Posts with «government» label

Juul asks appeals court to block the US ban on its vaping products

Juul has asked a federal appeals court to temporarily block a Food and Drug Administration ban on sales of its vaping products in the US. The agency issued the order on Thursday, citing a lack of sufficient evidence provided by the company to show its devices are safe. The FDA acknowledged that it wasn't aware of "an immediate hazard" linked to Juul's vape pen or pods.

“FDA’s decision is arbitrary and capricious and lacks substantial evidence,” Juul said in a filing with the US Court of Appeals for the DC Circuit, according to The Wall Street Journal. The company called the ban extraordinary and unlawful. It requested an administrative stay until it can file a motion for an emergency review of the FDA’s order.

Juul claimed that, without the stay, it would suffer significant and irreparable harm. The company makes the lion's share of its revenue in the US. If the stay is granted, Juul and retailers will be able to keep selling its products there. The company argued in the filing that the order marked a move away from the FDA's typical practices, which allow for a transition period. 

"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," Juul's chief regulatory officer Joe Murillo told Engadget after the FDA issued the order. "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."

In 2020, the FDA required makers of e-cigarettes to submit their products for review. It looked at the possible benefits of vaping as an alternative to cigarettes for adult smokers. It was weighing those up against concerns about the popularity of vaping among young people. The agency has authorized 23 "electronic nicotine delivery systems," including products from NJOY and Vuse parent Reynolds American.

The FDA slammed Juul in 2019 for telling students that its products are "totally safe." The Federal Trade Commission and state attorney generals have investigated Juul over claims it marketed its vape pens to underage users. In the last year, the company has agreed to pay at least $87 million to settle lawsuits in several states — including North Carolina, Washington state and Arizona — which alleged that it targeted young people with its marketing. It has faced similar suits in other states.

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 FDA rejected Juul's application to keep selling tobacco- and menthol-flavored pods as well as its vape pen.

The decision doesn't apply to Juul pens and pods that are already in the possession of the company's customers. However, it'll be difficult, if not impossible, to find those products 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 vs. 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.”

Juul can appeal the decision or challenge it in court. Engadget has contacted the company for comment. 

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 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 had used e-cigarettes said they used flavored varieties. However, vaping has become less popular among teens overall. 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. 

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.

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.

Senators introduce bipartisan bill to regulate crypto assets

Politicians are quickly seizing on US government efforts to study and regulate crypto. Reutersreports Senators Kirsten Gillibrand (D-NY) and Cynthia Lummis (R-WY) have introduced a bill, the Responsible Financial Innovation Act, that would forge a "complete regulatory framework" for cryptocurrency and other digital assets. The measure is meant to protect consumers and fold crypto into existing laws without restricting technical progress.

RIFA would set clearer definitions, such as establishing which assets are commodities or securities. It would also create requirements for stablecoins (cryptocurrencies pegged to another asset, such as conventional money) to minimize risks and enable speeder payments. The Commodity Futures Trading Commission (CFTC) would have the power to regulate digital spot markets, while providers would be subject to disclosure requirements. There would be a "workable" tax structure that would let you buy products with cryptocurrency without having to account for and report income.

The act would also prompt the government to further research digital assets. It would create a "sandbox" where federal and state regulators could work together on experimental launches of financial technology. The CFTC and Securities Exchange Commission would have to develop both security guidance and a self-regulatory organization. Other government agencies and offices would be tasked with studying energy consumption, the benefits (and dangers) of investing retirement savings in crypto and the security concerns around China's official digital currency.

The bipartisan nature of the bill could increase its chances of surviving a Senate vote. Reuters also points out that the CFTC is considered friendlier to crypto assets than the SEC, That's potentially useful for winning over regulation-averse politicians worried the SEC might limit crypto's growth.

A House equivalent has yet to exist, and it's unlikely that RIFA would reach President Biden's desk before the current session of Congress ends. It's likewise unclear just which digital assets are covered, and whether or not NFTs might be affected. We've asked for more details. The bill nonetheless represents the strongest effort yet to regulate crypto, and might just serve as a blueprint for future efforts to control and legitimize the blockchain in the US.

New York State passes a right-to-repair bill

New York has just passed the digital fair repair act (Assembly Bill A7006B), making it one of just a few states in the US to do so. The bill, which was introduced in April 2021, passed the senate on June 1st and passed assembly today. It's now headed to the governor for signing (or veto), and will take effect a year after it becomes law.

The act, titled "Digital Fair Repair Act," will require OEMs (original equipment manufacturers) to "make diagnostic and repair information for digital electronic parts and equipment available to independent repair providers and consumers if such parts and repair information are also available to OEM authorized repair providers." That means companies can no longer dictate where you can bring your devices to get them repaired by limiting the access to components or diagnostic information.

