In the midst of the covid-19 pandemic, a health products company called Xlear began advertising its saline nasal spray to people desperately searching for ways to protect themselves from a new virus. In its marketing, Xlear pointed to studies that it said supported the idea that ingredients in the spray could block viruses from sticking to the nasal cavity. Based on its interpretation of the science, Xlear promoted the product as one part of a “layered defense” against contracting covid.
In 2021, the Federal Trade Commission, in a bipartisan vote, decided to sue Xlear for making allegedly “unsupported health claims,” saying the company had “grossly misrepresented the purported findings and relevance of several scientific studies” in its advertising. Earlier this year, the Trump Justice Department, on the FTC’s behalf, asked for the lawsuit to be dismissed with prejudice, though it didn’t explain its reasoning. But Xlear still wanted its day in court. Now, it’s suing the FTC because it wants a court to make it harder for the agency to attempt to go after health claims.
Xlear is filing the lawsuit at a time where the government’s standard operating procedures around both science and administrative law have been upended. Health and Human Services Secretary Robert F. Kennedy Jr. recently expelled all the members of the Centers for Disease Control and Prevention’s vaccine policy advisory committee, a simultaneously radical and predictable outcome given his career in spreading anti-vaccine falsehoods. Meanwhile, the current FTC is engaged in helping President Donald Trump undermine the agency’s long-standing independence from the White House. After Trump purported to fire its two Democratic commissioners, the FTC has even openly taken up long-standing conservative grievances over alleged censorship in the digital sphere.
Like Kennedy, Xlear is advocating for a path that could open up the health products space to alternative — and possibly less-tested — upstarts. “There’s a tension here between the reform movement of MAHA [Make America Healthy Again] and the old-guard approach of the FTC,” Xlear’s lead counsel, Rob Housman, tells The Verge. “If you want to break our focus on drugs and pharmaceuticals, one of the things you have to do is make space for innovation and things like hygiene and other approaches.”
“There’s a tension here between the reform movement of MAHA and the old-guard approach of the FTC”
Xlear insists it’s not trying to lower the bar for health marketing claims, but simply hold the FTC to a reasonable legal standard. Housman believes the Supreme Court’s decision to strike down Chevron deference last year — removing long-standing precedent telling courts they should often defer to federal agencies’ expertise — makes the case even easier. “We don’t want people to think we’re trying to reduce the burden of science,” he says. “We, in fact, want to up the burden of science. We just want to make sure that companies are complying with the law — not the law as the FTC says it is.”
As Xlear sees it, the FTC has stepped beyond its authority to enforce the law against false and misleading claims, coming up with arbitrary standards of what kinds of evidence should be considered adequate to justify a health claim. Housman points to the agency’s 2022 guidance that says randomized controlled trials (RCTs), especially when replicated at least once, are most reliable to substantiate health claims. There’s no magic number for the number or kinds of studies, according to the guidance, but it says “randomized, controlled human clinical trials (RCTs) are the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims.” The FTC did not immediately respond to a request for comment on the lawsuit.
Xlear says this is far too high of a hurdle, especially for smaller companies that may not have the money to conduct such resource-intensive trials. Housman compares it to an adage about how there’s no RCT trials to prove parachutes work — the punchline being that no one would conduct a study where a control group jumped out of a plane without a parachute. (It’s unclear how removing this high hurdle would “up the burden of science.”)
One reason it’s bringing the lawsuit is so that it can freely make health claims about another product it sells, which it believes can be an alternative to fluoride
Xlear says that one reason it’s bringing the lawsuit is so that it can freely make health claims about another product it sells, which it believes can be an alternative to fluoride, which Kennedy wants to strip from the water supply. Fluoride is a mineral that prevents tooth decay. A recent study from the National Toxicology Program found that very high levels of fluoride (atypically high in the US) are linked to slightly lower IQ scores for kids, but fluoride has been the subject of conspiracy theories for almost a century, even making an appearance as a comedic bogeyman in the movie Dr. Strangelove, in which General Jack D. Ripper refers to it as “the most monstrously conceived and dangerous communist plot” to “sap and impurify all of our precious bodily fluids.”
Housman says that even if Xlear wins its lawsuit on every count, “this doesn’t allow people to make up bogus marketing claims.” The FTC will still have the authority to take down truly false and misleading claims, just not by the allegedly arbitrary standard it has been. He adds that the threat of private lawsuits is effective to keep egregious marketing claims at bay. “We don’t believe anybody should be making bogus claims,” Housman says, “but we also believe that the agency has the responsibility to do the work.”
Source link
#nasal #spray #company #harder #FTC #police #health #claims

![‘Cyberpunk: Edgerunners’ Creator’s New Manga Series Is a Love Letter to ‘Inception’ and Soulsborne Games
In the time before Cyberpunk: Edgerunners 2‘s imminent arrival on Netflix this fall, I’ve been living it up, rewatching the anime and re-reading manga from the folks responsible for its first season being Crunchyroll’s 2023 Anime of the Year.
