Qpharm Inc. · 99-39 · CANADA

Product code, Product and FDA notes

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 08/11/2017 Desc: Health Supplement Rhoziva Notes: Sections 403(e)(1), 403(i)(2), and 403(q)(5)(F) of the Act because the label of each multi- unit container does not meet the exemptions from required label statements. Specifically, the label of each multi-unit container does not bear: 1) the name and place of business of the manufacturer, packer, or distributor, 2) the common or usual name of each ingredient), and 3) nutrition information. The unit container is exempt from these requirements if the unit container bears the statement "This Unit Not Labeled for Retail Sale" [21 CFR 1.24(a)(14)]. Section 403(e)(2) of the Act because the multi-unit label fails to declare the net quantity of contents as required by 21 CFR 101.7. Section 403(s)(2)(B) of the Act because the multi-unit container fails to include a statement of identity as a dietary supplement as required by 21 CFR 101.3(g). Section 403(y) of the Act because the multi-unit container fails to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Dietary Supplement and Nonprescription Drug Consumer Protection Act) may receive a report of a serious adverse event with such dietary supplement.