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People vaping June 2015

Vaping has spiked in recent years as sweet and fruity flavors take hold among teens, creating the first upswing in tobacco use last year after two decades of decline. | Justin Sullivan/Getty Images

Health Care

At least 193 potential cases, including one death, have been reported to the federal government this summer.

A mysterious outbreak of critical lung disease in scores of teenagers and young adults is forcing federal agencies to grapple with a vast, nearly unregulated market of nicotine- and marijuana-based vaping products.

At least 193 potential cases, including one death, have been reported to the federal government this summer. Yet since the first case was logged in June, agencies have released no product recalls, nor any details or broad public awareness campaigns about which specific vaping products might be causing the illness.

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Leading scientists and public health experts, including former FDA commissioners, want the CDC and FDA to step in and warn people about certain vapes, or even pull some products off the market. Key congressional chairs want FDA to step in with regulations now to halt a growing youth vaping epidemic that has taken a tragic turn. Meanwhile, federal officials are struggling with few concrete leads — sometimes nothing more than an unlabeled plastic vaping tube — as they try to find answers.

“It’s important for CDC and FDA to tell the public what they know: Which products are [the illnesses] associated with?” said former FDA Commissioner David Kessler. Doing so wouldn’t mean other products are safe, he said — but agencies have to tell the public about known risks.

Vaping has spiked in recent years as sweet and fruity flavors take hold among teens, creating the first upswing in tobacco use last year after two decades of decline.

To many public health groups’ chagrin, FDA in 2017 pushed a deadline for e-cigarette review back to 2022, though it recently moved it up a year. Many — but not all — e-cigarette brands on sale in the U.S. are legal. But none have undergone review, and hundreds of new flavored and THC-infused vapors have flooded the market as vapes' popularity grows. THC is the part of marijuana that creates the “high” — and while some states have legalized it, others have not. Because the federal government still designates it a dangerous drug, there are no national safety standards or safeguards.

Sen. Dick Durbin (D-Ill.), an outspoken vaping critic whose state announced the only death reported so far from the mystery illness, called Tuesday for more e-cigarette regulation. “Press releases and incremental bureaucratic half-measures have failed,” Durbin wrote in a letter to acting Commissioner Ned Sharpless. “FDA’s inaction is alarming and has become dangerous."

State health officials, who are conducting their own investigations, are scrambling to step into the vacuum of federal regulatory limbo on e-cigarettes and marijuana products. Some are frustrated there isn’t a centralized database where state officials can report cases and double-down on detecting the cause — or causes — of the outbreak.

“That lack of ability to quickly share information across the country and to CDC electronically complicates things, slows things down and makes it harder to spot commonalities,” said Minnesota Health Commissioner Jan Malcolm. “We hope the public attention prompted by what appears to be an outbreak can call attention to the need for that infrastructure.”

In the meantime, states are sharing data amongst themselves. Wisconsin and Illinois jointly developed investigative tools that other states are using while officials work toward developing a national system with the CDC.

Federal officials and states are also developing uniform definitions so all the cases can be registered and counted the same way, state officials familiar with the discussions said.

In an alert to clinicians earlier this month, the CDC urged doctors to ask about e-cigarette use when they talk to patients with an unclear respiratory or pulmonary illness and to report cases involving a vaping patient to state or local health departments.

CDC is also in early-stage discussions about releasing a national alert, two state officials said. FDA is testing samples, searching for a pattern in the vaping products used by the dozens of sick teens and young adults. But sometimes they have little to go on besides a plastic tube with no company name or other identification on it. Still, the patchy information they have released has led to growing criticism of the regulatory response.

FDA has weathered criticism of its approach to e-cigarette regulation before. The agency earlier this year released a draft plan for curbing underage sales and in May was ordered by a federal judge to speed up its timeline for manufacturers to submit marketing applications. It also recently proposed adding some e-cigarette ingredients to its list of harmful and potentially harmful ingredients.

A recent survey conducted for POLITICO by Harvard's T.H. Chan School of Public Health found that nearly half of Americans think electronic cigarettes are “very harmful” — double the percentage who think the same of marijuana. Two-thirds of those polled thought e-cigarettes should be taxed at the same rate as cigarettes.

Federal officials have ratcheted up general warnings about vaping. Then-FDA Commissioner Scott Gottlieb called the phenomenon an epidemic last year, and Surgeon General Jerome Adams issued a rare public health warning shortly after Gottlieb's call to curb teen use.

CDC did not respond to multiple requests for comment. An FDA spokesperson said the agency is working with CDC and state health officials "as quickly as possible to gather more information" and urged the public to report possible cases through its online Safety Reporting Portal.

