FDA WARNING_LETTER - Natural Ginger, Corp/Jonaus Corp - June 25, 2024

The FDA issued a Warning Letter to Naturgin, LLC, following a June 2024 review of their websites (www.naturgin.com and www.facebook.com/naturgin/). The FDA determined that Naturgin's products—Syrup for Children Ginger, Honey, and Aloe Vera; Syrup for Adults Ginger and Honey; Syrup for Adults Forte Ginger, Honey, and Aloe Vera; AFA Blue Green Algae 1000 mg; Magnesium Complex All in One Capsule Magnesium and Potassium; and Vitamin C 1000 mg/caps—are unapproved new drugs and misbranded drugs.

The claims made on Naturgin's websites establish that these products are intended for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Since these products are not generally recognized as safe and effective for their stated uses, they are considered "new drugs" under section 201(p) of the Act and require prior FDA approval for interstate commerce introduction, which they lack, violating sections 301(d) and 505(a).

Furthermore, Syrup for Children Ginger, Honey, and Aloe Vera and Syrup for Adults Forte Ginger, Honey, and Aloe Vera are misbranded under section 502(f)(1) of