Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) issued guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID19). SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. Hand hygiene is an important part to control COVID-19. Washing hands often with soap and water for at least 20 seconds is essential, If soap and water are not readily available, then use an alcohol-based hand sanitizer.
Isopropyl alcohol and ethanol are two of the active ingredients currently being used for hand sanitizers for use in reducing bacteria on the skin that potentially can cause disease or decrease the presence of bacteria on the skin. One safety precaution with alcohol-based hand sanitizer is the use of denatured alcohol. This makes the sanitizer bitter-tasting and less appealing to children. All active, as well as other ingredients, must be pharmacopeia grade. The finished hand sanitizer product is compounded according to the recommendations of the World Health Organization (WHO): Ethanol formulated to 80%, v/v in an aqueous solution; or Isopropyl Alcohol to 75%, v/v in an aqueous solution.
Impurities meet the interim limits listed in Table 1 below and no other potentially harmful impurities are present other than those addressed in Table 1.
|Methanol||NMT 630 ppm|
|Benzene||NMT 2 ppm|
|Acetaldehyde||NMT 50 ppm|
|Acetal (1,1-diethoxyethane)||NMT 50 ppm|
|Sum of all other impurities||NMT 300 ppm|
Health Risk Due to Presence of Impurities
- Methanol is metabolized to formaldehyde or formic acid in the body, which is more toxic and harmful than those produced by other alcohols. This can lead to a dangerous build-up of acid in the bloodstream that damages organs and tissues, particularly the optic nerve, causing vision impairment and blindness
- Acetaldehyde appears to be genotoxic, and potentially carcinogenic, when in direct contact with tissues.
- Benzene causes harmful effects on the bone marrow and can cause a decrease in red blood cells, which can affect the immune system, increasing the risk of benzene-related cancers.
- Acetal can cause skin inflammation and long exposure leads to cancer or mutations.
Ethanol produces acetate in the body and isopropanol produces acetone in the body. Recently FDA detected some hand sanitizer brands that are labeled to contain ethanol but that have tested positive for methanol contamination and also contain potentially fatal ingredients.
Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the substance can be toxic when absorbed through the skin or life-threatening if ingested, according to the Food and Drug Administration (FDA). Recent reports of Skin allergy, redness, dryness, cracks, and even blisters that cause itching or pain blindness. In some cases, hospitalizations and death following tainted hand sanitizer ingestion by both adults and children highlight the potential dangers.
Signs and symptoms of methanol exposure may include nausea, vomiting, headache, and blurred vision. Serious adverse effects may include permanent blindness, seizures, coma, permanent nervous system damage, and death. Risks of health hazards are being increased further amid the current COVID-19 pandemic since many people are using hand sanitizer more frequently to try to protect against the devastating new coronavirus.
“Unfortunately, there are some companies taking advantage of the increased usage of hand sanitizer during the coronavirus pandemic and putting lives at risk by selling products with dangerous and unacceptable ingredients.”
Hand sanitizers that are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection. Some are marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Centre for Drug Evaluation and Research (CDER) March 2020 Updated June 1, 2020.
- World Health Organization. WHO Guidelines on Hand Hygiene in Health Care. First Global Patient Safety Challenge: Clean Care is Safer Care; WHO: Geneva, Switzerland, 2009.
- Health Canada. Two Deaths Linked to Ingestion of Hand Sanitizer Containing Methanol. 2013.
- Qiao, J.S.; Guo, L.M. Six cases of methanol poisoning caused by skin absorption. J. Henan Med. Univ. 1992, 27, 186–187.
- Bolon, M.K. Hand hygiene: An update. Infect. Dis. Clin. North Am. 2016, 30, 591–607.
Centre for Health Protection. Guidelines for Hand Hygiene. 2017. Available online: https://www.chp.gov.hk/files/pdf/guidelines_for_hand_hygiene.pdf