If a part is no longer available to the OEM, it will not need to make the same part available to everyone. For things that require security-related locks or authorizations, the OEM has to, "on fair and reasonable terms," supply the tools or documentation needed to access or reset such devices "through appropriate secure release systems."

The amended version of the bill also states that the proposed requirements will apply to "products with a value over ten dollars" and that OEMs or authorized repair providers don't have to make available any parts, tools or documentation if the intended use is for modification of the products. It also excludes public safety communications equipment and "home appliances with digital electronics embedded within them" from the act. Given the way companies have been trending towards making smart fridges, washing machines and more, this could potentially be an enormous loophole or at the very least exclude a large number of products.

Massachusetts previously passed its own Digital Right to Repair Act, which covered parts or machines containing microprocessors. The state has recently expanded that to include connected automobiles. Meanwhile, the California state Senate introduced its own right to repair bill in February, which appears to have bipartisan support. 

New York passes a bill to limit bitcoin mining

New York lawmakers have passed a bill that would temporarily ban new bitcoin mining operations. Early on Friday, state senators voted 36-27 to pass the legislation. It's now bound for the desk of Governor Kathy Hochul, who will sign it into law or veto the bill. The law would come into effect immediately after it's signed.

An attempt to enact similar legislation last year hit a wall when the New York State Senate passed it but Assembly members did not. The latest bill passed the Assembly in April.

The legislation seeks to establish a two-year moratorium on licenses for cryptocurrency mining operations that use power-hungry proof-of-work authentication methods for validating blockchain transactions. Right now, bitcoin and ethereum (the two largest cryptocurrencies) fall under that category, though the latter is shifting to a different setup.

The moratorium only covers mining operations that run on carbon-based power sources. Any that harness entirely renewable energy sources or an alternative to proof of work that requires less power won't be affected. Existing operations and those already going through a permit renewal process won't be impacted either.

While the moratorium is in place, New York will carry out a study into the environmental impact of proof-of-work authentication methods, per the bill. As CNBC notes, New York has ambitious climate goals that require the state's greenhouse gas emissions to be reduced by 85 percent by 2050 under the Climate Leadership and Community Protection Act.

New York became a hotbed for crypto mining operations in part due to its plentiful hydroelectricity, low electricity prices and cooler climate than other areas of the US (which means less energy is needed to cool mining hardware). 

Some mining companies have threatened to leave New York due to regulatory uncertainty and set up shop in more crypto-friendly states. Even so, crypto proponents have suggested that, given New York's status as a legislative leader, other states could follow suit with similar regulations. 

Meanwhile, the Biden administration is working on a policy regarding bitcoin mining. The White House is looking into the impact of such technology on greenhouse gas emissions.

Texas's bizarre social media law suspended by Supreme Court

Texas's HB20 was put on hold Tuesday by the Supreme Court, five-to-four. As is typical for emergency for emergency requests, the majority did not define its reasoning; Justice Alito wrote a six page dissent joined by fellow conservatives Gorsuch and Thomas, while Kagan, a moderate, wrote she would "would deny the application to vacate stay" without signing onto the dissent.

The bill — which has been tied up in court since it was passed by the state's Congress and signed into law by Governor Greg Abbott last September — targets "censorship" by online platforms, insofar as conservatives have in recent years been wont to conflate any form of content moderation with censorship. It reframes large social platforms as "common carriers" similar to telecom companies, but uses that logic to restrict the ability of platforms to limit the spread of, ban or demonetize content based on “the viewpoint of the user," whether or not that view is expressed on the platform. 

Unsurprisingly, the content, users and viewpoints the law's supporters believe are being unfairly targeted hew rightward: as the Texas Tribunereported last year, Governor Abbott said he believed social platforms were working to "silence conservative ideas [and] religious beliefs." The aggrievement of the interested parties and their desired outcomes weren't lost on Judge Robert Pitman of West Texas's District Court, who wrote that "the record in this case confirms that the Legislature intended to target large social media platforms perceived as being biased against conservative views." 

An emergency application to the Supreme Court to suspend HB20 was filed earlier this month by two tech industry groups — NetChoice and the Computer & Communications Industry Association (CCIA) — after a Fifth Circuit court had lifted an injunction on the law, doing so in a startling 2-1 decision for which no explanation was provided. Netchoice's members include Airbnb, TikTok, Amazon and Lyft among many other; Apple, Google, eBay, Meta and others count themselves among those associated with CCIA. Counsel for NetChoice at the time told Protocol that the Texas law was "unconstitutional" and would compel "online platforms to host and promote foreign propaganda, pornography, pro-Nazi speech, and spam.”

These same concerns were given new urgency after the Buffalo, New York shooting, in which a gunman with white supremacist beliefs killed 10 people and injured three others in a majority-black neighborhood while live-streaming the carnage. Social media companies worked to remove copies of the footage from their services. Even as they did so, the question remained unsettled as to whether those removals would result in Texas dragging these platforms into court. Confusion as to the law's application was not limited to interested observers, either: in a Twitter exchange with Techdirt's Mike Masnick, the sponsor of the bill seemed unsure on how such situations would play out. 

