Picture: REUTERS
Picture: REUTERS

Washington — 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 US, “specifically with respect to children”. Health and human services secretary Alex Azar said that 5-million children say they have  vaped in 2019, a steep and startling jump from the 3.6-million who told government surveyors they had  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 (FDA) commissioner Ned Sharpless, said 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 flavourings, sleek electronic devices and on-trend social-media marketing have also lured teens. The jarring rate at which teens have adopted devices such as the compact, easy-to-hide one made by Juul Labs has made health officials in Washington and around the country snap to attention.

Mysterious lung disease

Additionally, vaping appears to be making more and more people sick. A mysterious lung disease that has been linked to inhaling vaped smoke has killed six people and injured hundreds more people across the US in the past few months. State and federal investigators are racing to identify 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 flavoured vaping products. The US 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, flavoured vaping products with the exception of tobacco-flavoured offerings would be removed from the market within 30 days. Producers of other flavours 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 flavoured 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 on Wednesday instead it 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 US market for e-cigarettes, is one of the country’s most richly valued closely held startups. Marlboro maker Altria Group 2018 invested about $13bn in Juul at a valuation of approximately $35bn. Altria shares fell as much as 1.7% in New York trading on Wednesday.

“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-cigarettes) products is a top priority for Altria.”

Juul voluntarily pulled many of its flavours, with the exception of mint and menthol, out of stores already in response to the youth vaping epidemic. Juul did not 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 on 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.

US 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 September 6, according to the Centers for Disease Control and Prevention. The severity of the cases vary.

The links between that disease and vaping nicotine have not been firmly established. Some health officials have connected the ailment to inhaling vapour tinted with THC, the chemical that creates the high from smoking marijuana. Regulators have said some users reported inhaling vapour 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 on 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 on 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 flavours 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 did not add e-cigarettes to its portfolio until 2016. According to a statement from the health department, 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 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.

With assistance from Tiffany Kary.

Bloomberg