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Jessica Glenza, The Guardian – October 18, 2019
Company said 33,000 bottles will be recalled amid lawsuits alleging they knew the baby powder was contaminated
Johnson & Johnson has voluntarily recalled a single batch of its baby powder after US Food and Drug Administration (FDA) regulators found trace amounts of asbestos in the product. The company said 33,000 bottles of talcum powder will be recalled “out of an abundance of caution”.
The recall comes amid thousands of lawsuits alleging the company knew its baby powder was contaminated with asbestos, a carcinogen. Johnson & Johnson strenuously denied the claims. This is the first time the company has recalled its leading baby powder product.
The same day, the Arizona attorney general announced a $116m settlement against the company, related to its transvaginal mesh implants. The company is also being sued over its role in the US opioids crisis, in a challenging period for its reputation as one of the most trusted brands in the world.
Johnson & Johnson said in a statement that tests conducted by the FDA found sub-trace levels of chrysotile asbestos contamination at concentrations not exceeding 0.00002% in a single bottle purchased from an online retailer. The recall applies to lot #22318RB.
The company said it could not confirm whether the sample was cross-contaminated, whether the product’s seal was intact, or whether the sample was taken from an authentic bottle of Johnson & Johnson talcum powder.
The company said it has conducted “thousands of tests over the past 40 years repeatedly to confirm that our consumer talc products do not contain asbestos”.
Although pediatricians have advised against using talcum powder on infants for decades, arguing there is a risk of inhalation and infection to babies, talcum powder has remained Johnson & Johnson’s best-known household staple. The product is made from pure talc, a mineral which often appears in veins alongside asbestos in the earth.
“Our talc comes from ore sources confirmed to meet our stringent specifications that exceed industry standards,” the company said. “Not only do we and our suppliers routinely test to ensure our talc does not contain asbestos, our talc has also been tested and confirmed to be asbestos-free by a range of independent laboratories, universities and global health authorities.”
Concerns have also been raised about the health impacts of talc itself. For decades, talc was routinely used as a dry lubricant in condoms and latex gloves, until physicians raised health concerns about talc, particularly for women.
In a series of investigations by the New York Times and Reuters, internal documents from Johnson & Johnson revealed some company executives worried about the talcum products, including possible asbestos contamination, further government regulation and public backlash over health concerns.
Linda A. Johnson, Time – October 18, 2019
Johnson & Johnson on Friday recalled a single batch of its baby powder as a precaution after government testing found trace amounts of asbestos in one bottle bought online.
The recalled lot consists of 33,000 bottles which were distributed last year.
J&J said the U.S. Food and Drug Administration found minuscule amounts of asbestos in one bottle during routine testing and notified the company on Thursday. J&J said it immediately began investigating with the FDA.
“The FDA’s testing on prior occasions, and as recently as last month, found no asbestos,” said spokesman Ernie Knewitz.
J&J said it was checking where the bottles were shipped, if the tested bottle is counterfeit or authentic and whether the sample might have been contaminated during testing.
The recall comes as J&J fights thousands of lawsuits in which plaintiffs claim its iconic baby talcum powder was contaminated with asbestos and that it caused ovarian cancer or mesothelioma, a rare cancer linked to inhaling asbestos fibers.
At multiple trials, J&J’s expert witnesses have testified asbestos hasn’t been detected in the talc in its baby powder in thousands of tests over the last 40 years. Several juries have reached multimillion-dollar verdicts against the company, nearly all of which are being appealed or have been overturned on appeal.
Talc, the softest of minerals, is mined from deposits around the world, which can be contaminated with asbestos. J&J says the company and its talc suppliers routinely test their talc to ensure there’s no asbestos. The talc is then crushed into a white powder and purified for use in personal care products to absorb moisture.
The recalled lot of 22-ounce bottles is #22318RB. Consumers who have a bottle from that lot should stop using it; refunds are available through the company’s website .
The company’s shares dropped 5% to $129.33 at midday Friday, following the recall news and, just a day earlier, the announcement of a $117 million settlement with 41 states over allegations the company deceptively marketed its pelvic mesh products by concealing risks.
Jacqueline Howard, CNN – October 18, 2019
Johnson & Johnson announced on Friday that it’s initiating a voluntary recall in the United States of its popular Johnson’s Baby Powder due to low levels of asbestos contamination.
The recall, which is limited to one lot of baby powder bottles produced and shipped in the United States last year, comes in response to a US Food and Drug Administration test that found levels of chrysotile asbestos contamination in samples from a bottle purchased online, according to the company.
“I understand today’s recall may be concerning to all those individuals who may have used the affected lot of baby powder,” Acting FDA Commissioner Dr. Ned Sharpless said in a statement on Friday. “I want to assure everyone that the agency takes these concerns seriously and that we are committed to our mandate of protecting the public health.”
“The FDA continues to test cosmetic products that contain talc for the presence of asbestos to protect Americans from potential health risks,” Sharpless said.
People with a bottle of Johnson’s Baby Powder from lot #22318RB, which includes 33,000 bottles, are advised to discontinue using the product and can contact the company for a refund.
The company noted that the levels found were no greater than 0.00002%, and that at this early stage of its investigation into the matter, it cannot confirm whether cross-contamination occurred, whether the sample came from a bottle with an intact seal or whether the tested product is authentic.
The FDA stands by the quality of its testing and results, and noted that the agency is not aware of any adverse events related to exposure to the lot of affected products.
“FDA handling of the sample and testing followed standard operating procedures for laboratory analysis and FDA sees no indication of cross-contamination,” FDA spokeswoman Lyndsay Meyer wrote in an email to CNN on Friday.
“FDA will be working with Johnson & Johnson to facilitate further investigation to substantiate that the product is authentic. At this time, there is no indication that the product is counterfeit. Additionally, FDA is not aware of any records pointing to counterfeit Johnson’s baby powder in the US market,” Meyer’s email said.
Johnson & Johnson “has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results,” the company said in its announcement.
The company “has a rigorous testing standard in place to ensure its cosmetic talc is safe and years of testing, including the FDA’s own testing on prior occasions — and as recently as last month — found no asbestos. Thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.”
