FDA warns JUUL Labs for misleading e-Cigarette Marketing

(Sept. 11, 2019) The FDA warned JUUL Labs this week for misleading young people with aggressive e-Cigarette marketing campaigns. The FDA warning – announced Sept. 9, 2019 – included the agency’s objections to JUUL’s claims that its products lower or modify the risk of nicotine-loaded tobacco products. The agency also voiced its objections to JUUL’s youth-outreach programs, under the banner of which JUUL promoted e-cigarettes to adolescents herded into JUUL-run classrooms at the behest of the company. The dubious claims JUUL made to captured underage audiences in the schools were never approved by the FDA. Hence the warning.

The FDA requested with the warning that JUUL provide the agency with more information regarding several issues that include the company’s outreach and marketing practices.

FDA Warning to JUUL

“Today, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school. The agency also sent a letter to the company expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. These letters are the latest (development) in the FDA’s ongoing investigation related to JUUL.”

Acting FDA Commissioner Ned Sharpless, M.D., added:

“[B]efore 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. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth. In addition, we’re troubled about several issues related to JUUL’s outreach and marketing practices that came to light in a recent Congressional hearing.”

Dr. Sharpless said the agency will continue to “scrutinize tobacco product marketing” and act to ensure the public is not misled into believing a certain product has been proven less risky or less harmful when it has not been proven so. “We’ve also put the industry on notice,” he said.  “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.”

Modified Risk Tobacco Products?

The main issue is that JUUL has marketed its e-cigarettes as “modified risk tobacco products” without an appropriate FDA order in effect to represent them as such. The violation occurred because JUUL marketed a product to lead consumers to believe several things which are unproven.  JUUL illegally claimed in its marketing that its e-cigarettes:

1) present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products;

2) contain a reduced level of a substance or present a reduced exposure to a substance; and/or

3) do not contain or are free of a substance or substances.

The FDA warning letter identifies several statements (discussed) in testimony from a July 2019 Congressional hearing. According to that testimony, a JUUL representative speaking with students at a school presentation erroneously claimed:

  • JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
  • JUUL was “totally safe.”
  • A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
  • “FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”

Parent’s Complaint to JUUL Heard

The FDA warning to JUUL also included a letter from JUUL’s CEO that appeared on the company’s website and also in an email JUUL sent to a parent who complained that JUUL sold its products to her child. The CEO’s letter states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

450 e-Cigarette Injuries, Six (6) Deaths

E-cigarettes have come under fire this summer (no pun intended) as hundreds of otherwise healthy, mostly young people who used the devices have struggled to breathe and were hospitalized. A respiratory illness from the products has mystified public health officials who continue to investigate by testing products and patient specimens. As of late last week, 450 cases were reported across the country, according to the CDC. Six of those patients have died. All that’s known about the victims is the state where they lived and their age – all were at least 18.

FDA warns JUUL Labs for misleading e-Cigarette Marketing

One JUUL pod delivers as much nicotine as 30 to 40 cigarettes. Users quickly find themselves physically addicted and suffering from a range of side effects that include seizures, lung and respiratory problems, strokes, heart disease and other potentially long-term health-related complications. We still don’t know the scope of lasting damage caused by high-dosage delivery of nicotine on still-developing brains. We don know that attorneys are beginning to file JUUL E-Cigarette Lawsuits against the company.

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