FDA Issues Warning Letter to Company Marketing E-Cigarettes

The FDA has issued a letter to JUUL Labs Inc, requesting more information about the company's outreach and marketing practices of electronic nicotine delivery systems (ENDS) and related products. The letter specified concerns around marketing targeted at students. The FDA also issued a simultaneous warning letter regarding JUUL's marketing and advertising practices.¹

According to FDA policies, companies must scientifically demonstrate that their products pose less risk than traditional products before they are able to market products for reduced risk. Acting FDA Commissioner Ned Sharpless, MD, said JUUL has ignored this law in marketing their products.

The warning letter cited several statements examined during a July 2019 Congressional hearing on JUUL products. According to the testimony, a JUUL representative speaking with students at a school made statements that identified JUUL products as "much safer than cigarettes," and that 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."¹

"The agency is concerned these statements and representations may convey that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes," said the FDA statement.¹

E-cigarette use has been under increasing scrutiny over the past year. The FDA conducted a crackdown in October 2018, after concerns were raised regarding e-cigarette sales to minors.² The first death attributed to vaping was recorded in August 2019, according to the Illinois Department of Public Health.³

According to the CDC, JUUL sales have rapidly increased since 2016. Between 2016 and 2017, JUUL sales increased from 2.2 million devices sold to 16.2 million devices, a total increase of 641%. The CDC expressed concern that 74% of youth who used JUUL said they bought the device directly from a retail store.⁴

Like the CDC, the FDA also expressed concern regarding youth's perceptibility to marketing of e-cigarette products.

"Referring to your ENDS products as '99% safer' than cigarettes, 'much safer' than cigarettes, 'totally safe,' and 'a safer alternative than smoking cigarettes,' is particularly concerning because these statements were made directly to children in school," the warning letter said. "Our concern is amplified by the epidemic rate of increase in youth use of ENDS products, including JUUL's products, and evidence that ENDS products contribute to use of, and addiction to, nicotine, to which youth are especially vulnerable."⁵

The FDA requested documents and information on several issues, including JUUL's use of nicotine salts in its e-liquids and the concentration of nicotine in its products. Nicotine salts were described at the Congressional hearing as a tool to mask the harshness of nicotine.

The FDA also asked JUUL to provide information on why they use a nicotine concentration of 5% in their products, which could potentially increase addictiveness.¹

The FDA has requested that JUUL provide the requested documents and information within 30 days of the letter.¹

References

• FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth [news release]. Silver Spring, MD; September 9, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth. Accessed September 9, 2019.
• FDA Takes New Steps to Address Epidemic of Youth E-Cigarette Use, Including a Historic Action Against More than 1300 Retailers and 5 Major Manufacturers for their Roles Perpetuating Youth Access [news release]. Silver Spring, MD; September 11, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM620184.htm. Accessed September 9, 2019.
• Illinois Resident Experiencing Respiratory Illness After Vaping Dies. Springfield, Illinois [news release]. Springfield, IL; August 23, 2019: IDPH website. http://www.dph.illinois.gov/news/illinois-resident-experiencing-respiratory-illness-after-vaping-dies. Accessed August 26, 2019.
• Sales of JUUL E-cigarettes Skyrocket, Posing Danger to Youth [news release]. Atlanta, GA; October 2, 2018: CDC Newsroom. https://www.cdc.gov/media/releases/2018/p1002-e-Cigarette-sales-danger-youth-html. Accessed October 2, 2018.
• Sharpless N. JUUL Labs, Inc. - 509050 - 09/09/2019. Silver Spring, MD; September 9, 2019: FDA website. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/juul-labs-inc-590950-09092019. Accessed September 9, 2019.