The FDA noted in its statement that it has been conducting an ongoing survey of cosmetic products for asbestos since 2018 and to date has tested about 50 cosmetic products.
As part of that testing, two samples of Johnson’s Baby Powder were tested: one sample from lot #22318RB, which was found to be positive for asbestos, and a second from lot #00918RA, which tested negative for asbestos.
The agency said that it expects to issue the full results from this survey by the end of the year.
Talc is an ingredient used in many cosmetic products, such as baby powder and blush. The FDA has been conducting ongoing research into the potential contamination of talc with asbestos.
For instance, in March, the agency announced tests found asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers.
“Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen. There is the potential for contamination of talc with asbestos and therefore, it is important to select talc mining sites carefully and take steps to test the ore sufficiently,” according to the FDA.
Johnson & Johnson said in its Friday announcement that the “company is acting out of an abundance of caution.”
The company has faced previous allegations of asbestos contamination in its talcum powder.
A Reuters report published last year said that the company was aware for decades of asbestos in its baby powder but did not disclose that information to the public.
Lawsuits have been filed against the company in the United States alleging that asbestos in its talcum powder causes cancer. Some of those cases carried verdicts against Johnson & Johnson with multi-million dollar awards to plaintiffs.
Jen Juneau, People – October 18, 2019
“If you or someone you provide care for owns a bottle of Johnson’s Baby Powder Lot #22318RB, you are advised to discontinue use,” read a press release.
Johnson & Johnson has issued a voluntary recall on a lot of baby powder produced and distributed in 2018.
In a Friday press release out of the company’s headquarters in New Brunswick, New Jersey, Johnson & Johnson stated that they were “acting out of an abundance of caution” in recalling product lot #22318RB.
The recall was issued “in response to a U.S. Food and Drug Administration (FDA) test indicating the presence of sub-trace levels of chrysotile asbestos contamination (no greater than 0.00002 percent) in samples from a single bottle purchased from an online retailer,” the release explained.
“Despite the low levels reported and in full cooperation and collaboration with the FDA, JJCI is initiating this voluntary recall of Lot #22318RB of Johnson’s Baby Powder, from which the tested sample was taken,” it went on.
Furthermore, the company said it “has immediately initiated a rigorous, thorough investigation into this matter, and is working with the FDA to determine the integrity of the tested sample, and the validity of the test results.”
“At this early stage of the investigation,” the release continued, the company can’t confirm “if cross-contamination of the sample caused a false positive,” “whether the sample was taken from a bottle with an intact seal or whether the sample was prepared in a controlled environment” or “whether the tested product is authentic or counterfeit.”
This is not the first time there has been controversy surrounding Johnson & Johnson’s baby powder. A December 2018 report alleged that the company knew for decades that their baby powder had occasionally tested positive for small amounts of asbestos over the years.
In an in-depth Reuters investigation, which examined decades’ worth of internal company and court documents, the outlet found that from 1971 to the early 2000s, Johnson & Johnson had been made aware that the talc in their products sometimes tested positive for the carcinogen, and didn’t share the news outside of the company.
Johnson & Johnson vehemently denied the claims made in the report in a statement provided to PEOPLE, and branded the report “an absurd conspiracy theory.”
In recent years, Johnson & Johnson has faced mounting legal pressure. In 2017, a California woman was awarded $417 million from the company after she filed a lawsuit claiming that their baby powder gave her ovarian cancer. Additionally, this July, a jury in St. Louis awarded nearly $4.7 billion to 22 women who sued the company, claiming that asbestos in the company’s talcum powder had contributed to their ovarian cancer.
Johnson & Johnson has been sued by more than 9,000 women who claimed that the company’s talcum powder was linked to their cancer, although the company has denied this, according to CBS News.
“If you or someone you provide care for owns a bottle of Johnson’s Baby Powder Lot #22318RB, you are advised to discontinue use of the product,” the Friday press release urged of the voluntary recall.
Berkeley Lovelace Jr. and Angelica LaVito, CNBC – September 28, 2019
The furor over vaping reached a crescendo this week with two congressional hearings, hundreds of new cases of a mysterious lung disease, upheaval at e-cigarette maker Juul and canceled merger plans between Big Tobacco companies Altria and Philip Morris International.
The Centers for Disease Control and Prevention has dispatched more than 100 doctors and investigators to try to figure out what’s making 805 people sick and killed at least 13. The early symptoms include coughing, shortness of breath or chest pain, nausea, vomiting, diarrhea, fatigue or abdominal pain.
The Federal Drug Administration and Drug Enforcement Administration have opened a criminal probe into the vaping illnesses while Congress and other agencies conduct their own probes into the e-cigarette industry and market leader Juul.
Here’s what you need to know:
The vaping illness outbreak has now spread to 46 states and one territory with public health officials in 10 states reporting deaths.
The first illnesses cropped up in April and rapidly increased beginning in July. The first death was reported on Aug 23 in Illinois. The most recent fatalities were reported by health officials in North Carolina and Oregon on Thursday. The disease is mostly hitting men, and all reported cases have a history of e-cigarette or vaping use. Of the cases the CDC has demographic data on, 61.9% of the victims were between 18 to 34 years old and 16.2% are under age 18, the agency said Friday.
The specific chemical causing people to fall ill is still unknown. Among the 514 cases where the CDC has data on which substance they were vaping, 76.9% said they used THC and 56.8% reported using nicotine. More than a third of the patients, 36%, said they exclusively used THC while 16% said they only vaped nicotine.
It’s unclear what role e-cigarettes have played in the illnesses. Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products, said there’s “no common thread” in hundreds of cases. Most patients said they vaped THC, the marijuana compound that produces a high. But the CDC has not ruled out anything yet, noting that some people reported using only nicotine.
Until they have more information, the CDC is urging consumers not to buy e-cigarette products off the street or add any substances that are not intended by the manufacturer. Adults who used e-cigarettes containing nicotine to quit cigarette smoking should not return to smoking cigarettes, the agency said.
Advertisements of e-cigarettes with young models, bright colors and fruity flavors have been criticized by health officials, lawmakers and parents for attracting young people to vaping. States, local and international health regulators are taking action.
