Updated on Sept. 27 at 7:06 p.m. ET to reflect the latest information from federal agencies
An outbreak of severe lung disease among users of electronic cigarettes continues to spread to new patients and states.
According to the latest report from the Centers for Disease Control and Prevention, a total of 805 cases have been reported in 46 states and the U.S. Virgin Islands. The CDC has confirmed 12 deaths, in 10 states. The median age of patients was 23 and 69% were male, according to a report published Friday by the agency.
Public health officials are taking urgent steps to identify what is causing previously healthy vape users to develop pneumonia-like symptoms. But the results are still inconclusive.
In a press briefing on Friday, the CDC reported that the investigation is ongoing, and involves several federal agencies and state health departments.
"CDC recommends people consider refraining from using e-cigarette, or vaping, products, particularly those containing THC," said Dr. Anne Schuchat, the CDC's principal deputy director.
Here's what we know so far about the outbreak.
What seems to be causing the illness?
"We do not know yet what exactly is making people sick," said Schuchat. But the CDC is now reporting that "THC may play a role." There is still no definitive link to any brand of device, ingredient, flavor or substance among all outbreak patients, but according to the CDC's most recent statement, health officials are beginning to see "patterns emerge."
The outbreak has affected users of both THC- and nicotine-containing products, but it is more prevalent among people using THC than people who report using only nicotine products. Among 514 patients for whom the CDC has information on substances used, nearly 77% report having vaped THC, 36% report using THC as well as nicotine, and 16% report vaping only nicotine.
According to a report published Friday on 86 cases in Wisconsin and Illinois, investigators found that of the THC-products used by patients, nearly all were prepacked, pre-filled cartridges acquired from informal sources like friends and illicit dealers.
In all confirmed cases, patients reported vaping within 90 days of developing symptoms, and most had vaped within a week of symptom onset. Patients with confirmed cases have been tested to rule out infections that could explain their symptoms. There is no indication that the outbreak is contagious.
What are the symptoms?
Patients report experiencing rapid onset of coughing, weight loss and significant breathing difficulties. Other symptoms may include nausea, vomiting and diarrhea. Symptoms generally appear over the course of a few days but can take as long as a few weeks to arise. The majority of patients are hospitalized, and while many of their symptoms overlap, their various diagnoses have included lipoid pneumonia (which can occur when oil enters the lungs), acute eosinophilic pneumonia (caused by the buildup of a type of white blood cell in the lungs) and acute respiratory distress syndrome.
What are public agencies doing to get to the bottom of this?
The CDC is working closely with affected states to understand the nature of the illness and the extent of its impact. The Food and Drug Administration issued a statement saying it is "deeply concerned about these incidents" and is working closely with the CDC to investigate the outbreak as quickly as possible. The FDA is analyzing a collection of over 120 product samples provided by state public health officials for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids, cutting agents, additives, pesticides, opioids, poisons, heavy metals and toxins.
"More information is needed to better understand whether there is a relationship between any specific products and any specific substances in those products and the reported illnesses," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a press briefing in mid-September.
On Sept. 16, the CDC announced it activated its Emergency Operations Center to provide increased operational support for the response.
The FDA announced Sept. 19 it has enlisted the help of its office of criminal investigations, the law enforcement arm of the FDA. "We are in desperate need of facts," Zeller said. He emphasized that the FDA is not looking to prosecute anyone for personal use of any of the substances linked to the vaping illnesses.
Is vitamin E involved?
Possibly. As NPR reported this month, vitamin E became a "key focus" of New York state health officials' investigation after cannabis-containing vaping cartridges submitted by those who had fallen ill tested positive for vitamin E acetate. But of the e-cigarette products tested by the FDA to date, Zeller said "no one substance or compound, including vitamin E acetate, has been identified in all the samples tested."
Nonetheless, the FDA said in a statement, "it is prudent to avoid inhaling this substance." Vitamin E is a component of many topical consumer products and supplements.
How can a vape user stay safe?
The CDC recommends that people refrain from using e-cigarettes altogether while this investigation is ongoing and especially avoid products from unlicensed vendors. The FDA urges consumers to avoid using THC vaping products, regardless of whether the products were purchased on the street or in stores, owing to the possibility that the products may contain vitamin E acetate.
If people are unable to stop vaping, the CDC suggests they monitor themselves for symptoms and seek prompt medical attention if they experience cough, shortness of breath, chest pain or nausea and vomiting.
Are flavored vapes more likely to be dangerous, and is that why the FDA is planning to ban them?
The role of flavored vape products in the current outbreak is unknown at this time. Some lawmakers and public health advocates have been pushing for flavored vape products to be banned since flavors first entered the market, out of concern that they appeal to children. The timing of the recent move to ban flavored vape products may be linked to the current public concern about overall e-cigarette safety. Paul Billings, national senior vice president of advocacy at the American Lung Association, told NPR that "unfortunately it's taken this crisis to finally prompt this action."
Is this really new, or has it always been a risk of vaping?
Public health officials are working to confirm that this is a new phenomenon and not simply a case of raised awareness among medical providers and patients, but it's too soon to know for sure. Jennifer Layden, chief medical officer of the Illinois Department of Public Health, told reporters, "I don't think we can say if it's a new or newly recognized phenomenon," although according to preliminary findings, "it does appear to be an increase of cases."