small airway epithelia of smokers and COPD patients:implications for COVID-19. Eur Respir J 2020;55:20000688.
  15. Simons D et al. The association of smoking status with SARS-CoV-2 infections, hospitalisation andmortality from COVID-19: a living rapid evidence review. Qeiosi. www.qeios.com/read/UJR2AW.4.
  16. Healthcare improvement Scotland. Assessment of COVID-19 in primary care.https://eprints.gla.ac.uk/215857/1/215857.pdf (accessed May 2020).
  17. Patanavanich R, Glantz SA. Smoking is associated with COVID-19 progression: a meta-analysis. NicotineTob Res 2020;May 13.

Here’s how that rumor that smokers can’t get COVID-19 got started

Three experts told Salon that people should not jump to conclusions about recent studies into nicotine and COVID-19

 

MATTHEW ROZSA
MAY 13, 2020 11:00PM (UTC)

 

Old cigarette ads often made outrageous claims about cigarettes, including, infamously, that they could cure asthma. (They can’t.) So the rumors that smokers might be at lower risk for contracting COVID-19 seem similarly specious.

Oddly, such rumors seemed to be rooted in a grain of truth. (We’ll get to that later.) Still, Salon spoke with three experts, all of whom said the same thing: it is almost certain that smoking puts you at greater risk of dying from a coronavirus infection.

“They’re not saying that smoking prevents [coronavirus]. They’re saying that nicotine prevents it,” Dr. William Haseltine, the founder and former CEO of Human Genome Sciences, and currently the chair and president of the global health think tank Access Health International, told Salon regarding an April study in “Comptes rendus biologies” led by French neuroscientist Jean-Pierre Changeux.

“Smoking clearly exacerbates it. The nicotine, maybe an acetone,” Haseltine continued. “I can tell they have to show the data, and I don’t think they show the data here. All they do is speculate. But the danger is that many people may conflate nicotine with smoking. That’s definitely bad for you.”

He added, “There are many studies around the world, many different populations have shown that if you are a current smoker, your chance of dying from an infection is much higher than if you were not. This paper opens the possibility that nicotine may be a useful treatment; it doesn’t show it, but speculates based on some detective logic. That logic may be correct. I can’t say because I have to do the experiments to know if it is correct.”

The study that Haseltine referenced was popularized by a Vice article last month with the headline “Why Are Smokers Being Hospitalized Less Often From Coronavirus?” It noted how the Changeux study found that “of 343 hospitalized patients, only 4.4 percent were recorded as smokers; of 139 outpatients, only 5.3 percent were recorded as smokers.” Changeux notes that “more than a quarter” of the French population smokes cigarettes.

The article also featured a study led by Greek cardiologist and tobacco harm-reduction specialist Dr. Konstantinos Farsalinos, which concluded that their “preliminary analysis does not support the argument that current smoking is a risk factor for hospitalization for COVID-19 . . . . Instead, these consistent observations, which are further emphasized by the low prevalence of current smoking among COVID-19 patients in the US (1.3%), raises the hypothesis that nicotine may have beneficial effects on COVID-19.” It acknowledged that “other confounding factors need to be considered and the accuracy of the recorded smoking status needs to be determined. However, the results were remarkably consistent across all studies and were recently verified in the first case series of COVID-19 cases in the US.”

“The generalized advice to quit smoking as a measure to improve health risk remains valid, but no recommendation can currently be made concerning the effects of smoking on the risk of hospitalization for COVID-19,” the study concluded.

Dr. Russell Medford, chairman of the Center for Global Health Innovation in Atlanta, shared his own thoughts with Salon about the studies in question.

“The nicotinic acid hypothesis that is the basis for all of these studies is not unreasonable from a molecular standpoint,” Medford explained. “The data that relates to cigarette smoking to the progression of COVID-19, in the most recent study that I’m referring to, shows a significant risk of progression of disease in patients who have a current or recent or have a history of smoking. The two are not linked.”

 

MATTHEW ROZSA

Matthew Rozsa is a staff writer for Salon. He holds an MA in History from Rutgers University-Newark and is ABD in his PhD program in History at Lehigh University. His work has appeared in Mic, Quartz and MSNBC.

MORE FROM MATTHEW ROZSA

 

Vaping damages arteries and blood vessels like smoking – study

UK News | Published: 

 

The study was made up of non-smokers, cigarette smokers, e-cigarette users and people who both smoked and vaped.

 

Vaping damages the arteries and blood vessel function much like smoking traditional cigarettes, a new study has found.

Researchers studied more than 400 men and women aged between 21 and 45 made up of non-smokers, cigarette smokers, e-cigarette users and people who both smoked and vaped.

The team studied measures of blood vessel function in e-cigarette and dual users who had been using e-cigarettes for at least three months.

All e-cigarette users were former cigarette smokers.

The study, published in the Journal of the American Heart Association on Wednesday, found that former smokers who switched to e-cigarettes and dual users had arteries that were just as stiff as those in traditional smokers.

The evidence from scientific studies is growing that e-cigarettes might not be the safer alternative to smoking traditional cigarettes when it comes to heart health. Our study adds to that evidence

Dr Jessica Fetterman, Boston University School of Medicine

Author Jessica Fetterman, assistant professor of medicine at Boston University School of Medicine, said that stiffening of the arteries can contribute to heart disease.

She added: “Many people believe e-cigarettes are safer than combustible cigarettes.

“In fact, most e-cigarette users say the primary reason they use e-cigarettes is because they think e-cigarettes pose less of a health risk.

“Meanwhile, the evidence from scientific studies is growing that e-cigarettes might not be the safer alternative to smoking traditional cigarettes when it comes to heart health.

“Our study adds to that evidence.

“Stiffening of the arteries can cause damage to the small blood vessels, including capillaries, and puts additional stress on the heart, all of which can contribute to the development of heart disease.”

The study was funded through the Tobacco Centre of Regulatory Science of the American Heart Association.

The researchers also found that the cells that line the blood vessels – called endothelial cells – appeared to be equally as damaged whether people used e-cigarettes, cigarettes or both.

Dr Fetterman added: “The endothelial cells from e-cigarette users or dual users produced less of the heart-protective compound nitric oxide, compared to non-tobacco users.

“Their cells also produced more reactive oxygen species, which cause damage to the parts of cells such as DNA and proteins.

“Our study results suggest there is no evidence that the use of e-cigarettes reduces cardiovascular injury, dysfunction or harm associated with the use of combustible tobacco products.”

An independent report, commissioned by Public Health England (PHE), said that vaping among young people in England has remained steady, with estimates putting it at 6% of 11- to 15-year-olds in 2018, and 5% of 11- to 18-year-olds in 2019.

The report, published in March, also found that vaping among adults in England had also remained stable since 2014 and was between 5% and 7% in 2019.