Michigan is the first state to ban sales of flavored e-cigarettes, while San Francisco became the first U.S. city to prohibit the sales of flavored e-cigarette products. Boulder, Colorado, has passed a similar measure. Washington state Gov. Jay Inslee directed officials to ban the products on Friday.
Israel’s Ministry of Health is imposing an immediate ban on the sales of oil-based flavored vaping pods, according to the Times of Israel. Health and Human Services Secretary Alex Azar said earlier this month that President Donald Trump was preparing a ban on flavored e-cigarettes as the vaping-related deaths intensified.
U.S. lawmakers are seizing on the outbreak to scrutinize the e-cigarette industry. A House panel that is investigating the market leader Juul pressed a top CDC official on Tuesday for answers on what’s making people sick. The FDA has also come under fire from lawmakers and public health groups for dropping the ball in regulating the vaping industry.
The nation’s leading e-cigarette maker, Juul, has come under pressure over the last year for allegedly marketing to underaged kids. But it’s now getting caught up in the public health crisis, even though federal officials say illegal or counterfeit products are likely to blame. Doctors still can’t rule anything out, they say.
Juul replaced its CEO Kevin Burns with former Altria executive K.C. Crosthwaite on Wednesday, the day after confirming it was going to reduce its staff and slow hiring.
Federal prosecutors in California have also reportedly opened a criminal probe of Juul.
Lawmakers grilled the CDC, and then the FDA, over two days of hearings this week looking into the vaping crisis.
CDC Principal Deputy Director Anne Schuchat told Congress the outbreak reinforces the need to curb teen vaping. Preliminary federal survey data shows more than one-quarter of high school students say they use e-cigarettes.
She also said doctors worry the nicotine salts used by Juul make its e-cigarettes especially dangerous for teens. Doctors believe they could cross the blood-brain barrier and cause difficulty in learning, memory and attention, as well as priming the body to become addicted to other substances, she said.
She added that the CDC is particularly worried about flavored e-cigarettes, “and the role that they play in hooking young people to a life of nicotine, and we really want to avoid another generation being addicted to nicotine so addressing flavors directly is a good idea.”
Frank Pallone Jr., D-N.J., the chairman of the House Energy and Commerce Committee, blamed the spike in teen e-cigarette use and outbreak on a 2017 decision by the Food and Drug Administration to delay its review of those products.
“I firmly believe that many aspects of the youth vaping epidemic could have been addressed if the FDA had moved forward with reviewing all e-cigarettes on the market when it first had the chance two years ago” he said.
Tobacco giants Philip Morris International and Altria called off merger talks that would have created a $200 billion global behemoth.
According to the Wall Street Journal, Philip Morris’ board became increasingly uncomfortable with the deal amid the shifting U.S. regulatory environment on vaping. Altria, the top investor in Juul, unsuccessfully tried to salvage the talks, the Journal said.
The companies, which said in August they would discuss a possible all-stock merger of equals, now say they will focus on jointly launching IQOS, a heated tobacco product, in the United States.
CNBC’s Jasmine Wu and Elijah Shama contributed to this report.
Mike Stobbe, Associated Press – September 25, 2019
An outbreak of vaping illnesses. A surge in teens using electronic cigarettes. They’re often spoken of in the same urgent breath, but it’s not clear how — or even if — they are connected.
Following a shakeup at Juul Labs Inc., the largest U.S. seller of e-cigarettes, here are some questions and answers about vaping:
WHAT HAPPENED WITH JUUL?
The San Francisco-based company that controls about 70% of the market announced Wednesday that it will no longer run TV, print or digital advertisements for its e-cigarettes.
Juul, which rose to the top through viral marketing that promoted nicotine pods with dessert and fruit flavors, also said it’s replacing its CEO and promised not to lobby against a proposed U.S. ban on flavors.
Some health advocates were not impressed.
“No one should mistake the company’s suspension of its marketing efforts as anything other than a naked attempt to ease public pressure and curry favor with elected officials,” American Heart Association chief executive Nancy Brown said in a statement.
WHY ARE OFFICIALS CONCERNED ABOUT JUUL?
Health officials say Juul has triggered an explosion in teen vaping in recent years. Recent surveys found 1 in 4 high school seniors reported vaping nicotine in the month before they were asked about it.
Health officials have said vaping may be a less-deadly alternative for adult smokers who are trying to quit cigarettes, but they’re worried about kids using the devices. Nicotine is harmful to developing brains, and surveys suggest that as many as 1 in 8 high school seniors vape nicotine daily.
The youth vaping boom has led to backlash. This month, President Donald Trump said the government will act to ban thousands of flavors used in electronic cigarettes because they appeal to underage users.
Rhode Island, Michigan and New York have banned flavored vaping products.
On Tuesday, the governor of Massachusetts ordered a four-month ban on the sale of vaping products. Republican Gov. Charlie Baker said he was alarmed not only by the popularity of vaping but also a rash of vaping-related breathing illnesses that have caused deaths.
ARE THE RECENT VAPING ILLNESSES RELATED?
That’s not clear.
Over the summer, health officials in a few states began noticing reports of people developing severe breathing illnesses, with the lungs apparently reacting to a caustic substance. The only common factor in the illnesses was that the patients had all recently vaped.
More than 500 people are suspected or confirmed to have gotten the illness and at least 10 have died.
WHAT’S CAUSING THE ILLNESSES?
We don’t know. No single vaping product or ingredient has been linked to them, and health officials haven’t released a national breakdown of what product each sick person vaped.
Among 53 of the earliest cases in Illinois and Wisconsin, the vast majority of patients said they had vaped products containing THC, the ingredient in marijuana that produces a high. Nearly one-fifth said they had only vaped nicotine products.
The investigation does seem to be largely focused on products containing THC, with some attention on ingredients added to marijuana oil.
Anecdotally, a common thread has been products purchased on the street, not at dispensaries in states with legal pot sales. There is one puzzling outlier: A death in Oregon linked to a product bought at a legal cannabis retailer.
Another consideration: Juul and other brands of nicotine e-cigarettes have been around for years, but the illnesses surfaced only recently.
WHAT DO OFFICIALS THINK ABOUT VAPING OVERALL?
