FDA issues guidance on COVID-19 related sanitation tunnels
Today, the U.S. Food and Drug Administration issued a guidance for industry and investigators titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels” to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19.
At this time, there is a lack of data to demonstrate that sanitation tunnels are effective in reducing the spread of SARS-CoV-2 infection or in treating COVID-19. Additionally, chemicals used in sanitation tunnels can irritate the skin, eyes, or airways and cause other health issues. Airway irritation can also cause coughing that may facilitate the transmission of SARS-CoV-2. The agency is also concerned that people may find it difficult to review the tunnels’ labeling, including important safety information to consider, and consent to treatment before walking through a sanitation tunnel. Given serious safety and ethical concerns and the lack of data to demonstrate that sanitation tunnels are effective in reducing the spread of SARS-CoV-2 infection or in treating COVID-19, FDA strongly discourages the use or development of sanitation tunnels.
FDA is aware of interest in approval or authorization of sanitation tunnels and similar products to prevent COVID-19. If sponsors are interested in pursuing development of sanitation tunnels, FDA recommends that sponsors submit a pre-investigational new drug application meeting request for COVID-19 drug development. In a meeting package, sponsors should address the concerns outlined in the guidance and how the proposed study design will ensure that human subjects are not exposed to an unreasonable and significant risk of illness or injury.
This guidance remains in effect only for the duration of the public health emergency (PHE). For more information, please refer to the guidance.
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