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FDA warns Juul about marketing practices

The FDA has issued a warning letter to Juul Labs for marketing its products as modified risk tobacco products, without an appropriate FDA order in effect, through labeling, advertising and other activities directed to consumers, including a presentation given to youth at a school, according to an agency press release.

“Regardless of where products like [electronic] 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. Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Ned Sharpless, MD, acting FDA commissioner, said in the release. “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. 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. 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. 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.”

Unauthorized claims

In the letter, the FDA states that Juul’s labeling, advertising or other activities directed at consumers represent or would be reasonably expected to result in consumers believing that Juul’s products present a lower risk for tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products; contain a reduced level of a substance or present a reduced exposure to a substance; and/or do not contain or are free of a substance or substances.

Specifically, the warning letter identifies several statements discussed in testimony from a July congressional hearing on Juul, according to the FDA release. In that testimony, a Juul representative speaking with students at his presentation in a school stated that:

• 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 [Juul] was 99% safer than cigarettes ... and that ... would happen very soon.”

Further, the FDA cited a “Letter from the CEO” that appeared on Juul’s website and in an email that Juul sent to a parent in response to her complaint that the company sold Juul products to her child stating that “[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,” according to the release.

The agency has requested that Juul provide a written response within 15 working days describing its corrective actions and plan for maintaining compliance with the Federal Food, Drug, and Cosmetic Act, including its plan to prevent the same or similar violations. Failure to ensure compliance with the Food, Drug, and Cosmetic Act may lead to further action by the FDA, such as civil money penalties, seizure or injunction.

Marketing practices

Additionally, the FDA sent another letter to the company expressing concern and requesting more information about several issues raised at the congressional hearing regarding Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. The letter noted that despite commitments Juul has made to address the epidemic of youth e-cigarette use, the company’s products continue to represent a significant proportion of the overall use of electronic nicotine delivery system products by children. Some of this youth use appears to have been a direct result of Juul’s product design and promotional activities and outreach efforts, according to the release.

For instance, the FDA’s letter expressed concern about statements and representations made as part of Juul’s “Make the Switch” campaign and Juul’s “Switching Program” presentation at the Cheyenne River Sioux Tribe, including:

• “[Juul] is a smart, really well-thought-out alternative to smoking. Make the switch.”

• “I think [Juul is] an amazing invention. ... I don’t know how we lived without that. The alternative for adult smokers.”

• “Elimination of combustible cigarettes is crucial to reduce risk of harm.”

• “Improve the lives of the world’s 1 billion adult smokers.”

In the release, the FDA stated that it is concerned that these statements and representations may indicate that switching to Juul is a safer alternative to cigarettes, in that using Juul products poses less risk or is less harmful than cigarettes. The FDA is requesting documents and information about these practices including any scientific evidence or data, such as consumer perception studies, related to whether these statements and representations explicitly or implicitly convey that Juul products pose less risk, are less harmful, present reduced exposure and are safer than other tobacco products or that the products are smoking cessation products.

The FDA is also asking Juul to explain why it uses nicotine salts, which was described at the congressional hearing as masking the harshness of nicotine. The FDA also is questioning why Juul uses a nicotine concentration of 5% in its products, which the agency is concerned could potentially increase their addictiveness. Furthermore, the FDA is requesting documents and information on, among other things, Juul’s use of nicotine salts in its e-liquids and the concentration of nicotine in its products.

The agency has also requested that Juul provide the requested documents and information within 30 days.

Previously, the FDA requested documents from Juul in April 2018 to investigate high rates of youth use and the youth appeal of Juul’s products. The FDA has also conducted an unannounced inspection of Juul’s corporate headquarters as well as inspections of several of Juul’s contract manufacturing facilities to determine compliance with all applicable FDA laws and regulatory requirements.

In the release, the FDA also emphasized its continued efforts with the CDC and state and local public health partners to investigate the recent rash of respiratory diseases associated with e-cigarette use, or vaping, and stated that it is committed to taking appropriate actions as the facts emerge.