FDA’s Juul Inquiry Found Consumers Had 2,600 Health ComplaintsJanuary 13, 2020
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,”…