To get FDA approval to sell a prescription drug in the United States, you have to prove that the drug is safe and effective. What is required to get FDA to clear an e-cigarette for marketing approval?
We don't talk about “approving” tobacco products, because tobacco products are inherently harmful, and are not judged by the same standard as drugs. Instead, we talk about marketing “authorizations.” But it's a very important distinction between the safety and efficacy standard for approving drugs and the one needed to issue marketing authorization for e-cigarettes. [...]
On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. In a press release, Rep. Sherrill stated, “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”
A California company planning to pursue drug approval for an inhaled nicotine replacement therapy product appears to also run a website containing false allegations that a scientist commissioned by Public Health England had financial ties to the tobacco industry.
The company, Respira Technologies, Inc., has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration (FDA) to adopt standards that would prevent most consumer vapor products from being authorized for sale.
Dozens of vaping shops are urging customers to write to their local TDs to stop a proposed ban on flavoured vapes.
The campaign comes after the Irish Heart Foundation and the Irish Cancer Society urged TDs to use an upcoming tobacco Bill to ban flavours they say are encouraging children to take up vaping.
A search by Extra.ie found Ireland’s largest vaping retailer, Hale, sells bubblegum, cola, rhubarb and custard, cherry bakewell tart, lime ice cream and chocolate mint among other flavours that campaigners say will encourage young people to start smoking.
With nine out of 10 Filipino smokers believing that the government should enact laws to encourage them to switch to less harmful alternatives to cigarettes, Senators who voted to pass the so-called vape bill believe the measure can actually save the lives of smokers and end the smoking epidemic in the country. A recent study conducted by ACORN Marketing & Research Consultants found that 94 percent of 2,000 Filipino respondents agree that the government should enact policies to encourage adult smokers to switch to less harmful alternatives to cigarettes, while also ensuring these products are not used by minors.
The National Treasury has published a discussion paper outlining a proposal on the taxation of electronic nicotine and non-nicotine delivery systems (ENDS).
This follows signals from the government in its previous two budget speeches that it plans to start taxing these two products.
“ENDS are part of new generation products that have been introduced in the market either as harm reduction or reduced-risk products compared to traditional tobacco products,” the National Treasury said.
If giving up tobacco is one of your New Year’s resolutions, know that it won't be easy but don't give up. Fifty million ex-smokers in the United States are proof that it can be done. "More than 70% of smokers want to quit smoking and 40% will make an attempt this year, but only between 4% and 7% can quit without support," Jennifer Folkenroth, national senior director of tobacco programs with the American Lung Association.
The Government is not doing enough to stem the number of teenagers vaping, despite growing evidence it can be harmful, school principals and health advocates say.
A recent survey of 19,000 high school students found more than a quarter had vaped in the last week, even though sale of vape products to under 18s was prohibited. Advocates say this shows dairies are flouting new rules around sales.
Seventy-five per cent of the students who vaped were doing it once or several times a day, most with high nicotine doses.
The U.S. Food and Drug Administration (FDA), led at the time by then-Commissioner Scott Gottlieb, published a regulatory plan in July 2017 to reduce tobacco-related disease and death.
Gottlieb proudly announced that “envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.” His plan was to encourage smokers to quit using combustible tobacco either through abstinence or by switching to reduced-risk nicotine products such as e-cigarettes or heated tobacco.
Retailers in Armenia are now banned from displaying tobacco products as some important provisions of tobacco control law come into force.
On 11 February 2020, the Parliament of Armenia voted to pass the Law on reduction and prevention of harm to health as a result of use of tobacco products and their substitutes.
These provisions prohibit the public display of any tobacco product, such as traditional cigarettes, e-cigarettes, liquid-based nicotine products (vapes), and electronic nicotine delivery devices at trade centers or in public catering establishments, says MP Arsen Torosyan, who was Minister of Health at the time the law passed.
If you're one of many Beijingers who lives life in a cloud of vape juice, then you may have heard tell of shifting tides in the electronic cigarette industry. Some of you may have even been urged by your suppliers to stock up on your favorite flavor [...]
