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U.S. FDA gives marketing nod to an e-cigarette for the first time

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The U.S. Food and Drug Administration (FDA) on Tuesday allowed British American Tobacco Plc (BAT) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, making it the first-ever vapor product to get clearance from the health regulator.

The FDA said the approval came after analysis of data from the manufacturer that showed that using Vuse’s tobacco-flavored products could help users reduce exposure to harmful chemicals emitted by combustible cigarettes.

“Today’s order represents an important moment for Reynolds,” a British American Tobacco spokesperson said, referring to the company’s American unit R.J. Reynolds Vapor Co, which had filed for Vuse’s marketing approval.

The FDA granted permission to R.J. Reynolds to market its Vuse Solo closed electronic nicotine-delivery device and two accompanying tobacco-flavored e-liquid pods, which have a nicotine strength of 4.8%, which is roughly equivalent to a pack of cigarettes.

Nicotine is a chemical released during the combustion of tobacco and is the addictive stimulant that gives smokers a rush. It isn’t immediately clear what diseases it causes.

The agency denied the company’s request to sell flavored products for failing to demonstrate they would appropriately protect public health. An application to keep selling a menthol version continues to be evaluated, however.

The FDA’s decision comes on the heels of a 2021 survey conducted by the CDC that indicated that an estimated 2.06 million U.S. middle and high school students are still using e-cigarettes, with Vuse and Juul among the most popular brands. Most users said they used flavored products, with fruit, candy and desserts among the most common.

A broader U.S. study tracking adolescents between the ages of 12 and 15 for three years showed that adolescents who used e-cigarettes before trying any other tobacco products were more than four times as likely to be smoking traditional cigarettes within a couple of years compared to those who tried any vapes.

The BAT Group spokesperson said FDA’s “market denial orders” were for five flavored products that were currently not being sold in the market and said it was carefully studying the “FDA’s limited concerns” with those applications.

BAT last month announced that Vuse was now the No. 1 global vaping brand by retail sales in the United States, Canada, France, the United Kingdom and Germany, which account for an estimated 77% of the closed system vapour market.

BAT said it is now awaiting approvals for its other e-cigarette products, including Vuse Alto, whose marketing approval application was submitted nearly a year after Vuse Solo, and Vuse Vibe and Ciro, whose applications “share a foundational science” similar to Vuse Solo.

“We remain confident in the quality of our applications,” the spokesperson said.

In September, the FDA delayed its decision on whether BAT rival Juul and other major manufacturers including BAT could sell their e-cigarette products in the United States, as it weighed the public health impact of the products.

The FDA on Tuesday also imposed strict digital, radio and television advertising restrictions on R.J. Reynolds.

Juul did not immediately respond to a Reuters request for comment.

BAT shares were up marginally in afternoon trading.

 

(Reporting by Amruta Khandekar and Siddharth Cavale; Editing by Devika Syamnath and Bernadette Baum)

Health

Whooping cough is at a decade-high level in US

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MILWAUKEE (AP) — Whooping cough is at its highest level in a decade for this time of year, U.S. health officials reported Thursday.

There have been 18,506 cases of whooping cough reported so far, the Centers for Disease Control and Prevention said. That’s the most at this point in the year since 2014, when cases topped 21,800.

The increase is not unexpected — whooping cough peaks every three to five years, health experts said. And the numbers indicate a return to levels before the coronavirus pandemic, when whooping cough and other contagious illnesses plummeted.

Still, the tally has some state health officials concerned, including those in Wisconsin, where there have been about 1,000 cases so far this year, compared to a total of 51 last year.

Nationwide, CDC has reported that kindergarten vaccination rates dipped last year and vaccine exemptions are at an all-time high. Thursday, it released state figures, showing that about 86% of kindergartners in Wisconsin got the whooping cough vaccine, compared to more than 92% nationally.

Whooping cough, also called pertussis, usually starts out like a cold, with a runny nose and other common symptoms, before turning into a prolonged cough. It is treated with antibiotics. Whooping cough used to be very common until a vaccine was introduced in the 1950s, which is now part of routine childhood vaccinations. It is in a shot along with tetanus and diphtheria vaccines. The combo shot is recommended for adults every 10 years.

“They used to call it the 100-day cough because it literally lasts for 100 days,” said Joyce Knestrick, a family nurse practitioner in Wheeling, West Virginia.

Whooping cough is usually seen mostly in infants and young children, who can develop serious complications. That’s why the vaccine is recommended during pregnancy, to pass along protection to the newborn, and for those who spend a lot of time with infants.

But public health workers say outbreaks this year are hitting older kids and teens. In Pennsylvania, most outbreaks have been in middle school, high school and college settings, an official said. Nearly all the cases in Douglas County, Nebraska, are schoolkids and teens, said Justin Frederick, deputy director of the health department.

That includes his own teenage daughter.

“It’s a horrible disease. She still wakes up — after being treated with her antibiotics — in a panic because she’s coughing so much she can’t breathe,” he said.

It’s important to get tested and treated with antibiotics early, said Dr. Kris Bryant, who specializes in pediatric infectious diseases at Norton Children’s in Louisville, Kentucky. People exposed to the bacteria can also take antibiotics to stop the spread.

“Pertussis is worth preventing,” Bryant said. “The good news is that we have safe and effective vaccines.”

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AP data journalist Kasturi Pananjady contributed to this report.

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The Associated Press Health and Science Department receives support from the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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Scientists show how sperm and egg come together like a key in a lock

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How a sperm and egg fuse together has long been a mystery.

New research by scientists in Austria provides tantalizing clues, showing fertilization works like a lock and key across the animal kingdom, from fish to people.

“We discovered this mechanism that’s really fundamental across all vertebrates as far as we can tell,” said co-author Andrea Pauli at the Research Institute of Molecular Pathology in Vienna.

The team found that three proteins on the sperm join to form a sort of key that unlocks the egg, allowing the sperm to attach. Their findings, drawn from studies in zebrafish, mice, and human cells, show how this process has persisted over millions of years of evolution. Results were published Thursday in the journal Cell.

Scientists had previously known about two proteins, one on the surface of the sperm and another on the egg’s membrane. Working with international collaborators, Pauli’s lab used Google DeepMind’s artificial intelligence tool AlphaFold — whose developers were awarded a Nobel Prize earlier this month — to help them identify a new protein that allows the first molecular connection between sperm and egg. They also demonstrated how it functions in living things.

It wasn’t previously known how the proteins “worked together as a team in order to allow sperm and egg to recognize each other,” Pauli said.

Scientists still don’t know how the sperm actually gets inside the egg after it attaches and hope to delve into that next.

Eventually, Pauli said, such work could help other scientists understand infertility better or develop new birth control methods.

The work provides targets for the development of male contraceptives in particular, said David Greenstein, a genetics and cell biology expert at the University of Minnesota who was not involved in the study.

The latest study “also underscores the importance of this year’s Nobel Prize in chemistry,” he said in an email.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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Turn Your Wife Into Your Personal Sex Kitten

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