Updated August 31, 2020 (FDA Recalls Alcohol-Based Hand Sanitizers for Food & Beverage Containers, Flavoring, 1-Propanol & Methanol Contamination)
Abstract: Alcohol-based hand rub (ABHR) sanitizer intentional abuse and accidental misuse is reported in people of all ages including children at U.S. K-12 schools. A substance rehabilitation center1 website states, “…drinking a bottle of the stuff is equivalent to drinking five shots of hard liquor”. School discipline laws by State2 are specific with alcohol as a prohibited substance although some schools require children to bring ABHR on campus. Therefore, it is prudent to analyze alternatives to ABHR – including alcohol-free hand rub (AFHR) and sanitizing products- when it comes to child safety.
This report, HAND SANITIZER: CHILD SAFETY PROTECTION, RISK REDUCTION: ALCOHOL-FREE HAND RUB (AFHR) & SANITIZING PRODUCTS, is based on published research data and explains the difference between ABHR and AFHR and alcohol-free sanitizing products.
Due to COVID-19, consumers have stockpiled products including ABHR. Sales of ABHR skyrocketed to as much as a 561% year-over-year increase3 in highly affected global regions. For parents and caregivers, awareness of the documented toxic and deadly effects of ABHR misuse and abuse is warranted.
The internal organs needed to process alcohol are not fully developed in children. Topical alcohol overuse has had lethal effects with children. Also documented in the news are cases of intentional oral consumption of ABHR by teens and adults. Children accidentally ingesting ABHR is on the rise.
Prior to the coronavirus/COVID-19/SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) world pandemic, the CDC’s recommendation for alcohol content in consumer-grade hand sanitizer was 60% ethanol (ethyl alcohol, “grain alcohol”) or 70% isopropyl (2-propanol, isopropanol, “rubbing alcohol”, IPA). Research shows that ABHR oral consumption4 of this formulation is equivalent to 120/140 proof liquor.
Amid the coronavirus/COVID-19/SARS-CoV-2 world pandemic, the World Health Organization (WHO) now recommends a new formulation5 of 80% ethanol or 75% isopropyl (isopropyl) – an equivalent of 160/150 proof liquor.
In addition, the U.S. FDA warns consumers and health care providers6 that a sharp increase in hand sanitizer products labeled to contain ethanol tested positive for methanol (methyl alcohol, “wood alcohol”) contamination. A cited manufacturing website in this report states one “shot” of methanol can be deadly. CNN Health released a list of recalled hand sanitizing products containing methanol.
This report is intended to create child safety awareness of the potential risks associated with access, overuse, and abuse of ABHR at home and in public settings including K-12 schools.
HAND SANITIZER SALES UP 300-561%
Nielsen7 market research reports that hand sanitizer sales are up 300% – 470% as of February through the first week of March 2020. A European study indicates as much as a 561% increase in hand sanitizer sales from February 24th – 15th, 2020 are reported in Italy, a location that was highly impacted by the COVID-19 virus. There are reports across the world of supermarkets, pharmacies, hospitals, and other healthcare facilities running out of hand sanitizers.
What is the difference between isopropyl, ethanol, and methanol alcohols?
ALCOHOL CONTENT – ISOPROPYL ALCOHOL (ISOPROPANOL, 2-PROPANOL, IPA, “RUBBING ALCOHOL”)
Isopropyl alcohol is a highly flammable substance that is typically used as a disinfectant and is readily absorbed through the skin.
One product safety website8 reports, “…spilling large amounts of IPA on the skin may cause accidental poisoning. Small amounts of IPA on the skin is generally not dangerous, but repeated skin exposure can cause itching, redness, rash, drying, and cracking. Prolonged skin contact may cause corrosion.”
The website continues to explain, “Your body can handle small amounts of isopropyl alcohol. In fact, your kidneys remove approximately 20 to 50 percent of IPA from your body. The rest is broken down into acetone by enzymes known as alcohol dehydrogenases. This acetone is filtered out of your body through the lungs or kidneys.”
Ingestion of IPA, the website cites, “…causes rapid intoxication, people sometimes drink it when conventional alcohol is unavailable, or as a means of suicide. Ingesting isopropyl alcohol has an immediate effect on the central nervous system, which controls the involuntary actions of the body, including heartbeat, breathing, and gag reflex. Isopropyl alcohol slows these functions and may shut them down altogether. IPA is so strong that it can induce hypothermia and subsequent cardiac arrest. The blood’s thinning also causes blood sugar levels to fall so sharply that seizures may result.”
The CDC now recommends a formulation for ABHR with 75% isopropyl alcohol to address COVID-19; this is equivalent to 150 proof liquor.