While I’ve already waxed poetic about writer Bartosz Sztybor‘s Rebecca-centric prequel manga showcasing Night City as having plenty more stories to tell, season one creator Rafał Jaki has spun the block off the momentum of being one of Manga Plus’ first Western manga creators post-Edgerunners with an inventive new manga series that’s giving Inception meets Elden Ring. Coming off the heels of his refreshingly imaginative sci-fi series No\Name, in which folks’ powers were derived from the meanings of their given names, Jaki and artist Machine Gamu‘s newest series, Brain Alive—which he announced on his official X/Twitter account with a Google Drive link to read its first chapter for free—looks poised to carry that energy forward with a dark fantasy premise geared toward cinephiles and gamers alike. [embed]https://www.youtube.com/watch?v=01qvd0J-6Fc[/embed] In patented Edgerunners heart-shattering fashion, Brain Alive opens with a father named Daniel awakening from a car crash to the news that his wife didn’t survive and his son is in a coma. To keep his son company, Daniel reads him new volumes of the dark fantasy novel that inspired the Soulsborne video games they used to play together as a family. After falling asleep by his son’s bedside, Daniel finds himself stark naked inside a dungeon. Turns out, his dreams run on a kind of Kamen Rider ZETZ rule where he enters his son’s dreamscape influenced by his mind’s imaginings of their favorite video game series. But things are far from fun and games.
© Rafał Jaki/Machine Gamu Fortunately, if Daniel dies in the dream, he doesn’t die in real life. Any progress he makes in the dream follows a roguelike-meets-Soulsborne rule, with bonfire checkpoints featuring the dream-eating yokai, Baku, as a save state statue, and he returns a bit stronger as he retraces his steps in his son’s dreams. Unfortunately, Daniel can’t honk shoo-mimimi into his son’s dreams willy-nilly. He’s got a limited number of times he can go into his son’s dreams to make as much progress as he can and inch closer to saving his son’s life. Meaning, runs can’t be redone by closing his eyes and diving into his dreams multiple times a night. Think Persona 3 dungeon runs where, instead of planning dates and going to school in the interim of making doubly sure if you want to get your shit rocked in Tartarus, Daniel dedicates every waking moment to “git gud” at Soulsborne games to save his son’s life. Buddy can’t catch a break.
© Rafał Jaki/Machine Gamu As Soulsborne enemies are wont to do, everything from skeleton warriors and giant yokai to poisonous snakes wants to run the dozens with Daniel for keeps, leaving the weary father with nothing but his Soulsbourne techniques, like perfect dodges, attacking enemy weak points, and real-life sword lessons, to keep himself alive. It also doesn’t hurt that Daniel’s got the boon of a fire sabre with the spirit of his dead wife guiding him through his son’s lucid dark fantasy dreams. If the dead wife of it all isn’t the most Christopher Nolan-ism of all time, I don’t know what is. © Rafał Jaki/Machine Gamu © Rafał Jaki/Machine Gamu As is evident from its first chapter, Jaki owes a lot to both anime and the video games he’s played and helped bring into fruition in the stories he crafts. “I create in order to give back even a small fraction of what I have received from loving the work of other creators,” Jaki told IGN. “My hope is to provide someone else with that same moment of awe that I have experienced myself, offering a glimpse into another person’s mind and sharing thoughts and feelings.”
© Rafał Jaki/Machine Gamu As a wary fan of the diminishing returns of isekai-adjacent storytelling, what Jaki and Machine Gamu have put forward in Brain Alive‘s first chapter feels far from the derogatory sameness I’ve encountered from manga and anime that take gamified RPG rules for the sake of power fantasy wish-fulfillment while handwaving their many icky implications. It probably helps that Jaki is no stranger to expansive video game scripts, as the writer of Dark Horse’s The Witcher 3: Ronin comic and The Witcher: Old World board game. Like Former Destiny writer Frank Barbiere and Swamp Thing: Twin Branches artist Morgan Beem’s Image Comics series The Author Immortal (which I also strongly recommend folks check out), Brain Alive is a story with stakes and teeth I can’t wait to see pan out. You can read the first chapter of Brain Alive here ahead of its English release coming later this year, and Jaki’s first-ever manga series, No\Name, on MANGA Plus. Want more io9 news? Check out when to expect the latest Marvel, Star Wars, and Star Trek releases, what’s next for the DC Universe on film and TV, and everything you need to know about the future of Doctor Who. #Cyberpunk #Edgerunners #Creators #Manga #Series #Love #Letter #Inception #Soulsborne #GamesCyberpunk: Edgerunners,Manga,Rafal Jaki ‘Cyberpunk: Edgerunners’ Creator’s New Manga Series Is a Love Letter to ‘Inception’ and Soulsborne Games
In the time before Cyberpunk: Edgerunners 2‘s imminent arrival on Netflix this fall, I’ve been living it up, rewatching the anime and re-reading manga from the folks responsible for its first season being Crunchyroll’s 2023 Anime of the Year.