They’re divided. Some say the devices seem to have helped accelerate a decline in cigarette smoking, which would make them an important weapon against the nation’s leading preventable cause of death.
But officials at the Centers for Disease Control and Prevention have for years worried that what’s in vaping products was not well understood. They also feared e-cigarettes would become a new way of introducing kids to nicotine and potentially hooking them on tobacco products in the future.
For now, doctors and health officials are suggesting people stay away from all vaping products until an investigation establishes what’s causing the illnesses.
Adeel Hassan, The New York Times – Oct. 7, 2019
With school districts across the United States scrambling to reverse the rise of vaping among teenagers, three of them on Monday filed suit against Juul, the e-cigarette manufacturer, accusing it of endangering students and forcing educators to divert time and money to fight an epidemic of nicotine addiction.
The school systems in St. Charles, Mo., Olathe, Kan., and on Long Island were believed to be the first in the United States to sue Juul, which dominates the e-cigarette market with devices that look like thumb drives and that have become wildly popular with American teenagers.
The districts say Juul explicitly marketed its products to youths, leaving schools to shoulder the costs of stopping students from vaping, disciplining them when they break school rules and providing support services when they become addicted.
“As smart as our students are, they don’t understand the long-term ramifications of vaping and the amount of addictive chemicals they are dealing with,” said John Allison, the superintendent of Olathe Public Schools, which serves 30,000 students in a suburb of Kansas City. “It’s our role to protect our students today and in the future.”
Juul, which has denied steering its products toward teenagers, did not immediately comment on the lawsuits.
Public officials have taken a stronger stance against e-cigarettes in recent weeks after health experts identified a link between vaping and lung problems in August. The number of people with lung illnesses associated with vaping has risen to 1,080, the Centers for Disease Control and Prevention reported last week. Twenty-two deaths have been confirmed in 19 states, according to the C.D.C. and state agencies.
Rhode Island, Michigan and New York have banned most flavored vapes while the Massachusetts governor has issued a four-month ban on the sale of all vaping products. In the private sector, Kroger and Walmart have said they would stop selling e-cigarettes, and some television networks have stopped broadcasting ads for Juul.
Given the unanswered questions about the exact cause of the illnesses, many health experts have said that people should not vape. According to the C.D.C., young people and pregnant women should never use e-cigarettes, and adults who do not smoke should not start using them.
Still, a recent survey of thousands of students found that about one in four high school seniors had vaped during the previous 30 days; in 2017, one in nine seniors said they had done so. The researchers who conducted the survey concluded that new safeguards were needed to protect teenagers, as “the developing brain is particularly susceptible to permanent changes from nicotine use and when almost all nicotine addiction is established.”
In one of the suits filed on Monday, the Francis Howell School District in St. Charles, which has about 18,000 students, accused Juul of “taking a page from big tobacco’s playbook” to develop “a product and marketing strategy that sought to portray its e-cigarette products as trendsetting, stylish and used by the type of people teenagers look up to.”
Three Village Central School District in New York State also filed a lawsuit on Monday. Similar suits were expected in the coming weeks, said Jonathan P. Kieffer, a partner with Wagstaff & Cartmell, the Kansas City, Mo., law firm that filed the first suits.
Among the steps that schools have had to take against vaping, Mr. Kieffer said, were installing sensors in bathrooms, removing bathroom doors, banning flash drives, hiring more staff and paying for programs that help students deal with nicotine addiction. The suits did not specify the amount of damages the districts were seeking.
“In numerous meetings that we have had with educators, administrators and board members across the country,” he said, “the consistent theme that we have heard is that districts do not intend to stand by and allow this crisis to escalate but instead are taking a stand to protect their kids.”
Legal experts said that though the suits were reminiscent of litigation against makers of guns, opioids and tobacco, the districts could face a stiff challenge in establishing their case.
“It has nothing to do with the school themselves,” said Kathleen Hoke, a law professor at the University of Maryland who studies tobacco regulation. “The connection is to the students who have been marketed into addiction. I do think it’s very unique.”
Heidi Li Feldman, a torts and product liability professor at Georgetown University Law Center, said the suits reminded her of school districts in the Houston area suing former lead-paint manufacturers to recoup the costs of lead-paint removal in their buildings.
She said that school boards could learn from cities that have filed litigation against manufacturers of guns, opioids and tobacco, adding that schools can be held liable for not protecting their students or failing to protect the children.
“Will they be dismissed or allowed to head to trial? It’s a live question,” she said.
Vanessa Swales contributed reporting.
Hannah Knowles and Lena H. Sun, The Washington Post – October 8, 2019
Health officials, lawmakers and parents have been raising alarms about vaping for a couple of years, warning that products touted as healthier alternatives for smokers are instead drawing in young people with fun flavors and slick marketing — concerns the Trump administration cited this month while announcing plans to ban most flavored e-cigarettes.
The caution has taken on new urgency in recent weeks as authorities scramble to understand a rash of mysterious vaping-linked illnesses that have put healthy people in the hospital with serious lung diseases. Federal officials say there have been at least 1,080 injuries and 18 deaths connected to e-cigarettes, battery-powered devices that can look like flash drives and pens and that mimic smoking by heating liquids containing substances such as nicotine and marijuana.
E-cigarettes have been sold for more than a decade, but reports of vaping-linked illness started proliferating this year.
An investigation by state health departments in Illinois and Wisconsin traces the first signs of illness among 53 tracked patients to April. The victims — mostly young men with a median age of 19 — overwhelmingly ended up in the hospital, many under intensive care. A third went on respirators.
Patients typically experienced coughing, chest pain or shortness of breath before their health deteriorated to the point that they needed to be hospitalized, according to the Centers for Disease Control and Prevention. Other reported symptoms include nausea, vomiting, diarrhea, fatigue, fever and weight loss.
Many victims have ended up with acute respiratory distress syndrome, a life-threatening condition in which fluid builds up in the lungs and prevents the oxygen people’s bodies need to function from circulating in the bloodstream.
The Washington Post’s Lena Sun chronicled one Utah man’s experience with the disease:
Within days, Alexander Mitchell had gone from being a 20-year-old hiking enthusiast to being kept alive by two machines forcing air into and out of his lungs and oxygenating his blood outside of his body.
