The FDA today formally rejected marketing applications for all current Juul Labs products, confirming yesterday’s leaked report. The agency has issued Marketing Denial Orders (MDOs) for the JUUL device, and Virginia Tobacco and Menthol flavored refill pods in both 3 and 5 percent strengths.
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 FDA also cited “concerns” over “potentially harmful chemicals leaching from the company’s proprietary e-liquid pods,” and said there “is no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.” (These were apparently not concerns for the similar pod-based NJOY Ace, which FDA authorized in April.)
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.”
“FDA seems to be relying on vague and generalized concerns about Juul toxicology evidence, but it offers no evidence of any sort of health risk or it would have mentioned it,” Clive Bates, former head of the UK’s Action on Smoking and Health (ASH), told Vaping360.
“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.”
FDA Commissioner Robert Califf and the FDA’s Center for Tobacco Products (CTP) have been under constant pressure from Democrats in Congress and anti-vaping tobacco control groups to reject Juul’s PMTA (and to ban vape flavors and synthetic nicotine products). The toxicological “concerns” look like a weak pretext for satisfying political demands.
“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.”
Not only did the agency authorize sales of Philip Morris’ IQOS, it also gave the nod to actual combustible tobacco, authorizing sales of very low nicotine cigarettes (VLNCs) made by 22nd Century Group. The agency is preparing to announce it will force all cigarette manufacturers to reduce nicotine below addictive levels.
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 Labs has two immediate options for challenging the agency’s decision. The company could file an administrative appeal with the FDA, or it can file a petition for review of the MDO in a federal circuit court of appeals. Juul can also ask the court to grant a stay of the denial order until the review is complete, which would allow it to continue selling products at least temporarily.
“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.”
More than three dozen small vape companies have challenged FDA denial orders in court. Some have received stays allowing them to continue doing business. Others have had MDOs rescinded by the FDA, which forces the agency to move the company’s PMTA back into scientific review.
Juul Labs’ Chief Regulatory Officer Joe Murillo, in a statement issued today, strongly disputed the FDA’s claim that the company lacked robust toxicological evidence. Murillo seemed to indicate the company will seek immediate relief in the courts.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” Murillo said. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”