The U.S. Food and Drug Administration has issued a warning about illegal marketing activities to JUUL Laboratories, maker of the most popular e-cigarette. The warning states that the company’s marketing has promoted their products as “safer” alternatives to cigarette smoking. The FDA has ordered JUUL Labs to respond with a corrective action plan within 15 days.
As JUUL is the leading e-cigarette manufacturer and responsible for about 70% of the market, JUUL activities have been heavily criticized and this is not the first exchange that JUUL has had with regulators at the FDA.
Recent JUUL FDA Warnings
The September 9, 2019 FDA warning issued to JUUL Laboratories expressed concerns that the company had been engaged in inappropriate or illegal marketing. JUUL’s outreach projects were criticized, particularly those addressing “students, tribes, health insurers, and employers.”
The Agency stated “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. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth.”
Early FDA Criticism of JUUL
In early-2018, the FDA requested that JUUL turn over documents and research that supported their claims that e-cigarettes were safer or less addictive than cigarettes but JUUL failed to alter their practices or products and stuck to the claim that flavors were needed to meet adult customers’ needs.
The Agency had already expressed concern about flavored vape juices which would appeal to minors. Warning letters were issued to a number of manufacturers stating that their packaging could lead to accidental ingestion by children as the vape products appeared to be “juice boxes, candies, and cookies”.
Vaping on the Rise
In November, the Agency, along with other health authorities indicated that vaping had increased about 80% amongst high school-aged minors and had increased a shocking 50% amongst middle schoolers in a single year period.
Simultaneously, in November of 2018, the FDA issued a warning letter to additional manufacturers regarding vape juice products and packaging. The Agency cited more manufacturers for inappropriately labeling products and packaging them in a manner that made them look like candy, cereal or other child-friendly foods. All of the products cited by the FDA, have been withdrawn from the market but JUUL has taken no action on their separate issues. JUUL has been soundly rebuked by a number of state agencies as well. Several states have moved to restrict sales to those over 21 years of age and most recently, following hundreds of high-profile illnesses involving at least six deaths, Michigan state authorities have acted to ban sales of flavored e-cigarette products. President Trump has also indicated that his administration will be evaluating e-cigarette use in preparation for a possible ban.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.