The FDA Tells Congress E-Cigarettes Are Unsafe—and Illegal

Public pressure is mounting against e-cigarettes. At a US House Committee on Energy and Commerce hearing today on e-cigarettes’ effect on public health, US representatives blasted government officials for being slow to act, and those officials responded with concern but few solutions.

“E-cigarette products are not safe,” said Ned Sharpless, acting commissioner of the Food and Drug Administration, before a US House Committee on Energy and Commerce hearing today on e-cigarettes’ effect on public health.

Sharpless then clarified that all e-cigarettes currently on the market are illegal because they haven’t been assessed by the FDA. But Sharpless said the agency is still weeks away from finalizing any policies that would increase enforcement and remove products from the market.

Originally marketed as a safer alternative to combustible cigarettes, vaping has come under intense scrutiny after a recent spate of illnesses. The US Centers for Disease Control and Prevention and the FDA are investigating a mystery respiratory illness related to vaping. So far, 530 cases, mostly involving formerly healthy young adults, have arisen across the United States, and seven individuals have died. Patients have experienced shortness of breath, chest pains, and even nausea, and some sufferers have been put on ventilators. But after more than a month of investigation, the CDC and FDA haven’t yet named the cause of the illnesses, and the CDC estimates the number of cases will continue to rise.

Now federal agencies are taking action. Earlier this month, the FDA warned the largest US e-cigarette maker, Juul, that it could no longer claim its products are safer than cigarettes. The Federal Trade Commission recently started investigating Juul’s marketing techniques, specifically whether the company used social media influencers to illegally target children. On Monday, federal prosecutors in California announced they are also launching a probe, the exact target of which is currently unknown.

Congressional representatives at the hearing expressed frustration with the FDA for not acting sooner. “Given the potential risks associated with these products, it would be reasonable to assume these products had been reviewed and approved by the FDA,” said Diana DeGette, the Democratic representative from Colorado who chaired the hearing. “But they haven’t.” Frank Pallone, a Democratic representative from New Jersey, said it was “long past time” for the agency to act.

Recent studies suggest e-cigarettes can cause acute harm to blood vessels and restrict blood flow. The products may also compromise the lungs’ ability to fight off infections, and vape juice has been found to contain toxic flavorings. Very little research supports e-cigarette companies’ claims that the devices can help adults quit smoking. One study did find that e-cigarettes were more effective than other smoking cessation therapies at getting smokers to quit regular cigarettes. But many of those quitters continued to vape a year later. Other work shows teenagers who vape are 30 percent more likely to start smoking combustible cigarettes than teens who don’t routinely use e-cigarettes.

Despite their apparent dangers, e-cigarettes continue to be wildly popular among teenagers and young adults. Last week, the National Institutes of Health released data showing that a quarter of high school seniors, and 20 percent of juniors, vape. Usage among high schoolers has doubled over the past two years, with e-cigarettes’ fruity and minty flavors reportedly appealing to many teens. At the hearing, CDC representative Anne Schuchat noted many kids aren’t even aware that e-cigarettes contain nicotine.

Sharpless says the FDA is finalizing a compliance policy for e-cigarettes, which may temporarily ban flavors including menthol and mint until the agency can review their safety. That policy would not amount to a blanket ban, he says, as flavors may reappear on the market if e-cigarette companies can show they are what the agency terms “appropriate for the protection of the public health,” meaning that they provide a safer alternative to traditional cigarettes.

Retailers are also backing away from e-cigarettes. Walmart announced it will no longer sell e-cigarettes at Walmart or Sam’s Club stores. Rite Aid removed the products from stores in April. Last week, CNN, CBS, Viacom, and WarnerMedia all said they will stop running e-cig advertisements on their networks as well.

In response, Juul, the largest e-cigarette maker in the US, announced today it would cease all of its print, broadcast, and digital advertising. It will also stop lobbying the Trump administration and the FDA and promised to “fully support and comply” with the agency’s guidelines.

Juul also announced today that CEO Kevin Burns is stepping down and will be replaced by KC Crosthwaite, the chief growth officer of Altria, a tobacco company that owns 35 percent of Juul.

“This announcement strips away any doubt about Juul. It is Big Tobacco,” writes Matt Myers, president of the Campaign for Tobacco Free Kids, in a statement. “No one should be lulled into thinking that Juul has changed.”

Schuchat stopped short of saying no one should vape, but said the CDC advises against it for children and young adults, pregnant women, and adults who don’t smoke. The agency also doesn’t advise smokers to try using e-cigarettes to quit. Instead, it suggests more traditional alternatives, like nicotine-replacement gums and patches.