Swift Digital Group LLC dba Swadesii

Selected passages from the FDA letter

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

Passage 1

your Swadesii products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.

Passage 3

the labeling of your unapproved “Deekshant Thyroid Tablet,” “Hepatina Syrup,” “Dr. Vasishth's Guduchi Tinospora cordifolia ghan Tablets,” “Bico 14 Haslab,” “Singhnad Guggul (A.S.S.),” “Repl Dr. Advice No. 69 Measales (Measles),” “Baryta Carbonicum 200 CH,” “WG-5 Gold Drops,” and “WG-6 Gold Drops” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, cancer, diabetes, stroke, Alzheimer's, and hepatitis

Passage 4

your unapproved “Elaneer Kuzhambu,” drug product is concerning because ophthalmic drug products, which are intended for administration into the eyes, generally pose a greater risk of harm to users