In fact, there is good reason to believe that flavored vapes may soon be banned. Earlier this month, the government released a draft bill to the public for comment that, in its current form, would “forbid the selling of flavored e-cigarettes such as marijuana flavor and other flavors that can easily induce minors.” [...]
The new year provides changes for those wanting to alter their choices or lifestyle for the better. For many, one of those changes is ditching cigarettes for a healthier alternative. Brad Schmitt, Professor of Psychology and Director of The Anxiety and Behavioral Health Clinic, brings his input for those attempting to drop the smoldering habit. [...] “First off, it’s important to understand that quitting smoking is extremely difficult. More difficult than many drugs," Schmidt said. "Most quitting attempts fail, and most treatments don’t work very well. [...]
Sales of all cigarettes in Massachusetts declined by up to 33% after the state instituted a ban on menthol-flavored cigarettes, an analysis published Tuesday by JAMA Internal Medicine found. "We learn from Massachusetts that a menthol flavor ban effectively reduces both menthol and overall cigarette sales," study co-author Samuel Asare told UPI in an email. "Smokers who strongly preferred these flavors needed to quit or switch to non-flavored cigarettes," said Asare, principal scientist for tobacco control research for the American Cancer Society.
Smokers who want to start the new year off by kicking the habit are being offered vaping devices by Kirklees Council and the charity Yorkshire Cancer Research.
The devices are being offered as part of the Kirklees Wellness Service, a council funded initiative that supports over 18s in Kirklees to live healthier lives. They are also being supported by the Auntie Pam’s Service, which supports new parents and pregnant women to stop smoking.
On December 14, Dr. Robert Califf, President Joe Biden’s pick to be the commissioner of the Food and Drug Administration (FDA), faced questions from senators about how he would lead the agency over the next three years.
There had been some expectation that legislators would dig into Califf—a cardiologist who previously served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, [...] Anyone hoping for a clear indication of how Califf would position the FDA around tobacco harm reduction was disappointed, and observers were left to pick through limited past indications of his potential future impact in the field.
The HSE is considering a total ban on the sale of tobacco in a bid to bring an end to cigarette smoking in Ireland.
Another strategy under consideration is to reduce the number of shops licensed to sell tobacco products - which are defined as anything containing tobacco for inhaling but does not include e-cigarettes. These are both options being explored by an office of the HSE, according to an The Irish Times report on Thursday.
It reported that the group is looking into making major tobacco companies cover the State's health costs associated with nicotine addiction.
SEVERAL consumer and harm reduction advocacy groups urged President Rodrigo Duterte to sign a proposed legislation that aims to help at least 16 million Filipinos quit smoking and provide them less harmful alternatives. [...] "In passing the Vape Bill, the lives of 16 million Filipino smokers will be saved because legitimate alternative products will be allowed to be sold to smokers who want to stop smoking. The Vape Bill will also put an end to the sale of unregulated and illegal products that do not pay excise taxes to the government," the groups said in their letter to Duterte.
While the world is embracing science, innovation, and safety at the heart of policy making, India still lags far behind. India has a strange affinity to ban products and services cursorily, mostly on political or moral considerations rather than delving into available empirical evidence recognized globally. Resultantly, Indian consumers are denied the freedom to choose products and services which are available to consumers elsewhere in the world. Consumers mostly do not find representation in the decision-making process, which leads to framing and adoption of ineffective policies which may be doing more harm than good.
E-cigarette use grew from 0.6 percent in 2018 to 1.7% last year, said the study which gathered responses 25,000 people aged 18 or older. The age groups with the highest rates of use were men aged 26 to 30 AT 6.3% and women aged 21 to 25 (4.6%), revealed the HPA.
“To put this growth into perspective, use of traditional cigarettes grew only marginally over this period, from 13 percent in 2018 to 13.1 percent in 2020,” said HPA Tobacco Control Division official Lu Meng-ying. “The situation needs urgent attention, especially as new e-cigarette users are almost all young people.”
An Asia-Pacific advocacy group sent a letter to President Rodrigo Duterte, pleading him to sign the vape bill into law and help save about 100,000 Filipinos who die from smoking each year.
The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) requested the President to urgently sign the Vaporized Nicotine Products Regulation Act into law which was earlier ratified by the Senate and the House of Representatives.