Nearly a year into the pandemic now and we’re still trying to do the best we can to avoid both catching and spreading the virus. Aside from masks, isolating and distancing, hand sanitizers and other disinfectant products have been an effective way combat the spread. Unfortunately, in our zeal to protect ourselves, we may be exposing ourselves to other health risks by using the wrong sanitizing product.
There are several types of cleaning /sanitizing products on the market that are regulated in different ways. Consumers should take notice of what they are purchasing to ensure they are using the right product for the right purpose.
Surface disinfectants are regulated by the Environmental Protection Agency (EPA) and will typically have (and should!) list the active ingredients on the front panel as well as show an EPA registration number somewhere on the packaging. Such products are intended for killing germs on surfaces; consumers should wear gloves when using these because the chemicals are often present in concentrations that can cause irritation to the skin.
Some companies try to avoid EPA registration (which is an expensive undertaking) by not making a “disinfectant” claim and/or using natural ingredients. Consumers should read the labeling carefully before determining if the product will meet their needs.
Cleaning products that are intended for use on humans are regulated by the Food and Drug Administration (FDA) and can be marketed as either as cosmetics (e.g., soaps, baby wipes or make-up removers) or as over-the-counter (OTC) topical antimicrobial drugs.
Cosmetic cleansers, if used properly, are very effective in removing dirt, debris and even germs however they do not have disinfecting properties so will not kill the bacteria and viruses that live on the skin. Consumers are advised to read the ingredients on the label; for cosmetics, ingredients are listed by their predominance in the formula. For liquid and wipe products, this is often water (sometimes declared as “aqua”).
Finally, there are those products that are considered OTC antiseptic drugs. These are easily identifiable by the Drug Facts panel on the package. [Side note: if the hand sanitizer does not have a Drug Facts panel, it serves as an indicator that the company is not familiar with the regulations so should be avoided.]
Hand sanitizers can be marketed as antiseptic washes (intended for use with water) or rubs (to be used without water); and either type can be marketed as liquids, gels or wipes but there are slight differences in allowable active ingredients. Washes should only have the active ingredients benzalkonium chloride, benzethonium chloride or chloroxylenol while the rubs will contain alcohol (ethanol or isopropyl) or benzalkonium chloride as active ingredients.
When COVID hit the country last year, the FDA relaxed some of the rules regarding the manufacture of hand sanitizers in order to quickly meet the increased demand. While this was a seemingly wise move at the time, it unfortunately opened the doors to many rogue companies taking advantage of the situation. From my vantage point as a regulatory consultant to the pharmaceutical industry, it has been concerning to see what has transpired.
Perhaps most alarming is the number of products labeled as containing ethanol (which on the label may be declared as “ethyl alcohol” or just “alcohol”) but actually are formulated with methanol (or wood alcohol) which can be toxic when absorbed through the skin. This has been most notable on hand sanitizers coming from Mexico and has occurred with sufficient frequency that the FDA issued an import alert last month on all hand sanitizer products from Mexico. These will now undergo heightened scrutiny before being allowed entry into the U.S. Consumers should check any hand sanitizer products in their home; if the labels indicate that the product was made in Mexico (which is a Customs and Border Protection requirement), they should be discarded or at least used with caution.
Another area of FDA concern has been hand sanitizers with food flavors or scents or labels with graphics depicting food items (e.g., strawberries). The agency issued a safety alert last August after receiving numerous reports of children being poisoned by ingesting such products. Adverse events associated with ingestion of hand sanitizers include effects on the heart or central nervous system which have resulted in both hospitalizations and death, according to FDA. If you have children or grandchildren in your home, it’s advisable to avoid purchasing these products.
Lastly, having reviewed hundreds of hand sanitizer labels over the past year, it’s clear to me that there are many companies that should not be in the pharmaceutical business, even with seemingly good intentions of providing a much-needed product. The FDA has only limited resources so is appropriately concentrating its efforts on those products that present the greatest risk to the public. However, as consumers, we need to educate ourselves by reading product labels to ensure that we are using the right product for the right purpose.
Susan Crane is a resident of Big Canoe and president of OTC Compliance, LLC, providing regulatory consulting services to pharmaceutical companies involved in the manufacture, sale and distribution of OTC drugs, cosmetics and dietary supplements.