Toxic Politics: FDA's Flimsy JUUL Denial Will Send Many to Cigarettes

The order takes effect immediately. The FDA could, if it chose to, begin enforcement against Juul Labs and retailers selling JUUL at any time.

The agency based its decision on the flimsiest of grounds, claiming in a press release that Juul Labs’ Premarket Tobacco Application (PMTA) “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

The statement went on to admit that the FDA has no real-world evidence “to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.”

“The FDA was looking for excuses”

“FDA admits it has no evidence of an immediate hazard,” Bates added. “This is another case of FDA arbitrarily raising a previously invisible regulatory hurdle. Juul spent $100 million on its PMTA. I think we can be pretty confident it did a thorough job on toxicology.”

"The FDA was looking for excuses to look tough and ban Juul and this is how low they had to stoop to justify it," American Vaping Association President Gregory Conley told Vaping360. “This is the same FDA that correctly gave PMTA and MRTP authorization to IQOS, a heat-not-burn tobacco product that creates many more chemicals than a Juul does.”

FDA suggests JUUL is more toxic than actual cigarettes

Cigarettes, whether they contain nicotine or not, pose vastly higher risks than vaping products. It is the chemicals, gasses and particulates released by burning tobacco that cause almost all of the harms of smoking—not nicotine.

“The whole [FDA review] process is becoming surreal now,” says Bates. “No one could make a vape product as toxic as a cigarette, but guess which one got the green light. We have to remember that while FDA is forcing Juul to pull the most successful anti-smoking device ever made, there are 3,000 cigarette products out in the market largely untouched by FDA regulation and steadily killing 480,000 Americans annually.”

Juul will seek a stay of the FDA order

"If FDA wants Juul to remove their products from the market without an opportunity to wait for Juul to file for an administrative stay,” says the AVA’s Conley, “Juul should immediately sue in federal court to halt enforcement."