Throughout the duration of the COVID-19 pandemic, the demand for protective equipment, hand sanitizers, and other disinfecting materials has been on a steady rise, ushering an increased effort for mass production both in the United States and around the world. While many domestic and international factories shift from manufacturing consumer goods to medical-grade supplies, there is a considerable effort that goes into testing the reliability of these products as they are bought and sold around the country. In fact, the high demand for hand sanitizers and liquid gel disinfectants in pharmacies and supermarkets has led the United States Food and Drug Administration (FDA) to ease regulations regarding factory licensing, even implementing policies that streamline and facilitate the transition from consumer manufacturing to medical and sanitization products. While a pandemic requires an increased and coordinated effort to follow health and safety recommendations made by healthcare authorities, relaxing regulations can also be detrimental to public health when medical-grade products are contaminated, mislabeled, or inadequate to their primary function.
In June 2020, the FDA issued a statement to alert consumers and retailers of imported hand sanitizers containing methanol as an active ingredient. Concentrations of methanol as high as 81 percent were found in many different sanitization products imported to the United States. Methanol is a synthetic chemical made from distilling wood and is typically used in the production of fuel and antifreeze radiator liquid. Due to its chemical similarity to the less harmful substance ethanol, or ethyl alcohol, methanol was substituted and subsequently mislabeled as ethanol in over 67 hand sanitizer products from a number of Mexican manufacturing companies, including EskBiochem SA de CV of Celaya, Guanajuato. High concentrations of methanol were found in a variety of EskBiochem’s product lines, including CleanCare NoGerm Advanced Hand Sanitizer, Saniderm Advanced Hand Sanitizer, and Good Gel Antibacterial Hand Sanitizer which are all manufactured, bottled and exported in the Celaya facility.
“Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects,” the FDA declared in a press release on June 29, 2020.
If a significant amount is ingested or absorbed through the skin, methanol can be highly toxic and even lethal. Methanol forms the metabolites formaldehyde and formic acid when it is digested in the body, which are potentially lethal toxins. Mild side effects of ingesting methanol include nausea, vomiting, headache, and blurred vision. More serious side effects include seizure, coma, permanent damage to the nervous system, or even death. Numerous accounts of permanent blindness in adults and children have been reported simultaneous to the detection of the contaminated hand sanitizers.
According to the Centers for Disease Control and Prevention, hand sanitizers are effective in killing certain germs on the surface of the skin. Alcohol-based sanitizers can efficiently reduce the number of germs but are less effective than hand washing, especially when hands are visibly dirty or greasy. Hand sanitizer is most effective in avoiding the spread of viruses and germs as long as the product is made up of 60 percent or more of alcohol. Typically, alcohol-based hand sanitizers contain anywhere from 60 to 95 percent of isopropyl alcohol, ethanol or n-propanol. Methanol is considered to be a cheaper substitute, as it is synthetic and can be easily derived from abundant natural gas sources.
In addition to warning consumers about the negative consequences of methanol ingestion and absorption into the skin, the FDA statement called for a voluntary recall of mislabeled products from the EskBiochem manufacturing plant after the company had not taken action to remove these potentially dangerous products from the market as of June 29. However, it is alleged that many products from EskBiochem remain on shelves of retailers and in warehouses of distributors because of their high demand and slow and inadequate awareness of product recalls.
Concerning consumer protection and manufacturer liability, producers can be held liable for injury or death as a result of defects, mislabeling, or false advertising. They can also be held liable for failures to communicate and warn against negative externalities of use. Medications and medical-grade products are no exception. Often, these are held to a higher regard due to the importance of accuracy in labeling and instructions, because of patient dependency for their general well-being.
In the court of law, it is often difficult for plaintiffs or victims to prove that their injuries or adverse effects are solely related to a defective product. In the case of consumers using hand sanitizers amid a global pandemic, the defect, contamination and mislabeling are extremely problematic. However, it would need to be proved that they were the only source of hand sanitizer used by the victim.
Furthermore, the announcement of a recall does not immediately signify that products are defective or substandard. FDA warnings can serve as a baseline for claims and lawsuits regarding faulty products, but they are not admissions of guilt. Companies often issue recalls and apply “assumption of risk” clauses that shift responsibility from manufacturer to consumer if any injuries are sustained after the initiation of the recall. Estimates show that weekly recalls cost the nation over $1 trillion per year and significantly range from labeling mistakes or misspellings to contamination with potentially deadly chemicals.
If companies do not recall contaminated or defective products, they could face significant penalties
due to their role and liability in injury or death that may be intrinsically linked to their products. However, many negligent retailers or distributors may not receive or may disregard important notices regarding recalls and customers would not have any way to know the product was dangerous.
The Federal Trade Commission’s (FTC) Bureau of Consumer Protection is the acting authority tasked with taking action against deceptive claims about products or services. During the course of the COVID-19 pandemic, the FTC has worked alongside the FDA to monitor the surge in medical products on the market. They have actively issued cease and desist for the trade and sale of unapproved products intended to prevent, treat or sanitize.
Amid the pandemic, the FDA granted permission to certain brands that do not normally produce sanitary products or hand sanitizer to temporarily produce them without a license as a measure to combat the high demand. As a direct result, entities that were not considered drug manufacturers were able to register as over-the-counter manufacturers, granting them special permissions during the state of emergency. Legal practitioners consider this move to be dangerous, as it relaxes rules and regulations for compounding and manufacturing hand sanitizers, increasing the likelihood of impurities or potential contamination of consumer products.
Due to the resurgence of cases around the United States, liquid gel hand sanitizing products constitute some of the highest sought-after commodities. In some jurisdictions, hand sanitizer is even required for entry in retail stores, supermarkets, and office buildings. Behind medical-grade masks and protective face coverings, hand sanitizer continues to be one of the most commodified products throughout the pandemic.
Meanwhile, the FDA and consumer protection agencies remain busy with heading federal oversight and inspection of imported medical and safety equipment to ensure compliance and proper labeling as a way to protect the health and safety of consumers. The FDA is actively working to prevent false and misleading claims for hand sanitizers, such as that they can provide prolonged and specific protection for COVID-19. There is no evidence to support these claims and currently, there are no hand sanitizers approved by the FDA. Anything advertised saying differently is a fraudulent claim. As an effort to stabilize the number of active cases and protect citizens from the dangers of the virus, regulations regarding health and sanitation products are of the most importance.
Regarding hand sanitizer, the demand will remain high as the coronavirus persists around the country. When consumers are unable to find their usual hand sanitizer in stores or online, they will likely turn to new alternatives or brands that may or may not have manufactured sanitary products before the onset of the novel coronavirus, potentially putting them at even more of a risk amid the health emergency.
For more on COVID-19, see our special coverage.
Kevin McKie is an experienced lawyer at The Environmental Litigation Group, P.C., a partner of The Law Center, a national network of top law firms with decades of experience in advocating for those who have suffered from personal injury, asbestos-related diseases, motor vehicle accidents and more. As a former elected official, Kevin served for 2 years on the Board of Directors for the Birmingham Water Works Board, one of the country’s largest water systems.
Suggested citation: Kevin McKie, Balancing Public Health and Consumer Demand for Hand Sanitizer in a Pandemic, JURIST – Professional Commentary, August 6, 2020, https://www.jurist.org/commentary/2020/08/kevin-mckie-toxic-handsanitizer/.
This article was prepared for publication by Cassandra Maas, a JURIST staff editor. Please direct any questions or comments to her at commentary@jurist.org
