FDA Authorizes an E-Cigarette for the First Time (2021)

Table of Contents

1. What the FDA Did on October 12, 2021
2. Key Terms: ENDS, PMTA and Marketing Granted Orders
3. The Three Products Authorized and the Ten Denied
4. The Legal Standard: “Appropriate for the Protection of the Public Health”
5. What the Review Found for Adult Smokers
6. How the Review Weighed the Risk to Young People
7. Questions the Review Left Open
8. The Marketing Restrictions Attached to the Orders
9. Reporting and Record-Keeping After Authorization
10. What the Authorization Does Not Do
11. Dates and Legal Status as of October 18, 2026
12. How It Fits Earlier and Later FDA Tobacco Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the FDA Did on October 12, 2021

On October 12, 2021, the Director of the Office of Science in the FDA’s Center for Tobacco Products (CTP) signed “marketing granted orders” for three products from one e-cigarette maker. The letter states that the FDA had “determined that permitting the marketing of the new tobacco products … is appropriate for the protection of the public health,” and that the orders authorize the maker to sell the products in interstate commerce “in accordance with the marketing order requirements outlined in these orders, including all appendices.”

The FDA’s table of marketing granted orders for the premarket application pathway lists no e-cigarette authorized before this date. Earlier entries on that table are smokeless tobacco products (2015) and cigarettes and heated “noncombusted” cigarette products (2019 and 2020). The FDA’s program page on marketing orders lists October 12, 2021 as a date of “Marketing Granted and Denial Orders,” because the same decision also denied ten flavored cartridges of the same product line (section 3).

The orders were letters to the applicant, not Federal Register documents, so there was no public rulemaking docket. The FDA later posted a redacted copy of the order letter and the agency’s full scientific review, the “Technical Project Lead (TPL) Review,” on fda.gov. The review is signed by the technical project lead on October 12, 2021, with the Office of Science Director’s concurrence the same day.

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2. Key Terms: ENDS, PMTA and Marketing Granted Orders

• ENDS stands for “electronic nicotine delivery systems,” the FDA’s term for e-cigarettes, vapes and their parts and liquids.
• PMTA means “premarket tobacco product application,” an application submitted under section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) asking the FDA to permit a new tobacco product to be sold.
• Marketing granted order (MGO) is the FDA’s written authorization for a new tobacco product. The FDA’s marketing-orders page states that to legally market a new tobacco product in the United States, “a company must receive a written marketing order from FDA.” A marketing denial order (MDO) is the opposite decision.
• HPHCs are “harmful and potentially harmful constituents,” the chemicals the FDA measures in tobacco smoke or e-cigarette aerosol.
• Biomarkers of exposure are substances measured in blood or urine that show how much of a chemical a person has taken in.

The authorization came during the FDA’s review of the millions of applications filed for “deemed” tobacco products, including e-cigarettes, that were on the market on August 8, 2016. The FDA’s marketing-orders page states that these applications were due by September 9, 2020, “as required by the Court.” The FDA reported in August 2021 that it had received applications from over 500 companies covering more than 6.5 million products. That review and the first flavored-product denials are told on the 2021 flavored e-cigarette denials page.

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3. The Three Products Authorized and the Ten Denied

Appendix A of the order letter lists the three authorized products. The applications were submitted on October 10, 2019 and received on October 17, 2019:

• A power unit, the rechargeable battery part of the device, with a USB charger. The order lists no characterizing flavor for it.
• Two replacement cartridges in the maker’s “original” flavor, which a footnote in the order identifies as a tobacco-flavored e-liquid. Each holds 0.5 mL of e-liquid at a nicotine concentration of 57.4 mg/mL, listed as 4.8%, and they are sold two to a pack. The review says the two cartridge designs, a first and second generation, differ mainly in the outer tube material and in where an authentication and memory chip sits.

The review describes the device as a closed system: the cartridges come prefilled, and “The power unit and cartridge settings are not adjustable by the user.”

On the same day the FDA “denied marketing applications for … ten non-tobacco-flavored e-liquid cartridges” of the same product line. This is stated in a later FDA news release of March 17, 2023, which retells the 2021 decision. Two menthol cartridges of the same line were not decided in October 2021; the FDA denied them in March 2023 (section 11).

