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FDA authorizes first e-cigarette, cites benefit for smokers

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FDA authorizes first e-cigarette, cites benefit for smokers

For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying the vaping device from R.J. Reynolds can help smokers cut back on conventional cigarettes.

E-cigarettes have been sold in the U.S. for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market.

The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending.

Tuesday’s decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their exposure to the harmful chemicals in traditional cigarettes.

While the products can now be legally sold in the U.S., the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Launched in 2013, Vuse Solo is a rechargeable metallic device that’s shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products. The agency is still reviewing the company’s request to sell a menthol-flavored nicotine formula.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s tobacco center, in a statement.

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption.”

E-cigarettes first appeared in the U.S. around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into a vapor that’s inhaled.

But there has been little rigorous study of whether e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.

In recent years, the vaping market grew to include hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs, which is partially owned by Altria, and Vuse.

Vuse is the No. 2 vaping brand in the U.S. behind Juul, accounting for about a third of all retail sales. Its parent company R.J. Reynolds sells Newport, Camel and other leading cigarettes.

A company spokesperson said in a statement that the FDA decision confirms “that Vuse Solo products are appropriate for the protection of the public health, underscoring years of scientific study and research.”

The company said it is still awaiting an FDA decision on its more popular vaping device, Vuse Alto.

To stay on the market, companies must show that their products benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

Kenneth Warner, a tobacco expert at the University of Michigan’s school of public health, said the news was a positive step for reducing the harms of smoking. But he lamented that only a vaping device backed by a Big Tobacco company was able to win the FDA’s endorsement.

“The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel — in terms of scientists, lawyers, researchers — are able to file successfully,” said Warner.

He said smaller companies and vape shops should have a separate path to get their products authorized.

The FDA declared underage vaping an “epidemic” in 2018 and has taken a series of measures aimed at the small cartridge-based devices that first sparked the problem, including limiting their flavors to tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.

Survey data collected earlier this year showed Vuse was the second-most popular e-cigarette brand among high schoolers who vape, preferred by 10%. Juul was the fourth-most popular e-cigarette, cited by less than 6%.

FDA said it was aware of the data on Vuse’s popularity but decided to authorize its tobacco flavor “because these products are less appealing to youth and authorizing these products may be beneficial” for adult smokers.

The most popular brand among teens was a disposable e-cigarette called Puff Bar that comes in flavors like pink lemonade, strawberry and mango. Disposable e-cigarettes are not subject to the tight flavor restrictions of products like Juul.

Overall, the survey showed a drop of nearly 40% in the teen vaping rate as many kids were forced to learn from home during the pandemic. Still, federal officials cautioned about interpreting the results because they were collected online for the first time, instead of in classrooms.


WASHINGTON (AP)

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Amazon-sponsored artwork that ‘learns’ debuts at Smithsonian

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Amazon-sponsored artwork that 'learns' debuts at Smithsonian

The artificial intelligence at the heart of a new art exhibit, “me + you,” does not judge you necessarily, but it does analyze and interpret what you have to say.

Sponsored by Amazon Web Services, the sculpture by artist Suchi Reddy listens to what you have to say about the future and renders your sentiment in a display of colored lights and patterns.

The artwork is a centerpiece of a new exhibit at the Smithsonian Arts and Industries Building, which is opening to the public for the first time in 20 years. The exhibition, called Futures, opens Nov. 20.

Viewers are invited to interact with the sculpture, which listens for the words “My future is …” at several circular listening posts integrated into the sculpture.

The words and the sentiments behind them are then reinterpreted as a pattern of colored lights. On a very basic level, positive emotions tend to translate into soothing blends of blue, green and purple. Words that suggest anger might prompt a cascade of colors on the opposite spectrum of the color wheel. If you use a swear word, the lights will turn red.

No matter the sentiment, Reddy said, “I want to show all human emotion as beautiful.”

And the interpretations will evolve and become more nuanced over time as the artificial intelligence progresses. Swami Sivasubramanian, vice president of Amazon Machine Learning at Amazon Web Services, said the artwork incorporates sentiment analysis that not only decodes the meaning of words but a speaker’s sentiment behind the words.

