The Difference Between Hand and Surface Sanitizers
- The FDA regulates sanitizers that are effective on human skin and anything else that is alive.
- The EPA regulates sanitizers intended for use on inanimate surfaces.
Bac-Off is an FDA-regulated product and a hand sanitizer with 0.13% benzalkonium chloride as the active ingredient.
Bac-San is an FDA-regulated product and a hand sanitizer with 70% ethyl alcohol as the active ingredient.
The FDA does not allow individual kill claims. Here is a link that shows when the FDA enforced this rule against Purell: https://www.cnn.com/2020/01/27/business/fda-purell/index.html.
Both Bac-San and Bac-Off are hand sanitizers and equally effective in the eyes of the FDA. Here are the text and link from the FDA:
At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safety and effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for use in OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. Currently, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.
The CDC acknowledges that benzalkonium chloride hand sanitizers are eligible according to the FDA. According to the CDC, “available evidence indicates benzalkonium chloride has less reliable activity against coronavirus than either of the alcohols”. They cite one article that states concentrated ethanol-based hand sanitizers are more effective than benzalkonium chloride-based hand sanitizers. Note that hand sanitizers with benzalkonium chloride still have efficacy and the CDC does not override the FDA.
EPA-registered products (e.g. QDII Sanitizer, QDII Food Service Sanitizer, Golden Sanitizer, Sanitizer Concentrate, Security Floor Sanitizer, and One Step Quaternary Cleaner and Disinfectant) can have kill claims against individual organisms. The FDA does not allow for this type of claim.
Labels for all EPA-registered products are supposed to contain the following text: “It is a violation of Federal law to use this product in a manner inconsistent with its labeling.” This type of product label will not contain direction for sanitizing skin or any other living tissue. Therefore, technically it is illegal to use an EPA-registered product as a hand sanitizer.
Summary: In the eyes of the FDA, both Bac-Off and Bac-San are equally effective and legal. The CDC recently provided guidelines stating that while products like Bac-Off are effective, products like Bac-San are more effective than those like Bac-Off. We cannot make kill claims against individual viruses on these FDA-regulated products because the FDA does not allow for that type of claim.
The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates who can buy and sell ethyl alcohol. This includes the ethyl alcohol used in hand sanitizer applications. The TTB does not control any product claims. They do limit who can buy which grades of ethyl alcohol and how much they can buy. Note that The TTB has removed limits for the current purchasing season that ends June 30, 2020.
The United States Department of Transportation (DOT) regulates how hazardous materials (including many alcohol-based hand sanitizers) are packaged for transport and shipped within the United States. The DOT has revised its regulations for alcohol-based hand sanitizers until July 2, 2020. This revision allows companies to ship a variety of hand sanitizers with available packaging.
November 2020 Update:
After extending the enforcement direction on the shipping of alcohol-based hand sanitizers until October 31, 2020, the Pipelines and Hazardous Materials Safety Administration (PHMSA) division of the DOT let the enforcement standard revert back to the one that existed pre-pandemic. This means that shipments of alcohol-based hand sanitizers above the limited quantity exception (1L for Bac-San) must be in UN-regulated packaging with DOT-compliant labeling.