The review also records the steps before the decision. The FDA sent an acceptance letter on October 30, 2019, a filing letter on November 22, 2019 and a deficiency letter on May 19, 2020, and its staff reviewed the applications in two cycles, in May 2020 and in October 2021. A finding of no significant environmental impact was signed on October 8, 2021. Shelf-life figures in the order and the review are redacted as confidential, so this page does not give them.

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4. The Legal Standard: “Appropriate for the Protection of the Public Health”

The order letter says the authorization “confirms that you have met the requirements of section 910(c) of the FD&C Act.” Under that section the FDA has to find that permitting the product is “appropriate for the protection of the public health,” abbreviated APPH in the FDA’s documents.

The review’s conclusion explains how the FDA applies the standard. Section 910(c)(4) “directs FDA to consider the risks and benefits to the population as a whole, including users and nonusers of tobacco, taking into account, among other things, the likelihood that those who do not use tobacco products will start using them.” The review adds that the FDA’s scientific review “is not limited to considering only information in a PMTA, but also extends to any other information before the Agency, including the relevant existing scientific literature.”

In practice the decision weighed two groups. One was adult smokers who might switch from cigarettes. The other was people who do not use tobacco, especially young people, who might start. The review’s summary puts its conclusion in one sentence: “the potential to benefit smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.”

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5. What the Review Found for Adult Smokers

The FDA’s review reports these findings from the applicant’s studies and from the published literature:

• Chemicals in the aerosol. The products’ aerosol contained “significantly lower levels (greater than 65% decreases in aerosol HPHCs such as aromatic amines, carbonyls, and TSNAs)” of measured constituents than the cigarette comparison data. TSNAs are tobacco-specific nitrosamines. Glycerin and propylene glycol, the main liquids in e-cigarette aerosol, were higher than in cigarette smoke and comparable to other e-cigarettes on the market.
• Laboratory toxicity. In cell tests, cigarette smoke fractions were mutagenic, cytotoxic and genotoxic (damaging to genes and cells). The review states that, “even at the maximum dose levels tested,” the aerosols of the new products and of the comparison e-cigarettes were not, under the test conditions. In animal inhalation studies the products’ aerosols caused “substantially lower nonclinical toxicity and histopathological changes” than the comparison cigarette smoke.
• Exposure in people. In five-day in-clinic studies, smokers who switched to the products had “significant reductions in the urinary and blood” biomarkers of exposure, “of similar magnitude to the reductions in the participants who abstained from smoking.” The review also notes that the reductions were similar to those seen when smokers switched to nicotine gum.
• Abuse liability is a product’s ability to promote continued use, addiction or dependence. The review found it “lower than combusted cigarettes and … similar to, or lower than, that of other ENDS.” For one cartridge it was slightly greater than 4 mg nicotine gum.
• Who wanted to buy the products. On a 1-to-10 scale of intention to buy, current established cigarette smokers scored highest (4.6), and never and former tobacco users scored low (2.5 and 1.9). Adults showed the highest purchase intent for the tobacco (“original”) flavor (28.6%), compared with menthol (23.2%) and mint or fruit flavors (6.4% to 14.7%).

From these findings the review concluded that “the applicant has demonstrated the potential for these new products to benefit adult smokers.” Questions about stopping smoking, and about any nicotine product, are for a clinician; this page reports only what the FDA review states.

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6. How the Review Weighed the Risk to Young People

The review calls youth “a vulnerable population for various reasons, including that the majority of tobacco use begins before adulthood.” It reports that in 2020 about 19.6% of high school students and 4.7% of middle school students reported current e-cigarette use. It also reports that 42.2% of young people who had used e-cigarettes in the past 30 days were still doing so one year later, from 2013–2015 survey data.

The deciding point was flavor. The review states: “Existing evidence consistently indicates that use of tobacco-flavored ENDS is less common compared to non-tobacco flavored ENDS among youth.” The figures it cites include these:

• In the 2013–2014 wave of the national Population Assessment of Tobacco and Health (PATH) Study, over 80% of youth aged 12–17 reported that the first e-cigarette they used was non-tobacco flavored.
• In the 2016–2017 PATH wave, 93.2% of youth and 83.7% of young adults who had ever used an e-cigarette said their first one was flavored, compared with 52.9% of adults aged 25 and older.
• In the 2020 Monitoring the Future survey, tobacco flavor was used by 2.9% of 10th and 12th graders who vaped, compared with 26.9% for mint and 59.3% for fruit.