ALCOHOL CONTENT – ETHYL ALCOHOL (ETHANOL, “GRAIN ALCOHOL”)
Ethyl alcohol (grain alcohol, ethanol) is a clear, colorless liquid and is the principle ingredient in alcoholic beverages. According to Chemical Safety Facts9, ethanol is a common ingredient in cosmetics and can be used as an astringent and a preservative in lotions.
Products containing ethanol include paints, lacquers, and varnish, as well as personal care and household cleaning products. As a food additive, ethanol can help evenly distribute food coloring, as well as enhance the flavor of food extracts. More than 97 percent of U.S. gasoline contains ethanol.
The CDC now recommends a formulation for ABHR with 80% ethanol to address COVID-19; this is equivalent to 160 proof liquor.
FDA ALCOHOL WARNING – METHYL ALCOHOL (METHANOL, “WOOD ALCOHOL”)
Ethyl alcohol (ethanol) and methyl alcohol (methanol) are two types of alcohol; ethyl alcohol contains two carbon atoms while methyl alcohol contains one carbon atom. The difference between ethanol and methanol has triggered an FDA warning10 to consumers and healthcare workers of health risks with consuming mislabeled AHBR products said to contain ethanol yet tested for methanol contamination.
CNN Health released a list of recalled alcohol-based sanitizing products containing methanol.
A science11 website explains, “Formaldehyde forms as a byproduct of degrading methanol — some industries use this byproduct to make everything from plastics to explosives.”
The online article12 by a distilling supply company states, “As little as 10 ml of pure methanol could blind someone and as little as 30 ml could kill someone. 30 milliliters is equivalent to the amount of liquid in a standard shot glass.”
The FDA warning13 explains, “The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.”
The agency’s warning continues explaining that symptoms of methanol poisoning include:
The warning clearly states, “…all persons using these products on their hands are at risk for methanol poisoning, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk.”
The U.S. FDA has recalled products for:
For more information, click on the links below.
HOSPITAL-GRADE HAND SANITIZER
Prior to COVID-19, the CDC recommended ABHR with greater than 60% ethanol or 70% isopropanol in healthcare settings. However, recent ABHR formulation research14 suggested by the WHO was conducted by the Department for Molecular and Medical Virology at Ruhr-Universität Bochum, in Germany. This new report indicates that 80% ethanol or 75% isopropyl alcohol is effective on COVID-19 at 30-second applications.
This new formulation increases what was an equivalent of three shots of alcohol to now four shots per bottle of ABHR.
ABHR – RISKS TO HEALTHCARE WORKERS
The WHO recommends 30-second applications of 80% ethanol or 75% isopropyl alcohol ABHR to be effective with COVID-19.
The frequency of ABHR use by healthcare workers is documented by the CDC15 as, “…as many as 100 times per 12-hour shift, depending on the number of patients and intensity of care.”
It is well documented that healthcare workers are non-compliant with hand care safety. One report16 cites, “The major problem with the use of alcohol sanitizers is the low compliance.”
The report17 continues, “In a 2017 study of healthcare professionals in an emergency department, the compliance rate was only 54%. In a survey of EMS providers regarding hand hygiene practices, compliance was even lower.”
ABHR overuse has been documented to create skin itching, redness, rash, drying, cracking, and “corrosion”.
A question that comes to mind is if ABHR overuse can also affect one’s blood alcohol level?
ABHR & HEALTHCARE ENVIRONMENT RISKS – POSITIVE BLOOD TESTS
Research has determined that consumption of isopropyl and ethyl alcohol can lead to intoxication and serious health consequences.
Positive findings of blood ethanol18 and urinary ethyl glucuronide (EtG) were reported after sustained exposure to ethanol-based hand sanitizers. Unknowingly being exposed to alcohol during surgery can lead to lawsuits. When ethanol is used on open wounds, one report19 states, “There is a risk of ethanol being absorbed into the bloodstream if damaged skin is washed with surgical spirits, which may have ramifications in civil litigation,” (e.g. responsibility for accidents, insurance claims).
ABHR RISKS – SKIN ABSORPTION
One report20 states, “…topically applied ethanol acts as a skin penetration enhancer and may facilitate the transdermal absorption of xenobiotics (e.g. carcinogenic contaminants in cosmetic formulations). Ethanol use is associated with skin irritation or contact dermatitis, especially in humans with an aldehyde dehydrogenase (ALDH) deficiency.”
This report continues, “After regular application of ethanol on the skin (e.g. in the form of hand disinfectants) relatively low but measurable blood concentrations of ethanol and its metabolite acetaldehyde may occur, which are, however, below acute toxic levels. Only in children, especially through lacerated skin, can percutaneous toxicity occur. As there might be industry bias in many studies about the safety of topical ethanol applications, as well as a general lack of scientific research on the long-term effects, there is a requirement for independent studies on this topic. The research focus should be set on the chronic toxic effects of ethanol and acetaldehyde at the point of impact, with special regard to children and individuals with genetic deficiencies in ethanol metabolism.”
