When the demand for hand sanitiser products surged in 2020, businesses rushed to respond. Some pivoted existing businesses, others set off anew.The market presented global opportunities, albeit that all businesses faced the same challenge: how to bring their products to market in accordance with local regulatory requirements.
The initial reaction of many regulators was to introduce “fast-track” type procedures, which varied the usual route to market and helped to accelerate supply. (See https://www.shb.com/-/media/images/covid19/handsanitizer-info-graphic-2020.pdf?la=en for a helpful infographic detailing regulatory requirements and the initial approaches taken by regulators in the UK, US, Canada and Mexico).
Regulators’ attention has subsequently shifted to monitoring products which have flooded the market and taking enforcement action in relation to those products that do not meet the required standards.
As well as regulatory obstacles, related concerns have also arisen for business, including a marked increase in poisonings from hand sanitiser ingestion and claims that adverse health issues have been caused by hand sanitiser use.
Outlined below are a number of key issues which are likely to continue to present challenges to hand sanitiser businesses in 2021 and guidance as to how to effectively manage them.
Non-Compliant Products – Investigation, Enforcement and Border Control
The primary objective of any business should be to ensure that products meet regulatory requirements before they are placed on the market. However, there will inevitably be instances where requirements are not met. Enforcement action has been seen across the globe in relation to various issues including:
- Product characteristics: Commonly insufficient quality or quantity of ethanol and toxic levels of methanol.
- Labelling: Including deficient warnings, hazard pictograms and information on toxicity and flammability.
- Packaging: Such as the absence of child resistant fasteners and making the sanitiser look like a food product.
Recalls, withdrawal from the supply chain and removal from online marketplaces has been the usual response to the discovery of such regulatory non-compliance. However, the story may not end there. While shortcomings in some products (such as insufficient ethanol) may lead them to be ineffective in killing viruses or bacteria, other products present much more serious direct issues from their use. Many hand sanitisers have been found to contain methanol which, if ingested or used for a prolonged period, may lead to serious health issues, including blindness and death. Such non-compliance, particularly if coupled with reports of any injuries, may attract considerable regulatory attention and the sums claimed in any associated civil action could be significant.
Businesses should also be aware of national border controls which are being employed to prevent non-compliant products reaching local markets. In Europe, recent action by OLAF (the European Anti-Fraud Office) has prevented 140,000 litres of Turkish hand sanitiser containing methanol from entering the EU market. Similarly, in the US, January 2021 saw the FDA issue a national import alert by for the presence of methanol in hand sanitisers shipped from Mexico.
With a rise in the prevalence of hand sanitiser products found in the home and across all social settings, it is of little surprise that the number of poisoning incidents has also increased over 2020.
In the UK, University of Oxford research has found that the number of poisoning incidents involving alcohol-based products in the first nine months of 2020 was rose from 155 in 2019 to 398 in 2020.Similarly, data from the American Association of Poison Control Centers indicates that in 2020, there were more than 20,000 exposures to hand sanitiser among children under 6, an increase of 40 percent from 2019.
Given that all sectors of society are using these products – including the young and the vulnerable - caution should be exercised by businesses with regard to requirements relating to warnings, child resistant fasteners and products which may be considered to imitate foodstuffs, such as sanitisers with sweet scents that mimic sweets.
There are a growing number of reports relating to alleged adverse health effects from the increased use of hand sanitisers, including eczema and dermatitis. In the US, manufacturers have faced consumer claims relating to personal injury and regulatory actions regarding alleged misleading claims. Similar issues are likely to arise in other global markets.
Managing the Risks
Be prepared: Hand sanitiser producers should ensure that they are familiar with the requirements of all markets in which products are intended to be sold. Preventing claims or regulatory action is always preferable to having to respond to it.
Rapid Response: Monitoring complaints is crucial. Such monitoring is frequently a regulatory obligation, and complaints are often an indicator of potential safety issues and the subject of future potential litigation.