There have been 450 reported cases of lung illnesses from vaping in the US There's no denying that vapes and e-cigarettes are huge right now, with nearly three million UK users.
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What is the appeal of vaping?
Is vaping dangerous?
Is it safe to smoke e-cigs?
Does vaping increase the number of smokers?
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When did the FDA start regulating e-cigarettes?
It is important to note FDA’s initial efforts to regulate e-cigarettes began more than a decade ago. Between 2008 and 2010, FDA attempted to regulate e-cigarettes as unapproved drug/device combination products. FDA’s action was challenged and ultimately, the U.S. Court of Appeals for the D.C. Circuit ruled that while FDA could choose to regulate e-cigarettes and other products “made or derived from tobacco” under its new tobacco authorities, it could not regulate these products under FDA’s drug and device authority unless they were marketed for therapeutic purposes. 1
How many youth use e-cigarettes in 2020?
While we are seeing some progress in youth prevalence rates, the fact that there are still 3.6 million youth e-cigarettes users in 2020 is deeply concerning and underscores the critical need for FDA to address youth use of e-cigarettes and other ENDS.
How many inspections has the FDA done?
Since 2010, FDA has conducted more than 900 inspections of manufacturing establishments, some of which manufacture ENDS products (including e-liquids). Since the Deeming rule took effect on August 8, 2016, FDA has conducted more than 2,500 vape shop inspections.
How many warning letters did the FDA issue in 2021?
As of May 31, 2021, FDA had issued more than 120 warning letters to firms selling or distributing unauthorized ENDS and that did not submit premarket applications by the September 9 deadline. Collectively these companies have listed a combined total of over 1,280,000 products with FDA.
Why is the FDA investing in research?
FDA is investing in regulatory science research to learn more about how ENDS products are being used and their health impacts. Research findings help inform the Agency’s regulatory decision-making.
Why did the FDA suspend inspections?
Suspending inspections was necessary to protect the health and safety of FDA’s staff and contractors (both adults and youth) who participate in the inspections. However, FDA’s monitoring and surveillance of websites, publications, and social media continued without interruption during that time.
What is the FDA's role in tobacco?
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to oversee the manufacture, marketing, distribution, and sale of tobacco products and protect the public from the harmful effects of tobacco product use.
Which countries have voluntary reporting?
In European countries like the U.K. and France, which have voluntary reporting systems, there’s not much evidence of this problem, and experts cite tighter e-cigarette regulations in Europe than the U.S.
How many incidents of health problems with nicotine containing e-cigarettes have been reported to the regulator's voluntary?
Over the past year, according to the country’s Medicines and Healthcare products Regulatory Agency (MHRA), only 12 incidents of health problems with nicotine-containing e-cigarettes have been reported to the regulator’s voluntary system.
Is there a ban on flavored e-cigarettes?
It’s not clear anyone would know if it was. U.S. President Donald Trump on Wednesday moved to finalize a ban on flavored e-cigarettes in light of the country’s outbreak of a vaping-related illness that’s made 450 people sick and resulted in at least six deaths.
Who is the head of tobacco control at Public Health England?
Martin Dockrell , head of tobacco control at Public Health England, was quick to offer reassurances about the safety of legal vapes. “What little we know of recent reports from the U.S. is that the devices used appear to be linked to ‘home brews’ of illicit drugs and not legitimate vaping products,” he said.
Do manufacturers have to notify consumers of e-liquids?
Manufacturers have to notify in advance the contents of e-liquids — meaning officials at least know which legal products contain oils that could collect in the lungs, making them easier to recall if necessary. Yet when it comes to home brews, “that of course is difficult to regulate,” said Vardavas.
Is banning a product a problem?
History has taught us that simply banning a product may not fully or properly address a ‘complex’ problem, and often times, comprehensive and carefully considered plans are needed to resolve such problems.
Is vaping safe?
The existing data clearly show that vaping is not risk free. This together with the growing concern that vaping may lead to nicotine addiction and smoking, especially among youth, underscores the importance of investigating the health risks associated with vaping.