ABHR AND CHILDREN – POTENTIAL TO POISON
The CDC’s21 website recommendation for when and how to use hand sanitizers states:
CDC data22 from poison control centers from January – March 2020 indicates an increase in exposures from cleaners and disinfectants. This report states, “The increase in total calls was seen across all age groups; however, exposures among children aged ≤5 years consistently represented a large percentage of total calls in the 3-month study period for each year.”
Documentation of adverse reactions including death were reported with skin absorption of ethanol. This report23 states, “…ethanol poisoning in 28 children, aged one to 33 months, after application of alcohol-soaked cloths to relieve abdominal pain (which was a common practice in Argentina). Two of the children with ethanol poisoning died.” The report goes on to state ethanol is transported by the blood stream to susceptible organs.
Another report24 on potential AHBR risks to children states the reason, “Younger kids are more susceptible to adverse effects.” The reason, the report cites, “…is because there is not as much glycogen in their liver.”
The data25 source of this report indicates that some schools might require children to carry hand sanitizers and:
This report explains, the most common adverse health effects of accidental ingestion are “ocular irritation, vomiting, conjunctivitis, oral irritation, cough, and abdominal pain” and rare effects included “coma, seizure, hypoglycemia, metabolic acidosis, and respiratory depression”.
CBS News26 reported teens intentionally ingesting ABHR and explains, “If a liquid hand sanitizer contains 62 percent ethyl alcohol, that means a ‘drink’ can be as high as 120 proof, whereas a shot of hard liquor such as whiskey or vodka is typically 80 proof.”
These ingestion statistics may increase as ABHR has been stockpiled by consumers.
ABHR AND ADULTS – POTENTIAL TO POISON
A rehabilitation website states, “…drinking a bottle of the stuff is equivalent to drinking five shots of hard liquor”.
According to the American Association of Poison Control Centers, in 2015 there were 1,394 incidents of intentionally ingested hand sanitizer. Fourteen published case reports27 in medical journals recount adults intentionally ingesting hand sanitizer, with the median age being 44; one of these individuals died.
The reasons given for intentional ingestion of hand sanitizer is society-based. For those facing addiction, it may be perceived as more acceptable to carry a bottle of alcohol-based hand sanitizer versus a mini bar bottle of alcohol on their person or in an accessory bag.
Reports of intentional ingestion of ABHR include:
While the FDA has banned certain ingredients on consumer-grade AHBR, the focus on alcohol content has not changed until the WHO’s recommendation to increase alcohol content from 60% ethanol to 80% and 70% isopropyl to 75% to address COVID-19.
ALCOHOL-FREE HAND RUB (AFHR) & SANITIZING PRODUCTS
The FDA’s final rule30 on sanitizing products defers these active ingredients from further rule making:
The FDA press release on the final sanitizing products ruling states that the agency, “…does not intend to take action to remove hand sanitizers containing these three active ingredients from the market”.
With primary U.S. government health agencies promoting alcohol-based sanitizing, it is prudent to evaluate alcohol-free sanitizing products for lower risk with children.
Alcohol-free hand rub (AFHR) and alcohol-free sanitizing products result in:
An active ingredient in most AFHR is benzalkonium chloride (BZK, BC). Low concentrations of BZK are reported as “relatively non-toxic”. Often water-based foams containing BZK are much easier on hands and continue to provide protection well after the solution has dried. As society returns to once highly trafficked public places – especially K-12 schools – deciding between ABHR and AFHR is a conscious choice.
BACTERIA: ALCOHOL VS BZK
The American Journal of Infection Control31 published a research report titled “Evaluation of a benzalkonium chloride (BZK) hand sanitizer in reducing transient Staphylococcus aureus bacterial skin contamination in health”. While Staphylococcus is not COVID-19, it is a bacterium that can lead to a serious infection.
The study32 findings state, “The results showed a significant reduction in total bacterial colony counts of S aureus during the week of BZK use as compared with the week of 70% ethanol sanitizer use.”
The study explains, “BZK has been used as a hand hygiene antimicrobial for almost 90 years. It has a long history of use in both surface disinfectants used in the food industry and as a skin sanitizer. The mechanism of action for BZK is related to its ability to become adsorbed to and then penetrate the bacterial cell wall that leads to damage and loss of cell membrane structural integrity. This causes leakage of low molecular weight components of the cell and eventually cell wall lysis.”
The report33 shares a key fact of alcohol’s lack of potency at high concentrations:
Data proves that, when it comes to bacteria and child safety, BZK is a viable alternative.
