In 2009, FDA Was Sent An E-Cigarette Device With A Warning That A Vaping Crisis Was Coming. What Happened In The Next Ten Years?
Ten years after that warning, the FDA has not vetted the vast majority of vaping devices or flavored liquids for safety. Where did everything fall through the cracks? In other news on the vaping crisis: social media messaging, reported re-hospitalizations, a name for the mysterious vaping-related lung illness, state bans, and more.
In 2009, not long after Dr. Margaret Hamburg became commissioner of the Food and Drug Administration, a package arrived at her home. Inside was a clunky device called an e-cigarette. 鈥淚t was my first exposure to this emerging, new technology,鈥 Dr. Hamburg recalled. The package was sent by an antismoking activist as a warning about a product that was taking off in the United States. But over the next decade, the federal government 鈥 across the span of two presidential administrations 鈥 allowed the rise of a largely unregulated industry that may be addicting a new generation to nicotine. (Thomas and Kaplan, 10/14)
A congressional committee and the Massachusetts attorney general are investigating whether millions of bot-generated social-media messages about e-cigarettes have been misleading consumers about safety and health issues. In information requests to five big manufacturers of vaping products in August, House investigators asked each of the firms whether it had used social media bots to market its products. The House Energy and Commerce Committee request also asked for lists of all the usernames involved, as well as whether the bots have disclosed their connection with the manufacturer. (McKinnon, 10/14)
Federal health officials investigating mysterious vaping-related lung injuries said Friday that some patients are being hospitalized for a second time, a disturbing new development in the ongoing national outbreak that has spread to every state except Alaska. 鈥淲e are aware of a handful of patients who have been readmitted for clinical care after discharge for lung injury,鈥 said Anne Schuchat, the principal deputy director at the Centers for Disease Control and Prevention, which is heading the public health investigation. (Sun, 10/11)
In the spring, Kathleen Fimple buried her husband, John, and by the fall, she had reluctantly settled into her new life as a widow. She accepted what the doctors told her: that he had died at 68 from respiratory failure and pulmonary disease after years of smoking cigarettes, coupled with a bout of pneumonia. She went back to work. She canceled a trip around Europe that the couple had planned to take this month. Then she got an unexpected call from a doctor at Nebraska鈥檚 health department. (Bosman, 10/14)
As illnesses and deaths linked to vaping continue to rise, health experts on Friday updated their advice to doctors on how best to recognize symptoms and treat patients, and warned that the start of the flu season would make it harder to arrive at the right diagnosis. 鈥淚 can鈥檛 stress enough the seriousness of these lung injuries associated with e-cigarettes or vaping products,鈥 Dr. Anne Schuchat, principal deputy director of the federal Centers for Disease Control and Prevention, said at a news briefing. 鈥淲e are not seeing a meaningful drop-off in new cases, and unfortunately many more people have been hospitalized with lung injury each week.鈥 (Grady, 10/11)
Indiana on Thursday confirmed two more deaths from a mysterious lung illness linked to e-cigarettes, bringing the total number of fatalities to 29 across the country, as U.S. health officials investigate the outbreak that has shown no signs of easing. (10/12)
British American Tobacco Plc unit Reynolds American Inc said on Friday it had filed for a review of its Vuse e-cigarettes by the U.S. Food and Drug administration, giving it a lead over its main rival Juul Labs Inc. The FDA has set a May 2020 deadline for e-cigarette makers to submit a formal application to keep their products on the market amid its efforts to curb the use of e-cigarette among teens. (10/12)
The Reynolds filing, which totals more than 150,000 pages, gives it a jump on its two main rivals, Juul Labs Inc. and NJOY Holdings Inc. The FDA, which regulates tobacco, has given companies until May 2020 to submit any products they want to keep on store shelves after that date. The reviews have taken on new importance as the FDA prepares to pull off the market all e-cigarettes other than those formulated to taste like tobacco in a move intended to curb a rise in teen vaping. (Maloney, 10/11)
The vaping-related condition that has sickened hundreds of people has a new name: EVALI, or e-cigarette or vaping product use-associated lung injury. The new name, noted Friday in newly issued guidance for clinicians from the Centers for Disease Control and Prevention, is a sign of the rapidly evolving investigation into the illness, which has sickened 1,299 people across 49 states, Washington, D.C., and the U.S. Virgin Islands. The case count has continued to climb week after week. (Evali, 10/11)
The federal investigation into what exactly is causing a peculiar outbreak of vaping-related lung injuries nationwide could continue for months. The ongoing investigation "may take a few months" and could yield "multiple causes and potentially more than one root cause," Dr. Anne Schuchat, principal deputy director at the US Centers for Disease Control and Prevention, said during a briefing with reporters on Friday. (Howard, 10/11)
The Centers for Disease Control and Prevention Health released new guidance on Friday for clinicians to evaluate and treat patients they suspect might have lung injury related to using e-cigarettes. The CDC's interim guidance is an update to prior recommendations from August related to addressing vaping-related illness. Dr. Anne Schuchat, the CDC's principal deputy director, said the updated guidelines incorporate more data than was collected for the August recommendations since the number of illnesses have spiked in the last couple of months. (Johnson, 10/11)
The conventional wisdom is that e-cigs are safer than traditional cigarettes for adult smokers, and federal regulators need to figure out how to help them quit while keeping vapes away from young people. But amid an outbreak of a vaping-related lung disease, independent scientists say they are not so sure about that. (Allen, 10/11)
Patients buying Ohio medical marijuana vape products will start seeing the ingredients on more product labels, in a transparency move amid continuing reports of people becoming sick after using e-cigarettes. Three licensed processors 鈥 Eastlake-based Buckeye Relief, Huron-based Ohio Patients Choice (which does business as Firelands Scientific) and Standard Wellness in Sandusky County 鈥 together decided to disclose ingredients as a way to help patients feel confident that their products are safe. (Hancock, 10/13)
For many years, my lead-in question with adolescents, after I asked the parent to leave the room at pediatric appointments, was whether the kid had ever tried smoking cigarettes. It made a reasonable lead-in because it felt less highly charged than asking about marijuana or other substances, and in recent decades, the answer was very often no. Youth tobacco smoking in the United States was on the decline. (Klass, 10/14)
Oregon will ban all flavored vaping products for six months starting Tuesday as federal officials remain stumped about exactly what鈥檚 causing severe lung injuries associated with e-cigarettes. The action followed Gov. Kate Brown鈥檚 order last week that the Oregon Liquor Control Commission and the Oregon Health Authority temporarily ban the products -- including those with THC, the active chemical in marijuana, CBD and those with nicotine. (Zarkhin, 10/11)