U.S. Food and Drug Administration (FDA) Denies Thousands of Flavored E-Cigarettes and Targets Youth-Appealing Disposables (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did
2. The Marketing Denial Orders of 12 May 2023
3. Why Flavors Were the Deciding Question
4. Import Alerts and Retailer Inspection Blitzes
5. E-Cigarettes Made to Look Like Toys, School Supplies and Drinks
6. Fines Against Retailers
7. The 2023 National Youth Tobacco Survey
8. The December Seizure at Los Angeles
9. How the Enforcement Count Grew Through 2023
10. What These Actions Do Not Do
11. Dates and Legal Status as of 18 October 2026
12. How the 2023 Actions Fit Earlier and Later U.S. Food and Drug Administration Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the U.S. Food and Drug Administration Did

The 2023 story is not one rule but a run of orders and enforcement actions by the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the part of the agency that regulates cigarettes, e-cigarettes and other tobacco and nicotine products. The main steps, as the U.S. Food and Drug Administration’s own announcements describe them:

• 12 May 2023 — marketing denial orders to 10 companies for about 6,500 flavored e-liquid and e-cigarette products (CTP Newsroom).
• May 2023 — import alerts placing all products of the two most popular youth-appealing disposable brands, and certain associated firms, on the “red list” (described in the June and December releases).
• 31 May 2023 — warning letters to 30 retailers, including one distributor, after a nationwide inspection blitz targeting two disposable brands that the 2022 youth survey had ranked first and third among young users.
• 22 June 2023 — warning letters to 189 retailers after a second blitz, aimed at two further disposable brands sold in flavors “known to appeal to youth, including bubblegum and cotton candy.”
• 23 August and 16 November 2023 — warning letters to online retailers selling e-cigarettes packaged to look like television and video-game characters, school supplies, toys and drink containers.
• 28 September 2023 — civil money penalty complaints against 22 retailers, seeking the maximum amount for a single violation, plus 168 more warning letters.
• 2 November 2023 — release of the 2023 National Youth Tobacco Survey with the U.S. Centers for Disease Control and Prevention, and penalty actions against 20 more retailers.
• 14 December 2023 — announcement of a joint seizure with U.S. Customs and Border Protection of about 1.4 million units with an estimated retail value of more than $18 million.

Back to Table of Contents

2. The Marketing Denial Orders of 12 May 2023

Under federal law a new tobacco product, which includes an e-cigarette, needs a marketing authorization from the U.S. Food and Drug Administration before it can be legally sold. A company asks for one through a premarket tobacco product application (PMTA). If the U.S. Food and Drug Administration concludes the application does not meet the legal standard, it issues a marketing denial order (MDO).

On 12 May 2023 the U.S. Food and Drug Administration issued MDOs to 10 companies which, together, made and marketed approximately 6,500 flavored e-liquid and e-cigarette products. The CTP Newsroom notice says the applications “did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health.” Flavors among the denied products included citrus, strawberry cheesecake, cool mint and menthol. The U.S. Food and Drug Administration named eight of the companies and withheld the names of the other two “to protect potential confidential commercial information.”

The notice spells out what a denial means in practice: products subject to an MDO “may not be offered for sale, distributed or marketed in the United States,” may not be shipped across state lines, and a product already on the market “must be removed from the market or risk enforcement.” Retailers who sell these products, it adds, “risk U.S. Food and Drug Administration enforcement action.”

The orders were part of a much larger review. The U.S. Food and Drug Administration said it had received applications for over 26 million new tobacco products since spring 2020, most of them for e-cigarettes, and had completed review and taken action on over 99% of them.

Back to Table of Contents

3. Why Flavors Were the Deciding Question

The U.S. Food and Drug Administration evaluates a PMTA against a public health standard that, in the notice’s words, “considers the risks and benefits of the product on the population as a whole.” For these applications the agency asked one central question: did the flavored products show an added benefit to adult smokers, compared with tobacco-flavored e-cigarettes, that could outweigh the risk flavored products pose to young people? The U.S. Food and Drug Administration found that the evidence submitted “was not sufficient to demonstrate such a benefit.”

The director of the U.S. Food and Drug Administration’s Center for Tobacco Products stated that it is the applicant’s responsibility to supply that evidence, that “That bar of scientific sufficiency has not been met to date for any flavored e-cigarette product, including in this instance,” and that “if an applicant were to meet that bar, U.S. Food and Drug Administration would authorize the product.” The director of the center’s Office of Science said the decision “was based on the lack of scientific evidence provided in the applications.”