“He went from being sick to being on death’s door in literally two days,” recalled his father, Daniel Mitchell, as he struggled to grasp the unthinkable. “The doctor said he was dying. In all honesty, I was preparing to plan a funeral for my child. I wept and wept for this boy.”
… Six weeks after he left the hospital, Mitchell has resumed hiking. But with his lung capacity diminished by 25 percent, he doesn’t go for long or as often as he used to. He also struggles with his short-term memory. Doctors say they’re not sure whether he will fully recover.
The first death to a vaping-related illness was reported Aug. 23 in Illinois. At that time, federal and state officials were investigating almost 200 cases of the baffling sickness in 22 states, according to the CDC.
Oregon officials announced a second death, saying a middle-aged adult fell seriously ill after vaping with marijuana oil. It was the first casualty linked to a store-bought product.
The list of states with deaths has grown quickly.
Officials say they are not sure why the afflictions are just now surfacing.
“We’re all wondering if this is new or just newly recognized,” the CDC’s Dana Meaney-Delman said recently.
Some argue doctors may have missed previous cases: Susan Walley, chair of the American Academy of Pediatrics tobacco control section, told BuzzFeed News that based on her experience, young people might not recognize their use of common e-cigarette brands such as Juul as “vaping” when pediatricians ask.
But others are skeptical that older cases could have gone under the radar.
“You have a lot of otherwise healthy young people suddenly arriving with fast-developing pneumonia in emergency rooms — that will raise red flags in a hurry,” Sean Callahan, a physician at the University of Utah, told BuzzFeed. “This is new.”
As of Oct. 1, officials counted at least 1,080 confirmed and probable cases of vaping-related injuries reported by 48 states and the U.S. Virgin Islands, according to the CDC. At least 18 deaths have been confirmed in 15 states: Alabama, California (2), Delaware, Florida, Georgia, Illinois, Indiana, Kansas (2), Minnesota, Mississippi, Missouri, Nebraska, New Jersey, Oregon (2), and Virginia.
At least three more deaths have since been reported in Connecticut, Massachusetts and New York. In New York, the 17-year-old male from the Bronx appears to be the first publicly reported death of a teenager. New York Gov. Andrew Cuomo (D) reported the death Tuesday. The teen was hospitalized in early September with a vaping-related respiratory illness and re-admitted in late September. He died Oct. 4. New York health officials are investigating the products he vaped.
Most of the patients who have fallen sick are male and young, with 80 percent of patients under 35 and more than one-third under 21. But until the report of the New York teen’s death, the deaths had been in older adults. Anne Schuchat, the CDC’s principal deputy director, said in a briefing with reporters Oct. 3 that the median age of the patients who died is about 50, with ages ranging from 27 to 71.
Officials are still trying to figure out what, exactly, is causing people to fall ill. They think chemicals are to blame.
“The focus of our investigation is narrowing, and that is great news, but we are still faced with complex questions in this outbreak that will take time to answer,” said Ileana Arias, CDC acting deputy director for noninfectious diseases.
The Post reported in early September that investigators at the Food and Drug Administration found the same vitamin E-derived oil in marijuana products vaped by multiple people sickened around the country. But officials cautioned that they could not yet pin the illnesses on it.
The chemical, vitamin E acetate, was present in almost all of the cannabis samples from victims identified in New York, according to the state’s health department. New York Gov. Andrew M. Cuomo (D) has directed his health department to subpoena three companies selling “thickening agents” used to adjust THC levels in products found on the black market. The thickening agents are “nearly pure” vitamin E acetate, officials say.
Vitamin E acetate has also been found in samples collected from across the country and tested by the FDA. An FDA official said Thursday that some samples showed only THC in varying concentrations, while others showed both THC and vitamin E acetate, with the vitamin E oil in varying concentrations.
Some patients have said they vaped only nicotine products, even though urine tests have showed the presence of THC, authorities said. Doctors say patients may be hesitant to admit using marijuana.
The FDA disclosed that it has launched a criminal investigation with the Drug Enforcement Administration. That is happening alongside the probe by the Centers for Disease Control and Prevention into the cause of the illnesses. Federal officials are not pursuing individual vapers. But if the FDA determines “someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act,” said acting FDA Commissioner Norman “Ned” Sharpless.
In testimony before a House panel, Sharpless said the FDA has received 300 samples from vaping-related injury patients and tested 150. About 70 percent are products containing THC, the psychoactive component of marijuana, and about half of those contain vitamin E oil, which Sharpless said has “no business” being in the lungs.
New York’s health commissioner, Howard Zucker, has urged medical marijuana patients to discuss alternatives with their doctors, although no sicknesses have been reported among patients in the state’s medical marijuana program.
Black market marijuana products, which industry experts say are typically cheaper than legally sold items, are drawing increasing scrutiny.
California, home to the largest legal marijuana market in the world, has a black market three times bigger. Changes in the ingredients used in popular marijuana vaping devices in the state could be making people sick, according to experts in the legal and illicit cannabis markets, as well as doctors and health officials. They say black market operators are using more thickening agents to dilute THC oil because of a crackdown by state authorities that has made the oil scarcer on the black market.
THC oil is used to fill tiny disposable containers known as vape cartridges, which are heated to create inhalable vapor. Vaping cartridges are among the most popular items in the legal and illicit markets, industry analysts said.
The CDC has identified a number of brands as “largely counterfeit,” saying distributors use packaging easily purchased online to “market THC-containing cartridges with no obvious centralized production or distribution,” as one report from the agency states.
Authorities in Wisconsin and Illinois, where the earliest illness reports emerged, say most of their interviews with patients point to illicit THC products with Dank Vapes cartridges. They also reported using THC products under the the brands TKO, Off White, Moon Rocks, Chronic Carts, Cookies, Smart Carts, Kingpen, Dabwoods, Rove, Mario Carts, California Confidential and Supreme G.
Patients in those two states who reported using nicotine e-cigarettes named Juul, Smok, Suorin Drop, Naked, Solace, Mr Salt-E, Salt Nic, Air Factory and Vuse Alto, the CDC report states.
Officials are imposing tough new sales restrictions and declaring public health emergencies, advising people to put away their e-cigarettes while investigators try to get to the bottom of the illnesses.
