Nurisher Processing Co Ltd · 99-39 · GHANA

Product code, Product and FDA notes

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 04/15/2016 Desc: Osompa D.P. food Supplement Notes: The product appears to be misbranded within the meaning of; (1) Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the labels fail to bear nutrition information ("Supplements Facts" panel) as required by 21 CFR 101.36.; (2) Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because the label fails to declare each ingredient by the common or usual name required by 21 CFR 101.4(a) and 21 CFR101.4(g). Specifically; the label appears to fail to include "dietary ingredients" and "other ingredients" in full ingredient list; (3) Section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement; (4) Section 403(s)(2)(B) of the Act [21 U.S.C. 343 (s)(2)(B)] because it does not include a statement of identity as a "dietary supplement" as required by 21 CFR 101.3(g).