FDA Tightens Hand-Sanitizer Oversight and Warns About Vapors and Eye Injuries (2021)

Table of Contents

1. What the FDA Did in 2021
2. February 2021: A Methanol-Testing Policy for Drug Alcohol
3. Why the FDA Focused on Methanol
4. October 2021: Ending the Pandemic Shortcuts for Making Hand Sanitizer
5. June 2021: The Safety Communication on Vapors
6. November 2021: The Safety Communication on Eye Injuries
7. The Steps the FDA Listed for Consumers and Caregivers
8. What the 2021 Actions Did Not Do
9. Dates and Legal Status as of October 18, 2026
10. How It Fits Earlier and Later FDA Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the FDA Did in 2021

The FDA’s 2021 hand-sanitizer actions came in four documents, two published in the Federal Register (the U.S. government’s daily journal of agency rules and notices) and two posted as Drug Safety Communications (the FDA’s formal public notices about a safety issue with a medicine):

• February 23, 2021: notice of a final guidance for industry, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)” (86 FR 10977; Docket No. FDA-2020-D-2016). The notice states the guidance was “immediately in effect.”
• June 16, 2021: Drug Safety Communication, “FDA warns that vapors from alcohol-based hand sanitizers can have side effects.”
• October 13, 2021: notice withdrawing three temporary guidance documents on making alcohol-based hand sanitizer and the alcohol that goes into it (86 FR 56960; Docket No. FDA-2020-D-1106).
• November 2, 2021: Drug Safety Communication, “FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury.”

A docket is the public file, identified by a number such as FDA-2020-D-2016, that holds an agency document together with the comments filed on it. The two Federal Register notices were guidance actions, not new regulations, and the two safety communications reported findings from FDA reviews of case reports.

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2. February 2021: A Methanol-Testing Policy for Drug Alcohol

The February 23, 2021 notice announced a final guidance “intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol.” Compounding here means a pharmacist preparing a drug product in a pharmacy rather than a factory.

According to the notice, the guidance “outlines a policy intended to help pharmaceutical manufacturers and pharmacists … avoid the use of pharmaceutical alcohol that is contaminated with or substituted with methanol in drug products.” The FDA uses the term pharmaceutical alcohol for ethanol or isopropyl alcohol used as an active ingredient in drugs, and the notice describes these as “widely used active ingredients in a variety of drug products.”

The FDA issued the guidance without first asking for public comment. The notice explains that, given the COVID-19 public health emergency, the agency had “determined that prior public participation is not feasible or appropriate,” and that the guidance “remains subject to comment in accordance with the Agency’s good guidance practices.”

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3. Why the FDA Focused on Methanol

The February 2021 notice gives two reasons. First, the FDA stated it was “aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizers that were manufactured with methanol or methanol-contaminated ethanol.” Second, the agency said it was “concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol) … could be similarly vulnerable to methanol contamination.”

The notice links the concern to pandemic demand: “As the COVID-19 pandemic has increased the demand for hand sanitizer products, the demand for pharmaceutical alcohol as the active ingredient of those products has also increased.”

The FDA also kept a public list of hand sanitizers it described as products consumers should not use. That list, now marked “no longer being updated,” gives reasons for its entries such as products found to contain methanol or 1-propanol, along with recalls, import alerts and warning letters. The list names manufacturers and products; none are repeated here. A CDC report of serious illness and deaths after people swallowed methanol-containing hand sanitizer in 2020 appears under Key Research Papers below.

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4. October 2021: Ending the Pandemic Shortcuts for Making Hand Sanitizer

Early in the pandemic, the FDA had issued three temporary policies, in the form of guidance documents, that let firms make hand sanitizer, or the alcohol for it, outside the usual requirements. The October 13, 2021 notice names them:

• “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”
• “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”
• “Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”

The notice states they were issued in March 2020 and updated on March 27, 2020, April 15, 2020, June 1, 2020, August 7, 2020 and February 10, 2021.

The FDA’s stated reason for withdrawing them: “current data indicate that consumers and healthcare personnel are no longer experiencing difficulties accessing alcohol-based hand sanitizer products, and these temporary policies are no longer needed to help meet demand for alcohol-based hand sanitizer products or for alcohol for use in alcohol-based hand sanitizer.”