Is vaping a health risk?
The health-risk profile of vaping should be determined both relative to smoking (to inform smokers about the relative risks), and in absolute terms (to inform never-smokers of potential risks posed by vaping).
What is the appeal of vaping?
The appeal of vaping advertising is also stronger and more focused on younger markets. Specifically, “vaping..attracts young people who have never even smoked cigarettes, encouraged by aggressive marketing and the variety of alcopops type flavors available.”.
Is vaping dangerous?
With this much public and government pressure to enforce health and safety, it would be wise to consider the potential dangers of vaping. Even despite the lack of clarity on e-cigarettes, data does show that the people of the United States and the larger global community should take the threat of this epidemic seriously. We must be aware of the potential injury it poses to ourselves and our country’s way of living.
Is it safe to smoke e-cigs?
Despite the significant increase in the amount of recent lung injury cases, the positive and empowering intentions of e-cigarettes should not be overlooked. E-cigarettes were originally introduced to the market about 15 years ago as a safe alternative to smoking, delivering nicotine through a seemingly less harmful heated liquid. Multiple professional studies, such as a British study, published as recently as February 2019 in the New England Journal of Medicine suggests that “e-cigarettes are more efficient than patches, gum or other products in helping people to stop smoking cigarettes.” Even though it’s currently difficult to quantify their health ramifications, these studies show that there is evidence that e-cigarettes are indeed less toxic than traditional cigarettes.
Does vaping increase the number of smokers?
Of further concern is that the growing number of vape users has been shown to also correlate to an increase in the number of first-time and daily smokers of real cigarettes, particularly in younger crowds, as noted before. This is quite opposite of the initially intended effect. William Shadel, a scientist at the RAND Corporation in Pittsburgh, Penn. says “vaping could make you more dependent on nicotine, and cause you to later want to take up cigarette smoking.” The role of vaping as an onramp to smoking real cigarettes cannot be cautioned against enough.
Introduction
- Good morning, Chairman Krishnamoorthi, Ranking Member Cloud, and Members of the Subcommittee. Thank you for the opportunity to be here today to discuss the Food and Drug Administration’s (FDA or the Agency) efforts to address youth use of electronic nicotine delivery systems, or ENDS, which include e-cigarettes. I am Janet Woodcock, Acting FDA Comm...
Background
- Let me start with some information on our tobacco regulatory authorities and our recent regulatory efforts regarding ENDS and e-cigarettes. Tobacco use is the single largest preventable cause of disease and death in the United States. Each year, more than 480,000 people in the United States die prematurely from diseases caused by cigarette smoking and exposure to tobacco sm…
Regulatory Requirements For Ends Products
- When the Deeming rule took effect in August 2016, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, cigarette tobacco, and roll-your-own tobacco since 2009, as well as several new requirements specific to deemed products, became applicable to manufacturers of e-cigarettes and other ENDS products. These …
Data on Youth Use of E-Cigarettes
- FDA collaborates with the Centers for Disease Control and Prevention (CDC) to administer the National Youth Tobacco Survey (NYTS) to middle and high school students each year. The survey provides important data that allow us to understand current youth tobacco product use in a larger historical context. NYTS data from 2018 and 2019 showed disturbing increases in the use …
FDA’s Actions to Address Youth Use of Ends Products
- Protecting our nation’s youth from the dangers of tobacco products is among the Agency’s most important responsibilities, and we are taking aggressive steps to make sure tobacco products are not being marketed or sold to kids. Our work to protect youth from tobacco products is comprehensive and includes compliance and enforcement, premarket review, public education, …
Conclusion
- Thank you again for the opportunity to testify about FDA’s comprehensive efforts to regulate ENDS, including our actions to prevent youth access to, and use of, these products. The efforts described here are just a part of the important work FDA and the Administration are undertaking to protect children and youth from the harms of tobacco products. We still have much to accomp…