CVS, Walgreens Among Companies Flagged by FDA for Selling Sketchy Eye Drop Products

The Food and Drug Administration is warning several companies, including the retail chains CVS and Walgreens, to stop selling unapproved, potentially dangerous eye drop products. The agency claims that the companies have committed a number of violations in manufacturing or marketing these products. The FDA is also worried about the inclusion of silver compounds in some products, since silver can turn people’s skin or eyes permanently blue with long-term use.

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The FDA announced Tuesday that it was issuing warning letters to eight different companies regarding their eye drop products. These companies include CVS Health and Walgreens Boots Alliance, Inc, both of which own retail pharmacy chains that sell store-brand versions of popular over-the-counter drugs and healthcare products. Other flagged companies such as Similasan and Boiron produce products commonly sold in retail or online pharmacies.

The FDA alleges that the cited eye drop products sold by these companies are illegally marketed. The labeling of these products often includes language claiming that they can treat or cure conditions such as conjunctivitis (pink eye), cataracts, glaucoma, and others. As a general rule, however, anything sold in the U.S. that explicitly claims to fix a medical problem needs to have been cleared, authorized, or approved by the FDA beforehand, and the agency says that these products have not gone through that process.

Some of the eye drop brands have also allegedly been made at facilities that have recently failed to meet standard manufacturing guidelines for product safety and quality, including the eye drops sold by CVS and Walgreens. The FDA further says that these two eye drop brands in particular are labeled to contain silver, ostensibly used as a preservative. While silver can be used medicinally (often for its antimicrobial properties), the FDA is worried that its inclusion in eye drop products could be dangerous. Long-term consumption of silver as a drug is known to potentially cause a condition called argyria, which can turn our skin, internal organs, and soft tissues (including those of the eye) permanently blue.

“The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the agency said in its announcement.

Many of the products mentioned by the FDA in these letters are additionally branded as homeopathic remedies. Homeopathy is a not-so-ancient form of alternative medicine that has no good evidence for its effectiveness in treating any medical problem. The agency notes that people using unapproved products such as these might delay or stop using products that have actually been proven to be safe and effective for their intended use.

The companies are expected to respond to the FDA within 15 days on how they will correct their alleged violations. Failing a response, the agency has the ability to take further steps, including legal action to seize or stop the manufacturing of these products. The FDA has also added some of the companies to a list of import alerts, which allows the FDA to detain products shipped from overseas without examination before they can enter the country.

“When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, in a statement. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”

via Gizmodo

September 13, 2023 at 02:03PM

Swiss students just set a mind-bending EV acceleration record

Last year, a team of German students set a world record for the fastest-accelerating electric car, pulling 2.5Gs while reaching 62 mph (100km/h) in a staggering 1.461 seconds. Now, that record has been shattered by another team of students from Switzerland, whose car just crossed the one-second threshold.

The AMZ team’s car, named Mythen, made the 0-62 mph (0-to-100 kph) run in just 0.956 seconds, knocking more than half a second off the previous team’s record – a lifetime in any sort of timed automotive event. Research team members from ETH Zurich and the Lucerne University of Applied Sciences and Art built the car, which took just 12.3 meters to break the acceleration record.

Built by hand, the stubby-looking car weighs just 140 kg (around 309 pounds) and is powered by a custom 321-horsepower engine. AMZ’s head of aerodynamics, Dario Messerli, said, “Power isn’t the only thing that matters when it comes to setting an acceleration record; effectively transferring that power to the ground is also key.” He went on to describe the way Formula 1 cars use downforce to achieve that power transfer and said that the team developed a vacuum system to effectively suction the car to the ground.

That’s an approach McMurtry Automotive took with its mind-bending Speirling EV, which is now for sale with a more than $1 million price tag. The track-only (for now) car can hit 60 mph in 1.4 seconds and run the quarter mile in 7.97 seconds. The company credits its aerodynamic design over its purported 1,000 horsepower as the driving force behind its performance.

The Speirling has two turbines behind its cockpit that suck the air from underneath the car, allowing it to outrun cars like the Rimac Nevera. However, all of that still doesn’t match the effort put in by the Swiss team, but at least the Speirling has a roof.

via Autoblog

September 13, 2023 at 11:02AM

France Says the iPhone 12 Is Radioactive

French regulators halted iPhone 12 sales on Tuesday over concerns that the devices emit levels of radiation over the legal limits. The government’s Agency of National Frequencies (ANFR) said it will send agents to Apple stores to ensure the devices aren’t being sold, and threatened to recall all iPhone 12s in circulation if the company doesn’t address the problem. Apple said its phones comply with international radiation guidelines.