The CTP’s 2023 news index lists further denial orders during the year for individual products of other makers, among them menthol-flavored e-cigarettes in January, March and July and six flavored products in October.

Back to Table of Contents

4. Import Alerts and Retailer Inspection Blitzes

Import alerts. In May 2023 the U.S. Food and Drug Administration issued import alerts for all products under the two most popular youth-appealing disposable brands. An import alert places products on the agency’s “red list,” which makes them subject to Detention Without Physical Examination: the U.S. Food and Drug Administration can hold a shipment at the border without opening and inspecting it. The December release adds that certain firms associated with those brands were also placed on the red list in May.

The May blitz. On 31 May 2023 the U.S. Food and Drug Administration announced warning letters to 30 retailers, including one distributor, after investigations of hundreds of retailers and distributors. All the products cited were disposable e-cigarettes, which the release calls “the most commonly used e-cigarette product type among youth.” According to the 2022 National Youth Tobacco Survey, the two brands involved were the first and third most popular among young e-cigarette users, and about 20 percent of youth users said they usually used one of them.

The June blitz. On 22 June 2023 the U.S. Food and Drug Administration announced warning letters to 189 retailers for selling two other unauthorized disposable brands. The U.S. Food and Drug Administration Commissioner said the agency “is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids.” The release cited two U.S. Centers for Disease Control and Prevention studies published in the Morbidity and Mortality Weekly Report (both listed under Key Research Papers):

• a retail-sales study, which found that one of the brands was the top-selling disposable e-cigarette in the United States in December 2022;
• a poison-center study, which found thousands of e-cigarette exposure cases reported in the previous year, most of them in children younger than 5. Among the limited number of cases with brand information (April 2022 to March 2023), the same brand was cited more than all other brands combined, with nearly all of those cases in children under 5.

What a warning letter is. The U.S. Food and Drug Administration explains that it generally sends a warning letter the first time an inspection or investigation reveals a violation. Recipients have 15 working days to describe how they will correct it. The agency says most recipients do correct the violation; failure to do so can lead to an injunction, seizure or civil money penalties.

Back to Table of Contents

5. E-Cigarettes Made to Look Like Toys, School Supplies and Drinks

On 23 August 2023 the U.S. Food and Drug Administration sent warning letters to 15 online retailers for selling unauthorized e-cigarettes packaged to resemble:

• characters from television shows, films and video games;
• school supplies such as highlighters, and toys such as handheld video-game consoles and digital cameras;
• drinks, including coffee-shop cups, soda and water bottles.

The CTP director called the designs “a shamelessly egregious attempt to target kids.” Because the products “can be deceiving,” the agency said it was also seeking to raise awareness among parents, teachers and other adults before the new school year, and pointed to its Vaping Prevention and Education Resource Center, an online hub of lesson plans and materials that includes how to spot “stealth” and disposable e-cigarettes.

On 16 November 2023 the U.S. Food and Drug Administration warned seven more online retailers about e-cigarettes packaged to look like milk cartons, soft-drink bottles, slushies, dice, phones and action figures. The notice says such designs may help young people hide the devices from adults, and that a product confused with an everyday object could have its contents “accidently ingested by young children.” The CTP director noted that these products contain nicotine, “which is highly addictive and can harm the developing adolescent brain.”

Back to Table of Contents

6. Fines Against Retailers

A civil money penalty (CMP) is a fine the U.S. Food and Drug Administration can seek through an administrative complaint. On 28 September 2023 the U.S. Food and Drug Administration filed CMP complaints against 22 retailers for selling one unauthorized disposable brand. Each retailer had already received a warning letter, and follow-up inspections found the violations had not been corrected.

• Each complaint sought the maximum penalty for a single violation, $19,192. The U.S. Food and Drug Administration said this was the first time it had sought the maximum amount against retailers for this type of violation.
• A retailer could pay, settle, ask for more time, or file an answer and request a hearing; one that took no action within 30 days risked a default order imposing the full penalty.
• The same day the U.S. Food and Drug Administration announced 168 more warning letters to store retailers, the result of a nationwide inspection effort through August.

On 2 November 2023 the U.S. Food and Drug Administration announced that it was seeking penalties of similar amounts against 20 more retailers that had been warned and were found still selling the same brand, which the 2023 youth survey identified as the most popular among young users.