While I’ve already waxed poetic about writer Bartosz Sztybor‘s Rebecca-centric prequel manga showcasing Night City as having plenty more stories to tell, season one creator Rafał Jaki has spun the block off the momentum of being one of Manga Plus’ first Western manga creators post-Edgerunners with an inventive new manga series that’s giving Inception meets Elden Ring. Coming off the heels of his refreshingly imaginative sci-fi series No\Name, in which folks’ powers were derived from the meanings of their given names, Jaki and artist Machine Gamu‘s newest series, Brain Alive—which he announced on his official X/Twitter account with a Google Drive link to read its first chapter for free—looks poised to carry that energy forward with a dark fantasy premise geared toward cinephiles and gamers alike. [embed]https://www.youtube.com/watch?v=01qvd0J-6Fc[/embed] In patented Edgerunners heart-shattering fashion, Brain Alive opens with a father named Daniel awakening from a car crash to the news that his wife didn’t survive and his son is in a coma. To keep his son company, Daniel reads him new volumes of the dark fantasy novel that inspired the Soulsborne video games they used to play together as a family. After falling asleep by his son’s bedside, Daniel finds himself stark naked inside a dungeon. Turns out, his dreams run on a kind of Kamen Rider ZETZ rule where he enters his son’s dreamscape influenced by his mind’s imaginings of their favorite video game series. But things are far from fun and games.
© Rafał Jaki/Machine Gamu Fortunately, if Daniel dies in the dream, he doesn’t die in real life. Any progress he makes in the dream follows a roguelike-meets-Soulsborne rule, with bonfire checkpoints featuring the dream-eating yokai, Baku, as a save state statue, and he returns a bit stronger as he retraces his steps in his son’s dreams. Unfortunately, Daniel can’t honk shoo-mimimi into his son’s dreams willy-nilly. He’s got a limited number of times he can go into his son’s dreams to make as much progress as he can and inch closer to saving his son’s life. Meaning, runs can’t be redone by closing his eyes and diving into his dreams multiple times a night. Think Persona 3 dungeon runs where, instead of planning dates and going to school in the interim of making doubly sure if you want to get your shit rocked in Tartarus, Daniel dedicates every waking moment to “git gud” at Soulsborne games to save his son’s life. Buddy can’t catch a break.
© Rafał Jaki/Machine Gamu As Soulsborne enemies are wont to do, everything from skeleton warriors and giant yokai to poisonous snakes wants to run the dozens with Daniel for keeps, leaving the weary father with nothing but his Soulsbourne techniques, like perfect dodges, attacking enemy weak points, and real-life sword lessons, to keep himself alive. It also doesn’t hurt that Daniel’s got the boon of a fire sabre with the spirit of his dead wife guiding him through his son’s lucid dark fantasy dreams. If the dead wife of it all isn’t the most Christopher Nolan-ism of all time, I don’t know what is. © Rafał Jaki/Machine Gamu © Rafał Jaki/Machine Gamu As is evident from its first chapter, Jaki owes a lot to both anime and the video games he’s played and helped bring into fruition in the stories he crafts. “I create in order to give back even a small fraction of what I have received from loving the work of other creators,” Jaki told IGN. “My hope is to provide someone else with that same moment of awe that I have experienced myself, offering a glimpse into another person’s mind and sharing thoughts and feelings.”
© Rafał Jaki/Machine Gamu As a wary fan of the diminishing returns of isekai-adjacent storytelling, what Jaki and Machine Gamu have put forward in Brain Alive‘s first chapter feels far from the derogatory sameness I’ve encountered from manga and anime that take gamified RPG rules for the sake of power fantasy wish-fulfillment while handwaving their many icky implications. It probably helps that Jaki is no stranger to expansive video game scripts, as the writer of Dark Horse’s The Witcher 3: Ronin comic and The Witcher: Old World board game. Like Former Destiny writer Frank Barbiere and Swamp Thing: Twin Branches artist Morgan Beem’s Image Comics series The Author Immortal (which I also strongly recommend folks check out), Brain Alive is a story with stakes and teeth I can’t wait to see pan out. You can read the first chapter of Brain Alive here ahead of its English release coming later this year, and Jaki’s first-ever manga series, No\Name, on MANGA Plus. Want more io9 news? Check out when to expect the latest Marvel, Star Wars, and Star Trek releases, what’s next for the DC Universe on film and TV, and everything you need to know about the future of Doctor Who. #Cyberpunk #Edgerunners #Creators #Manga #Series #Love #Letter #Inception #Soulsborne #GamesCyberpunk: Edgerunners,Manga,Rafal Jaki](https://gizmodo.com/app/uploads/2026/08/Brain-Alive-4.jpg)




Post Comment