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FDA bans sales of Juul vape products in the US
The Food and Drug Administration has banned e-cigarette maker Juul from selling and distributing its products in the US. It ordered the company to remove its wares from the market or face enforcement actions.
Reports earlier this week suggested that an FDA ban on Juul products was imminent. After a two-year review, the agency rejected Juul’s application to keep selling tobacco- and menthol-flavored pods, as well as its vape pen. Juul told Engadget that it intends to seek a stay on the decision. It is exploring all other options, including an appeal.
The ban doesn’t apply to Juul products that are already in the possession of the company’s customers. However, it’ll be difficult, if not impossible, to find its pens and pods in the near future.
In 2020, the FDA began a comprehensive review of all e-cigarette products sold in the US. It weighed up the potential benefits of vaping compared with cigarettes for adult smokers against the popularity of e-cigarettes among underage users. The agency has permitted other manufacturers to continue selling vape products, including NJOY and Vuse parent Reynolds American. To date, the agency has authorized 23 “electronic nicotine delivery systems” (to give vape pens their formal name).
In Juul’s case, though, the FDA said the company’s application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
The agency went on to say that it doesn’t have clinical information that suggests there is “an immediate hazard” linked to Juul’s pen or pods. “However, the [marketing denial orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products,” the FDA said. It noted that it’s not possible to grasp the possible harms of using other pods in a Juul vape pen or the company’s pods in third-party devices.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
The company became the leader in the US e-cigarette market in 2018. However, sales have dropped following a string of controversies. Juul slipped to second place behind Vuse in terms of US market share. The vast majority of the company’s revenue comes from the US, The Wall Street Journal noted this week.
Juul had been accused by federal agencies, state attorneys general and other officials of marketing its products to teens. The company agreed to pay eight-figure settlements related to lawsuits in North Carolina and Washington state, and it has faced suits in several other states.
The company halted sales of mint- and fruit-flavored vape pods in 2019 before the FDA banned most flavored variants in early 2020. According to the Centers for Disease Control and Prevention, nearly 85 percent of young people who tried e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall, according to data from 2021. In 2019, Juul revealed a new, connected version of its vape pen that can verify a user’s identity in an attempt to prevent underage use.
Update 6/23 12:50PM ET: Juul Labs’ chief regulatory officer Joe Murillo provided Engadget with the following statement:
We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.
In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being appropriate for the protection of the public health.
We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.
Juul’s e-cigarettes could be banned from sale in the US
The Food and Drug Administration could be set to bring the hammer down on vape pen maker Juul. The agency is preparing to order it to stop selling e-cigarettes in the US and the decision could come as soon as today, according to The Wall Street Journal.
Along with other e-cigarette makers, Juul was required to submit its products to the FDA for review in 2020. The agency has been looking into the possible benefits of vaping as an alternative to cigarettes, but the popularity of the products among young people has caused concern. The FDA has already cleared products from Juul’s rivals, Reynolds American (which is behind the Vuse brand) and NJOY.
The FDA has been scrutinizing Juul for several years. It seized marketing materials from the company for review in 2018 over concerns about underage vaping. In 2019, the FDA criticized the company for telling students its products were “totally safe” after it accused Juul of undermining efforts to clamp down on teen vaping.
The agency limited sales of flavored e-cigarettes in 2018 and banned several variants outright in early 2020 in an attempt to reduce the appeal of vaping among teens. Juul pre-empted that ban (perhaps in an attempt to get in the good graces of regulators and the public) when it stopped sales of mint- and fruit-flavored vape pods in 2019.
Several states have sued Juul, alleging that it targeted minors with marketing. It paid $40 million to settle a North Carolina suit in 2021, and a $22.5 million settlement in Washington state earlier this year. The Federal Trade Commission has also reportedly looked into Juul’s marketing tactics.
Juul will have the option of appealing a federal ban on sales of its products, if the FDA does take that step, or challenging it in court. Some observers have suggested that the company may ask for a stay while the agency reviews a version of the vape pen that has age verification tech. Engadget has contacted Juul for comment.
A blanket ban would likely prove devastating for Juul’s business. The WSJ notes that the vast majority of the company’s revenue comes from the US. Juul became the top e-cigarette brand in the country a few years ago, but sales have dropped and it’s now said to be in second place in the US market behind Vuse.
Meanwhile, the FDA is aiming to remove nearly all nicotine from cigarettes to make them less addictive. That could lead to millions of smokers switching to vaping or giving up smoking entirely.
雇調金特例「出口」模索 コロナ下、累計支給額5.8兆円―財源枯渇、転職の動き妨げも:時事ドットコム
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黒田日銀、日本への利上げ圧力が強まるなか怒りの現状維持 : 市況かぶ全力2階建
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Automakers want Congress to drop the EV tax credit cap
The $7,500 federal EV tax credit has been used for several years to entice consumers to make greener car purchasing decisions, but it has expired for some automakers — and they feel the government needs to remove limits on that incentive. Reuters has learned the CEOs of Ford, GM, Stellantis and Toyota sent a letter to congressional leadership asking them to eliminate the sales-based tax credit cap. The move would help counter economic factors and supply shortages that have raised the costs of producing EVs, according to the companies.
The credit currently applies to the first 200,000 cars sold by any given brand. GM and Tesla have already reached the 200,000-unit mark, while both Ford and Toyota could hit the cap this year. This doesn’t affect state-level discounts. The companies hope Congress will replace the unit-based cap with a sunset date that would end the credit once the EV marketplace is “more mature.”
It’s not certain that enough politicians will warm up to the idea. Senator Joe Manchin, for instance, recently questioned the need for extended credits when EV demand regularly outstrips supply. And when the current Senate frequently shoots down bills without clear bipartisan support, any attempt to legislate the credit could fall apart.
The companies have strong motivations to act now, though. Republicans may regain control of one or both sides of Congress during this fall’s midterm elections, and car industry execs are concerned the shift in power could kill chances of extending tax credits. Former President Trump tried to axe the credit in his proposed 2020 budget, and had the support of Republicans — the chances aren’t high that the GOP will back an extension.
The customer tax breaks might not be as necessary as they once were, mind you. GM plans to sell a Chevy Equinox EV around $30,000, while Tesla has long-term plans for a $25,000 car. Although these models are years away and won’t compete with the lowest-priced conventional cars, they hint at a future where EVs are genuinely affordable without government subsidies.
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