Hand Sanitizer Regulations Explained

For hand sanitizers, the CDC website recommends a >60% ethanol, or >70% isopropyl version in healthcare settings. However, the CDC is only one agency. Comparatively speaking, the FDA will adhere to their own claims as to what is acceptable in healthcare, food processing, home use etc. And within each of these segments, there will be different approvals for different uses. For instance, a poultry plant will require specific claims to the efficacy to kill salmonella. The resulting EPA claim registration will be different for the chemical used to clean a cleaver to butcher a chicken compared to a surface on which the chickens are stored. In addition to this, the same product may have registered claims to kill 99.9% salmonella in 60 seconds, while another producer had the same claim, for the same chemical, approved with a 90-second kill claim. These could be different products at the retail level. Also, EPA approval does not constitute FDA approval, and vice versa. It’s easy to see that agency regulations can be very confusing.

Further to this, a Covid-19 kill claim does not exist. At the moment, the EPA claim that best encapsulates this effectiveness is against ‘emerging viral pathogens.’ So, if you see Covid-19 on any label, it is not authorized, however, some (very few) producers may be approved to make off-label claims.

How Do You Know What is Compliant?

The FDA has honored the WHO recommendations which Alchemy-Spetec used to officially set up our Labeler Code, and resulting National Drug Code. Deviating from this formula is not authorized. Is it possible to supply 70% IPA grade to meet the ‘CDC Healthcare’ recommendation, but we would no longer be FDA-compliant and could not use our registered NDC number on the packaging. Simply put, if sanitizers do not have an NDC number on their product, then they are not FDA-compliant. If they make Covid kill claims on the label, they are not EPA compliant. To further complicate things, there are benzalkonium chloride-based sanitizers that are not alcohol at all, yet have EPA sanitizer claims, but may not meet CDC or FDA regulations.

Hand Sanitizer is FDA Controlled

The most recognizable brands are not immune to this confusion. A quick Google search on inaccurate coronavirus kill claims will provide ample detail on some of the consumer confusion caused when an FDA-regulated company makes EPA-regulated claims. The FDA does not have any list of sanitizers that kill coronavirus. Again, this is an EPA-regulated claim for ‘emerging viral pathogens’, and more commonly used in disinfectants.

What is the Best Hand Sanitizer Formula?

All consumers want the safest, most-stringent formula on the market. WHO / FDA released the approved formulas in direct-response to Covid-19 to provide the safest formula to ensure protection against emerging pathogens. While many sanitizer products are available in the market with various alcohol concentrations and active ingredients, Alchemy-Spetec strongly recommends seeking the WHO / FDA mandated level, which is 75% IPA, found in our sanitizer. What we can say is that our current version meets the FDA / WHO regulations (although more stringent), exceeds the CDC Healthcare requirements, is manufactured and packaged at an FDA approved establishment, and is accompanied by a registered National Drug Code ID. Products that are <75%IPA, or <80% ethanol version, do not meet FDA / WHO requirements. Benzalkonium chloride versions, do not meet CDC or FDA / WHO requirements. Coronavirus kill claims on label are not EPA compliant. In this period of scarcity, Alchemy-Spetec has chosen to adhere to the FDA-regulated formula to ensure the safest and best-performing sanitizer product to all consumers.

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