Back to Table of Contents

7. The 2023 National Youth Tobacco Survey

The National Youth Tobacco Survey (NYTS) is run by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. The 2023 results, collected between March and June 2023 and released on 2 November 2023, showed:

• All students: 10% of U.S. middle and high school students, about 2.8 million young people, reported current use of any tobacco product.
• High school: current use of any tobacco product fell from 16.5% in 2022 to 12.6% in 2023, mainly because e-cigarette use fell from 14.1% to 10%, which the U.S. Food and Drug Administration translates as 580,000 fewer high school students using e-cigarettes. Use of cigars and of combustible tobacco overall also fell, to what the release calls all-time lows.
• Middle school: current use of any tobacco product rose from 4.5% to 6.6%, and use of more than one product from 1.5% to 2.5%. No significant change was seen for any single product type, including e-cigarettes.
• E-cigarettes remained the most commonly used tobacco product in both middle and high school for the 10th year in a row; a later U.S. Food and Drug Administration notice puts the number of young current users at 2.1 million. About a quarter of young users said they used e-cigarettes every day.
• Product type and flavors: disposables were the most common type used. Nearly all young users (89.4%) used flavored products, most often fruit, candy, mint and menthol.
• New questions: for the first time the survey asked about flavors with “ice” or “iced” in their names and “concept” flavor names that imply a taste without naming one. The U.S. Food and Drug Administration says the results suggest flavored use among youth “might be higher than previously thought.”

The CTP director called the high-school decline “a win for public health” and added that “There’s more work to be done to build on this progress.” The release states that “Youth use of tobacco products in any form – including e-cigarettes – is unsafe.”

Back to Table of Contents

8. The December Seizure at Los Angeles

On 14 December 2023 the U.S. Food and Drug Administration and U.S. Customs and Border Protection announced the seizure of approximately 1.4 million units of unauthorized e-cigarettes, with an estimated retail value of more than $18 million. The seizures came from a three-day joint operation at a cargo examination site at Los Angeles International Airport, prepared over months of reviewing shipping invoices, and covered 41 shipments.

• All of the shipments originated in China.
• They held various brands of flavored disposable e-cigarettes, including the brand the 2023 survey identified as the most used by young people, and the same maker’s products sold under new names adopted earlier that year.
• To evade duties and detection, many items were “intentionally mis-declared as various items such as toys or shoes” and listed with incorrect values.
• Once forfeited, the release says, unauthorized new tobacco products are generally destroyed.

Back to Table of Contents

9. How the Enforcement Count Grew Through 2023

Each U.S. Food and Drug Administration release in 2023 restated the agency’s running totals for e-cigarette enforcement. Read in order, they show the scale of the year:

• 31 May: more than 560 warning letters issued from January 2021 through May 2023; civil money penalty complaints filed against ten e-cigarette manufacturers, the first four of them in February 2023; the first permanent-injunction complaints filed against six manufacturers in October 2022.
• 16 June (stated 22 June): more than 570 warning letters; penalty complaints against 12 manufacturers.
• August: about 600 warning letters to firms; penalty complaints against 26 manufacturers; injunctions sought with the Department of Justice against 6 manufacturers.
• 19 September (stated 28 September): more than 400 warning letters to retailers and more than 600 to manufacturers and distributors; penalty complaints against 31 manufacturers.
• November: about 630 warning letters to manufacturers and distributors and more than 400 to retailers; penalty complaints against 35 manufacturers and 42 retailers.
• December: over 650 warning letters to firms for new tobacco products lacking authorization; penalty complaints against 38 e-cigarette manufacturers and 67 retailers; seven complaints for permanent injunctions.

Throughout the year the count of legal options stayed the same: the U.S. Food and Drug Administration said it had authorized 23 tobacco-flavored e-cigarette products and devices, “the only e-cigarette products that currently may be lawfully sold in the U.S.” The figure was repeated in the May, June, September and December releases.

Back to Table of Contents

10. What These Actions Do Not Do

• They are not a ban on e-cigarettes. The 23 authorized tobacco-flavored products and devices remained lawful to sell throughout 2023.
• They do not create a flavor standard by rule. Each denial order applies to the specific products in the applications. The separate proposed product standards for menthol cigarettes and flavored cigars are told on the Tobacco Product Standards Withdrawn (2025) page.
• They do not rule out a future flavored product. The CTP director said that if an applicant met the scientific bar, “U.S. Food and Drug Administration would authorize the product.”
• Warning letters are not penalties. A warning letter gives the recipient 15 working days to respond; fines, injunctions and seizures are later steps for violations that are not corrected.
• The survey figures are not a measure of any single action. The U.S. Food and Drug Administration releases quoted here report the survey figures next to the enforcement actions; they do not attribute the decline to any particular order or letter.

