Following a nearly two-year evaluation of the company's data, the agency concluded that the applications lacked "sufficient evidence" to demonstrate that the sale of the items would not be detrimental to public health.
The FDA stated that several findings prompted concerns owing to limited and contradictory evidence, including whether potentially dangerous substances may leach into Juul pods.
The corporation stated that it had accurately defined the toxicological profile of its goods and that the data complied with the legal requirement of being "suitable for the protection of public health."