The notice set a two-stage wind-down:

• December 31, 2021: the withdrawal date. Firms making hand sanitizer, or alcohol for it, under the temporary policies “must cease production of these products by December 31, 2021.”
• March 31, 2022: firms “must cease, by March 31, 2022, distribution of any remaining hand sanitizer products that were prepared under the temporary policies.” After that date, the FDA stated it “intends to cease its temporary policy of not taking action” on the distribution of such products.

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5. June 2021: The Safety Communication on Vapors

On June 16, 2021, the FDA warned that “symptoms such as headache, nausea, and dizziness can occur after applying alcohol-based hand sanitizers to the skin.” The agency wrote that these symptoms were “likely to have occurred because of vapors from the hand sanitizer, potentially from exposure in enclosed spaces or places with poor air circulation,” and that it had “received increasing reports of these side effects since the start of the COVID-19 pandemic.” Most people had “minor or minimal effects; however, some cases required treatment by a health care professional.”

The FDA drew on two data sources:

• FDA Adverse Event Reporting System (FAERS), the FDA’s database of side-effect reports. Between January 1, 2010 and December 31, 2020, the FDA found 50 cases of serious adverse events after hand sanitizer was applied to the skin. Although the review spanned 11 years, all 50 were received after March 2020. Most were adults; four were children aged 5 to 16. The FDA notes that the setting in which the sanitizer was used was rarely reported.
• U.S. poison control center calls (the National Poison Data System of the American Association of Poison Control Centers). Between January 1, 2018 and December 31, 2020, the FDA found 299 cases of skin (138) and inhalation or nasal (161) exposures with a related clinical effect. Children 5 or younger made up 12 percent. Effects included headache, nausea and dizziness or vertigo; a small number of moderate effects were recorded (12 from skin exposure, 2 from inhalation).

In both analyses the FDA excluded cases involving hand sanitizer with confirmed or suspected methanol contamination, so these numbers concern the ethanol-based products themselves. The FDA also cited published studies describing inhalation of vapors as a route by which alcohol is absorbed after hand sanitizer is applied, including one in which use in a confined space raised a urine test for alcohol use (see Key Research Papers).

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6. November 2021: The Safety Communication on Eye Injuries

On November 2, 2021, the FDA warned that “getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye.” The agency stated that eye exposure had been reported in all age groups but “has occurred most often in children,” and that such injuries “have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.”

What the FDA found:

• Poison control center calls, January 1, 2018 to April 30, 2021: 3,642 cases of eye-only exposure with related eye effects. The most common were eye irritation or pain and red eye or conjunctivitis. There were 160 cases of blurred vision and 58 cases of corneal abrasion, a scrape or injury to the clear front surface of the eye.
• The 58 corneal abrasions: all were treated by rinsing with water or saline, and 26 also received antibiotics. Of the 51 treated and released, 27 had a moderate effect and two a major effect (described by the FDA as life-threatening or leaving a lasting effect). Half (29) were in children and teens 19 or younger, and 21 percent (12) in children 5 or younger.
• Where exposures happened: in children 5 and younger, mostly at home; in children 6 to 19, mostly in school settings.
• Published reports: two articles described 18 children whose eye exposure required hospital or professional care; 10 had damage to the eye’s surface. One, from a pediatric eye referral center, described 16 hospitalized children in 2020 compared with one case in 2019; eight had a corneal or conjunctival ulcer (see the site’s Corneal Ulcer page).

The FDA noted that dispensers “often are at children’s eye level and can splash.”

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7. The Steps the FDA Listed for Consumers and Caregivers

Both safety communications included a section the FDA titled “What should consumers do?” The points below are the FDA’s, as written in those documents:

• Ventilation: the FDA advised using hand sanitizer in a well-ventilated area and, in an enclosed space such as a car, opening a window until the product is dry and the vapors have cleared.
• Fire risk: because it contains alcohol, the FDA described hand sanitizer as flammable and advised letting hands dry completely and vapors clear before any activity involving heat, sparks, static electricity or open flames.
• Eyes: the FDA advised against use in or near the eyes. If sanitizer gets into the eyes, the agency’s guidance is to rinse them right away under gently running water for at least 15 to 20 minutes, calling immediate rinsing “the most important thing you can do to reduce the risk of serious eye injury,” and to have an urgent eye examination if redness, pain, irritation, visual impairment, blurred vision or light sensitivity persist.
• Children: the FDA advised that adults supervise young children, particularly those younger than 6, when they use hand sanitizer, and store it out of children’s reach and sight. The agency stated that “Drinking even a small amount of hand sanitizer can cause alcohol poisoning in children, while larger amounts may be toxic in older children and adults.”
• Soap and water first: the FDA repeated the CDC’s position that washing hands with plain soap and water is the best way to prevent the spread of infections, and that when soap and water are not available, the CDC recommends an alcohol-based hand sanitizer containing at least 60 percent alcohol.
• Product lists: the FDA pointed consumers to its list titled “FDA updates on hand sanitizers consumers should not use,” because some products “may contain or be contaminated with harmful ingredients.”