Sivasubramanian said Amazon contributed 1,200 hours of programming to serve as the backbone of the artwork’s machine learning.

“Machine learning is one of our most transformative technologies,” he said. “I’m excited for people to engage with machine learning in an artistic setting.”

The artwork utilizes various aspects of machine learning, including basic speech-to-text technology.

A companion website lets people enter their thoughts over the internet and receive a visual interpretation of their sentiment that is also added to the archive.

In an era of deep skepticism over the data collected by Big Tech, Reddy and her team were careful to avoid data collection of any kind other than people’s thoughts about the future. No video is recorded and there is nothing that tracks people’s expressions back to them, Reddy said.

Other highlights in the exhibition include costumes from the Marvel Studios film “Eternals,” part of an interactive exhibit that shows how movies help us imagine our future, and objects including an experimental Alexander Graham Bell telephone and the first full-scale Buckminster Fuller geodesic dome built in North America.

“In a world that feels perpetually tumultuous, there is power in envisioning the future we want, not the future we fear,” said Rachel Goslins, director of the Arts and Industries Building.

The exhibition is scheduled to remain open through July 6. Eventually, the “me + you” sculpture will be relocated to Amazon’s new HQ2 headquarters in Arlington, Virginia.


WASHINGTON (AP)

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Charities see more crypto donations. Who is benefiting?

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Charities see more crypto donations. Who is benefiting

As the biggest cryptocurrencies flirt with record high values, they’re increasingly becoming bigger sources of revenue for charities. However, the number of charities accepting the virtual currencies, known for their volatility, remains limited.

Bitcoin, the world’s largest cryptocurrency, hit nearly $69,000 for the first time in its history last week, roaring back after sinking below $30,000 during the summer. The value of ethereum, the second biggest cryptocurrency, also hit a record high.

Both cryptocurrencies have dropped from their record levels after helping push the overall market cap of cryptocurrencies past $3 trillion, according to CoinGecko pricing. As of Monday morning, CoinMarketCap, another popular measure, listed the market cap at $2.8 trillion.

So far this year, Fidelity Charitable, the nation’s largest grantmaker, has received more than $274 million in cryptocurrency contributions — nearly quadruple its prior record of $69 million in 2017, according to a company spokesperson. And the cryptocurrency donation platform Engiven said last month it accepted what it called the largest single Bitcoin donation known to date: a $10 million Bitcoin gift to an undisclosed faith-based organization.

Many large charities and international aid agencies, like The American Red Cross and Save the Children, have set up mechanisms to accept cryptocurrencies or are using platforms that help them convert them into cash right away. But smaller organizations — who make up the vast majority of registered nonprofits in the country — are attempting to figure out how to accept these currencies, or if it even makes sense for them to do so, said Rick Cohen, the chief communications and operating officer at the National Council on Nonprofits.

“For a lot of organizations, it feels a little bit scary because it’s not the contribution of dollars that they’re used to,” Cohen said.

“It’s not something that’s free and easy” to set up, he said. “And they need to figure out if there’s even demand from their current donors to be able to do it.”

The global humanitarian organization Action Against Hunger started accepting cryptocurrency donations last year after a group of donors approached them about taking the assets, said Aron Flasher, who manages corporate partnerships for the organization. Since then, he says they’ve raised more than $1 million from virtual currencies.

“We feel like we’ve brought our issues to a very diverse cohort of supporters that we may not be reaching otherwise,” Flasher said. “And so far, all of our projections show it’s just going to increase.”

A Pew Research Center survey released last week indicated 16% of Americans have invested, traded or otherwise used cryptocurrencies in some way. Driven by interest from millennials, the digital currencies have become more mainstream since Bitcoin’s creation in 2009 but skeptics say their use is just a passing fad.

Gary Gensler, the chairman of the Securities and Exchange Commission, said in September investors lacked enough protection in the cryptocurrency market, which he called “rife with fraud, scams and abuse” and compared it to the “Wild West.” Regulators have noted that the digital assets pose more risks for money laundering, terrorist financing and other crimes. And some countries have moved to outlaw the transactions.

