U.S. Food and Drug Administration (FDA) Orders a Leading E-Cigarette Off the Market, Then Pauses Its Own Order (2022)

Table of Contents

1. What the U.S. Food and Drug Administration Did on June 23, 2022
2. The Reasons the U.S. Food and Drug Administration Gave
3. How a New Tobacco Product Gets Permission to Be Sold
4. A Fake “Cease and Desist” Letter, June 24, 2022
5. The Stay of July 5, 2022
6. Other E-Cigarette Marketing Decisions of 2022
7. What the Orders Did Not Do
8. What Happened Next: 2024 and 2025
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Earlier and Later U.S. Food and Drug Administration Tobacco Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the U.S. Food and Drug Administration Did on June 23, 2022

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 products, summarized the decision in a June 6, 2024 update: “On June 23, 2022, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to [the company] for all of their products marketed in the United States at the time.” The U.S. Food and Drug Administration’s running list of tobacco marketing decisions records the same date as marketing denial orders for the company’s e-cigarette system.

A marketing denial order is the U.S. Food and Drug Administration’s formal answer “no” to a company’s application to sell a new tobacco product. The U.S. Food and Drug Administration’s marketing-orders page explains what follows from it: new tobacco products that lack a written marketing order from the U.S. Food and Drug Administration, “including products covered under an MDO, cannot be legally introduced into interstate commerce in the U.S. and their sale or distribution is subject to administrative, civil, and criminal enforcement.” The same page adds that, beyond making sure manufacturers comply with issued MDOs, “U.S. Food and Drug Administration intends to ensure compliance by distributors and retailers.”

The orders were not a new rule. They were decisions on one company’s product applications, so they do not appear in the Federal Register, the U.S. government’s daily publication of rules and official notices.

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2. The Reasons the U.S. Food and Drug Administration Gave

The U.S. Food and Drug Administration’s 2024 update gives the agency’s reasons for the June 2022 orders. It says the U.S. Food and Drug Administration “had determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law.”

It then recalls what the agency said when it announced the orders: “some of the company’s study findings raised concerns due to insufficient and conflicting data regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods, which precluded the U.S. Food and Drug Administration from completing a full toxicological review of the products.”

Two of those terms in plain words:

• Toxicological profile means the information on whether, and how, the product and what it releases could harm the body.
• Genotoxicity means the ability of a substance to damage the genetic material (DNA) in cells.

In the U.S. Food and Drug Administration’s words the problem was a gap in the evidence: the data were “insufficient and conflicting,” which kept the agency from finishing its review. The documents read for this page do not say the U.S. Food and Drug Administration had found the products to be more harmful than others; they say the applications did not give the U.S. Food and Drug Administration enough to complete the toxicology review the law requires.

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3. How a New Tobacco Product Gets Permission to Be Sold

The U.S. Food and Drug Administration’s marketing-orders page sets out the system the June 2022 orders sit in:

• A written order is required. “To legally market a new tobacco product in the United States, a company must receive a written marketing order from U.S. Food and Drug Administration.”
• A public health standard, not “safe and effective.” The page states that the U.S. Food and Drug Administration’s “traditional ‘safe and effective’ standard for evaluating medical products does not apply to tobacco. Instead, U.S. Food and Drug Administration regulates tobacco products based on a public health standard intended to reduce the toll that tobacco product use takes on public health.”
• Three pathways. A company may seek authorization through a premarket tobacco product application (PMTA), a substantial equivalence report, or a request for exemption from substantial equivalence.
• What a PMTA review weighs. PMTAs are judged on factors including “whether permitting the marketing of a new tobacco product would be appropriate for the protection of the public health, which is determined with respect to the risks and benefits of the product to the population as a whole, including users and non-users.”
• Two possible outcomes. The U.S. Food and Drug Administration’s 2024 update explains that once an application is accepted and filed, it ultimately receives either a marketing granted order (a “yes”) or a marketing denial order (a “no”).

The page also explains why so many e-cigarettes were under review in 2022. The page notes that makers of a “deemed” tobacco product that was new and on the market as of August 8, 2016 were required to submit a marketing application by September 9, 2020, “as required by the Court.”

The rules for what a PMTA must contain were set by a U.S. Food and Drug Administration final rule published on October 5, 2021, “Premarket Tobacco Product Applications and Recordkeeping Requirements” (86 FR 55300; Docket No. FDA-2019-N-2854; effective November 4, 2021). Its summary says the rule is meant to “help ensure that PMTAs contain sufficient information for U.S. Food and Drug Administration to determine whether a marketing granted order should be issued for a new tobacco product,” and that it “codifies the general procedures U.S. Food and Drug Administration will follow when evaluating PMTAs.”

