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FDA plans to restrict sale of flavored e-cigarettes: Here’s what you need to know

The U.S. Food and Drug Administration (FDA) reportedly plans to sharply restrict the sale of most fl..

The U.S. Food and Drug Administration (FDA) reportedly plans to sharply restrict the sale of most flavored electronic-cigarettes (e-cigarettes) in retail stores and gas stations in an effort to decrease the prevalence of vaping.

The agency's plans, expected to be announced next week, are part of an effort to reduce the use of flavored e-cigarettes among teenagers. There are also plans to require age-verification measures for online sales to make sure minors are not able to buy them, according to reports this week in the New York Times and the Washington Post, which cite an unnamed senior FDA official describing the plans.

The agency has been raising red flags about e-cigarette use among teens for years.

“All Americans need to know that e-cigarettes are dangerous to youth and young adults,” then-U.S. Surgeon General Dr. Vivek Murthy said in 2016.

“Any tobacco use, including e-cigarettes, is a health threat, particularly to young people.”

Tobacco companies have fought efforts to cut e-cigarette flavors, stating they are not aimed at youth, but at adults, as an option to help transition from tobacco cigarettes. However, health advocates have pointed out that the advertising appeals to youth, featuring flavors including “unicorn milk” and “rocket popsicle.”

Public officials are trying to strike a balance between the use of e-cigarettes to help adult tobacco cigarette smokers quit, while also not hooking a new generation on nicotine through e-cigarettes.

The FDA has also warned 1,100 retailers to stop selling the devices to minors and has issued fines to some of them that have continued to sell them. Because the overwhelming majority of e-cigarette sales are through retail shops, the FDAs planned restrictions would have a huge negative impact on business.

What are e-cigarettes?

E-cigarettes are noncombustible tobacco products. They fall under the category or electronic nicotine delivery systems (ENDS). Other terms used to describe ENDS are vapes, vape pens, vaporizers, hookah pens, and e-pipes. These products use an “e-liquid” that may contain nicotine and may have different flavorings, vegetable glycerin, propylene glycol and other ingredients. This liquid is then heated, creating an aerosol that is inhaled by the user.

How prevalent is the use of e-cigarettes?

According to the FDA, in 2017 more than two million middle and high school students were users of e-cigarettes, which is the most commonly-used tobacco product in this population. This represents 11.7 percent of high school students and 3.3 percent of middle school students. Usage among these students is on the rise –- in 2011, only 1.5 percent of all high school and middle school students used e-cigarettes.

Are e-cigarettes safer than tobacco cigarettes?

More research is needed to answer this question. Researchers from Duke and Yale found that the flavoring compounds used in e-cigarettes combined with the e-liquid solvent can form a new compound that is often not reported as an ingredient in e-cigarettes but may lead to lung irritation.

What restrictions are already in place?

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law in June, 2009 by Congress and the president, gives the FDA authority to regulate manufacturing, distribution, and marketing of tobacco products in an effort to protect public health. This Act originally regulated tobacco cigarettes, smokeless tobacco, and roll-your-own tobacco.

Then in Aug. 2016, the FDA finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco.

What are the planned restrictions?

The planned restrictions would ban the sale of most flavored e-cigarettes in retail stores and gas stations. However, the FDA does not plan to include the menthol and mint flavors in the restrictions, because there is concern that some users would switch to traditional menthol-tobacco cigarettes. The FDA plans to require age-verification for online sales, which would prohibit minors from buying them online.

Are the planned restrictions likely to take effect right away?

Its unclear exactly when these restrictions will take place. The planned restrictions are likely to draw legal action. The Tobacco Control Act, as described above, gives the FDA authority to regulate manufacture, distribution, and marketing of tobacco products including e-cigarettes, but it “cannot ban face-to-face sales in a particular category of retail outlets.”

Johanna Kreafle, M.D. is an emergency medicine physician at the Carolinas Medical Center in Charlotte, North Carolina, and a member of the ABC News Medical Unit.

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The organization helping to bring new drugs for rare diseases to market

A research team has reason to celebrate after the Food and Drug Administration granted it approval o..

A research team has reason to celebrate after the Food and Drug Administration granted it approval on Friday to begin a clinical trial for a new pediatric brain cancer drug, one that might have ended up overlooked by pharmaceutical companies.

The lead researcher on the team, Dr. Teresa Purzner has already beat impossible odds. The neurosurgeon and mom of three managed to get the approval in record time and with little money thanks to the help of a team of scientific altruists called SPARK.

The development of new medications in the United States is driven by pharmaceutical companies; researchers at universities rarely bring their discoveries to the bedside. For every 10,000 potential new medicines sitting on laboratory shelves around the country, only one will ever reach patients in need, according to the National Institutes of Health. Why? Because the process can take 10 to 15 years, costing upwards of a billion dollars per drug.

As a result, the number of new medications approved by the FDA has remained stagnant at about 31 per year over the past 10 years. The majority of these medications are similar to already existing ones, and many target diseases for which there are large markets — like hypertension and high cholesterol — and therefore, a return on investment.

