Flora Inc

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your 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 products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].