Skip to Content

The FDA Moves to Ban Flavored E-Cigs. What Happens Next?—Brainstorm Health

Hello and happy hump day, readers!

The reckoning has begun for the e-cigarette and vaping industry. Following increasingly urgent reports of an epidemic of youth vaping and hundreds of cases of mysterious lung illnesses—and, now, six deaths—allegedly linked to such products, the Trump administration is moving to ban flavored e-cigarettes from the market altogether.

"The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities," said Health and Human Services (HHS) Secretary Alex Azar in a statement on the Food and Drug Administration (FDA) website. "We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth."

This story has escalated rapidly. While the Obama-era Tobacco Control Act of 2009 gave the FDA far more authority to regulate tobacco products like conventional cigarettes, e-cigs weren't added to the agency's purview until 2016. By then, the youth vaping trend had already begun to accelerate—and, now, Azar states an estimated 5 million American school children vaped in the past year.

(Anecdotally, I've heard from a number of school teachers that children as young as 12 or 13 have openly vaped in their classrooms, and that administrators have had to develop new protocols to prevent on-campus vaping.)

So what comes next? First, the FDA will release its official guidance and rulemaking over the next several weeks. This is expected to include requirements that any flavored vaping products, or those that aren't specifically "tobacco" flavored, would have to yank such products from the market within 30 days. Companies that take offense would have to justify remaining in stores by showing their products are more beneficial than harmful (a claim that Juul has previously made, much to the FDA's chagrin).

There is, of course, also the specter of litigation. There are now several lawsuits, including at least planned class-actions, against Juul over health and safety concerns and marketing allegedly targeting teens.

Much more on this soon.

Read on for the day's news.

Sy Mukherjee, @the_sy_guy, sayak.mukherjee@fortune.com

DIGITAL HEALTH

New stem cell tech could herald mass production of embryo-like structures. Researchers have successfully used stem cells in order to create early embryo-like structures that could herald a major in advance in both drug development and fertility research. “This study could help to understand and help prevent early pregnancy loss,” UCLA stem cell biologist Amander Clark tells Nature. “Women who have repeat early pregnancy failure should now have hope that scientists are working on approaches to help understand why this occurs.”(Nature)

INDICATIONS

Report: OxyContin maker reaches tentative opioid settlement. Reuters reports that OxyContin maker Purdue Pharma has reached a tentative settlement in some of its pending opioid litigation. The settlement, encompassing more than 2,000 plaintiffs over Purdue’s alleged role in exacerbating the opioid crisis, could be worth up to $12 billion. (Reuters)

THE BIG PICTURE

The number of children with health insurance is falling. The number of insured American children fell for the second consecutive year, according to a new Census Bureau report. 5.5% of children under the age of 19 are now uninsured, according to the study, reversing a decade-long trend of falling uninsurance among American youth. Several factors may be playing a role, including more challenging, recent requirements to qualify for Medicaid in certain states. (NPR)

REQUIRED READING

10 Questions to Ask in a Job Interview to Really Stand Outby Anne Fisher

Will Apple’s New Streaming Service Mean Upside for Investors? by Anne Sraders

Oracle Co-Chief Mark Hurd Takes Health-Related Leave of Absenceby Bloomberg

What We Learned from the Fortune Global Sustainability Forumby Eamon Barrett

Find past coverage. Sign up for other Fortune newsletters.