August 8, 2016: FDA begins regulating vapes as tobacco products

The FDA extended the definition of tobacco product as defined in the Federal Food, Drug, and Cosmetic Act and the Tobacco Control Act to include e-cigarettes and vaping products. [81]

July 12, 2019: Court ruling requires new product applications for all vaping products

The U.S. District Court for the District of Maryland ordered all vaping manufacturers with products “deemed new” on the market as of August 8, 2016, to submit applications for premarket review by May 12, 2020. An extension for submission was granted (September 9, 2020) because of the COVID-19 pandemic. “Deemed new” referred to products that were not “commercially marketed in the United States as of February 15, 2007.” [82] [83]

September 11, 2019: President Trump plans to end flavored vape sales

Pres. Donald Trump’s administration announced plans to have the FDA end sales of nontobacco e-cigarette flavors such as mint or menthol in response to concerns over teen vaping. E-cigarette manufacturers were required to request FDA permission to keep flavored products on the market; the FDA had until September 9, 2021, to make a decision. [46] [49]

September 9, 2021: FDA denies almost one million applications for vaping products

Acting FDA commissioner Janet Woodcock and director of the FDA’s Center for Tobacco Products Mitch Zeller announced that the FDA had made decisions on about 93 percent of the over 6.5 million submitted applications for deemed new tobacco products (“deemed new” meaning that the FDA has authority to review products that are already on the market). The FDA denied more than 946,000 vaping products “because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use.” [55] [56] [57]

October 12, 2021: FDA authorizes Vuse e-cigarette and cartridges

The FDA authorized the Vuse e-cigarette and cartridges, marketed by R.J. Reynolds, one of the world’s largest cigarette manufacturers. The move is the first time the FDA authorized any vaping product. According to a statement from the FDA, the organization “determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.” [58]

June 23, 2022: FDA orders Juul to stop selling all products in the United States

The FDA ordered Juul to stop selling all products currently marketed in the United States, including vape pens and pods, to protect public health. Critics had grown especially concerned about the skyrocketing popularity of vaping among teens and the role Juul’s colorful packaging, flavored varieties, and use of young models in their marketing campaigns had played in this phenomenon.

The following day, June 24, 2022, a federal appeals court temporarily put the ban on hold while the court reviewed Juul’s products’ appeal. [61] [62]

September 6, 2022: Juul settles lawsuits with states and Puerto Rico

A lawsuit brought against Juul by 32 states and Puerto Rico accused Juul of marketing to minors. Juul admitted no wrongdoing in settling the lawsuit, but the company had to pay $438.5 million, stop marketing to youth, stop funding education in schools, and stop misrepresenting the amount of nicotine in the products. [63]

February 22, 2023: FDA files civil money complaints against four manufacturers

For the first time, the FDA filed civil money complaints (CMPs) against tobacco product manufacturers. The companies had sold unauthorized vaping liquids. The maximum CMP penalty, which the FDA generally seeks, is $19,192 for one violation. [90]

March 15, 2023: FDA completes reviewing most of the applications submitted in 2020

The FDA announced that it had made determinations on more than 99 percent of the almost 26 million tobacco products for which deemed new applications were submitted in 2020. Only 23 products received marketing granted orders. [84]

May 12, 2023: FDA issues marketing denial orders to 10 companies

The FDA denied the applications of 10 companies that manufacture and market about 6,500 flavored vaping products. It stated, “The premarket tobacco product applications (PMTAs), which were for a variety of flavored e-cigarette products, did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.” [85]

September 28, 2023: FDA fines 22 companies for selling unauthorized vaping products

For the first time, the FDA imposed the maximum civil money penalty for a single violation ($19,192) from each company for selling “illegal youth-appealing e-cigarettes.” Brian King, director of the FDA’s Center for Tobacco Products, said:

The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable. These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences. [93]

October 12, 2023: FDA issues marketing denial orders to R.J. Reynolds

Six flavored vaping products were denied marketing orders, including three menthol and three mixed berry flavored products. The FDA stated:

Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth. [87]

November 2, 2023: FDA announces drop in vape use among high-school students

In the 2023 National Youth Tobacco Survey, the FDA and CDC found that among high-school students overall tobacco product use declined from 16.5 percent in 2022 to 12.6 percent in 2023. The decline was driven mainly by reduced e-cigarette use, which fell from 14.1 percent in 2022 to 10 percent in 2023 and represented 580,000 fewer high-school students using e-cigarettes. [88]

December 14, 2023: FDA announces seizure of 1.4 million unauthorized vaping products

The three-day joint operation between the FDA and U.S. Customs and Border Protection resulted in the seizure of 41 shipments of e-cigarettes from China worth more than $18 million. [91]

2024: FDA issues warning letters to vape retailers

The FDA issued over 690 warning letters and over 140 civil money penalty actions to retailers for selling unauthorized vape products popular among young people, some with the brand names Geek Bar, Lost Mary, and Bang. The letters (see a sample here) gave retailers 15 working days to respond with actions to address the violations. [76] [78]

June 10, 2024: Justice Department and FDA announce federal task force

The U.S. Department of Justice (DOJ), the FDA, Bureau of Alcohol, Tobacco, Firearms, and Explosives, the U.S. Marshals Service, the U.S. Postal Inspection Service, and Federal Trade Commission joined forces to curb the illegal sale of vapes. In a press release, the DOJ said that the groups will

coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution, and sale of e-cigarettes, vapes, and other electronic nicotine delivery system (ENDS) responsible for nicotine addiction among American youth. [80]

June 2024: FDA lifts Juul ban and approves four types of Njoy menthol vapes

In June 2024 the FDA reversed its ban on Juul products and approved four types of menthol-flavored vapes made by Njoy. The approval made the vapes the first flavored e-cigarettes that could be legally sold in the United States. The move came amid a debate about whether to ban traditional menthol cigarettes at the federal level. [64]

September 5, 2024: FDA announces drop in youth vaping

The FDA released data collected by the National Youth Tobacco Survey, which found that the number of young vapers had dropped from over 5 million in 2019 to 1.63 million in 2024. [86]

October 30, 2024: FDA issues warning letters about vapes with smart technology designs

The FDA warned a number of e-cigarette sellers against selling and distributing vapes that mirrored features of smart technology, making them particularly appealing to young people. It stated:

The [vaping] products cited in the warning letters are advertised as having a variety of designs and functions that may appeal to youth, such as the ability to play games, connect to a smartphone, receive text or call notifications, play music, or personalize products with custom wallpaper.