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4. A Fake “Cease and Desist” Letter, June 24, 2022

The day after the orders, the CTP posted a short statement. It said: “It has come to our attention that certain retail stores have received a ‘cease and desist’ letter purporting to be from U.S. Food and Drug Administration regarding [the company’s] products. U.S. Food and Drug Administration did not create or distribute this letter and is not collecting [the company’s] products from retailers.”

The statement does not say who sent the letter.

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5. The Stay of July 5, 2022

The U.S. Food and Drug Administration’s 2024 update describes the turn twelve days later in one sentence: “On July 5, 2022, the U.S. Food and Drug Administration administratively stayed the MDOs after determining that certain scientific issues warranted additional review.” An administrative stay is a pause the agency places on its own decision: the orders were not withdrawn, but they were put on hold.

The same update says what the agency did during the pause: “the U.S. Food and Drug Administration has conducted this additional review and has also conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science, and clinical pharmacology.”

The stay was not a permission to sell. The 2024 update states that the agency’s continued review “does not alter the fact that all e-cigarette products, including those made by [the company], are required by law to have U.S. Food and Drug Administration authorization to be legally marketed.” During the stay the products had neither a denial in force nor an authorization.

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6. Other E-Cigarette Marketing Decisions of 2022

The June 23 orders were one of several e-cigarette decisions the U.S. Food and Drug Administration lists for 2022 on its marketing-orders page. With the makers described generically, the 2022 entries are:

• March 24, 2022: marketing granted and denial orders for one maker’s e-cigarette products.
• April 8, 2022: marketing denial orders for another maker’s products.
• April 26, 2022: marketing granted and denial orders for a third maker’s products.
• May 12, 2022: marketing granted and denial orders for a fourth maker’s products.
• June 10, 2022: marketing granted and denial orders for another product line from the third maker.
• June 23, 2022: marketing denial orders for the company on this page.
• October 6, 2022: marketing denial orders for a further maker’s products.
• October 26, 2022: marketing denial orders for the first maker’s menthol e-liquid packages.

A “granted and denial” entry means that, within one set of applications, some products were authorized and others were refused. The same year, a new law brought e-cigarettes made with synthetic nicotine under the U.S. Food and Drug Administration; that story is told on the 2022 synthetic nicotine page.

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7. What the Orders Did Not Do

• They were not a ban on e-cigarettes. The orders covered one company’s products only. Products from other makers that the U.S. Food and Drug Administration had authorized, such as those granted in the orders listed in section 6, remained lawful to sell.
• They rested on gaps in the evidence. As the U.S. Food and Drug Administration later described them, the orders were based on insufficient and conflicting toxicology data that kept the agency from completing its review (section 2).
• The stay was not an authorization. While the orders were stayed, the products still had no U.S. Food and Drug Administration marketing authorization; the U.S. Food and Drug Administration states that every e-cigarette needs one to be legally marketed (section 5).
• They were not a rule. No Federal Register rule was issued; the orders were decisions on product applications.
• They did not turn into a final “no.” The orders were rescinded in 2024 and the applications went back into review (section 8).

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8. What Happened Next: 2024 and 2025

June 6, 2024: the orders are rescinded. The CTP update of that date reports: “Today, the U.S. Food and Drug Administration rescinded the MDOs issued in June 2022.” It gives two reasons: the action was taken “in part, as a result of the new case law, as well as the U.S. Food and Drug Administration’s review of information provided by the applicant.” The update explains that since the 2022 stay the U.S. Food and Drug Administration had “gained more experience with various scientific issues regarding e-cigarette products,” and that there had been “new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” some of which “establish new case law and inform the U.S. Food and Drug Administration’s approach to product review.” The court cases themselves were not read for this page.

The update is careful about what the rescission meant: it “is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied.” Instead, it “returns the applications to pending status, under substantive review by the U.S. Food and Drug Administration.” The U.S. Food and Drug Administration added that its regulations “significantly limit what the agency can disclose regarding the content of pending applications.”

