Insomnia claims continue to attract FDA attention

Replace “insomnia” with lower-risk alternatives

Insomnia claims continue to attract FDA attention

#WarningLetterWednesday highlights insomnia claims that continue to attract FDA's attention. There were 22 FDA warning letters in 2021 with insomnia claims, dramatically up from 14 in 2020, 2019 (13), and 2018 (7). This is a clear indication of an FDA enforcement trend and a good reminder for marketers to remove the high-risk buzzword "insomnia" from their marketing.


As many of you know I have an "Asa Risk Scale" where certain claims are rated on a 1-5 risk scale, with anything 3+ likely to attract a warning letter. Insomnia is rated as a solid 3.5+, which means it should never be used.


The best way to reduce regulatory marketing risk is by finding and replacing high-risk buzzwords. If truthful and not misleading here are some alternatives for insomnia.

*feeling refreshed in the morning

*a restful night's sleep

*healthy slumber support

*sleep support

*supports a healthy night's sleep

*support rest

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