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HealthBrainstorm Health

Brainstorm Health: The FDA’s E-Cig Ultimatum, Apple Watch ECG, Cancer Around the Globe

By
Sy Mukherjee
Sy Mukherjee
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By
Sy Mukherjee
Sy Mukherjee
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September 12, 2018, 2:31 PM ET

Hello and happy hump day, readers. This is Sy.

The Food and Drug Administration (FDA) has taken steps over the past several years to ramp up crackdowns on tobacco use, particularly among young Americans. Now, the regulatory body is taking aim at one of the fastest-growing sectors in the nicotine and tobacco industries—e-cigarettes and vapes, the use of which the FDA says has become an “epidemic” among teens. And a number of popular products, including flavored smokes like JUUL and Blu—could potentially be yanked off shelves if their manufacturers don’t do more to clamp down on teenage use.

“We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” said FDA Commissioner Scott Gottlieb in a statement Wednesday. “This starts with the actions we’re taking today to crack down on retail sales of e-cigarettes to minors.”

“Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications,” continued Gottlieb. Translation: these five e-cigarette developers, alongside other online liquid nicotine retailers, risk their right to sell at all if they don’t provide satisfactory plans to curb youth use of vaping products.

Last year, the FDA announced preliminary plans to cut the amount of nicotine in cigarettes in an effort to fight addiction.

Read on for the day’s news.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

Apple Watch will have the first OTC heart monitor. Some big news out of Apple's major September 12 event: The Apple Watch Series 4 will, as expected, include an electrocardiogram that can monitor your heart rate. That will make the device the first over-the-counter, commercial ECG on the market—and is sure to raise plenty of debate about the usefulness of the heart data gleaned from the device, including its potential applications in widescale, real-world scientific studies. (Fortune)

INDICATIONS

Hurricane Florence hits Pfizer manufacturing in North Carolina. Underscoring the broader effects that natural disasters can have on critical industries, the specter of Hurricane Florence has forced drug giant Pfizer to pause operations at a manufacturing plant in North Carolina. The devastating storms that hit Puerto Rico last year had an outsize effect on generic and IV drug production. (BioPharma Dive)

THE BIG PICTURE

Cancer swells around the world. The number of cancer-related deaths is expected to reach 9.6 million this year, a 1.4-million-person increase from 2012 (the total number of cancer cases is also expected to rise from 14.1 million cases six years ago to 18.1 million in 2018, according to the International Agency for Research on Cancer (IARC) report). But there are a number of factors driving that trend—including longer life expectancies and an ever-growing population around the globe. In the United States, for instance, the rate of cancer-related deaths has actually been among the falling causes of death in the country, potentially spurred by more widespread insurance coverage, cuts in adult tobacco smoking, and the advent of new drugs. Still, matters are more complicated abroad and in poorer nations. (BBC)

REQUIRED READING

The Low Expectations for Alibaba's New CEO, by Clay Chandler

You Discovered Your Genetic History. Is It Worth the Privacy Risk? by Monica Rodriguez

California Commits to 100% Carbon-Free Power by 2045, by Brittany Shoot

CEO Turnover Reached an All-Time High In August, by Emma Hinchliffe

Produced by Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

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