The FDA’s fact list adds that hand sanitizers “do not reduce all types of germs, do not work as well when hands are visibly dirty or greasy, and may not remove harmful chemicals.” Questions about a particular exposure belong with a clinician or Poison Help (1-800-222-1222), the number given in the FDA documents.

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8. What the 2021 Actions Did Not Do

• They did not change the label. In both safety communications the FDA stated it was “not making any changes to the Drug Facts label” (the standard label on OTC medicines). The eye communication notes that the label already warns the product should not be used in or near the eyes.
• They did not restrict sales. The safety communications reported findings and said the FDA would keep monitoring; neither ordered a recall or sales limit.
• The methanol-testing guidance was not a new regulation. It was announced as a guidance for industry, issued without prior comment and open to comment under the FDA’s good guidance practices.
• They were not COVID-19 emergency-use actions. Hand sanitizers are OTC drug products; the October 2021 notice ended pandemic-era temporary policies rather than creating new ones.
• The vapor data did not concern methanol. The FDA excluded methanol-contaminated products from its vapor analyses.

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

• February 23, 2021: methanol-testing guidance announced in the Federal Register, in effect immediately (86 FR 10977).
• June 16, 2021: vapor safety communication.
• October 13, 2021: withdrawal of the three temporary policies announced (86 FR 56960).
• November 2, 2021: eye-injury safety communication (page content current as of November 9, 2021).
• December 31, 2021: the three temporary policies withdrawn; production under them had to stop.
• March 31, 2022: deadline to stop distributing remaining product made under the temporary policies.
• October 17, 2023: the FDA announced a revised final guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol” (88 FR 71576; same Docket No. FDA-2020-D-2016). Its notice states that it “replaces” the earlier guidance of the same name “Including During the Public Health Emergency (COVID-19),” which it describes as published in January 2021.

Status as of October 18, 2026:

• Methanol-testing policy: replaced, policy continues. The 2021 guidance was replaced in October 2023 by a revised final guidance on the same docket, which keeps the same purpose of alerting manufacturers and compounding pharmacists to methanol contamination of drug alcohol. A Federal Register check through October 18, 2026 found no later document withdrawing the 2023 guidance.
• Temporary manufacturing policies: withdrawn (effective December 31, 2021, with distribution ending March 31, 2022).
• Safety communications: unchanged. No later label change from them was found; the FDA’s list titled “FDA updates on hand sanitizers consumers should not use” carried entries through 2024 and is now marked “no longer being updated” (content current as of April 2, 2026).

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10. How It Fits Earlier and Later FDA Actions

Before 2021. The three temporary manufacturing policies date from March 2020 and were updated five times through February 2021. The earliest items on the FDA’s do-not-use list page, dated June 19 and July 2, 2020, are a drug alert and a press release about hand sanitizers, the second on products containing methanol. The February 2021 testing guidance extended the methanol concern from hand sanitizer to any drug that uses ethanol or isopropyl alcohol.

After 2021. The temporary policies wound down by March 31, 2022, and the methanol-testing guidance was reissued in October 2023 under a title without the pandemic phrase (section 9). The do-not-use list kept adding entries through 2024 before it was frozen.

Related 2021 actions. Other 2021 FDA actions covered here also deal with OTC products and with contaminants in medicines and personal-care products: the proposed order for nonprescription sunscreens, the temporary impurity limit set during the varenicline recalls, the warning on abuse of the nasal decongestant propylhexedrine, the 2021 asbestos testing of talc cosmetics and the end of lead acetate in hair dyes. All 2021 actions are listed on the FDA Actions of 2021 hub.

