Nutraq as · 99-39 · NORWAY

Product code, Product and FDA notes

41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 05/05/2015 Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 05/05/2015 Desc: nbg 24 7 Dietary Supplement W/ Vit. C Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 05/05/2015 Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 05/05/2015 Desc: nbg 24 7 Dietary Supplement W/ Vit. C Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 54 A - - 99 Vitamin, N.E.C. Date Published: 05/05/2015 Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 54 A - - 99 Vitamin, N.E.C. Date Published: 05/05/2015 Desc: nbg 24 7 Dietary Supplement W/ Vit. C Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/05/2015 Desc: ImmunoPlus/ Immunoplus Dietary Supplement W/ Norwegian Betaglucan Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/05/2015 Desc: nbg 24 7 Dietary Supplement W/ Vit. C Notes: The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. 343(y)] in that each label fails 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 a dietary supplement. The articles are subject to refusal of admission pursuant to section 801(1)(3) in that they appear to be misbranded within the meaning of section 403(f) of the Act [21 U.S.C. 343 (f)] because each product label contains information in two languages, but does not repeat all of the required information in both languages; The articles are subject to refusal of admission pursuant to section 801(a) (3) in that they appear to be misbranded within the meaning of section 403 (q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that each product label fails to include a supplement facts panel as required by 21 CFR 101.36. Published on 05/05/2015