The causes of the outbreak aren’t clear, said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “However the fact that these companies, e-cigarette companies, have not been required to submit their products for review for all of these years is one of the reasons we have so little information.”

In the absence of hard answers from the federal government, speculation abounds. California and New York state reported at least some of their cases were linked to THC products, fueling speculation — backed by the nicotine vaping industry — that black-market THC vape makers are responsible. Minnesota officials said seven of nine confirmed cases involved THC vapes.

The leading theory at the moment is that the culprits are largely counterfeit vapors, bought on the black market or tampered with in some way — resulting in clusters of cases in certain states and cities. That makes finding answers all the more difficult. States have shipped product samples to FDA for testing, but without standardized packaging and ingredient lists it’s difficult for the agency to know what it’s looking for or what to recall.

“It’s a little mind boggling how illegal — or unregulated — products can be out there without adequate monitoring. It’s a classic example of chasing the horse after it’s out of the barn, and the federal government needs to catch up,” said former FDA Commissioner Kessler.

Even if the cause is the illegal brands it doesn’t mean big companies like Juul, with its sleek, USB-like technology and easily inserted cartridges — should be let off the hook, Gottlieb said.

“The manufacturers bear some responsibility here because these things are being vaped on top of legitimate hardware,” Gottlieb said. “The manufacturers are responsible for their legitimate hardware getting in the hands of the kids.”

Democratic lawmakers seem to agree. Besides Durbin, Energy and Commerce Chair Frank Pallone (D-N.J.) this month asked Juul and four other e-cigarette makers to provide the committee with details on their products’ safety and potential toxicity. He followed up with a request this week that CDC and FDA brief him on their response to the lung cases. House Appropriations Chair Nita Lowey (D-N.Y.) joined the chorus Tuesday.

Some scientists argue that the disease is not caused by one-off batches of bad products or marijuana vape problems, but points to a larger risk of vaping that has been ignored.

Irfan Rahman, a researcher at the University of Rochester Medical Center, suspects that the main cause is the oil used as a suspension for many vaping products, including nicotine, THC or another popular marijuana component, CBD, producing a disease called lipoid pneumonia. Since e-cigarette manufacturers have not filed applications with FDA yet, it’s difficult to know how many nicotine-based products use these oils and which could be most problematic. A January medical journal article, for instance described a case of severe lung illness linked to butane hash oil that bears a strong resemblance to the current spate of cases across the country.

There are no standard medical codes for vaping injuries so no one has been tracking them, pointed out Ilona Jaspers, a toxicologist at the University of North Carolina. This is an “I told you so” moment for her, because the health risks of cigarettes and vaping are not comparable since they contain different substances.

“It’s something I expected from the beginning,” she said. “We’re going to be finding things we’ve never seen with smoking cigarettes. It’s a different disease.”

For doctors, there is the looming possibility that past cases may have been written off as other illnesses, such as severe cases of pneumonia or the flu.

“Do I think it's missed? It is. But not because we're bad doctors, but this is a new epidemic,” said Dr. Panagis Galiatsatos, director of the Tobacco Treatment Clinic at Johns Hopkins.

“Anyone who cares for adolescents needs to be asking the right questions. If we’re not asking specifically about Juul or other e-cigarette devices, we don’t know whether or not a child is at risk,” said Dr. Jonathan P. Winickoff, a pediatrician at MassGeneral Hospital for Children and a past chair of the American Academy of Pediatrics’ tobacco consortium.

The vaping industry is adamant that these cases do not have to do with well-known products. Nearly every product identified in the outbreak has been a THC product “bought on the street,” claimed vapor industry lobbyist Mike Hogan, who represents the Smoke-Free Alternatives Trade Association. Calling it a vaping illness “is like blaming food poisoning on ‘eating,’" Hogan said.

While FDA can lay out guidelines for what should be in e-cigarette products, inspecting facilities and order bad products off the market, it can’t touch THC vapes as long as marijuana is still an illegal drug. That leaves state public health officials and doctors to figure out how to quell the current outbreak and regulate marijuana vapes in the future. In the meantime, frustration grows over the lack of federal action.

“I view this as very atypical. I have never seen CDC act in this way,” said Michael Siegel, a Boston University tobacco control researcher who has also worked in CDC’s office on smoking and health. The agency has given “vague” answers to questions about the products and current cases, he said.

“My feeling is that based on the evidence out CDC should be issuing warnings against three things: 1) don’t vape THC oils. 2) don’t vape any oil-based product; and 3) don’t vape products off the street,” Siegel said.

“Until there is some breakthrough with lab testing we’re just not able to pinpoint the cause,” said Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials. “It’s a whole lot of, we don’t really know.”

Arthur Allen and Joanne Kenen contributed to this report.


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