Swiftly on the heels of incendiary national news stories like this one in the New York Times about the growing number of cases of serious vaping-related lung illnesses, the Food and Drug Administration issued a warning letter to SF-based Juul Labs saying the company has already violated federal regulations with its marketing claims.
As the Times reported Monday, the letter states that because Juul never received federal approval to promote and sell its vape pens as a healthier alternative to cigarette smoking, it has acted illegal in its marketing campaigns that say just that. The letter gives Juul Labs 15 days to submit a plan to comply with the issues outlined in the letter.
The letter cites several examples of ways the company has violated the law, including a presentation by a Juul rep at a school presentation in which the rep said that Juul's products are "much safer than cigarettes" and "totally safe." The letter also points to some copy on the Juul website in which CEO Kevin Burns states that Juul's vape pen technology "deliver[s] smokers the satisfaction that they want without the combustion and harm associated with it."
Juul has been at the center of nearly every news story about the still mysterious lung illnesses that have cropped up in hundreds of cases around the country. Some public health experts believe that something new must have hit the market in recent months, possibly bootleg vape cartridges or other products, that may explain the recent rise of these cases — however no single source, ingredient, or product has yet been identified as a culprit. The Times story from over the weekend included experts hypothesizing that basic vaping itself — the heating coils in the devices — could be to blame for emitting small metal fragments, though it's strange that the technology has been around for over five years with this preponderance of sick people arising only in the last few months.
Juul and other vape manufacturers were initially given an August 2018 deadline by the FDA to present proof of the health benefits of e-cigarettes, but FDA commissioner Dr. Scott Gottlieb pushed that deadline back four years, to 2022.
New acting FDA commissioner Ned Sharpless tells the Times this week, "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."
All in all this has not been a good summer for Juul Labs, which has seen its valuation rise to $38 billion this year, up from $16 billion last year, all while trying to overturn a San Francisco law that banned e-cigarettes outright, and dealing with a growing public health crisis that may or may not have something to do with the entire vaping industry. The CDC issued a broad warning just two weeks ago suggesting that no one who doesn't already use tobacco products should be trying vaping right now.
Juul has said that it did not specifically target teenagers in its marketing, and a company spokesperson today said, "We are reviewing the [FDA's] letters and will fully cooperate."