July 17, 2025: five products authorized. A CTP release of that date reports that the U.S. Food and Drug Administration authorized the marketing of five of the company’s products through the PMTA pathway: the device itself and tobacco-flavored and menthol-flavored pods, each at 3% and 5% nicotine concentration. The U.S. Food and Drug Administration stated that the evidence the company provided, “including new information the company submitted in response to a deficiency letter from the U.S. Food and Drug Administration,” showed these specific products meet the legal standard of the 2009 Family Smoking Prevention and Tobacco Control Act. It described that standard as requiring the U.S. Food and Drug Administration to weigh the benefits to adults who smoke and switch completely or significantly cut down against the risks, “including to any youth and adults who are not current users of tobacco products.” The release says the company submitted data, “including a two-year longitudinal cohort study,” showing “high rates of adults completely switching from cigarettes” to the tobacco- or menthol-flavored products.

The same release sets limits on what the authorization means: it permits these products “to be legally marketed in the U.S. to adults 21 and older,” but “it does not mean these tobacco products are safe, nor are they ‘U.S. Food and Drug Administration approved.’ There is no safe tobacco product.” Its subtitle states that the U.S. Food and Drug Administration will monitor compliance with restrictions meant to limit youth exposure to marketing. With this decision, the U.S. Food and Drug Administration said it had authorized 39 e-cigarette products, “the only e-cigarette products that currently may be lawfully marketed and sold in the U.S.”

August 28, 2026. The U.S. Food and Drug Administration’s marketing-orders page, current as of that date, lists marketing granted orders for a newer device from the same company.

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9. Dates and Legal Status as of October 18, 2026

• September 9, 2020: deadline, set by a court, for marketing applications for deemed new tobacco products on the market as of August 8, 2016.
• October 5, 2021: the U.S. Food and Drug Administration publishes its PMTA final rule (86 FR 55300), effective November 4, 2021.
• June 23, 2022: marketing denial orders for all of the company’s products then marketed in the United States.
• June 24, 2022: the CTP warns that a “cease and desist” letter sent to retailers in the U.S. Food and Drug Administration’s name is fake.
• July 5, 2022: the U.S. Food and Drug Administration administratively stays the orders for further scientific review.
• June 6, 2024: the U.S. Food and Drug Administration rescinds the 2022 orders; the applications return to pending review.
• July 17, 2025: the U.S. Food and Drug Administration authorizes five of the company’s products (the device and tobacco- and menthol-flavored pods at 3% and 5% nicotine).
• August 28, 2026: marketing granted orders for a newer device from the same company.

Status as of October 18, 2026: the 2022 orders are rescinded. They were stayed on July 5, 2022 and withdrawn on June 6, 2024; five of the company’s products have been authorized since July 17, 2025, and a newer device since August 28, 2026. A check of the Federal Register through October 18, 2026 found no U.S. Food and Drug Administration document about these orders; the only U.S. Food and Drug Administration notices there that mention marketing denial orders in this period are routine information-collection notices on PMTAs (2022 and 2024), which do not change the orders’ status.

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10. How It Fits Earlier and Later U.S. Food and Drug Administration Tobacco Actions

The June 2022 orders came in a busy year for the U.S. Food and Drug Administration’s tobacco program. In March 2022 a new law made clear that the U.S. Food and Drug Administration can regulate products containing nicotine from any source, including synthetic nicotine, told on the synthetic nicotine page. In April 2022 the U.S. Food and Drug Administration proposed banning menthol cigarettes and flavored cigars, told on the menthol and flavored cigar proposals page.

The review of e-cigarette applications continued into 2023, when the U.S. Food and Drug Administration denied thousands of flavored e-cigarettes and acted against disposable products popular with young people; see the 2023 youth e-cigarette page. In January 2025 the U.S. Food and Drug Administration authorized the first nicotine pouches, told on the 2025 nicotine pouch page, and the menthol, flavored-cigar and nicotine-level proposals were later withdrawn, as reported on the 2025 withdrawn tobacco standards page.

Seen against those pages, the 2022 orders show how a marketing decision on one product line can move through denial, stay, rescission and, years later, partial authorization, all under the same application file. A Federal Register docket, mentioned in the documents below, is the public file for a rule or notice, where its documents and public comments are kept on regulations.gov. Product applications are handled differently: the U.S. Food and Drug Administration’s 2024 update notes that its regulations significantly limit what it can disclose about pending applications.