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11. Primary Documents

1. Food and Drug Administration, HHS (2021). Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19); Guidance for Industry; Availability. Notice of availability. Federal Register 86 FR 10977, February 23, 2021. Docket No. FDA-2020-D-2016 — FR Doc. 2021-03548
2. U.S. Food and Drug Administration. FDA warns that vapors from alcohol-based hand sanitizers can have side effects. Drug Safety Communication, June 16, 2021 — fda.gov Drug Safety Communication, June 16, 2021
3. Food and Drug Administration, HHS (2021). Alcohol-Based Hand Sanitizer Products; Withdrawal of Three Temporary Guidance Documents Issued During the Public Health Emergency of the Coronavirus Disease 2019. Notice; withdrawal. Federal Register 86 FR 56960, October 13, 2021. Docket No. FDA-2020-D-1106 — FR Doc. 2021-22108
4. U.S. Food and Drug Administration. FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury. Drug Safety Communication, November 2, 2021; content current as of November 9, 2021 — fda.gov Drug Safety Communication, November 2, 2021
5. Food and Drug Administration, HHS (2023). Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry; Availability. Notice of availability. Federal Register 88 FR 71576, October 17, 2023. Docket No. FDA-2020-D-2016 — FR Doc. 2023-22843
6. U.S. Food and Drug Administration. FDA updates on hand sanitizers consumers should not use. Drug Alerts and Statements page, marked no longer being updated; content current as of April 2, 2026 — fda.gov hand sanitizer do-not-use list
7. Public docket FDA-2020-D-2016 — regulations.gov FDA-2020-D-2016
8. Public docket FDA-2020-D-1106 — regulations.gov FDA-2020-D-1106

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Key Research Papers

1. Martin GC, Le Roux G, Guindolet D, Boulanger E, Hasle D, Morin E, Vodovar D, Vignal C, Gabison E, Descatha A, French PCC Research Group (2021). Pediatric Eye Injuries by Hydroalcoholic Gel in the Context of the Coronavirus Disease 2019 Pandemic. JAMA Ophthalmology 139(3):348-351 — PubMed PMID: 33475712
2. Yangzes S, Grewal S, Gailson T, Grewal SPS (2021). Hand Sanitizer-Induced Ocular Injury: A COVID-19 Hazard in Children. JAMA Ophthalmology 139(3):362-364 — PubMed PMID: 33475717
3. Yip L, Bixler D, Brooks DE, Clarke KR, Datta SD, Dudley S Jr, Komatsu KK, Lind JN, Mayette A, Melgar M, Pindyck T, Schmit KM, Seifert SA, Shirazi FM, Smolinske SC, Warrick BJ, Chang A (2020). Serious Adverse Health Events, Including Death, Associated with Ingesting Alcohol-Based Hand Sanitizers Containing Methanol — Arizona and New Mexico, May–June 2020. MMWR. Morbidity and Mortality Weekly Report 69(32):1070-1073 — PubMed PMID: 32790662
4. Arndt T, Schröfel S, Güssregen B, Stemmerich K (2014). Inhalation but not transdermal resorption of hand sanitizer ethanol causes positive ethyl glucuronide findings in urine. Forensic Science International 237:126-130 — PubMed PMID: 24631832
5. Emerson BL, Whitfill T, Baum CR, Garlin-Kane K, Santucci K (2016). Effects of alcohol-based hand hygiene solutions on breath alcohol detection in the emergency department. American Journal of Infection Control 44(12):1672-1674 — PubMed PMID: 27614708
6. Brewer C, Streel E (2020). Is Alcohol in Hand Sanitizers Absorbed Through the Skin or Lungs? Implications for Disulfiram Treatment. Alcohol and Alcoholism 55(4):354-356 — PubMed PMID: 32400852

The first two papers are the two pediatric eye-injury reports the FDA cited in its November 2021 safety communication. The third is a CDC report of serious illness and deaths among people who swallowed hand sanitizer containing methanol in two states in 2020. The last three are the published studies on alcohol absorption from hand-sanitizer vapors that the FDA cited in its June 2021 safety communication.

PubMed Topic Searches

1. PubMed: hand sanitizer eye injury
2. PubMed: hand sanitizer methanol poisoning
3. PubMed: hand sanitizer vapor inhalation and absorption

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Connections

• FDA Actions of 2021
• FDA and Regulation
• Household Chemicals
• Triclosan
• Alcohol
• Conjunctivitis
• Corneal Ulcer
• Blurred Vision
• Sunscreen Proposed Order (2021)
• Varenicline Nitrosamine Recall and Limit (2021)
• Propylhexedrine Inhaler Abuse Warning (2021)
• Talc Cosmetics Asbestos Testing (2021)
• Lead Acetate Hair Dye Ban (2021)

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