Everymarket Inc.

Selected passages from the FDA letter

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

Passage 1

Your “Vail-Bon Jie Yang Wan” and “Ossos-Sans” products are drugs as defined by 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 FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violate sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 3

The labeling for “Vail-Bon Jie Yang Wan” does not declare that the product contains the drug ingredients dexamethasone and chlorpheniramine. The failure to disclose the presence of dexamethasone and chlorpheniramine in the product’s labeling renders “Vail-Bon Jie Yang Wan” misbranded under section 502(a) of the FD&C Act.