Yesterday, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs for marketing unauthorized modified risk tobacco products. The FDA also sent a letter to JUUL requesting more information about its marketing practices, including those targeted at students, tribes, health insurers, and employers.
In its warning letter, the FDA said that JUUL -- by making statements such as the product was "much safer than cigarettes," was "totally safe," and "would be better for the kid to use" -- marketed modified risk tobacco products without an appropriate FDA order in effect. The FDA also pointed to a "Letter from the CEO" that appeared on JUUL's website which said that the product "delivers smokers the satisfaction that they want without the combustion and harm associated with it."
In the separate letter that the FDA sent to JUUL requesting additional information about the company's marketing practices, the FDA said that it was "particularly troubled" by reports that JUUL had "engaged in a wide variety of promotional activities and outreach efforts to persuade potential customers, including youth, to use JUUL products." The FDA pointed to practices such as advertising on social media channels frequented by underage teens and the use of influencers and discount customers to attract new customers. The FDA also expressed concerns that JUUL's "Make the Switch" marketing campaign conveyed that switching to JUUL is a safer alternative to cigarettes.
The FDA gave the company 15 days to respond to the warning letter, instructing JUUL to describe the corrective actions that it is taking and its plan for maintaining compliance with federal law. The FDA gave JUUL 30 days to provide the requested documents and information in response to its other letter.
The message to e-cigarette marketers is loud and clear. The federal government is going to continue to aggressively crack down on anyone that attempts to market smoking products to kids. And, if you're going to market your product as a safer alternative, you'd better get the proper approvals to do so.
For marketers more generally, one of the interesting things about the FDA's action here is how much the FDA is focused on alternative marketing practices. Don't get addicted to focusing all of your legal compliance efforts on your bigger budget marketing programs. As demonstrated by the FDA's letters, presentations in schools, statements by influencers, a letter from the CEO, and social media posts are not a safer alternative.
"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" -- Acting FDA Commissioner Ned Sharpless