Mahita LLC dba PushMyCart

Selected passages from the FDA letter

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

Passage 1

Your Mahita 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

Your Mahita products are especially concerning from a public health perspective. As described below, the labeling of your unapproved “Morbillinum 10M CH,” “Morbillinum 200 CH,” “Cornus Circinata 12 CH,” “Ocimum Canum 200 CH,” “Tarentula Hispana 30 CH,” “Nux Mosch 10M,” “Kerala Ayurveda Parkinsons Choornam,” “Maharishi Ayurveda Erand Pak,” “Dibonil Drop,” and “Wheezal WL16 Drop” drug products includes claims to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as measles, cancer, diabetes, Parkinson’s and hepatitis, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process.

Passage 3

In addition, your unapproved “REPL Dr. Advice No.45 Glaucoma Drop,” drug product is concerning because ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

Passage 4

Your Mahita products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).