New Green Nutrition, 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 website and social media websites establish that your “Xiao Ke Wan,” “Diabetee-Care,” and “Specific Jiang Tang Remedy” products are drugs under section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (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 function of the body.

Passage 2

No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d), 21 U.S.C. 331(d), and 505(a) of the FD&C Act.

Passage 3

The aforementioned products are offered for conditions that, with certain exceptions not applicable here, are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use the products

Passage 4

By offering a drug containing glyburide, an active pharmaceutical ingredient in multiple FDA-approved drug products, without requiring a prescription, you are jeopardizing patient safety and misbranding the drug under section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1).

Passage 5

Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act, 21 U.S.C. 331(k).