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Mysterious youth vaping illness reveals gaping gaps in regulation

  People vaping June 2015 "title =" People vaping June 2015

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

A mysterious outbreak of critical lung disease in many teens and young adults is forcing federal agencies to plunge into a large, almost unregulated market of nicotine- and marijuana-based weapons products.

At least 193 potential cases, including one death, have been reported to the federal government this summer. Yet, since the first case was filed in June, agencies have not released any recalls of the products, nor any details or broad public awareness campaigns on what specific weapons products could cause the disease.

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Leading scientists and public health experts, including former FDA commissioners, want the CDC and FDA to train and warn people about certain vapes, or even pull some products out of the market. Major congressional chairs want the FDA to pass regulations now to stop a growing youth vaping epidemic that has taken a tragic turn. Meanwhile, federal officials are struggling with few concrete wires – sometimes nothing but an unlabeled plastic tube – while trying to find answers.

"It's important for the CDC and the FDA to tell the public what they know: What products are [the illnesses] associated with?" Said former FDA Commissioner David Kessler. To do so would not mean that other products are safe, he said – but agencies must tell the public about known risks.

Vaping has spiked in recent years as sweet and fruity flavors grab the teens and create the first rise in tobacco use last year after two decades of decline.

For many public health chagrin, the FDA in 2017 pushed a deadline for reviewing e-cigarettes back to 2022, although it recently moved it up a year. Many – but not all – e-cigarette brands sold in the United States are legal. But no one has gone through the review, and hundreds of new flavors and THC-infused vapors have flooded the market as vape's popularity grows. THC is the part of marijuana that creates it "high" – and although some states have legalized it, others have not. Because the federal government still designates it as a dangerous drug, there are no national security standards or guarantees.

Sen. Dick Durbin (D-Ill.), An outspoken gun critic whose state announced the only death reported so far from mystery disease, pleaded Tuesday for more regulation of e-cigarettes. "Press releases and incremental bureaucratic half-measures have failed," Durbin wrote in a letter to Acting Commissioner Ned Sharpless. "The FDA's inaction is alarming and has become dangerous."

State health officials conducting their own investigations are entering the vacuum of the federal statutory limbo on e-cigarettes and marijuana products Some are frustrated that there is not a centralized database where state officials can report cases and double-check to discover the cause – or causes – of the outbreak.

"The lack of ability to quickly share information across the country and to The CDC electronically complicates things, slows things down and makes it more difficult to detect commonalities, "said Minnesota Health Commissioner Jan Malcolm." We hope the public attention that is fueled by what appears to be an outbreak can bring awareness to the need for that infrastructure. ”

Meanwhile, states divide data among themselves. Wisconsin and Illinois jointly developed investigative tools that other states use while officials work to develop a national system with the CDC.

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

In a notice to clinicians earlier this month, the CDC urged doctors to inquire about the use of e-cigarettes when talking to patients with unclear airway or lung disease and to report cases involving a vaping patient to state or local health departments.

The CDC is also in the early stages of discussions to release a national alert, said two state officials. The FDA tests and searches for a pattern in the weapons products used by dozens of sick teenagers and young adults. But sometimes they have little to go on besides a plastic pipe without a company name or other identification. Still, the uneven information they have released has led to increasing criticism of the legislative response.

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

Federal officials have picked up general warnings about gunfire, from then-FDA commissioner Scott Gottlieb, who last year called it an epidemic to Surgeon General Jerome Adams giving a rare public health warning shortly after Gottlieb's call to curb teenage use.

The CDC did not respond to several comment requests. A spokesman for the FDA said the agency is working with the CDC and state health officials "as quickly as possible to gather more information" and urged the public to report possible cases through its online security reporting portal.

The causes of the outbreak are not clear, said Matthew Myers, president of the Campaign for Tobacco-Free Children. "The fact that these companies, e-cigarette companies, have not been required to submit their products for review in all these years, is one of the reasons we have so little information."

