Updated September 10, 2021 at 8:28 a.m. ET
The Food and Drug Administration said it has decided whether some e-cigarette products can stay on the market, but is also delaying action on products made by Juul, which accounts for 40 percent of the e-cigarette market.
FDA said Thursday it has issued market denial orders for more than 946,000 flavored vaping products because their applications “lacked sufficient evidence that they were of sufficient benefit to adult smokers to overcome the public health threat posed by the levels. alarming and well-documented use of these products by young people. “
The decisions affect 93% of applications submitted by companies for approval, but Juul, the largest vape company, was not included in Thursday’s action.
A federal judge had given the FDA one year to act on a flood of claims submitted by vape companies in a ruling stemming from a trial brought by anti-smoking groups. The agency said it had made progress but needed more time.
“We continue to work expeditiously on the remaining applications that were submitted before the September 9, 2020 deadline, many of which are in final review stages,” the FDA said.
The news comes after years in which critics have called for tighter federal controls on vaping to combat a further increase in nicotine use among underage people.
The FDA has a long history of regulating the marketing and sale of traditional tobacco products such as cigarettes. But so far, the agency hasn’t demanded the same scrutiny for vapes, allowing the market to thrive.
Decisions are pending on many vaping products
Manufacturers of electronic cigarettes, including Juul, claim their products are safer than traditional tobacco products such as cigarettes. But the FDA has evaluated about 6.5 million products made by more than 500 companies to determine if they are “suitable for the protection of public health.”
Products subject to FDA review range from refillable vape pens and liquids that fill them to disposable electronic cigarettes. Each of them requires a demand for a tobacco product before marketing, or PMTA, to file with the government and these requests are what the FDA has considered.
In the most serious cases, certain products should be withdrawn from the market.
Last month, the FDA issued its first marketing denials for some 55,000 flavored vape products from three companies, directing them to remove their products from stores. He also turned down requests from companies marketing flavors designed to appeal to children, such as Apple Crumble and Cinnamon Toast Cereal.
Regulators said the FDA’s first round of denial requests “lacked sufficient evidence” that any benefit to adult smokers outweighed “the threat to public health posed by the alarming and well-documented levels of use of these products by young people “.
FDA assesses health effects of vaping
Although vaping allows users to avoid some of the harmful carcinogens caused by consuming traditional cigarettes, studies have shown that e-cigarettes are still harmful.
Inhaling vapes can introduce harmful chemicals into the lungs, including, in some cases, vitamin E acetate. Dozens of people have died in recent years from vaping complications in the United States, and thousands more have been hospitalized. Most of these vaping injury cases were related to products containing THC and not nicotine.
Virtually all e-cigarette products contain nicotine, some at high levels, including Juul 5% pods, each of which contains as much nicotine as a whole packet of cigarettes. Nicotine also affects prenatal and adolescent brain development, making it dangerous for both teens and pregnant women to vape.
“If an electronic cigarette could actually help a smoker quit smoking, it would seek to become a drug through avenues other than the FDA. [has], and they would be shown to be safe and effective in helping smokers quit, ”said Erika Sward of the American Lung Association, which has advocated denial of all FDA claims for any product in the flavored tobacco.
“Instead, what we have seen is another generation of addicted children and a whole situation in which millions of smokers who might otherwise try to end their addiction are trying to use this product,” she declared.
Why the FDA was due to announce its decisions on Thursday
In 2019, a federal judge ordered e-cigarette manufacturers to submit applications to the FDA by 2020. Their products would be allowed to stay on the market for a year while the agency reviewed them. That one-year deadline arrived on Thursday.
The agency was not expected to respond to every product request before Thursday’s deadline. This said it will prioritize companies according to their market share, i.e. Juul, as well as British American Tobacco and Imperial Brands which respectively own the Vuse (formerly Vype) brands and blu should have been the first to face decisions.
“We respect the central role of the FDA and the in-depth, evidence-based, scientific review of our applications which is critical to advancing risk reduction and obtaining a license to operate,” said a carrier. word of Juul Labs in a press release. “We remain committed to keeping adult smokers away from combustible cigarettes while combating underage use.”
