Juul Issued Warning From FDA For Illegally Marketing Vaping Products As Less Harmful Alternative To Cigarettes
“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” said acting FDA Commissioner Ned Sharpless. The public rebuke came amid a burgeoning epidemic of vaping-related lung illnesses across the country.
USA Today:
Vape Maker Juul Under Fire For Safety, Teen Marketing Messages
Federal health officials warned electronic cigarette maker Juul Monday to stop saying vaping is safer than smoking because it hasn't complied with regulations that call on companies to prove that's true. The Food and Drug Administration also sent a letter to the company "expressing concern, and requesting more information" about the its outreach and marketing practices, especially to students, tribes, health insurers and employers, following congressional testimony this summer that included reported safety claims. (O'Donnell, 9/9)
The Wall Street Journal:
FDA Warns Juul About Marketing Products As Safer Than Cigarettes
The FDA Monday said Juul hadn’t been forthcoming in producing the documents the agency had requested, noting that the company had turned over records to a congressional subcommittee that it hadn’t provided to the FDA. “We are reviewing the letters and will fully cooperate,” a Juul spokesman said. The House Subcommittee on Economic and Consumer Policy, in a July hearing, heard testimony from two teenagers who said that a Juul representative had given a presentation in their high school and told them that Juul’s e-cigarettes were “99% safer than cigarettes.” (Maloney, 9/9)
CNN:
E-Cigarettes: Juul Warned By FDA About Its Marketing Practices
"We will continue to scrutinize tobacco product marketing and take action as appropriate to ensure that the public is not misled into believing a certain product has been proven less risky or less harmful," he said. "We've also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we'll take even more aggressive action." (Gumbrecht and Howard, 9/9)
The Associated Press:
Juul Warned Over Claims E-Cigarette Safer Than Smoking
The Food and Drug Administration also upped its scrutiny of a number of key aspects of Juul's business, telling the company to turn over documents about its marketing, educational programs and nicotine formula. The FDA action increases the pressure on the nation's best-selling vaping company, which has been besieged by scrutiny from state and federal officials since a recent surge in underage vaping. Federal law bans sales to those under 18. The FDA has been investigating Juul for months but had not previously taken action against the company. (Perrone, 9/9)
Reuters:
Juul Warned By FDA Over Marketing Practices
Juul has already come under scrutiny for its marketing initiatives, including its use of social media influencers to promote its vaping devices, with the Federal Trade Commission launching an investigation last month. "The law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful," acting FDA Commissioner Ned Sharpless said in a statement. (9/9)
The New York Times:
Juul Illegally Marketed E-Cigarettes, F.D.A. Says
In a second letter to Juul on Monday, the F.D.A. sought further documents about the company’s practices, details about some of its products, including nicotine-salt e-liquids, and any scientific evidence it has amassed to prove its claims. The agency singled out Juul’s ad campaign, “Make the Switch,” saying it may convey that its devices are less harmful than tobacco cigarettes and may also violate limits on health claims. The company’s switching campaign has also drawn fire from lawmakers and public health experts, who contend that the message implies that Juul’s products are a smoking cessation option. (Kaplan and Richtel, 9/9)
The Washington Post:
FDA Warns Juul, Says It Marketed Vapes As Less Harmful Than Regular Cigarettes Without Agency Authorization
The FDA, in the letter to Burns, also said that in April 2018 it had asked the company for documents relating to marketing practices and research into marketing, effects of product design, public health impact and adverse experiences. But it said the company apparently provided Congress more documents than it gave the FDA. (McGinley, 9/9)
Politico:
FDA Warns Juul For Marketing With Unproven Safety Claims
The agency has been under pressure to tighten restrictions on the e-cigarette industry. Sen. Dick Durbin (D-Ill.) has called on Sharpless to take such actions or resign. FDA inspected Juul offices late last year and seized documents tied to an earlier ad campaign. FTC has also launched a probe into Juul marketing practices, as has the House Oversight and Reform subcommittee on Economic and Consumer Policy. (Owermohle, 9/9)
Bloomberg:
Is Juul Safe? FDA Warns Over Claims On Vaping Devices
Representative Raja Krishnamoorthi, an Illinois Democrat, wrote Sharpless last week urging the agency to look into the claims Juul has made, including some before his House Oversight and Reform subcommittee. During a subcommittee hearing in July, Krishnamoorthi’s staff revealed that a Juul representative had told students that the company’s device “was much safer than cigarettes” and called the products “totally safe.” The FDA highlighted those statements Monday.(Edney, 9/9)
CNBC:
Juul Illegally Marketed E-Cigarettes, FDA Says In Warning Letter
Juul spokesman Ted Kwong said the company was “reviewing the letters and will fully cooperate.” (LaVito, 9/9)
Reuters:
U.S. Doctors' Group Says Just Stop Vaping As Deaths, Illnesses Rise