The review also records limits on this evidence. The applicant “did not provide direct data on youth”; it used adults aged 18 to 24 as a stand-in, and some of those subgroups were small. The review notes that cartridge-based devices are the type young people use most often, and that these products are “sleek and small in design, user friendly cartridge-based, and easily rechargeable.” It still judged the risk of youth starting with these tobacco-flavored products to be low. It adds that “the available evidence to date does not adequately address whether new product use in youth and young adults leads to regular smoking.”

Because of “the strong evidence regarding the impact of youth exposure to marketing on youth appeal and initiation of tobacco use,” the review concluded that any authorization needed marketing restrictions and post-market requirements (sections 8 and 9).

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7. Questions the Review Left Open

The review is explicit about what the evidence could not show:

• Long-term health effects. “Although conclusions on long-term health benefits cannot be made at this point,” the review accepted the short-term findings. The switching studies lasted five days, and their design limits included “small sample sizes, short-term exposure durations, and generally healthy participants.”
• Dual use. The studies did not assess using cigarettes and e-cigarettes together, the pattern the review calls “more likely to occur in real-world conditions.” It reports published data in which dual users can have higher levels of some biomarkers than people who only smoke cigarettes. It also cites a meta-analysis in which cutting cigarettes by at least half was linked to lower lung cancer risk but not to lower risk of death from all causes.
• Seizure reports. Two of the four consumer health-related adverse-event reports for these products in the FDA’s Safety Reporting Portal described seizures. The review states that “it is premature to determine whether current seizure reports indicate an association” with the products.
• Lung injury and burns. No cases of e-cigarette or vaping use-associated lung injury (EVALI) appeared in the applicant’s studies. The review still asked for post-market monitoring of respiratory illness, neurological symptoms and overheating or burn injuries.
• Other vulnerable groups. The applicant gave no data on groups with higher tobacco use or greater difficulty quitting. The review states that the products’ impact on them “is unknown.”
• The population model. The applicant’s computer model of population health effects was judged “not particularly informative.” The review found that it likely overestimated product use and switching and relied on optimistic risk assumptions.

On accidental exposure in children, the review notes that the products are closed systems not meant to be opened. It states that this design and the cartridge chip likely mitigate the risk.

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8. The Marketing Restrictions Attached to the Orders

The order letter states that the marketing restrictions in its Appendix D “are necessary to our conclusion” and that “Absent these restrictions, a marketing granted order for these applications could not issue.” They require the maker to:

• use independent age- and identity-verification services, checked against sources such as public records, for any online or mobile sales;
• use the same kind of verification at the first point of access to its own product websites and apps;
• use the age-restriction controls available on social media platforms for its product accounts and for content posted on its behalf, including by influencers;
• aim paid digital advertising only at people whose age has been verified (data the letter calls “first- and/or second-party age-verified”), not at audiences inferred from browsing or buying behavior;
• place TV or radio advertising only on programs whose audiences are at least 85% adults of legal age, with audience indices of 99 or lower for children aged 2–11 and for youth aged 12–17;
• track where its ads are actually delivered, in real time, and stop delivery to people under the minimum age of sale;
• disclose any paid relationship with influencers, bloggers or brand ambassadors, for example with a “sponsored by” statement.

The letter also notes the maker’s own marketing commitments, such as no models under age 25 and no content designed to target youth. The FDA “encourage[d]” the maker to implement them. Separately, the FDA recommended limiting print advertising to publications where at least 85% of readers are 21 or older. The letter observes that “no broadcast TV network currently accepts tobacco advertising.” It warns that changes in media policies that widen access to youth could change the FDA’s assessment of the products.

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9. Reporting and Record-Keeping After Authorization

• Annual reports beginning twelve months after the orders. They cover labeling and advertising, manufacturing changes, studies and literature, sales by region and channel, buyer demographics, how well the age-verification and youth-access policies work, and where ads were actually delivered.
• Serious and unexpected adverse experiences must be reported within 15 calendar days of the maker receiving the report. The annual report must also summarize adverse experiences involving liver abnormalities, seizures or neurological symptoms, and respiratory symptoms characteristic of EVALI.
• Advance notice of marketing. The maker must notify the FDA at least 30 days before using new labeling or advertising. This applies on an ongoing basis for TV and radio, and for six months from first use for other media. The letter states that this is “not for pre-approval”; it gives the FDA a chance to comment, including on youth appeal.
• Records such as applications, studies, manufacturing, sales and advertising records generally have to be kept for four years.

