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Op-Ed: Coronavirus — New alert over substandard hand sanitizers

Effective hand sanitization is one of the recommended contamination control measures for reducing viral transmission. This article looks at hand sanitizers and the dangers of substandard products entering the market. For both those who purchase hand sanitizers and members of the public who use them, the focus of the article is with what makes a hand sanitizer poor quality or dangerous, and what needs to be checked.

The issue of hand sanitization is an important one for entering buildings, from retail spaces to workplace offices. The correct washing technique, type of sanitization or antiseptic agent to be use, frequency of hand sanitization and more importantly the consequences of not following the basic principles are key in ensuring the safety of people.

The premise of effective application assumes that the agent is suitable and contains a sufficient level of water. Pure alcohols have limited effectiveness on the skin surface as they quickly evaporate which results in low contact times for penetration through the cell membrane of the microorganism.

Typically a mixture of 60 percent or 70 percent alcohol to 30 percent purified water is used. The addition of water helps to facilitate the diffusion through the membrane of the bacterial cell or to inactive viral genetic material. This formulation also improves the skin contact time by slowing down evaporation.

The biocidal function is the consequence of the active ingredients, which will vary for different disinfectants. According to the World Health Organisation, the specification for an effective hand sanitizer is:

Alcohol (ethanol) (80% volume/volume) in an aqueous solution; or isopropyl alcohol (75% v/v) in an aqueous solution;
Glycerol (1.45% v/v);
Hydrogen peroxide (0.125% v/v); and
Sterile distilled water or boiled cold water.

One consequence of the global pandemic has been a shortage of disinfectant products, including hand sanitizers. To meet the global demand, and to meet the void created by established disinfectant companies being unable to meet demand, other companies have entered the production space.

This is either by producing alcohol to be used in sanitizers and then selling this to disinfectant manufactures (as some brewing companies have done, as well as the owners of the Louis Vuitton, Givenchy, Tiffany, and Christian Dior lines) or by creating start-up businesses to produce hand hygiene products.

A concern is that many of start-up companies are not producing safe or efficacious products.

To help to accelerate demand, the FDA has issued a temporary enforcement discretion policy : “Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) .” This document was issued on the 27th March 2020 and then updated on 15th April, 1st June and most recently on 7th August of the same year.

Exemptions included within the temporary policy are :

Adverse event reporting,
Registration and listing.

The FDA guidance has maintained the importance of only using products where the active ingredients are either isopropyl alcohol or ethyl alcohol (ethanol).

For safety reasons these alcohols need to be denatured. Furthermore, the only permissible inactive ingredients are glycerine, hydrogen, peroxide and purified water (other ingredients, either active or inactive, such as might be added to alter the aroma, cannot be introduced since for safety reasons the product must smell like alcohol to discourage accidental ingestion).

The guidance also stated that no product should be marketed with inflated superiority claims or labeling which was in any such way false. This includes any claim that a disinfectant can inactivate the specific coronavirus causing the spate of COVID-19 symptoms, because no specific disinfectant test standard has been developed for SARS-CoV-2 .

During August 2020 the FDA issued warnings about certain hand sanitizer products. Generally the warnings fell into two groups: either because of methyl alcohol (methanol) contamination (an alcohol that is toxic to human health) or because of sub-potent levels of alcohol (70 percent and above is regarded as effective at killing skin bacteria and 61 percent and above is considered effective at killing the SARS-CoV-2 virus).

Other warnings were regarding the use of methanol which is not very good at killing microorganisms, compared to isopropyl and ethyl alcohol (a fact established during the 1920s) and toxicity concerns have been known of since at least the 1930s . Unscrupulous or ignorant manufacturers are using methanol (‘wood alcohol’) in the hand sanitizer production process. Methanol’s practical use is as an industrial solvent, not as a disinfectant.

The FDA has described such adulterated products as dangerous and toxic to human health. Moreover, there has been some reports of consumers experiencing serious side effects from methanol like skin damage (it is easily absorbed into the dermis) or more dangerously, by poisoning by ingestion (unfortunately something that is not as uncommon as you might expect) .

The hazards of methanol ingestion include nausea, vomiting, headache, blurred vision, and seizures. In very serious cases, permanent blindness, coma, permanent damage to the nervous system and even death can occur. This happens as the liver digests alcohol using an enzyme called alcohol dehydrogenase. Whereas ethanol is broken down into acetate, which is essentially harmless in low quantities, methanol is broken down into formic acid which is toxic. Aside from methanol, other ineffective hand sanitizers have been found to have been produced using 1-propanol, which is different to isopropyl alcohol and classed as a harmful toxin .

Under the temporary measures, the FDA has been forced to issue several alerts about substandard products entering the market. These are primarily products labelled as containing ethanol which are later shown by agency testing to be partial or wholly methanol containing sanitizers.

To date, the FDA has issued warnings about over 100 hand sanitizer products . Many of these products of concern have been subject to recalls or import bans. These are listed on the FDA website.

For those operating public spaces, it is important to assess that the product is suitable, so please check:

The product name.
The exact name of the active substance(s), and ensure this is ethanol or isopropyl alcohol.
The exact % content of the active substance(s).
The relevant instructions for use.
The type of formulation.
Name and address of the manufacturer.
Safety and sustainability notices.
Disposal details.
Poisons Information.

The current situation means that sub-potent or products containing toxic methanol can enter the supply chain, leading either to the use of products that will not kill skin bacteria sufficiently or inactivate the coronavirus, or which pose a threat to human health. Purchasers need to be wary.

Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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