FDA would rather not have to review ‘sanitation tunnels’ for COVID

Regulatory NewsRegulatory News
| 09 February 2022 | By Michael Mezher 

In an unusual move, the US Food and Drug Administration (FDA) on Tuesday publicly discouraged sponsors from developing or seeking a regulatory nod for “sanitation tunnels” or other similar walkways or chambers intended to reduce the spread of COVID-19.
 
FDA explained that these tunnels were first deployed in China and have been developed in other countries outside the US and are typically placed outside of “crowded places such as food markets, shopping malls, hospitals, police stations, airports and train stations, offices, and industrial complexes.”
 
However, in a 6-page immediately effective guidance, FDA said it has “significant concerns” about the safety of these tunnels, which spray people and their clothing with disinfectants or aerosolized antiseptics.
 
The agency also said that such products would be considered new drugs and that there is “no evident basis under the [Federal Food, Drug, and Cosmetic Act] FD&C Act under which sanitation tunnels can be legally marketing without an approved application.”
 
FDA lists a several concerns about spraying or misting humans with various surface disinfectants or antiseptics that are not intended or labeled for such use. It points out that the Centers for Disease Control and Prevention (CDC) warn not to eat, drink, breathe or inject cleaning and disinfection products as doing so “can cause serious harm.” FDA adds that antiseptic drugs, such as hand sanitizers, are safe to use on one’s hands, but “are not intended for aerosolization,” and notes that it has had to issue multiple warnings about the misuse of hand sanitizers during the pandemic.
 
“We have received numerous reports of these side effects since the start of the COVID-19 pandemic. Although most people experienced minor or minimal effects, some cases required treatment by a health care professional. The risk of both inhalational toxicity and ocular injury may be greater with an aerosolized drug product than with a product applied to the hands,” FDA writes.
 
The agency also raises concerns about the ability of individuals to “adequately review product labeling” before walking into a sanitation tunnel and the risk of unnecessary exposure of others via residue and aerosolized droplets that make their way out of such tunnels.
 
If, with all that in mind, a sponsor is still interested in developing a sanitation tunnel, FDA recommends the sponsor submit a pre-investigational new drug application meeting request for COVID-19 drug development.
 
“In a meeting package, sponsors should address the concerns described in this 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,” FDA writes, warning that it may place an IND for sanitation tunnels on clinical hold.
 
FDA

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

15;20;25;27;