TAGS: Toiletries
The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency. FDA has updated the guidance to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizers to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizers.
FDA Updated the Guidance in April
The FDA appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers. The guidance were temporary updated in April to reflect data submitted by fuel ethanol manufacturers producing ethanol via fermentation and distillation, indicating that at least some of their fuel ethanol products have harmful chemicals, including gasoline and benzene, which are known human carcinogens (cancer-causing agents).
These impurities would not be expected from a typical fermentation and distillation process but may be present in the manufacturing environment of fuel or technical-grade ethanol, due to the use of certain chemicals, equipment or containers.
Hand Sanitizers Free of Harmful Impurities
The FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in these products. Based on careful review and consideration of available data, the association is specifying interim levels of certain impurities that FDA has determined can be tolerated for a relatively short period of time, given the emphasis on hand hygiene during the COVID-19 and to avoid exacerbating access issues for alcohol-based hand sanitizers.
The FDA is committed to ensure the appropriate balance between risk and benefit. The association believes that temporary guidance sets the proper level of flexibility at the current time to help protect Americans during this public health emergency. The association does not make any decision lightly and are continually assessing the needs and circumstances related to the temporary policies and how to protect public health. As relevant needs and circumstances evolve, the FDA intends to update, modify or withdraw these policies as appropriate.
Source: FDA