FDA bans Juul vape products; court orders a temporary stay

If you haven’t been following the Food and Drug Administration’s attempts to regulate the vaping industry, here’s the backstory:

In 2009, Congress approved the Family Smoking Prevention and Tobacco Control Act, which gave the FDA, for the first time, authority to regulate tobacco products for public health. In 2016, the FDA approved a rule to regulate all tobacco products, including vape products with nicotine derived from tobacco. 

As part of the regulatory process, vape product manufacturers were required by September 2020 to submit applications with clinical trial data about the health effects of their products, showing that they met regulatory standards. More than 6 million different vaping products were allowed to stay on the market while they were under FDA review.

So far, the FDA has approved applications for 23 electronic nicotine delivery systems (or “ENDS”), but it has rejected about a million other applications. Many of the rejected applications were for flavored vape products, which researchers claim are leading to a rise in teen vaping. Public health agencies have been concerned about flavored tobacco products for years, especially sweet-flavored tobacco products that appeal to children.

The U.S. Surgeon General has determined e-cigarette use poses significant health risks to young people. Relevant health risks include nicotine addiction, mood disorders, and permanent lowering of impulse control. The Centers for Disease Control and Prevention (CDC) notes that young people who use e-cigarette products may be more likely to smoke cigarettes in the future. 

All Juul e-cigarettes have a high level of nicotine, according to the CDC. In fact, Juul is one of few e-cigarettes that use nicotine salts, which allow particularly high levels of nicotine to be inhaled more easily and with less irritation. Nevertheless, roughly two-thirds of Juul users aged 15 to 24 are unaware that Juul products always contain nicotine.

Yet vape industry advocates point out that some adults successfully use vaping products to wean themselves away from cigarettes as part of efforts to quit smoking. The mission of Juul Labs is, in part, “to transition the world’s billion adult smokers away from combustible cigarettes.”

When announcing the Juul ban in June 2022, the Food and Drug Administration acknowledged that it “has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or JUULpods.”

However, the FDA also said that the information it had received from Juul was “insufficient” for the agency to “assess the potential toxicological risks of using the Juul products.”

The FDA said some of the research findings the company had submitted “raised concerns due to insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods — that have not been adequately addressed.”

The agency also said there’s no way for it to determine “the potential harms” of using third-party vape juice with Juul devices, or of using Juul vape-juice pods with a non-Juul device.  It’s Juul’s responsibility to demonstrate that its products meet FDA standards, and according to the FDA, Juul hasn’t provided the data the agency needs to determine relevant health risks. 

On July 6, 2022, Juul issued a statement saying it feels the clinical trial data it submitted was complete and met FDA requirements.

The statement was attributed to Juul Labs Chief Regulatory Officer Joe Murillo, who asserted “We have provided sufficient information and data based on high-quality research to address all issues raised by the agency.”

The company was “exploring all of our options under the FDA’s regulations and the law,” according to the statement from Murillo, who added that Juul might appeal.

“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,” Murillo’s statement concluded.

News of the ban initially prompted a run on Juul products in some places. Other stores saw a more low-key response, with shop owners predicting that vapers would switch to other approved brands. Some stores had already pulled Juul products from their shelves in anticipation of the move.

Since the FDA Juul ban is under an administrative stay, for now, businesses can market Juul products, sell Jull products, and ship Juul products as allowed by law. Certain states, counties, and cities have set limitations on shipping vapor products, and it’s illegal to ship vaping products through the U.S. Postal Service. Additionally, FedEx and UPS will not ship vaping products.

The FDA itself recommends that vape shop operators contact their suppliers and manufacturers for up-to-date guidance, as vape products on the market without FDA authorization are “marketed unlawfully and are subject to enforcement action,” the agency said, adding that sales of unauthorized vaping products are “among our highest enforcement priorities.”

As of April 24, 2023, the Food and Drug Administration has neither lifted the temporary stay on the Juul ban nor reestablished the ban. Businesses that market and sell Juul products are in the proverbial waiting place.

To help get things moving, on September 20, 2022, Juul Labs filed a lawsuit with the U.S. District Court for the District of Columbia to obtain access to FDA documents related to the agency’s marketing denial order (MDO) of Juul products. Juul maintains there’s a “troubling pattern of decreasing transparency at the agency,” and says it has exhausted its administrative remedies.

Juul also published its administrative appeal of the marketing denial order issued by the Food and Drug Administration. The appeal, known as the 10.75 appeal, “explains the company’s position, based on science and evidence, that the MDO was substantially and procedurally flawed.” The 10.75 appeal was submitted in July 2022 and made public in October 2022.

There’s still no response from the FDA, but Juul has plenty else on its plate.

Since the events of June 2022, Juul has been working to “resolve issues from the company’s past.”

In an April 17, 2023, announcement of a settlement with the Minnesota Attorney General, Juul Labs said, “We have now settled with 48 states and territories, providing over $1 billion to participating states to further combat underage use and develop cessation programs. This is in addition to our global resolution of the U.S. private litigation that covers more than 5,000 cases brought by approximately 10,000 plaintiffs.

A recent payout to six states and the District of Columbia is the largest to date: $462 million. As a result of this settlement, retailers must keep Juul products securely behind counters and verify the age of purchasers. Additionally, Juul is prohibited from using people under 35 years of age in their marketing materials.

All told, Juul has paid states more than $1 billion and is reportedly “nearing total resolution of the company’s historical legal challenges and securing certainty for our future.” The company says it’s “positioned to dedicate even greater focus on our path forward,” which is to “advance tobacco harm reduction for over 31 million adult smokers in the U.S. and over 1 billion adult smokers worldwide.”

The action against Juul is just one round in the federal government’s attempts to get tighter control over the vaping industry. We discussed a related issue — the new law giving the FDA oversight of synthetic nicotine — back in May 2022.

This post has been updated; it was originally published June 28, 2022.