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|
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 the potentially fatal ingredient.
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 itch 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 marketed as “FDA-approved” since there are no hand sanitizers approved by FDA.
Centre for Health Protection. Guidelines for Hand Hygiene. 2017. Available online: https://www.chp.gov.hk/files/pdf/guidelines_for_hand_hygiene.pdf