Further, the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because the designs help conceal the nature of the products as tobacco products from parents, teachers, or other adults. [79]

December 2, 2024: U.S. Supreme Court hears FDA arguments about regulation of flavored vapes

The U.S. Supreme Court heard the FDA’s arguments that flavored vapes should be regulated. The case was brought by two companies whose applications to market vapes with flavors including “Rainbow Road,” “Crème Brulee,” and “Jimmy the Juice Man Peachy Strawberry” were rejected. The FDA rejected the applications on the basis that the flavored vapes were a “known and substantial risk” to kids and teens. [68]

The ruling in favor of the FDA was issued on April 2, 2025. [67]

January 2025: FDA lists 34 lawful vapes and vaping products

The FDA authorized 34 e-cigarette products and devices for legal marketing and sale in the United States. The list was updated in May 2026 to include 45 products. [77] [98]

January 15, 2025: FDA proposes new maximum nicotine content rule, excludes vapes

The FDA proposed a rule that would set a maximum nicotine content for combustible tobacco products. The new rule would not apply to vapes. [89]

April 2, 2025: U.S. Supreme Court rules in favor of FDA limitations

The two vape manufacturers who had taken the FDA to court after their request to market certain vapes had been rejected were handed a loss by the U.S. Supreme Court. New York Times journalists Adam Liptak, Abbie VanSickle, and Christina Jewett summarized the case and ruling:

The Supreme Court handed a victory to the Food and Drug Administration on Wednesday, tossing out an appeals court decision that had found the agency acted unlawfully in rejecting applications from two manufacturers of flavored liquids used in e-cigarettes with names like Jimmy the Juice Man Peachy Strawberry, Signature Series Mom’s Pistachio and Suicide Bunny Mother’s Milk and Cookies.

In a unanimous decision written by Justice Samuel A. Alito Jr., the justices left in place, for now, an F.D.A. order that prohibited retailers from marketing flavored tobacco products. [67]

June 20, 2025: U.S. Supreme Court rules vape retailers can seek judicial review of FDA denial

In a 7–2 ruling, the U.S. Supreme Court held that vape manufacturer R.J. Reynolds and retailer Avail Vapor could seek judicial review of the FDA’s rejection of submitted marketing applications on the basis that the companies were “adversely affected” by the denial. [65]

July 17, 2025: FDA authorizes Juul vapes for market

The FDA authorized the vapes themselves as well as menthol- and tobacco-flavored cartridges. It noted that Juul had offered “robust data” that about two million adults had stopped smoking after using Juul vapes. Having said that, the FDA cautioned people, saying that the authorization “does not mean these tobacco products are safe.” [16]

March 31, 2026: FDA lists civil money complaints against 7,778 companies

Between April 28, 2017, and March 21, 2026, the FDA issued 6,708 civil money complaints against brick-and-mortar companies selling vaping products, as well as 1,070 online retailers selling vape liquid or vapes, according to the FDA’s Tobacco Compliance Check Outcomes. [92]

May 5, 2026: FDA authorizes first fruit-flavored vapes

The FDA authorized four Glas vapes: Classic Menthol, Fresh Menthol, Gold, and Sapphire. The Gold vape has mango-flavored vape liquid, while the Sapphire has blueberry. The vapes contain 5 percent of tobacco-derived nicotine and function in concert with an app. The FDA explained:

The technology requires the user to verify their age and identity with a government-issued ID and pair the device [vape] with a smartphone via Bluetooth. Following verification, the device will not operate if separated from the phone. The app also conducts random biometric check-ins to periodically confirm the registered user is the one using the device. [99]

May 10, 2026: FDA revises premarket authorization requirement for vapes

The new FDA guidance indicates that the agency will use “enforcement discretion” for certain vaping products with pending applications, allowing some vaping and nicotine-pouch products—including potentially flavored vapes—to remain on the market while their applications are under review. Meanwhile, they will prioritize enforcement against products considered especially appealing to minors. The FDA maintained:

[The agency] lacks the resources to pursue enforcement against every product that has not received authorization. Products not falling within the categories set forth above are subject to FDA prioritized enforcement. FDA does not intend to prioritize enforcement against products falling within the categories set forth above, unless they have certain presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone, or gaming platform.

However, many have viewed the guidance as a removal of necessary guard rails to prevent a rise in youth vaping and nicotine addiction. [100] [101]

May 12, 2026: FDA Commissioner resigns over change in flavored vapes policy

FDA Commissioner Marty Makary resigned after the Trump administration—reportedly the president himself and U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr.—pushed to authorize the sales of fruit-flavored vapes, according to New York Times sources. [102]

The chief spokesperson for Kennedy, Rich Danker, resigned on May 13 for the same reason. In his letter of resignation, Danker wrote:

Senior HHS officials in the immediate office of the secretary have in recent months sought U.S. Food and Drug Administration marketing approval of e-cigarette flavors that would appeal to children and expose them to nicotine addiction, lung damage, and higher risk of cancer. [103]