Enter SPARK, a non-profit program created in partnership between Stanford University and volunteers from the biotechnology, pharmaceutical, and investment industries, which helps academic researchers bring their discoveries to patients. Since its founding, SPARK has given special consideration to projects typically neglected by pharmaceutical companies, including rare diseases and diseases affecting children.

Purzner put her neurosurgery practice on pause to study medulloblastoma, a type of childhood brain cancer. Compared to diseases like hypertension and high cholesterol, which affect millions of Americans, medulloblastoma is rare, affecting only 250 to 500 children every year.

“Theres something especially poignant about seeing children —beautiful, wonderful, innocent things — and seeing the impact of the therapies we are giving them. The medications, the radiation therapies impact their cognition, their quality of life and their ability to function as independent adults in the future,” Purzner said in an interview with ABC News.

Purzner had a clear goal: to find a targeted therapy that could shut down the basic biochemical pathway responsible for the development of this cancer, and she did. She tested the potential drug in mice with good results, and she just received FDA approval to test it in clinical trials, which she will do through the Pediatric Brain Tumor Consortium. She did it all in five years and for a price tag of $500,000.

“To get from my initial findings in the lab to the point where the Pediatric Brain Tumor Consortium picked it up for clinical trials would have never happened without the help of SPARK… they gave me a clear pathway and made me believe it was possible,” said Purzner.

Every year, SPARK provides 10 teams with funding and expert mentorship to promote efficient and cost-effective drug development. (more…)

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Widowed father works with congresswoman on legislation to prevent maternal deaths

Sitting in the hospital room, mother and newborn baby were sound asleep.

“I was overjoyed. I reme..

Sitting in the hospital room, mother and newborn baby were sound asleep.

"I was overjoyed. I remember thinking my family is complete," Charles Johnson told ABC News.

But then he looked down and saw his wife Kiras catheter turn pink and then red with blood.

April 12, 2016 was supposed to be a joyous day for the Johnson family, but it turned into a "nightmare."

Ten hours later, Kira Johnson died as a result of internal bleeding following a cesarean section.

Now, two years later, Johnson is raising two children on his own and advocating to rectify the country's maternal health policies and regulations to prevent anyone else from sharing the same tragedy. Johnson took to Capitol Hill to share his wife's story before members of Congress, working alongside a congresswoman who experienced her own personal difficulties during pregnancy.

Charles and Kira Johnson welcomed their first son Charles V. in 2014. He was delivered via C-section. Two years later, the Johnson family relocated from Atlanta to Los Angeles and learned they were expecting their second baby boy.

"Kira and I had always wanted two boys," Johnson said. "I was excited."

The Johnsons decided to have Langston delivered at Cedars Sinai medical center, a non-profit hospital that is currently ranked as the eighth best hospital in the country by U.S. News and World Report.

Charles Johnson said his wife was in exceptional health and that she took all the necessary prenatal measures to ensure their second child would be born healthy. Since their first son was born via C-section, the doctor suggested the same for their second. (more…)

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States look to breathalyze convicted drunk drivers to reduce fatalities

This story is from Kaiser Health News

On Jan. 1, California joined the majority of states that ha..

This story is from Kaiser Health News

On Jan. 1, California joined the majority of states that have laws requiring drivers with drunken-driving convictions to install breathalyzers in vehicles they own or operate.

Researchers, public health advocates and political leaders believe these laws are helping reduce alcohol-related road deaths.

The gadgets, known as ignition interlock devices, are mounted on the steering wheel of a vehicle and prevent it from starting if the drivers blood-alcohol reading is above a predetermined level.

In California, the breathalyzers are mandatory only for repeat offenders. Five other states — Georgia, Indiana, Massachusetts, Montana and Ohio — have similar laws. Thirty-two states and D.C. require the devices even for first-time offenders.

The advent of such laws across the United States in the past 15 years has been accompanied by some good news: Deaths involving drunken driving are only about half of what they were in the early 1980s, though they have ticked back up in recent years. The long-term decline is largely attributable to greater public awareness, stricter seat belt enforcement and the establishment in 2000 of a nationwide legal blood-alcohol threshold of 0.08 percent — far below the 0.15 percent standard commonly used before then.

State Sen. Jerry Hill (D-San Mateo), the author of the California law, said breathalyzers in cars will make roads safer than under the current law, which generally relies on license restrictions and suspensions.

“Weve seen people on a suspended license continue to drive and continue to cause destruction,” said Hill, who lost his best friend to drunken driving in the 1980s.

There is some evidence that the breathalyzers have an impact. Nationally, from 2006 to 2016, ignition-locking breathalyzers prevented 2.3 million attempts to drive by people with a blood-alcohol level at or above 0.08 percent — the legal threshold for driving under the influence — according to a 2017 report by the advocacy group Mothers Against Drunk Driving.

Emma McGinty, an associate professor at the Johns Hopkins Bloomberg School of Public Health, found that laws requiring interlocks for all DUI offenders were associated with a 7 percent drop in the rate of fatal crashes caused by drunken drivers. Another study found that laws covering all offenders were associated with 15 percent fewer alcohol-related fatalities compared with states that have less stringent laws. (more…)

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