In the absence of harsh answers from the federal government, speculation abounds. California and New York state reported that at least some of their cases were related to THC products, and fueled speculation – backed by the nicotine gun industry – that THC vape manufacturers of the black market are responsible. Minnesota officials said seven out of nine confirmed cases involved THC vapors.

The leading theory of 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. This makes it more difficult to find answers. States have submitted product samples to the FDA for testing, but without standard packaging and ingredient lists, it is difficult for the agency to know what it is looking for or what to remember.

"It's a bit tricky to guess how illegal – or unregulated – products can be out there without adequate surveillance. It's a classic example of chasing the horse after it is out of the barn, and the federal government needs to take over , "said former FDA commissioner Kessler.

Although the cause is the illegal brands, it does not mean that big companies like Juul, with its slim, USB-like technology and easily inserted cartridges – should be let off the hook, Gottlieb said.

"Manufacturers bear some responsibility here because these things become weapons on top of legitimate hardware," Gottlieb said. "Manufacturers are responsible for keeping their legitimate hardware in the hands of the children."

Democratic lawmakers seem to agree. In addition to Durbin, Energy and Commerce Director Frank Pallone (D-N.J.) This month asked Juul and four other e-cigarette manufacturers to provide the committee with information on the safety and potential toxicity of their products. He followed up with a request this week that the CDC and the FDA brief him on their responses to the lung cases. House Appropriations Manager Nita Lowey (DN.Y.) joined the choir on Tuesday.

Some researchers claim that the disease is not caused by one-off parties with poor products or problems with marijuana vape, but points to a greater risk of condemning 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, and produces a disease that is called lipoid pneumonia. Since e-cigarette manufacturers have not yet submitted applications to the FDA, it is difficult to know how many nicotine-based products use these oils and which can be the most problematic. For example, a medical journal article in January described a case of serious lung disease related to butane hash oil that shows a strong resemblance to today's case of cases across the country.

There are no standard medical codes for gun damage, so no one has tracked them, pointed out Ilona Jaspers, a toxicologist at the University of North Carolina. This is an "I said it" moment for her because the health risks of cigarettes and guns are not comparable since they contain different substances.

"It was something I expected from the beginning," she said. "We will find things we have never seen with cigarette smoking. It is another disease."

For doctors, there is an imminent possibility that previous cases may have been written off as other illnesses, such as severe cases of pneumonia or flu.

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

cares about adolescents, has to ask the right questions. If we don't specifically ask about Juul or other e-cigarette devices, we don't know if a child is at risk or not, says Dr. Jonathan P. Winickoff, pediatrician at MassGeneral Hospital for Children and a former chair of the American Academy of Pediatrics & # 39; Tobacco Consortium.

The vaping industry is adamant that these cases are not related to known products. Almost every product identified in the The rudder has been a THC product "bought on the street," claims steam industry lobbyist Mike Hogan, who represents the Smoke-Free Alternatives Trade Association. Calling it an arming disease "is like blaming food poisoning by" eating, "Hogan said.

While the FDA may issue guidelines on what is supposed to be in e-cigarette products, inspect facilities, and order bad products outside the market, it cannot touch THC vapes as long as marijuana is still an illegal substance. It allows state health agencies and doctors to find out how to interrupt the current outbreak and regulate marijuana vapes in the future. Meanwhile, frustration over the lack of federal action is growing.

"I look at this as very atypical. I have never seen CDC behave this way," said Michael Siegel, a Boston University tobacco control researcher who has also worked in the CDC's Office of Smoking and Health. has given "vague" answers to questions about the products and relevant issues, he said.

"My feeling is that based on the evidence from the CDC there should be warnings against three things: 1) do not vape THC oils, 2) do not vape any oi l-based product, and 3) do not vape products from the street," Siegel said .

"Until there is some breakthrough in laboratory testing, we just can't find the cause," said Chief Marcus Plescia, medical officer for the Association of State and Territorial Health Officials. "There's a lot, we don't quite know."

Arthur Allen and Joanne Kenen contributed to this report.

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