Back to Table of Contents

11. Dates and Legal Status as of 18 October 2026

• 12 May 2023: marketing denial orders for about 6,500 flavored products.
• May 2023: import alerts (red list) for two disposable brands and associated firms.
• 31 May and 22 June 2023: retailer warning letters (30 and 189).
• 23 August and 16 November 2023: online-retailer warning letters on disguised products (15 and 7).
• 28 September and 2 November 2023: civil money penalty actions against 22 and then 20 retailers.
• 2 November 2023: 2023 National Youth Tobacco Survey results released.
• 14 December 2023: joint seizure of about 1.4 million units announced.

Status as of 18 October 2026: the 12 May 2023 marketing denial orders are final orders. The enforcement totals above are a snapshot of 2023; the later status of individual products, letters and penalty cases was not checked one by one.

A check of the Federal Register through 18 October 2026 found two later U.S. Food and Drug Administration documents on e-cigarette applications and enforcement:

• 11 March 2026 (91 FR 11980, Docket No. FDA-2026-D-1817): notice of a draft guidance, “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk.” Its abstract says it describes the U.S. Food and Drug Administration’s current thinking on the evidence for applications for flavored e-cigarettes (ENDS stands for electronic nicotine delivery systems). Comments were due by 11 May 2026. No final version had appeared in the Federal Register by 18 October 2026.
• 12 May 2026 (91 FR 25892, Docket No. FDA-2026-D-5083): notice of a final guidance, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization,” which its abstract says describes enforcement policies for certain e-cigarettes and oral nicotine pouch products that lack premarket authorization.

A guidance, as the 2026 draft’s abstract puts it, describes the U.S. Food and Drug Administration’s “current thinking” and provides recommendations. A Federal Register docket is the public file, on regulations.gov, that holds a document and the comments on it.

Back to Table of Contents

12. How the 2023 Actions Fit Earlier and Later U.S. Food and Drug Administration Actions

The 2023 orders came out of the wave of applications the U.S. Food and Drug Administration says it received from spring 2020 onward, of which it had acted on over 99% by May 2023. Earlier enforcement steps that the 2023 releases mention include the first permanent-injunction complaints against six e-cigarette manufacturers in October 2022 and the first civil money penalty complaints against manufacturers in February 2023.

Two technical rules frame the year. On 20 March 2023 the U.S. Food and Drug Administration published conforming changes to its tobacco regulations (88 FR 16551, Docket No. FDA-2022-N-3262), required by the Consolidated Appropriations Act of 2022, which amended the legal term “tobacco product” to include products that contain nicotine “from any source.” On 30 August 2024 the U.S. Food and Drug Administration published conforming changes (89 FR 70483, effective 30 September 2024) that raised the federal minimum age of sale for cigarettes, smokeless tobacco and covered tobacco products in its regulations from 18 to 21, following the Further Consolidated Appropriations Act, 2020.

Later U.S. Food and Drug Administration tobacco actions are reported on their own pages: the withdrawal of the menthol cigarette and flavored cigar standards (2025) and the first marketing authorization for nicotine pouches (2025). Another 2023 page, Xylazine Import Restriction, describes the same import-alert tool used against a different product.

Back to Table of Contents

13. Primary Documents

1. U.S. Food and Drug Administration, Center for Tobacco Products (2023). U.S. Food and Drug Administration Issues Marketing Denial Orders for Approximately 6,500 Flavored E-Cigarette Products. CTP Newsroom, 12 May 2023 — fda.gov CTP Newsroom
2. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Conducts Retailer Inspection Blitz, Cracks Down on Illegal Sales of Popular Disposable E-cigarettes. News release, 31 May 2023 — fda.gov news release
3. U.S. Food and Drug Administration (2023). News release of 22 June 2023 on an inspection blitz leading to more than 180 warning letters to retailers (its title names two brands). Address, given as plain text because it carries a brand name: https://www.fda.gov/news-events/press-announcements/fda-inspection-blitz-leads-more-180-warning-letters-retailers-illegal-sale-youth-appealing-elf-bar
4. U.S. Food and Drug Administration, Center for Tobacco Products (2023). Retailers Warned to Stop Selling Illegal E-Cigarettes Resembling Youth-Appealing Characters, School Supplies, Toys, and Drinks. CTP Newsroom, 23 August 2023 — fda.gov CTP Newsroom
5. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes. News release, 28 September 2023 — fda.gov news release
6. U.S. Food and Drug Administration (2023). National Survey Shows Drop in E-Cigarette Use Among High School Students. News release, 2 November 2023 — fda.gov news release
7. U.S. Food and Drug Administration, Center for Tobacco Products (2023). U.S. Food and Drug Administration Warns Retailers to Stop Selling Illegal Youth-Appealing E-Cigarettes Disguised as Everyday Items. CTP Newsroom, 16 November 2023 — fda.gov CTP Newsroom
8. U.S. Food and Drug Administration (2023). Joint Federal Operation Results in Seizure of More Than $18 Million in Illegal E-Cigarettes. News release, 14 December 2023 — fda.gov news release
9. U.S. Food and Drug Administration, Center for Tobacco Products. 2023 News and Events (index of the year’s announcements) — fda.gov CTP 2023 index
10. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Definition of the Term “Tobacco Product” in Regulations Issued Under the Federal Food, Drug, and Cosmetic Act; Rule. Federal Register 88:16551, 20 March 2023. Docket No. FDA-2022-N-3262 — FR Doc. 2023-03950
11. Food and Drug Administration, U.S. Department of Health and Human Services (2024). Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age; Final Rule. Federal Register 89:70483, 30 August 2024. Docket No. FDA-2020-N-1395 — FR Doc. 2024-19481
12. Food and Drug Administration, U.S. Department of Health and Human Services (2026). Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk; Draft Guidance for Industry; Availability. Federal Register 91:11980, 11 March 2026. Docket No. FDA-2026-D-1817 — FR Doc. 2026-04732
13. Food and Drug Administration, U.S. Department of Health and Human Services (2026). Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability. Federal Register 91:25892, 12 May 2026. Docket No. FDA-2026-D-5083 — FR Doc. 2026-09368