The orders can be withdrawn or temporarily suspended under section 910(d) of the FD&C Act. The letter lists situations the FDA would consider, including “increases in the percentage or number of youth and young adults who report use of your products,” fewer smokers switching than expected, and new evidence that the products carry greater health risk than the FDA understood. It says the FDA “will continue to monitor the marketing of your products.” The orders also require the products to conform to any current or future tobacco product standard.

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10. What the Authorization Does Not Do

• It is not an FDA approval. The letter states that the APPH finding “does not mean FDA has ‘approved’ the new tobacco products,” and that the maker may not say or imply in labeling or advertising that they are FDA approved.
• It is not a finding that e-cigarettes are safe. The FDA’s list of authorized e-cigarettes states that authorization “does not mean these products are safe, nor are they ‘FDA approved,’” and that “All tobacco products are harmful and potentially addictive.”
• It did not authorize any flavored e-cigarette. Only the tobacco-flavored cartridges and the device were authorized; ten flavored cartridges were denied.
• It covers only the three named products. The letter notes that any modification to a product makes it a new tobacco product, which needs its own premarket review.
• It is not permanent. The orders can be withdrawn or suspended (section 9).
• It does not change the law or the standard. It is an order for one applicant, not a rule.

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

• October 10 and 17, 2019: the three applications are submitted and received.
• May 19, 2020: the FDA sends the applicant a deficiency letter.
• September 9, 2020: the court-required deadline for applications for deemed products already on the market.
• October 12, 2021: marketing granted orders for the device and two tobacco-flavored cartridges, and denial of ten flavored cartridges.
• October 19, 2021: in the same month, the FDA’s table records marketing granted orders for four mint-flavored oral nicotine discs and chews from a smokeless-tobacco maker.
• March 17, 2023: the FDA denies the two menthol cartridges of the same product line. It states that it has by then authorized 23 tobacco-flavored e-cigarette products and devices, including the 2021 device and its two tobacco-flavored cartridges.
• March 28, 2024: the FDA stops updating its marketing granted orders table and moves that information to its online tobacco products database (on fda.gov, titled “Searchable Tobacco Products Database”).
• August 28, 2026: the FDA’s list of authorized e-cigarettes, then current, names 48 e-cigarettes, “the only e-cigarettes that may be lawfully sold in the United States.”

Status as of October 18, 2026: in effect. All three products authorized on October 12, 2021 still appear on the FDA’s list of authorized e-cigarettes, current as of August 28, 2026. A check of the Federal Register through October 18, 2026 found no document withdrawing or suspending these orders. The later tobacco documents found there are paperwork-collection notices for premarket applications (2022 and 2024) and proposed rules on import data (2024) and on establishment registration and product listing (2026).

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12. How It Fits Earlier and Later FDA Tobacco Actions

The authorization was one decision among many in the FDA’s 2021 review of e-cigarette applications:

• April 29, 2021. The FDA commits to rules banning menthol cigarettes and flavored cigars. That story is on the 2021 menthol commitment page.
• August 26 – September 9, 2021. The FDA issues its first marketing denial orders for flavored e-cigarettes, 132 orders for more than 946,000 flavored products by September 9. That story is on the 2021 flavored e-cigarette denials page.
• October 5, 2021. One week before this authorization, the FDA publishes its final rule “Premarket Tobacco Product Applications and Recordkeeping Requirements” (86 FR 55300; Docket No. FDA-2019-N-2854), effective November 4, 2021. Its summary says it sets out what these applications must contain, codifies how the FDA evaluates them and creates post-market reporting requirements for products that are authorized.
• 2022. The FDA denies the market-leading e-cigarette and then pauses the order, on the 2022 e-cigarette denial and stay page.
• 2023. By March 15, 2023 the FDA reports determinations on more than 99% of the nearly 26 million deemed products for which applications were submitted, and it denies the two menthol cartridges of this product line. Enforcement against flavored and disposable e-cigarettes is told on the 2023 youth e-cigarette crackdown page.
• 2025. The FDA authorizes the first nicotine pouches (2025 nicotine pouch authorization).
• March 11, 2026. The FDA announces a draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk” (Docket No. FDA-2026-D-1817). Only its title was checked for this page.

A Federal Register docket is the public file for a rule or notice, where documents and comments are kept on regulations.gov. Individual marketing orders like these are issued as letters and have no docket.