Cryptocurrencies are an attractive asset to donate because they allow donors to bypass the capital gains tax. Donors would be subject to that tax if they convert the virtual currency into cash before giving it away, which means less money could go to their selected charity. Another bonus is an income tax deduction.

Tax savings, according to the small number of cryptocurrency owners who donated some of their holdings to charity, was a driving force behind their crypto gifts, Fidelity Charitable reported in October. Many of those investors also reported difficulty finding organizations that accepted the virtual currencies, which could be volatile for charities to hold.

When Ethereum co-founder Vitalik Buterin donated $1 billion worth of Shiba Inu coin — known as a “meme” or joke coin — to the India COVID-Relief Fund in May, the disclosure of the transfer drove down the token’s price 50%. Two months later, Sandeep Nailwal, the aid group’s founder, indicated only $20 million had been used due to complexities with both converting the cryptocurrency and complying with government regulations in India regarding the assets. (The value of Shiba Inu has since surged in price ).

The volatility in the crypto world is the reason why some giving platforms and donor-advised fund sponsors, like Fidelity Charitable, convert them into cash right away. Pat Duffy, the co-founder of the popular cryptocurrency donation platform The Giving Block, said though it’s rare, some nonprofits who use the platform choose to hold the assets.

Fidelity places the cash from crypto in a donor-advised fund, which allows donors to get tax deductions upfront before distributing any of the money to a working charity.

“You can have a situation where somebody donates cryptocurrency, and if we don’t sell it right away, it could lose 20% of its value in a day,” said Tony Oommen, a vice president and charity planning consultant at Fidelity Charitable.

“Or It could go the opposite direction,” Oommen added. “But we don’t try to speculate on that.”

Fluctuating prices aren’t the only concern. The environmental advocacy organization Greenpeace stopped taking Bitcoin earlier this year, citing environmental worries associated with mining the digital currency. Despite this pullback, James Lawrence, the CEO of the donation platform Engiven, says he believes the majority of nonprofits will begin accepting crypto donations within the next five years.

“By most estimates, there’s less than a few thousand that accept crypto,” he said. “There’s a lot of room for growth.”

Pete Howson, a senior lecturer at ​​England’s University of Northumbria who researches cryptocurrencies, says the use of the virtual currencies could, in some cases, increase what he calls “surveillance philanthropy.” For example, GiveTrack, a cryptocurrency crowdfunding website, uses blockchain technology as well as material from charities to send donors reports on how their crypto contributions were spent.

Connie Gallippi, the founder and executive director of The BitGive Foundation, which runs GiveTrack, says the report simplifies transactions recorded on the blockchain and shows donors what their contributions bought. She said the report also shows donors how a charity spends funds it converts into a local currency.

Gallippi said the software’s goal is to increase transparency in the nonprofit sector, adding any criticism of tracking is unwarranted because charities can decline to accept restricted donations.

“It’s transparency at its best when you have no control over the data that’s presented,” she said. “Other than your actions that are behind that data.”

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Amazon to allow employees to work remotely indefinitely

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Amazon Work remotely

Amazon said Monday it will allow many tech and corporate workers to continue working remotely indefinitely, as long as they can commute to the office when necessary.

The new policy was announced in a blog post and is a change from Amazon’s previous expectation that most employees would need to be in the office at least three days a week when offices reopen from the COVID-19 pandemic in January.

The Seattle Times reported Monday’s message was signed by Amazon CEO Andy Jassy and said company directors will have discretion to allow teams that they manage to continue working remotely.

“We expect that there will be teams that continue working mostly remotely, others that will work some combination of remotely and in the office, and still others that will decide customers are best served having the team work mostly in the office,” Jassy wrote.

Most of the online retail giant’s more than 1 million global employees cannot work remotely because they perform their duties in the company’s fulfillment and transportation division, grabbing orders and delivering them to customers.

But about 50,000 tech and office employees work at the company’s sprawling headquarters downtown Seattle campus and in the city’s South Lake Union neighborhood. Their absence will hurt nearby restaurants and other businesses.

Amazon’s update to its return-to-work policy followed similar moves from other big technology companies. Microsoft announced last month that it had postponed reopening its offices indefinitely.


SEATTLE (AP)

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