The Food and Drug Administration, in a warning letter issued to Juul Labs on Monday, declared that the company unlawfully branded its products as a safer alternative to cigarettes without gaining the FDA’s approval. It also targeted children.
“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 said in a statement.
“JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Sharpless added.
The FDA’s letter cited past incidents involving a Juul representative who was quoted as telling students at a school that Juul’s products are “totally safe” and that the “FDA was about to come out and say it was 99% safer than cigarettes.”
The FDA requested a written response within 15 days from Juul that will describe in detail the corrective actions it will take. If it does not believe its products violated federal regulations, it must provide a reasoning for why not.
“We are reviewing the letters and will fully cooperate,” a Juul spokesperson told HuffPost in response to the letter.
The FDA’s letter comes just days after the Centers for Disease Control and Prevention issued a nationwide warning against vaping after several deaths and hundreds of illnesses were linked to e-cigarette use.
As of Friday, health officials have identified 450 possible cases, including at least three deaths, in 33 states. A single product has not been tied to the illnesses. Many, but not all of them, involved individuals who have vaped THC, which is the psychoactive compound found in marijuana.