Back to Table of Contents

Key Research Papers

1. Birdsey J, Cornelius M, Jamal A, Park-Lee E, Cooper MR, Wang J, Sawdey MD, Cullen KA, Neff L (2023). Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morbidity and Mortality Weekly Report 72(44):1173-1182 — PubMed PMID: 37917558
2. Ali FRM, Seidenberg AB, Crane E, Seaman E, Tynan MA, Marynak K (2023). E-cigarette Unit Sales by Product and Flavor Type, and Top-Selling Brands, United States, 2020-2022. MMWR Morbidity and Mortality Weekly Report 72(25):672-677 — PubMed PMID: 37347717
3. Tashakkori NA, Rostron BL, Christensen CH, Cullen KA (2023). Notes from the Field: E-Cigarette-Associated Cases Reported to Poison Centers — United States, April 1, 2022-March 31, 2023. MMWR Morbidity and Mortality Weekly Report 72(25):694-695 — PubMed PMID: 37347709
4. Cooper M, Park-Lee E, Ren C, Cornelius M, Jamal A, Cullen KA (2022). Notes from the Field: E-cigarette Use Among Middle and High School Students — United States, 2022. MMWR Morbidity and Mortality Weekly Report 71(40):1283-1285 — PubMed PMID: 36201370
5. Leventhal AM, Miech R, Barrington-Trimis J, Johnston LD, O'Malley PM, Patrick ME (2019). Flavors of e-Cigarettes Used by Youths in the United States. JAMA 322(21):2132-2134 — PubMed PMID: 31688891
6. Kasza KA, Hammond D, Reid JL, Rivard C, Hyland A (2023). Youth Use of e-Cigarette Flavor and Device Combinations and Brands Before vs After FDA Enforcement. JAMA Network Open 6(8):e2328805 — PubMed PMID: 37578794

The first paper is the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration report of the 2023 National Youth Tobacco Survey released on 2 November 2023. The second and third are the two U.S. Centers for Disease Control and Prevention studies, on retail sales and on poison-center cases, cited in the U.S. Food and Drug Administration’s June 2023 release. The fourth reports the 2022 survey figures that the 2023 comparison starts from. The last two are independent studies of which e-cigarette flavors and device types young people in the United States use.

PubMed Topic Searches

1. PubMed: youth e-cigarette flavors
2. PubMed: disposable e-cigarettes and adolescents
3. PubMed: e-cigarette exposures in children reported to poison centers

Back to Table of Contents

Connections

• U.S. Food and Drug Administration Begins Regulating E-Cigarettes Made With Synthetic Nicotine (2022)
• U.S. Food and Drug Administration Orders a Leading E-Cigarette Off the Market, Then Pauses Its Own Order (2022)
• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Nicotine
• Nicotine Toxicity and Safety
• Addiction
• Asthma
• Lung Cancer
• Secondhand Smoke
• Tobacco Product Standards Withdrawn (2025)
• Nicotine Pouch Marketing Authorization (2025)
• Xylazine Import Restriction (2023)
• Cannabidiol Needs a New Regulatory Pathway (2023)

Back to Table of Contents

Featured Videos