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13. Primary Documents

1. U.S. Food and Drug Administration, Center for Tobacco Products. Marketing Granted Orders, letter of October 12, 2021, Submission Tracking Numbers PM0000551, PM0000553, PM0000560 (redacted, 20 pages) — fda.gov order letter (PDF)
2. U.S. Food and Drug Administration, Center for Tobacco Products. Technical Project Lead (TPL) Review of PMTAs PM0000551, PM0000553, PM0000560, signed October 12, 2021 (34 pages) — fda.gov TPL review (PDF)
3. U.S. Food and Drug Administration. Premarket Tobacco Product Marketing Granted Orders. Program page, content current as of March 28, 2024 (2021 table) — fda.gov marketing granted orders page
4. U.S. Food and Drug Administration. Tobacco Products Marketing Orders. Program page, content current as of August 28, 2026 — fda.gov marketing orders page
5. U.S. Food and Drug Administration. E-Cigarettes, “Vapes” and Other Electronic Nicotine Delivery Systems (ENDS) Authorized by the FDA. Content current as of August 28, 2026 — fda.gov list of authorized e-cigarettes
6. U.S. Food and Drug Administration. News release of March 17, 2023 denying two menthol cartridges of the same product line (later status; its address on fda.gov carries the brand name and is not linked here; it is listed under fda.gov “Press Announcements,” March 17, 2023).
7. Food and Drug Administration, HHS (2021). Premarket Tobacco Product Applications and Recordkeeping Requirements. Final rule. Federal Register 86 FR 55300, October 5, 2021. Docket No. FDA-2019-N-2854; RIN 0910-AH44 — FR Doc. 2021-21011

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Key Research Papers

1. Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, et al. (2019). A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. New England Journal of Medicine 380(7):629-637 — PubMed PMID: 30699054
2. Lindson N, Livingstone-Banks J, Butler AR, McRobbie H, Bullen CR, Hajek P, et al. (2026). Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews 8:CD010216 — PubMed PMID: 42642048
3. Shahab L, Goniewicz ML, Blount BC, Brown J, McNeill A, Alwis KU, et al. (2017). Nicotine, Carcinogen, and Toxin Exposure in Long-Term E-Cigarette and Nicotine Replacement Therapy Users: A Cross-sectional Study. Annals of Internal Medicine 166(6):390-400 — PubMed PMID: 28166548
4. Goniewicz ML, Smith DM, Edwards KC, Blount BC, Caldwell KL, Feng J, et al. (2018). Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes. JAMA Network Open 1(8):e185937 — PubMed PMID: 30646298
5. Wang TW, Neff LJ, Park-Lee E, Ren C, Cullen KA, King BA (2020). E-cigarette Use Among Middle and High School Students - United States, 2020. MMWR Morbidity and Mortality Weekly Report 69(37):1310-1312 — PubMed PMID: 32941408
6. Leventhal AM, Strong DR, Kirkpatrick MG, Unger JB, Sussman S, Riggs NR, et al. (2015). Association of Electronic Cigarette Use With Initiation of Combustible Tobacco Product Smoking in Early Adolescence. JAMA 314(7):700-707 — PubMed PMID: 26284721

The first paper is a randomized trial comparing e-cigarettes with nicotine replacement therapy for quitting smoking, and the second is the Cochrane systematic review of e-cigarettes for smoking cessation. The third and fourth measure nicotine and toxicant exposure in e-cigarette users compared with smokers, the kind of biomarker evidence the FDA review weighed. The last two concern young people: national 2020 survey figures on e-cigarette use among middle and high school students, and a cohort study of e-cigarette use and later cigarette smoking in early adolescence.

PubMed Topic Searches

1. PubMed: electronic cigarettes and smoking cessation
2. PubMed: e-cigarette biomarkers of exposure
3. PubMed: e-cigarette flavors and youth

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Connections

• FDA Actions of 2021
• FDA and Regulation
• Nicotine
• Addiction and Substance Use Disorders
• First Flavored E-Cigarette Denials (2021)
• Menthol Cigarette Ban Commitment (2021)
• Leading E-Cigarette Denied, Then Order Paused (2022)
• Menthol Cigarette and Flavored Cigar Proposals (2022)
• Flavored E-Cigarette Denials and Youth Disposables (2023)
• First Nicotine Pouches Authorized (2025)
• Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)

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