A related law in Florida, using a similar common carrier approach, had most of its major provisions deemed unconstitutional by the 11th Circuit Court of Appeals earlier this month. The question of constitutionality for HB20 will continue to move forward in the Fifth Circuit Court. 

Canada joins Five Eyes allies in banning Huawei and ZTE 5G telecom gear

Canada is banning 4G and 5G telecom equipment from Chinese companies Huawei and ZTE, joining its "Five Eyes" allies in doing so. The decision follows a three-year review that was delayed by political tensions with China after Huawei’s CFO Meng Wanzhou was arrested in Canada on a US warrant. 

"Our government will always protect the safety and security of Canadians and will take any actions necessary to safeguard our critical telecommunications infrastructure," said Canada's innovation minister, François-Philippe Champagne, in a press release.

"We’re disappointed but not surprised. We’re surprised it took the government so long to make a decision," Huawei spokesperson Alykhan Velshi told The Guardian. "We see this as a political decision, one born of political pressure primarily from the United States."

Two of Canada's largest wireless providers, Bell and Telus, switched to Ericsson and Nokia equipment in 2020 to build their next-generation 5G networks. However, both operators have some Huawei 5G equipment in place as part of so-called non-standalone 5G networks integrated with previous 4G networks. Those 4G networks were also built using Huawei equipment. Huawei has sold over $700 million in equipment to Canadian operators since 2018, mostly to Bell and Telus. 

Both operators reportedly approached the federal government in the past to ask about compensation from taxpayers for potential removal Huawei or ZTE gear. The CEO of a smaller Northern operator, Iristel, previously said that a requirement to remove existing equipment would be "catastrophic." 

However, Champagne said that operators will be required to remove any Huawei or ZTE gear at their own expense. Existing 5G equipment must be removed or terminated by June 28, 2024 and any 4G equipment by December 31, 2027, according to the policy statement.

Canada's Five Eyes intelligence allies, the US, Britain, Australia and New Zealand, have already banned Huawei and ZTE wireless equipment. Canada has faced growing pressure to do the same, over fears it could compromise the security of all five nations, given that China's laws require state companies to cooperate with intelligence services. 

Senate bill would break up Google’s ad business

A bill that would break up Google's advertising business if it becomes law has been introduced in the Senate. The Competition and Transparency in Digital Advertising Act, which has support on both sides of the aisle, would prevent companies that process more than $20 billion in annual digital ad transactions "from participating in more than one part of the digital advertising ecosystem," as The Wall Street Journal reports.

Google easily falls under that distinction. It generated $54.7 billion in ad revenue last quarter alone. While other companies meet the dollar-figure threshold of the proposed rules, Google has a hand in many aspects of the advertising process. It runs an exchange where ad networks bid on inventory. It also offers tools to help companies buy and sell ads.

A House of Representatives version of the legislation is also expected to be introduced imminently. If the bill becomes law, Google would have to exit some of those businesses. It would have a year to comply with the rules after the law is enacted. Meta may also be impacted by the legislation.

“When you have Google simultaneously serving as a seller and a buyer and running an exchange, that gives them an unfair, undue advantage in the marketplace, one that doesn’t necessarily reflect the value they are providing,” Sen. Mike Lee (R-Utah) told the Journal. “When a company can wear all these hats simultaneously, it can engage in conduct that harms everyone.”

Lee is the ranking member of the Subcommittee on Competition Policy, Antitrust, and Consumer Rights. Committee chair Sen. Amy Klobuchar (D-Minnesota) is a cosponsor of the bill, as are Sens.Ted Cruz (R-Texas) and Richard Blumenthal (D- Connecticut).

“Advertising tools from Google and many competitors help American websites and apps fund their content, help businesses grow and help protect users from privacy risks and misleading ads," a Google spokesperson told Engadget. "Breaking those tools would hurt publishers and advertisers, lower ad quality and create new privacy risks. And, at a time of heightened inflation, it would handicap small businesses looking for easy and effective ways to grow online. The real issue is low-quality data brokers who threaten Americans’ privacy and flood them with spammy ads. In short, this is the wrong bill, at the wrong time, aimed at the wrong target.”

Other provisions of the bill include rules for companies that process at least $5 billion of ad transactions per year. They'd be required to provide transparent pricing and act in their customers' best interest. Customers would have the option to sue over breaches of those.

There are other pieces of antitrust legislation in the works that target tech giants. Klobuchar's American Innovation and Choice Online Act, which advanced out of committee in January, would ban companies from giving preference to their own products over those from rivals on their own platforms. For instance, Apple wouldn't be able to position its own apps above competing ones in App Store search results.