The CDC — which is leading inquiries into the illnesses and working with state health departments — has told doctors to ask patients about e-cigarettes when they arrive with symptoms resembling the vaping-linked afflictions and to report the cases to health departments.
Some lawmakers have called for more urgent action from the federal government. Sen. Richard J. Durbin (D-Ill.) earlier this month accused the FDA’s acting chief, Norman “Ned” Sharpless, of “sitting on his hands,” tweeting that he would call for the leader’s resignation if he did not “take action in the next 10 days.”
Durbin’s calls for increased e-cigarette regulation came two years after the FDA pushed back its deadline to review the products, which the agency has yet to approve.
A plan for stricter regulations materialized Sept. 11, as Health and Human Services Alex Azar announced at a White House gathering with the president and other top officials that the FDA is working to outlaw most flavored vaping products. The policy, which would upend the e-cigarette market, will be finalized in a few weeks and then go into effect 30 days later, he said. The restrictions would be lifted only for products that the FDA approves.
Tobacco-flavored e-cigarettes will not be affected, officials said.
Although the move came amid the growing concern over vaping-linked illness, the Trump administration pointed to a broader rise in teen vaping as its motivation.
Michigan and New York have enacted similar bans on flavored vaping sales over industry protests, and Rhode Island’s governor announced plans to follow suit this week. Massachusetts recently announced the strictest statewide regulations to date, a four-month halt to sales of all vaping products effective immediately. Lawmakers elsewhere are mulling similar actions.
Washington state Gov. Jay Inslee (D) has also directed officials to impose an emergency ban on flavored vaping products — both nicotine and those containing THC. The governor told the state Board of Health to vote on the ban the next time it meets: Oct. 9. He also said he would push legislation to make the prohibition permanent.
“We’re seeing more and more states exploring what emergency powers they have,” said Michael Seilback, assistant vice president for state public policy at the American Lung Association.
Local policymakers are acting, too. San Francisco — home to Juul Labs — was the first city to ban all e-cigarette sales in June, a year after it outlawed flavored products.
Vaping has risen dramatically in popularity around the world — from 7 million users in 2011 to 35 million a few years ago — as smoking rates decline.
Tobacco and cigarette company Altria Group estimated nearly 14 million nicotine e-cigarette users in the United States earlier this summer. Another study found last year that more than half of American adult e-cigarette users are under 35 years old, stoking concerns about vaping among young people.
Studies showing vaping’s growing popularity among teens sparked particular worry last year. About 37 percent of 12th-graders reported vaping over the past year in one government-funded U.S. survey released in December — nearly a 10 percentage-point increase from 2017. Past-month nicotine vaping rates among the seniors doubled, and younger students also reported higher use; marijuana vaping rose, too. And a CDC report found last year that e-cigarettes were the most popular product among the nearly 5 million high school and middle school students who used tobacco within a 30-day period.
Vaping’s popularity among students continued to increase this year, according to preliminary data that found 1 in 9 high school seniors say they vape near-daily — a figure that researchers say suggests nicotine addiction.
Mysterious illnesses aside, many have accused e-cigarette manufacturers of exposing young people to addictive nicotine and luring them toward smoking. The National Academies of Science, Engineering and Medicine say they found “substantial evidence” that youths who try vaping are more likely to use conventional cigarettes. Advocates of vaping sales bans also cite research on nicotine’s effects on youth brain development.
Last fall, then-FDA Commissioner Scott Gottlieb called teenage vaping an “epidemic” as he announced a crackdown on more than 1,300 entities allegedly selling e-cigarettes to minors. He threatened to ban the flavored vaping liquids that have drawn so much scrutiny for their appeal to young people — unless e-cigarette manufacturers such as Juul Labs worked to substantially curb underage use.
E-cigarette makers have lobbied aggressively against new regulations making good on that threat and argue that their products can help smokers quit while giving those addicted to nicotine a safer option than burning tobacco. They say they’re working to address underage vaping and warn that an outright ban could just replace regulated sales with a black market.
The CDC agrees that e-cigarettes can help smokers who substitute them for regular tobacco products, and health professionals believe vaping to be safer than traditional smoking, which kills 8 million people per year, according to the World Health Organization. The debate over vaping regulations has split the public health community, experts say, as some point to harm reduction for smokers while others emphasize the threat to youth. England’s public health agency cites estimates that the practice is 95 percent less harmful than smoking.
But given that the FDA has yet to vet vaping products, experts caution that the long-term consequences of using e-cigarettes remain unclear.
Marisa Iati contributed to this report.
Arielle Dreher, The Spokesman-Review – September 16, 2019
The Washington State Department of Health confirmed Monday two cases of severe lung disease in Spokane County linked to vaping, bringing the statewide total to three.
The Spokane cases include a teenager and a person in their 20s. The first state-confirmed case of severe lung illness linked to prior vaping use was reported last week in King County.
Officials have not confirmed a connection between the illnesses and the type of vaping device or specific substance used in the three cases. E-cigarettes and vaping products can use nicotine as well as cannabinoids.
At the time the state’s first confirmed case was reported, the Spokane Regional Health District was investigating four cases for potential connections to vaping. Two of those cases do not have a confirmed link to vaping.
The Centers for Disease Control and Prevention reported 380 cases of lung illness across the country related to e-cigarettes,including six deaths. While all of the people have a history of vaping use, CDC officials still do not know the exact product or substance causing the severe lung diseases.
Symptoms of severe lung disease related to vaping include an unproductive cough (with no phlegm), sharp chest pain and low oxygen levels. Once physicians rule out other causes or infections but still find these symptoms paired with abnormal chest X-rays, it is possible that their patients meet the criteria to be considered to have severe lung illness due to vaping.
Spokane County Health Officer Bob Lutz said those diagnosed in Spokane County have been treated and discharged from the hospital, but questions remain about long-term complications from vaping.
“I think we need to look at the vaping issue very broadly, we know that it is increasing in our youth,” Lutz said at a news conference Monday. “We know that for any number of reasons that people are choosing vaping.
“They may think it’s a safe alternative to tobacco – we don’t know. It’s never been recommended; it’s never been confirmed as a means by which people can stop smoking, so I think our continued message is that tobacco cessation is a priority.”
