As the demand for hand sanitizers increased dramatically during this time of Coronavirus, a variety of manufacturers have pivoted to producing this product. Decernis has noticed several common global challenges with hand sanitizer as a result. First, there is a spate of recalls occurring globally on hand sanitizers that are potentially poisonous. For example, the US FDA has recalled more hand sanitizers due to the presence of methanol instead of ethanol and is warning that they have seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (or ethyl alcohol) but that have tested positive for methanol contamination. Methanol (wood alcohol) is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.

Canada has issued recalls for hand sanitizers that contain technical grade ethanol, which is prohibited. Canada has also issued guidance to industry on acceptable packaging materials and sizes for hand sanitizer products to ensure their availability during the COVID-19 pandemic. Secondly, we have seen certain governments taking on at least a role in the manufacturing itself of hand sanitizers to ensure safety and supply (New York State and Mexico, are two examples).

A third type of challenge we have seen is the lack of consistency, clarity or stability of regulations around the world pertaining to hand sanitizers. Some countries and regions have very well-established and clear regulations for hand sanitizers (Europe, for example, regulates hand sanitizers under its Biocidal Products Regulation (EU) No. 528/2012). The US is an example of a country with recently updated rules on this product, which became effective in April of 2020, that had a significant impact on the product formulation. Under the new FDA rules, 28 active ingredients were prohibited from use in hand sanitizers. Other countries continue to have little regulatory clarity on hand sanitizers. For example, in India, there is continuing uncertainty over the requirement of a stock and sale drug license has some manufacturers considering whether to formulate the product as a cosmetic or even as an Ayurvedic Indian medicine product or to position the product as a disinfectant.

Decernis can provide detailed analysis and insights on challenges such as these and more in over 200 countries to help bring into focus even the most fluid of regulatory environments. For more information, please contact our experts.

Posted on 23 July 2020