FDA WARNING_LETTER - Flora Inc - May 31, 2021

The FDA issued a Warning Letter to Flora, Inc. after reviewing their websites (florahealth.com/us and pinterest.com/florahealth/) from March-May 2021. The FDA determined that Flora, Inc. markets products with claims that establish them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

Specifically, the products Travel Care Probiotic, Sleep•Essence, Cardio•Essence, Grape Seed Extract Plus, Elderberry+, Elderberry Crystals, Flor•Essence, Hydro-Therm Pumpkin Oil, Pumpkin Oil, and Mãnuka Honey are cited for drug claims. The Elderberry+ product is additionally cited for claims related to mitigating, preventing, treating, diagnosing, or curing COVID-19.

Examples of violative claims include: "Reduces the risk of traveler’s diarrhea" (Travel Care Probiotic), "can help in cases of…insomnia due to mental stress" (Sleep•Essence), "protects against heart damage" (Cardio•Essence), "To relieve symptoms related to non-complicated CVI" (Grape Seed Extract Plus), "effective at reducing upper respiratory symptoms due to cold and flu" (Elderberry+), "reduce the length and severity of cold and flu symptoms" (Elderberry Crystals), "powerful detoxifier, it is used for the treatment of skin conditions" (Flor•Essence), "may help with