FDA WARNING_LETTER - Innova - July 11, 2024

On December 17, 2024, the FDA issued a Warning Letter to The Biscuit Factory (Daye) following a July 8-11, 2024 inspection in Bulgaria. The inspection revealed that Daye's Cannabinoid (CBD) coated tampons ("CBD Daye Tampons") and Vaginal Microbiome Screening Kits are unapproved and misbranded devices under the Federal Food, Drug, and Cosmetic Act.

The CBD Daye Tampons are adulterated because Daye lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded for introducing major changes to intended use (pain relief) without submitting a new premarket notification (510(k)), despite prior FDA notification that a 510(k) was inappropriate due to the CBD coating. The Vaginal Microbiome Screening Kits are adulterated for lacking PMA/IDE and misbranded for not notifying the FDA of intent to introduce the device into commercial distribution. Daye markets these kits with diagnostic claims (e.g., diagnosing yeast infections, STIs, fertility implications) that require premarket review, not general wellness device status.

Additionally, Daye failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). Complaints regarding CBD Daye Tampons, indicating potential health impacts, were not properly logged or evaluated