Texinkart Inc.

Selected passages from the FDA letter

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

Passage 1

“Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).

Passage 2

“Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” 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 3

“Thathu Busti Lehyam,” “Baidyanath Prostaid Tablets,” “Rajpro Capsules,” and “Rathina Purush Capsules” 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 conditions prescribed, recommended, or suggested in their labeling.

Passage 4

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).