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11. Primary Documents

1. U.S. Food and Drug Administration, Center for Tobacco Products. Tobacco Products Marketing Orders. Program page listing marketing decisions 2021–2026, content current as of August 28, 2026 — fda.gov Tobacco Products Marketing Orders
2. U.S. Food and Drug Administration, Center for Tobacco Products. CTP Statement. CTP Newsroom, June 24, 2022 — fda.gov CTP Statement, June 24, 2022
3. U.S. Food and Drug Administration, Center for Tobacco Products. Update on U.S. Food and Drug Administration’s Scientific Review of [the company’s] Product Applications. CTP Newsroom, June 6, 2024. Available in the CTP Newsroom on fda.gov; its title and web address name the company, so no link is given here.
4. U.S. Food and Drug Administration, Center for Tobacco Products. U.S. Food and Drug Administration Authorizes Marketing of Tobacco- and Menthol-Flavored [Company] E-Cigarette Products. CTP Newsroom, July 17, 2025. Available in the CTP Newsroom on fda.gov; its title and web address name the company, so no link is given here.
5. U.S. Food and Drug Administration, Center for Tobacco Products. 2022 News and Events. CTP Newsroom index, content current as of May 9, 2023 — fda.gov CTP 2022 News and Events
6. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2021). Premarket Tobacco Product Applications and Recordkeeping Requirements. Final rule. Federal Register 86 FR 55300, October 5, 2021; effective November 4, 2021. Docket No. FDA-2019-N-2854 — FR Doc. 2021-21011
7. Public docket FDA-2019-N-2854 — regulations.gov FDA-2019-N-2854

The U.S. Food and Drug Administration’s June 23, 2022 press release announcing the orders has been retired from fda.gov to the agency’s web archive and could not be read for this page; none of its wording is quoted here.

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Key Research Papers

1. Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob P 3rd, Benowitz N (2014). Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tobacco Control 23(2):133-139 — PubMed PMID: 23467656
2. Olmedo P, Goessler W, Tanda S, Grau-Perez M, Jarmul S, Aherrera A, Chen R, Hilpert M, Cohen JE, Navas-Acien A, Rule AM (2018). Metal Concentrations in e-Cigarette Liquid and Aerosol Samples: The Contribution of Metallic Coils. Environmental Health Perspectives 126(2):027010 — PubMed PMID: 29467105
3. Tommasi S, Blumenfeld H, Besaratinia A (2023). Vaping Dose, Device Type, and E-Liquid Flavor are Determinants of DNA Damage in Electronic Cigarette Users. Nicotine & Tobacco Research 25(6):1145-1154 — PubMed PMID: 36780924
4. Gotts JE, Jordt SE, McConnell R, Tarran R (2019). What are the respiratory effects of e-cigarettes? BMJ 366:l5275 — PubMed PMID: 31570493
5. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, Li J, Parrott S, Sasieni P, Dawkins L, Ross L, Goniewicz M, Wu Q, McRobbie HJ (2019). A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. The New England Journal of Medicine 380(7):629-637 — PubMed PMID: 30699054
6. Lindson N, Livingstone-Banks J, Butler AR, McRobbie H, Bullen CR, Hajek P, Wu AD, Begh R, Theodoulou A, Ma C, Notley C, Rigotti NA, Turner T, Fanshawe T, Hartmann-Boyce J (2026). Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews 8(8):CD010216 — PubMed PMID: 42642048
7. 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

The first three papers concern the toxicology questions at the center of the 2022 orders: chemicals measured in e-cigarette vapour, metals that pass from heating coils into the liquid and aerosol, and markers of DNA damage in people who vape. The fourth is a review of what is known about the effects of e-cigarettes on the lungs. The fifth and sixth concern the benefit side of the U.S. Food and Drug Administration’s public health standard: a randomized trial comparing e-cigarettes with nicotine-replacement therapy for quitting smoking, and the 2026 update of the Cochrane systematic review on e-cigarettes for smoking cessation. The last reports the 2022 youth e-cigarette survey figures from the U.S. Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration. None of the papers studies the company’s products by name.

PubMed Topic Searches

1. PubMed: e-cigarette aerosol toxicology
2. PubMed: e-cigarette genotoxicity
3. PubMed: pod-based e-cigarettes
4. PubMed: premarket tobacco product applications

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Connections

• U.S. Food and Drug Administration Denies Its First Flavored E-Cigarettes, Over 946,000 Products (2021)
• U.S. Food and Drug Administration Authorizes an E-Cigarette for the First Time (2021)
• U.S. Food and Drug Administration Actions of 2022
• U.S. Food and Drug Administration and Regulation
• Nicotine: The Research
• Nicotine Addiction and Withdrawal
• Nicotine Toxicity, Poisoning and Safety
• Addiction and Substance Use Disorders
• Asthma
• Synthetic Nicotine Comes Under U.S. Food and Drug Administration (2022)
• Menthol and Flavored Cigar Proposals (2022)
• Youth E-Cigarette Crackdown (2023)
• First Nicotine Pouches Authorized (2025)
• Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)

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