State Health Officer Kathy Lofy called the lung illnesses due to vaping a “statewide outbreak.”
The proportion of high school students using e-cigarettes and vaping increased from 11.7% to 20.8% from 2017 to 2018, a recent tobacco youth survey found. Vape pens and e-cigarettes account for the lion’s share of products high school students use nationwide.
Health officials say the wide variety of flavors that e-cigarettes and vape pens use appeals to teens. The Trump administration announced plans to ban flavored e-cigarette liquid just last week.
While the Food and Drug Administration has warned e-cigarette companies against marketing to youth, proposed federal rule changes for e-cigarettes are still pending. Some cities and states have taken regulatory actions, and Lutz said more is needed.
“We need to be regulating this product; we need to know what’s in there,” Lutz said at his news conference.
Vape shops sell e-cigarette liquids in a range of nicotine levels, from zero milligrams to 50 mg in pods. The average amount of nicotine in a cigarette is 12 mg but can range from 8 mg to 20 mg.
JUUL, the most commonly sold e-cigarette in the country according to the CDC, sells pods that contain either 40 mg or 23 mg of nicotine. The CDC equates one JUUL pod (which the company says lasts about 200 puffs) to a pack of cigarettes. The FDA sent JUUL a warning letter in early September for characterizing their products as modified risk tobacco products without an FDA order in effect.
The CDC is calling on state and local health departments to help in its nationwide investigation into the illnesses; thirty-six states are reporting lung illnesses linked to vaping. The CDC recommends that young adults not use e-cigarettes or vaping products. Washington residents under the age of 18 are not allowed to purchase tobacco or vaping products; however, in January 2020, this will change after lawmakers passed a new age-minimum of 21 years old for purchasing such products.
Lutz encouraged local physicians to inquire about vaping specifically when talking to patients, in order for health officials to get an idea of what product or substance is causing severe lung disease. Neither confirmed Spokane County lung disease case could be linked to specific products or substances, beyond vaping generally, Lutz said. Knowing what product or what substance (from nicotine, THC or other substances) a person used would be helpful for health officials.
“We would very much be interested in what they have been using, because again, that’s when we can start to find exactly the cause rather than look for different associations,” he said.
Berkeley Lovelace Jr. CNBC – October 3, 2019
The number of cases of a deadly vaping illness continues to rise “at a brisk pace” with 18 confirmed deaths and more than 1,000 cases throughout the U.S., according to the Centers for Disease Control and Prevention.
The CDC has identified 275 new cases over the last week and is investigating several other deaths that are suspected of being caused by vaping, Dr. Anne Schuchat, the CDC’s principle deputy director, told reporters on a conference call Thursday.
Schuchat called it a “very concerning outbreak” with no signs of abating.
“We haven’t seen a measurable drop in the occurrences of new cases,” she said. “The data that we’ve seen doesn’t suggest it has peaked, it doesn’t suggest this is declining.”
The CDC has confirmed 1,080 probable cases across 48 states and the U.S. Virgin Islands so far.
Doctors still don’t know what’s making people sick, Schuchat said. Of the 578 cases where doctors know what patients were using, roughly 78% of them said they vaped THC, the active ingredient in marijuana, while 17% percent said they exclusively used nicotine, according to the CDC.
“In light of the seriousness of this condition,” consumers should stop vaping, particularly THC and especially anything bought off the street, she said, or any substance not intended by the manufacturer.
The number of confirmed fatalities jumped from 12 last week to 18 this week, the CDC said. It’s proving to be an especially deadly illness for older adults.
“The fatalities that we’re seeing tend to be a bit older,” she said, adding that the median age among the deceased is close to 50 while the median age among all patients is 23.
The CDC has dispatched more than 100 physicians and investigators since the lung disease started to emerge as a public health threat in July. Doctors initially said the illness resembled a rare form of pneumonia, caused by oil in the lungs, but new research casts doubt on that theory.
Researchers at the Mayo Clinic published a study Wednesday that said a mix of “toxic chemical fumes,” not oils, may be what’s making patients sick. They examined lung biopsies from 17 patients suspected of having the mysterious illness.
“CDC will continue to work with FDA and state health partners to investigate the cause, or causes, of this outbreak and to bring an end to these lung injuries,” CDC Director Robert Redfield said.
Michael Sasso, Tiffany Kary and Lisa Du – The Seattle Times – October 6, 2019
As a public health crisis intensifies over vaping, Philip Morris International’s own cigarette alternative is quietly arriving in the U.S.
A minimalist, glass-front store in Lenox Square mall in the affluent Buckhead area of Atlanta, Georgia, is offering the company’s device, which heats a tobacco plug without burning it.
It’s one of two stores planned for the area that will also be complemented by points of sale such as kiosks, in-store displays in shops like Circle K and even mobile units that travel around the city. The goal is to provide guided trials to convert adult smokers.
The Lenox Square store is marked only with “IQOS,” giving little indication that it’s selling tobacco-related products. On the door, small white lettering says “Smokers 21 + welcome,” and a woman at the door checks IDs and asks potential customers if they’re smokers. If they say they aren’t, they can enter the store but can’t try the devices or buy them.
Philip Morris already sells IQOS in more than 40 countries, and had said that Atlanta would be a test market once it started U.S. sales. Altria Group, which split off from Philip Morris but still sells Marlboros in the U.S., is also marketing IQOS there. Philip Morris sells the Marlboro brand outside the U.S.
Altria spokesman David Sutton said Thursday that the store has been in “soft operational mode” for over a week, and that a second location will open soon at the Mall of Georgia, northeast of the city. Two mobile units will also start roaming Atlanta.
The discreet launch shows how Altria and Philip Morris are trying to delicately test the U.S. waters with IQOS — which is key to the companies’ future as tobacco use declines — even as health officials crack down on vaping amid an outbreak of illnesses and deaths.
“We’re looking to be as responsible as we can be as we commercialize and market this product,” Sutton said in a phone interview, citing the company’s 21-plus age limit that’s higher than the state’s legal smoking age of 18. The company doesn’t plan on using influencers to post about the devices on social media, and they won’t be sold online.
