Faced with a worsening epidemic of teenage vaping and a mysterious illness stalking users of cigarette alternatives, the Trump administration promised to ratchet up its oversight of a burgeoning but increasingly troubled industry.

President Donald Trump said Wednesday that vaping had become an urgent public-health concern in the U.S., “specifically with respect to children.” Health and Human Services Secretary Alex Azar told reporters that 5 million kids say they’ve vaped this year, a steep and startling jump from the 3.6 million who told government surveyors they’d used e-cigarettes in 2018.

“We may very well have to do something very, very strong about it,” Trump, flanked by Azar and Acting Food and Drug Administration Commissioner Ned Sharpless, told reporters in the White House Oval Office.

Vaping has been touted as a safe and effective way for adult smokers to quit their cigarette habits, and investors have poured billions of dollars into the business. But a combination of candy-like flavorings, sleek electronic devices and on-trend social-media marketing have also lured kids. The jarring rate at which teens have adopted devices like the compact, easy-to-hide one made by Juul Labs Inc. has made health officials in Washington and around the country snap to attention.

Additionally, vaping appears to be making more and more people sick. A mysterious lung disease that has been linked to inhaling vapor has killed six people and injured hundreds more people across the U.S. this summer. State and federal investigators are racing to identity the precise cause of the ailment.

Azar said the FDA would issue guidance in coming weeks intended to clamp down on the sale of almost all flavored vaping products. The U.S. health agency has been moving deliberately in regulating the industry, but the stunning increase in vaping by school-age children has increased public pressure for regulators to step in.

Under the changes previewed by Azar, flavored vaping products with the exception of tobacco-flavored offerings would be removed from the market within 30 days. Producers of other flavors would then have to apply to resume sales. To gain FDA approval, an e-cigarette manufacturer must prove that the benefits of its product outweighs the risks, including the potential for underage vapers to pick up the habit.

Big Business

The FDA had been looking to limit most flavored e-cigarette product sales, excluding mint and menthol, to online sales with age verification and vaping shops.

Former FDA Commissioner Scott Gottlieb originally viewed e-cigarettes as a possible way to help adult smokers quit and sought in 2017 to ease regulation on them, pushing back to 2021 the date vape manufacturers would have to apply for agency approval to stay on the market. The deadline was moved up to May 2020 by a judge in July who also ruled e-cigarettes could stay on the market for a year while FDA reviews their application.

The agency guidance announced Wednesday instead would require vape devices to come off the market soon and await FDA clearance.

Cigarette alternatives, including vaping pens, have become a big business. Juul Labs, which has the biggest share of the U.S. market for e-cigarettes, is one of the country’s most richly valued closely held startups. Marlboro maker Altria Group Inc. last year invested about US$13 billion in Juul at a valuation of approximately US$35 billion. Altria shares ended higher after a brief slide, gaining 1.1 per cent to US$44.72.

“We agree that urgent action is needed and we look forward to reviewing the guidance,” Steven Callahan, a spokesman for Altria, said. “Reducing youth use of e-vapor products is a top priority for Altria.”

Juul voluntarily pulled many of its flavors, with the exception of mint and menthol, out of stores already in response to the youth vaping epidemic. Juul didn’t respond to a request for comment.

Juul’s marketing tactics have drawn growing scrutiny from regulators and lawmakers. The FDA sent Juul a warning letter Monday that said the agency had determined that the company has marketed its products as less risky than cigarettes without gaining the agency’s approval. A Juul representative said then that the company was reviewing the letter and would cooperate with the agency.

Stricken Vapers

Around the U.S. this summer, doctors have seen hundreds of cases where patients — often youthful, previously healthy adults — have shown up in the emergency room, suddenly stricken with dangerous respiratory damage. More than 450 cases of the respiratory condition were reported as of Sept. 6, according to the Centers for Disease Control and Prevention. The severity of the cases vary.

The links between that disease and vaping nicotine haven’t been firmly established. Some health officials have connected the ailment to inhaling vapor tinted with THC, the chemical that creates the high from smoking marijuana. Regulators have said some users reported inhaling vapor of THC or CBD, another compound found in pot.

Vaping’s link to youth use and the lung illnesses has led to a growing call among lawmakers to crack down on the devices. Senator Mitt Romney, a Utah Republican, tweeted Tuesday that the FDA “should consider recalling e-cigarettes.”

Senator Dick Durbin, an Illinois Democrat, also told FDA’s Sharpless last week to better regulate e-cigarettes within 10 days or the lawmaker would call for his resignation.

“Finally, the FDA is doing its job,” Durbin said in a statement Wednesday.

Still, some observers worried that the shift could harm the health of people trying to quit tobacco. Daren Bakst, a senior research fellow at the Heritage Foundation, a conservative think-tank, said the move will make it harder to adults to stop smoking regular cigarettes by restricting the alternatives.

“The last thing you want to do is make it more difficult for smokers to quit smoking, and flavors do play a role for adults to quit smoking,” Bakst said in an interview. “The more options you have, the better for them to quit.”

Sickness’s Source

Congress gave the FDA the authority to oversee tobacco in 2009. The agency began policing cigarettes then, but it didn’t add e-cigarettes to its portfolio until 2016. According to a statement from HHS, the FDA plans to make more details of the plan and its implementation public soon.

The CDC has said anyone who uses a vape device should consider stopping while public-health officials investigate the cause of the condition. The public-health agency said on Friday that the lung-injury cases were appearing most often in people who used vaping products containing THC.

State health officials in New York have pointed to vitamin E acetate as a likely culprit. While thought to be harmless when used as a nutritional supplement, it could carry risks when inhaled and has been found in some products, said New York health officials.

Michael R. Bloomberg, the founder and majority owner of Bloomberg News parent Bloomberg LP, has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco.