Quantum Naturals India Private Limited · 99-39 · INDIA

Product code, Product and FDA notes

54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: ZenRex Capsules -Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: Zen Fem Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: ZenAlc Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: Zen Hab Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: ZenFlex Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/18/2017 Desc: ZenJoy Capsules-Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: ZenRex Capsules -Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenRex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenRex product blister pack label does not bear a domestic address or domestic phone number 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: ZenJoy Capsules-Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenJoy product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenJoy product blister pack label does not bear a domestic address or domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: ZenFlex Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFlex product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). And, the ZenFlex product label does not declare the source of the dietary ingredient Curcumin in accordance with 21 CFR 101.36(d). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: Zen Hab Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenHab product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFlex product blister pack label does not bear a domestic address or domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: ZenAlc Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenAlc product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenAlc product blister pack label does not bear a domestic address or domestic phone number. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/18/2017 Desc: Zen Fem Capsules- Herbal Supplement Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the products appears to be misbranded within the meaning of section 403 (q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the label is incorrect. The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears 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 the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. Specifically: The ZenFem product blister pack label does not bear nutrition information, nor does it bear the statement "This Unit Not Labeled For Retail Sale" in accordance with 21 CFR 101.36(i)(3) and 21 CFR 101.9(j)(15). The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of Section 403 (y) of the Act [21 U.S.C. § 343(y)] in that the 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 dietary supplement. Specifically, the ZenFem product blister pack label does not bear a domestic address or domestic phone number.