The American Medical Association on Monday urged Americans to stop using electronic cigarettes of any sort until scientists have a better handle on the cause of 450 lung illnesses and at least five deaths related to the use of the products. The AMA, one of the nation's most influential physician groups, also called on doctors to inform patients about the dangers of e-cigarettes, including toxins and carcinogens, and swiftly report any suspected cases of lung illness associated with e-cigarette use to their state or local health department. (Steenhuysen, 9/9)
The Washington Post:
Bloomberg To Spend $160 Million To Ban Flavored E-Cigarettes
Michael Bloomberg, the billionaire businessman and philanthropist who has financed efforts to combat tobacco use around the world for years, has a new target: e-cigarettes in the United States. Bloomberg Philanthropies announced Tuesday it would spend $160 million over three years to try to ban flavored e-cigarettes, which, it said, are specifically designed to entice kids to vape. (McGinley, 9/10)
CNBC:
Scott Gottlieb: 'Federal Reckoning' Needed After Vaping-Linked Deaths
Former FDA Commissioner Dr. Scott Gottlieb told CNBC on Monday the government needs to regulate cannabis products, after reports of 450 possible cases and five deaths from a mysterious lung disease linked to vaping. Most of the patients reported vaping both nicotine and THC, the marijuana compound that creates a high, though some reported only using nicotine. (Bursztynsky, 9/9)
Kaiser Health News:
Listen: Health Officials Warn People To Stop Vaping
As the number of patients combating mysterious lung illnesses grows, state and federal public health officials are warning people to stay away from e-cigarettes and vape pens, especially those obtained off the streets. As of Friday, public health officials were investigating more than 450 possible cases of severe pulmonary disease related to vaping, including five deaths, in 33 states, according to the Centers for Disease Control and Prevention. Investigators are looking into 60 possible cases in California, including one death. (9/9)
Meanwhile, in Delaware, Alabama, Colorado and New York —
The Associated Press:
Delaware Probes 3 Possible Cases Of Vape-Related Lung Issues
Delaware health officials are investigating three possible cases of severe lung disease related to the use of electronic cigarettes and vaping. News outlets report the state health department is urging residents to stop vaping as cases of lung disease possibly linked to e-cigarettes pop up across the country. The Centers for Disease Control and Prevention says there have been 450 possible cases of lung disease related to vaping reported in 33 states. As many as five cases have ended in death. (9/10)
The Associated Press:
Alabama Investigates 5 Cases Of Lung Disease Tied To Vaping
The Alabama Department of Public Health says it's investigating five reports of potentially severe lung disease associated with electronic cigarettes or vaping. The department told news outlets that it's evaluating the reports and will release information as it becomes available. A department statement says the group is joining other state health departments in requesting information from health care providers on any cases of suspected respiratory illness among patients who vape. (9/10)
CBS News:
Vaping Illness: Colorado Parents Say Vaping Nearly Took Their Daughter's Life
Ruby and Tim Johnson say instead of dropping their daughter, Piper, off for her freshman year of college, they were watching her fight for her life in the ICU. "She feels lucky to be alive," Ruby said. Piper had had a fever and a rapid heart rate. "Every doctor that she saw asked her, are you a smoker? She said no. And then they said, what about e-cigarettes? And she said yes," Ruby said.Piper was diagnosed with Colorado's first case of a vaping-related illness that has now sickened hundreds of people nationwide. The college freshman had been vaping for more than two years. (9/9)
Reuters:
New York Governor Proposes Ban On Flavored E-Cigarettes
New York Governor Andrew Cuomo proposed legislation on Monday to ban flavored e-cigarettes statewide in an effort to protect young people from the unknown consequences of vaping. "Common sense says if you don’t know what you’re smoking, don’t smoke it," Cuomo told reporters at a news conference. "And right now, we don’t know what you’re smoking in a lot of these vaping substances," he said. (9/9)
The Washington Post:
Firms Selling Vitamin E Acetate For Vaping Products Face New York Subpoenas
The companies are marketing and selling “thickening agents” that can be used in black market vaping products that contain THC, the active ingredient in marijuana that produces the high. Dealers have been using thickening agents to dilute THC oil in street and illicit products, industry experts said. These thickeners are being marketed and readily available on the Internet “as a cheaper, safer alternative that does not negatively impact flavoring or odor of existing products and can be used to cut vape products to any level of THC,” the governor’s office said in a news release. (Sun, 9/9)
Bloomberg:
Cuomo Signals N.Y. Crackdown On Vaping Products After Illnesses
Austin Finan, a spokesman for Juul Labs Inc., the largest manufacturer of vaporizing e-cigarette devices, emphasized that his company doesn’t market products including cannabis or its chemical derivatives, or vitamin E compounds such as those suspected of causing the respiratory illness. The company exists, “to help adult smokers switch off of combustible cigarettes,” and supported the 21 minimum wage for tobacco sales in New York, he said. (Goldman, 9/9)