BZK EFFECTIVE ON VIRUS
A recent report by John Hopkins Medicine34 explains the similarities and differences with influenza (coronavirus) and COVID-19/SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The difference is explained that SARS-CoV-2 is caused by one influenza strain while the “flu” may be caused by multiple influenza virus strains.
Research35 data on how BZK affects coronavirus indicates
Research reports on viruses and BZK indicate that a virus can be “enveloped”, and in the case of coronavirus, it is.
The author of this report sought the professional opinion of a health industry veteran, Jessica Chandler, for a basic explanation of what viruses are and how viruses react to alcohol. Ms. Chandler holds more than 22-years of experience in auto-immune research and diagnostics. Ms. Chandler explained, “Viruses are lipid encased; alcohol and fats don’t mix. Virus can penetrate cell membranes, however, know that alcohol evaporates in less than 30-seconds which is now the CDC’s recommendation for COVID-19. A long ‘wet’ time is needed and this results in overuse of alcohol-based sanitizing products and hand sanitizers.”
When asked about the frequency of ABHR use to create a longer “wet” time, Ms. Chandler states, “The hand sanitizing requirement is 20-30 seconds. Regardless of what you hear from the sanitizer manufacturers, alcohol evaporates quickly. Reapplying to the hands in 20+ second intervals is simply not practical. Hospitals, clinics and organizations that monitor hand hygiene are beginning to see this is the case.”
Ms. Chandler further explained that an extended “wet time” translates to, “Alcohol based sanitizers are harsh chemicals; alcohol is toxic, flammable and can be lethal if ingested. Skin is absorptive and repeated alcohol use on hands will dry hands leaving them cracked and itchy.”
The WHO’s recommendation is a 30-second application36 time for ABHR to address COVID-19. This means one would need to make sure the alcohol is present on a child’s or an adult’s skin for half a minute to be effective with the novel COVID-19 virus.
With alcohol’s flammable nature and toxicity to children, the risks appear to outweigh benefits.
ALCOHOL-FREE SANITIZING ADOPTION ON THE RISE
As countries begin returning to normalcy at private and public facilities as well as with modes of public transportation (planes, trains), disease risk mitigation is top of mind.
In a recent press release37, Mexico is now distributing AFHR and alcohol-free commercial grade sanitizing products in healthcare facilities, commercial businesses, and to consumers across all states in Mexico.
When entire countries decide to make a change, there is a reason for this decision.
For countries38 with cultural reasons for banning alcohol consumption, an AFHR and alcohol-free sanitizing products present a viable alternative solution to alcohol as a key ingredient in disinfectant and ABHR.
When it comes to child safety protection, the decision by countries to adopt an alcohol-free sanitizing protocol39 should be taken into consideration.
Every chemical has its risks; alcohol-free sanitizing products pose less risk than alcohol-based sanitizing products in the context of child safety protection.
Breakthrough in Science Propels Alcohol-Free Sanitizing Solutions
A new mode of action, as described by Dalrada Health’s GlanHealth, involves the science of polarity. As magnets attract or repel, a new mechanism of action attracts microbes.The microbe cell walls explode causing cell death.
New AFHR and Sanitizing Products Available
Alcohol-free sanitizing products selected by Mexico for open distribution and use in all Mexican states include:
With this many readily available choices, K-12 schools in the U.S. and around the world should be aware of alternatives to ABHR.
This report is focuses on the safety of children. Parents, teachers, and caregivers must be aware of the differences of three types of alcohol (isopropyl, ethanol, methanol) and the dangers of alcohol-based hand rub (ABHR) and sanitizing products for ongoing risk mitigation and safety.
With fear-driven consumer stockpiling of alcohol-based sanitizing products and government recommendations of 30-second applications, the potential for accidents and overuse must be considered at home and in schools.
Now, with a significant increase in alcohol content in ABHR recommended by the World Health Organization (WHO), healthcare workers and consumers must also be aware of the risks with topical absorption, oral consumption, and overuse.
Benzalkonium chloride (BZK), an alcohol-free alternative to ABHR, kills virus in addition to a broad spectrum of bacteria, fungi, molds according to an NIH article40. Repeated use of BZK has been noted to moisturize the skin; alcohol dries the skin with repeated use.
There are readily available alternatives41 to alcohol-based hand rubs (ABHR) with alcohol-free hand rubs (AFHR) and alcohol-free sanitizing products. The alcohol-free sanitizing products referenced in this article are long-lasting (20+ days on surfaces) and gentler on the skin than ABHR. Alcohol-free sanitizing products, by nature, deter intentional ingestion and misuse.
While it is the consumer’s choice of which sanitizing product to use, the research contained in this report makes one pause for consideration of all available options – especially when it comes to child safety.