Thursday’s deadline has left many industry watchers wondering if the FDA could impose a major crackdown on virtually all vape products, or if it could take a more targeted approach, like blocking the sale of flavored products or vape products. disposable electronic cigarettes or create marketing rules similar to those for traditional cigarettes.
The restrictions on marketing and packaging design are aimed “at reducing the initiation and use of young people,” said Kathleen Hoke, professor of public health law at the University of Maryland.
Some fear vaping limits will lead teens to smoke
Some researchers fear that a major crackdown on Juul and other manufacturers will simply send teens looking for traditional cigarettes instead.
“I think it would be a disaster for public health,” said Dr Michael Siegel, a researcher at Tufts University who studies tobacco and alcohol use among young people. “Vaping does not create a culture of smoking. It actually replaces that culture.”
Youth smoking rates have declined dramatically in recent years, as vaping has exploded in popularity. But other researchers are skeptical of reversing the trend.
“Whether these people choose to choose to go back to a cigarette that tastes like a cigarette or a vape product that tastes like a cigarette, I think anyone can guess,” Hoke said. ‘University of Maryland.
Copyright 2021 NPR. To learn more, visit https://www.npr.org.
The mention sources can contact us to remove/changing this article
What Are The Main Benefits Of Comparing Car Insurance Quotes Online
LOS ANGELES, CA / ACCESSWIRE / June 24, 2020, / Compare-autoinsurance.Org has launched a new blog post that presents the main benefits of comparing multiple car insurance quotes. For more info and free online quotes, please visit https://compare-autoinsurance.Org/the-advantages-of-comparing-prices-with-car-insurance-quotes-online/ The modern society has numerous technological advantages. One important advantage is the speed at which information is sent and received. With the help of the internet, the shopping habits of many persons have drastically changed. The car insurance industry hasn't remained untouched by these changes. On the internet, drivers can compare insurance prices and find out which sellers have the best offers. View photos The advantages of comparing online car insurance quotes are the following: Online quotes can be obtained from anywhere and at any time. Unlike physical insurance agencies, websites don't have a specific schedule and they are available at any time. Drivers that have busy working schedules, can compare quotes from anywhere and at any time, even at midnight. Multiple choices. Almost all insurance providers, no matter if they are well-known brands or just local insurers, have an online presence. Online quotes will allow policyholders the chance to discover multiple insurance companies and check their prices. Drivers are no longer required to get quotes from just a few known insurance companies. Also, local and regional insurers can provide lower insurance rates for the same services. Accurate insurance estimates. Online quotes can only be accurate if the customers provide accurate and real info about their car models and driving history. Lying about past driving incidents can make the price estimates to be lower, but when dealing with an insurance company lying to them is useless. Usually, insurance companies will do research about a potential customer before granting him coverage. Online quotes can be sorted easily. Although drivers are recommended to not choose a policy just based on its price, drivers can easily sort quotes by insurance price. Using brokerage websites will allow drivers to get quotes from multiple insurers, thus making the comparison faster and easier. For additional info, money-saving tips, and free car insurance quotes, visit https://compare-autoinsurance.Org/ Compare-autoinsurance.Org is an online provider of life, home, health, and auto insurance quotes. This website is unique because it does not simply stick to one kind of insurance provider, but brings the clients the best deals from many different online insurance carriers. In this way, clients have access to offers from multiple carriers all in one place: this website. On this site, customers have access to quotes for insurance plans from various agencies, such as local or nationwide agencies, brand names insurance companies, etc. "Online quotes can easily help drivers obtain better car insurance deals. All they have to do is to complete an online form with accurate and real info, then compare prices", said Russell Rabichev, Marketing Director of Internet Marketing Company. CONTACT: Company Name: Internet Marketing CompanyPerson for contact Name: Gurgu CPhone Number: (818) 359-3898Email: [email protected]: https://compare-autoinsurance.Org/ SOURCE: Compare-autoinsurance.Org View source version on accesswire.Com:https://www.Accesswire.Com/595055/What-Are-The-Main-Benefits-Of-Comparing-Car-Insurance-Quotes-Online View photos
to request, modification Contact us at Here or [email protected]