“If you are interested you can make an appointment online to go to a store and do the education — do the guided trial and begin your conversion,” Sutton said.
Altria also won’t market the product to those that vape. Like non-smokers, adult users of vape products can enter the store, but won’t be given a trial or a chance to purchase the product, Sutton said.
E-cigarette maker Juul Labs and competitors are under intense scrutiny as health authorities have blamed vaping products for at least 18 deaths and more than 1,000 illnesses. Their use of non-traditional flavors, like watermelon and strawberry milk, and marketing that appeals to underage users has particularly been lambasted and caused Juul to stop advertising and lobbying. It has also discontinued most flavors.
Altria last year invested almost $13 billion in Juul to get a 35% stake. That holding was blamed for helping to derail a deal that would have brought Altria and Philip Morris back together.
The U.S. Centers for Disease Control and Prevention is working with the Food and Drug Administration and state health authorities to investigate the ailments. A study published this week by Mayo Clinic pathologists said they are most likely caused by exposure to toxic chemicals.
Philip Morris says IQOS is a different kind of product than other vaping devices. It has been designed specifically to convert cigarette smokers with a similar tobacco flavor. It heats a dry tobacco product to create an aerosol, and unlike vape devices, it doesn’t have a liquid that is vaporized. An IQOS tobacco plug lasts about the same amount of time as a regular cigarette — around 14 puffs or 6 minutes.
Philip Morris Chief Operating Officer Jacek Olczak said in a phone interview with Bloomberg News earlier this week that the product should be marketed to people who vape, emphasizing that IQOS has been authorized for U.S. sales by the FDA after a review — a process that Juul and other vape products haven’t been through.
In authorizing it for U.S. sales, the FDA also restricted how it could be marketed, saying the device was akin to cigarettes and should be monitored to make sure it doesn’t attract youth. The agency has yet to approve a request that would allow IQOS advertisements that say product is less risky relative to cigarettes.
Philip Morris says that because the tobacco is heated and not burned, the nicotine-containing vapor produced has less harmful chemicals than cigarette smoke. The company says on its website the product is not risk-free, but offers less risk of harm compared with smoking tobacco products.
“If a vape user is getting scared, there’s a high-risk case they will return to conventional cigarette — which could be absolutely disastrous from a public health perspective,” Olczak said. “Altria should offer the alternative, which is IQOS.”
The device being sold in the U.S. is IQOS 2.4, and conversations with the FDA are underway about newer models.
Abby Haglage, Yahoo Lifestyle – September 26, 2019
It’s been a big week for Juul — and not necessarily a good one. Amid a criminal probe into the e-cigarette maker’s marketing tactics and a Centers for Disease Control and Prevention (CDC) investigation into vaping health effects, the company announced Wednesday that its CEO was immediately stepping down.
The company, reportedly valued at $38 billion, is one of the fastest-growing startups in history. In a statement posted to its website, Juul said current head Kevin Burns will now be replaced by K.C. Crosthwaite, a former Altria executive, who has advised the company to “suspend all broadcast print and digital product advertising in the U.S.” in response to concerns about their marketing tactics.
The news follows months of reports about a “severe lung illness” related to e-cigarettes and THC vaping products, an epidemic that began with eight hospitalizations in Wisconsin this August. Since then, the CDC has recorded 805 cases of the mysterious illness and at least 11 deaths thus far.
The news follows months of reports about a “severe lung illness” related to e-cigarettes and THC vaping products, an epidemic that began with eight hospitalizations in Wisconsin this August. The CDC launched an official tracking system shortly after, recording over 200 cases by the end of August. Since then, the caseload has soared. Last week the CDC recorded 530 cases in total, a number that jumped 52 percent to 805 cases this Monday. While the majority affected have been released from the hospital, doctors have linked the illness to 12 deaths.
While experts have yet to pinpoint a specific type of e-cigarette or THC vaping product that’s fueling the illnesses, there are clear on the risks associated with Juul. Lawmakers explored these further in an emergency hearing held by the House Oversight and Reform Committee this week.
During it, principal deputy director of the CDC, Anne Schuchat, PhD, described one of the lesser-known ingredients in Juul, one of what’s known as “fourth-generation” e-cigarettes. “Juul products use nicotine salts, which can lead to much more available nicotine,” Schuchat said. “We believe the product can cross the blood-brain barrier and lead to, potentially, more effect on the developing brain in adolescence.”
In a 2015 post on Pax Labs (Juul’s parent company) announcing the release of the product, the company expands on the salts. “Unlike other e-liquids, JUUL is the only e-cigarette that uses nicotine salts found in leaf tobacco, rather than free-base nicotine, as its core ingredient,” the statement reads.
Pax reportedly patented the nicotine salt technology in 2015, as detailed in a press release in December of that year. “To develop the nicotine salt e-liquid technology, the Pax Labs research team extensively explored the differences in chemical composition between cigarettes and e-cigarettes, demonstrating that the use of nicotine salts instead of free-base nicotine made an unequivocal difference in nicotine blood absorption profiles,” the company said. “Nicotine salts are the natural state of nicotine in the tobacco leaf.”
But while nicotine salt may make for a smoother way to consume the product, experts worry that it also allows much larger amounts of nicotine to be consumed in a short time. A single Juul pod, for instance, contains the same amount of nicotine as an entire pack of cigarettes.
Schuchat says this is especially dangerous for Juul users under the age of 18 — and as many as 56 percent of those who have tried Juul are that age. “The issue is [that] easier access of nicotine to the brain may have a higher risk of leading to … the learning difficulty, attention problems, memory issues — as well as priming for addiction,” Schuchat told Rep. Raja Krishnamoorthi, the subcommittee’s chairperson. “The brain is pretty central in the issue of addiction, as well as cognitive functioning, and we’re concerned that higher doses of nicotine getting into the brain may lead to larger problems.”
As the hearing came to a close on Tuesday, Schuchat expressed concern that the epidemic — which is primarily affecting those under 25 — will only get worse. “We are seeing more and more cases each day,” she said. “I expect the next weekly numbers will be much higher.”
At the time of publishing, Juul had not replied to Yahoo Lifestyle’s request for comment.