FDA Orders Juul Products Removed from US Market
The FDA issuing a marketing denial order against all Juul e-cigarette products and ordered that all Juul e-cigarettes be removed from US market. The reason FDA issued its decision to remove Juul from the US market was concerns over safety data Juul submitted to the agency. FDA noted, “(a)s with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.” 

It is important to note that FDA has authorized other tobacco flavored e-cigarette products to remain on the market, so the agencies decision appears to be unique to the Juul products and likely does not set a precedent for other e-cigarette manufacturers.

While public health advocates celebrated FDA’s decision, it may be a temporary setback for Juul. There is nothing preventing Juul from submitting additional data to respond to FDA’s safety concerns. Further, Juul has already announced its intention to litigate FDA’s decision in court.

The ATS will continue to pressure FDA to issue effective regulations on all tobacco products, including e-cigarettes.