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FDA Sends Warning Letter to JUUL for Illegal, Youth-Targeted Marketing as CDC Reports on Deaths from Vaping-Related Lung Illness

The U.S. Food and Drug Administration (FDA) recently sent a warning letter to e-cigarette maker JUUL regarding illegal and youth-targeted marketing. The letter came only three days after the U.S. Centers for Disease Control and Prevention (CDC) confirmed a vaping-related lung illness has caused numerous deaths in the United States.   

Lung Illness Tied to Use of E-Cigarettes

As of late September 2019, 805 people from 46 different states have developed symptoms associated with a respiratory condition linked to vaping, and safety officials still do not know exactly how e-cigarettes cause the illness. The CDC first alerted the public to the outbreak in August, when numerous patients in the country came down with an unexplained lung illness.

Officials have eliminated infectious disease as the source of the illness, and the only known connection between all of the patients is use of e-cigarettes. The CDC has been working with state health officials to come up with a uniform definition for the illness in order to classify cases consistently.

Patients who have confirmed cases of the respiratory illness present with the following symptoms:

  • Coughing
  • Chest pain
  • Difficulty breathing or shortness of breath
  • Nausea and vomiting
  • Diarrhea
  • Fatigue
  • Fever
  • Unexplained weight loss

Patients’ symptoms vary in degree and in onset. Many patients have been admitted to intensive care units and have been intubated because of the severity of their symptoms. Twelve patients in 10 states have died from the illness, according to the CDC. Doctors have reported no associated lung infections, and the illness generally does not respond to antibiotics.

The CDC is recommending that while the investigation continues, people should refrain from using e-cigarette products. Regardless of the investigation, however, the CDC states that pregnant women should not use e-cigarettes, and youth and young adults should not use e-cigarettes. Of the vaping-related lung illness patients for whom the CDC has identifying information (771 out of 805), 16 percent are under the age of 18, 22 percent are between the ages of 18 and 21, and 62 percent are between the ages of 18 and 34.

FDA Warns JUUL About Illegal Marketing, Targeting Youth

On September 9, the FDA sent a letter to the CEO of JUUL Labs Inc., Kevin Burns, saying that the agency had found the company in violation of federal regulations with regard to the marketing of its e-cigarettes. JUUL has advertised its vaping devices as “modified risk tobacco products,” according to the FDA, meaning the company is leading consumers to believe its e-cigarettes are safer than traditional cigarettes.

This advertising is unlawful, the FDA said, because the FDA has never issued an appropriate order for JUUL as a modified risk tobacco product or approved JUUL as a cigarette-smoking cessation device. Acting FDA Commissioner Ned Sharpless, M.D., stated that to claim its product is less harmful than combustible cigarettes, JUUL is required to present scientific evidence of such. Of special concern to the FDA, Sharpless said, is that JUUL has been making these claims to kids, even giving a presentation at a school.

“JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Sharpless said in a press announcement.

The FDA identified several troubling statements discussed during Congressional testimony at a July 2019 hearing. The testimony indicated that a JUUL representative told children at a school presentation that JUUL was “much safer than cigarettes,” that the FDA was about to approve the device, that the FDA was going to tell the public that JUUL was “99 percent safer than cigarettes,” and that students should tell their friends who smoke cigarettes to use JUUL, instead.

“We remain committed to using all available tools to ensure that e-cigarettes and other tobacco products aren’t being marketed or sold to kids,” Sharpless 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.”

In its letter to JUUL, the FDA requested a written answer within 15 business days as to the company’s plans to correct its advertising and to comply with federal regulations. The agency further requested additional information on the use of nicotine salts in JUUL’s products, which have been said to mask nicotine harshness, and on the nicotine concentration of JUUL’s pods. JUUL’s products currently have a 5 percent nicotine concentration, which the FDA says is a concerning amount that can potentially lead to higher instances of addiction.

The FDA also noted in its press announcement that it was working with the CDC to investigate the respiratory illnesses tied to vaping.

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