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Hours before Apple announced the iPhone 15 at its “Wonderlust” event, France’s radiation watchdog announced that iPhone 12s were temporarily withdrawn from the French market “due to non-compliance of these devices with European regulations.” The ANFR said tests found that the phone’s “specific absorption rate,” which measures the level of electromagnetic waves absorbed by the human body, was over limits set by the European Union.

EU standards set allowable radiation levels lower than standards in Asia and North America out of an abundance of caution, in the typical consumer-friendly European regulatory mode. Barrot told Le Parisien the EU standard “is ten times lower than the level of emissions which, according to scientific studies, can have consequences for users,” (translated from French).

The ANFR found the iPhone 12’s specific absorption rate exceeds the legal limit at a distance of five millimeters, a test set to replicate the radiation exposure when a phone is in your hand or pants pocket. At a distance you’d expect for a phone in a jacket pocket or a bag, radiation from the iPhone 12 is within legal limits.

Apple did not immediately respond to a request for comment, but told Reuters that the iPhone 12 was certified as compliant with global radiation standards by multiple international bodies.

It seems the problem isn’t inherent to the design of the device. Jean-Noel Barrot, France’s junior minister for the digital economy, who oversees the ANFR, reportedly told Reuters that a software update could fix the problem. “Apple is expected to respond within two weeks,” Barrot said. “If they fail to do so, I am prepared to order a recall of all iPhones 12 in circulation. The rule is the same for everyone, including the digital giants.” Barrot said he expects the ANFR’s finding would cause a “snowball effect” of similar action from other countries in the EU.

Before you dunk your iPhone in concrete, understand that most electronic devices emit radiation. The word “radiation” often brings images of mushroom clouds to mind, but radiation is the just name for energy that travels through space, and it isn’t necessarily dangerous. Not all radiation is “ionizing” radiation, the kind that can melt your skin off or alter your DNA at high levels. The heat given off by a candle is a form of radiation, for example, and it’s safe at a distance of a few inches.

Cell phones communicate using microwaves, the same frequencies used by WiFi and the microwave in your kitchen, as the name implies. (That explains the interference that makes your voice sound like a robot on phone calls sometimes, or causes the WiFi cuts out in some houses when you heat up a Hot Pocket.)

There’s a conspiracy theory — and a small amount of evidence-based medical debate — that suggests the radiation emitted by cell phones is dangerous. However, the current medical consensus is that cell phones are safe.

via Gizmodo

September 13, 2023 at 10:33AM

Forza Motorsport’s Blind Drive Assist Is A Breakthrough For Gaming Accessibility

Recent Forza games have been trailblazers for upping the ante when it comes to accessibility. 2021’s Forza Horizon 5 came with in-game sign language for cinematics, and a time-slowing option for those with slower reaction times. Incredible stuff. This October’s Forza Motorsport is aiming to push the boundaries even further, introducing a mode designed for blind players, called Blind Drive Assist.

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Steve Saylor, a blind games player, has recently tested it out, and tweeted to describe how the suite of audio cues and customizations work.

The ensemble of aural guidance appears to combine the co-driver spoken guidance more familiar to rally driving games, in which upcoming turns are described, along with what essentially boils down to sophisticated sonar. A collection of bleeps, bloops and tones that tell a player where their car is on a track relative to its sides and turns, and when they need to brake or accelerate.

Steve Saylor

Saylor was able to play a specific track in the unreleased car-tuning racing game, and described his first attempt to use the audio cues as “a cacophony of sound.” Then, after meticulously adjusting the volume meters and tone levels of all the different sounds to suit him, Saylor said his racing considerably improved. In the video above, he explains how fixing these settings, and getting familiar with the cues, eventually saw him winning a race.

There’s often a lot of confusion about what “blind” means, with many assuming it’s a term for seeing nothing whatsoever. This isn’t the case; rather, it describes visual impairment, where sight is affected to a degree that vision is seriously altered. Steve Saylor describes this eloquently, with excellent visual explanations, in this video.

With audible indicators informing a player where they are on a track using stereo sound, alongside sonar-like feedback for how close they are to barriers, accompanied by cues for when to brake or accelerate, Forza Motorsport becomes an aural experience with visuals to support. Which is, to our knowledge, a first for racing gaming.

Other accessibility options include removing car collisions for single-player gaming and turning AI cars into ghosts, along with audio descriptions for cutscenes and extremely specific volume options for every aspect of the game’s sounds.

Forza Motorsport, the eighth game in this branch of the Forza franchise, comes from the same studio that has developed every entry, Turn 10 Studios. The studio worked with accessibility consultant Brandon Cole to develop the Blind Drive Assist mode, along with support from Saylor. It’s due out October 10, with four-day early access for those who pay for the eye-wateringly expensive Premium Edition.


via Kotaku

September 12, 2023 at 10:28AM