FDA’s Juul Inquiry Found Consumers Had 2,600 Health Complaints

Juul Labs Inc. received roughly 2,600 complaints about adverse health effects related to its e-cigarette during its first three years in operation, with customers citing issues such as burning sensations in the lungs, blistered lips and vomiting, according to an internal report by the U.S. Food and Drug Administration.

The report, which was released to Bloomberg News under the federal Freedom of Information Act, contains few details about the anonymous consumers’ complaints or health outcomes. It cites only one “serious adverse event,” in which a woman reported that her throat bled after she used a Juul product.

The rate of complaints received per Juul pods sold “is very low,” said Austin Finan, a Juul spokesman. “We take product safety very seriously and implement stringent quality control measures to ensure the safety of all our products.”

The customer complaints were contained in a Juul Labs database that the FDA reviewed as part of a high-profile inspection of the San Francisco firm in September 2018. While the company has said its mission is to provide “adult smokers with a real alternative to cigarettes,” federal regulators in 2018 began taking steps to stem the proliferation of its products, citing fears of an epidemic of regular nicotine use among teens. In addition to staging sting operations to catch retailers selling Juuls to minors, FDA officials conducted the inspection at Juul’s headquarters. The agency’s inquiry remains ongoing.

The company’s internal database logged nearly 1.3 million general complaints from both adults and youth between June 1, 2015, when Juul first launched its product, and Sept. 26, 2018. Only 317 of them were categorized as “health experiences” or “health events,” but Juul later uncovered an additional 2,300 health-related complaints that weren’t captured by the database. The additional cases surfaced only after the company became aware in July 2018 that some consumers were submitting complaints through an online channel that asked users to “elaborate on their Juul experience.”

The combined total for health-related complaints, roughly 2,600, represents about 0.2% of the entries in the database.

In the report, the company defines the term “health experience” as “an illness, safety concern, or adverse event that a customer attributes to using Juul products, or an unintended exposure to Juul products, which may or may not have involved a visit to a health-care provider.”

The health complaints included reports of a range of symptoms, including pain in the mouth, burning sensation of the lungs, canker sores, numbness or “tingling” of the mouth and lips, fever, chills and lightheadedness. The report provides details about one of the more serious consumer complaints.

“I tried to utilize the starter packs pods and the fruit flavor was so harsh that it made me cough to the point where my throat started to bleed. I am not exaggerating,” the customer said, according to the FDA’s report. She saw a doctor and was prescribed an antibiotic after being “diagnosed with a burned throat.”

She had used Juul’s mango pods, according to the report. The company took that flavor off the market in October, along with creme, fruit and cucumber flavors, in response to growing concerns that such flavored nicotine products are too enticing for kids.

About 12% of the complaints, roughly 156,000, stemmed from a problem with Juul pods that caused the highly concentrated nicotine liquid to leak into users’ mouths — an issue that has dogged Juul since its inception. Only a few of those complaints cited health-related issues: Some customers reported having “accidentally ingested” nicotine liquid that leaked from pods and becoming ill, according to the report. One consumer reported a burning sensation in the eyes after the liquid squirted from a leaky pod.

Juul investigated and “determined that leaks did not constitute a significant health hazard,” said Finan, the company spokesman. That determination was “based on a review of related complaints, scientific analysis, including toxicology, and literature review, conducted by various subject-matter experts,” he said.

The FDA’s report stated that while the company had a mechanism in place to recall products, it had never done so in the U.S. market. The report said that in response to health or medical complaints, the company “typically offered consumers free product replacements or percentage off coupons” for new Juul products.

As Juul executives continued to review “root causes” of the leaks, they decided that they couldn’t make any changes to the pod and its design without first submitting a new marketing application for FDA approval, which could take months or years to obtain. Under the agency’s so-called deeming rule, any changes made to e-cigarettes already on the market that occurred after August 2016 could be considered a new tobacco product.

Juul remains committed to the FDA’s approval process, Finan said, “and to that end we have built a robust scientific research program to assess the harm-reduction potential of Juul products.”

According to the report, Juul executives were grappling with other issues at the time of the September 2018 inspection — specifically, the company was looking into questions about the “purity and quality of raw materials” associated with Juul pods and the “mislabeling of products with incorrect flavors,” the report says.

Finan said the purity and quality testing was “preventive,” and that all products tested “met specifications with no further action required.” After receiving a consumer complaint, Juul did find some mislabeled boxes of flavor pods, he said, but the company found that those pods were all filled correctly. A health hazard evaluation “determined the product did not present a health hazard,” he said.

The company has been under fire from the FDA and other federal agencies for a variety of reasons, including whether it illegally marketed Juul to kids, and made unapproved cessation and modified risk claims. The agency issued a warning letter to Juul in September saying the company had made unauthorized claims about its products being safer than combustible cigarettes. It sent a second letter requesting more information about the company’s outreach and marketing. Juul has also been the target of a congressional investigation, and lawsuits by state attorneys general as well as consumers.

The company, which had become the world’s third-most-valuable startup after cigarette maker Altria Group Inc. invested $12.8 billion in December 2018, found itself embroiled in a public health crisis last summer. People who used vaping products began showing up at hospitals with chronic lung injuries that shared pneumonia-like symptoms and signs of chemical burns. None of those cases has been tied to Juul or its pods; in November the Centers for Disease Control announced that the injuries likely resulted from inhaling vitamin E acetate, a viscous additive in some vaping products, mainly those that contained oils from THC.

Still, there are lingering questions over the safety of vaping, including the long-term health effects of routinely inhaling the base components of most e-liquids, as the fluids are commonly called. Those include propylene glycol, vegetable glycerin, benzoic acid and flavoring compounds that often contain hundreds of constituent chemicals.

On Jan. 2, the FDA announced a ban on all cartridge-based flavored nicotine products, except tobacco and menthol flavors, in response to increasing pressure from anti-vaping advocates.

–With assistance from Robert Langreth.