# Quantum Naturals India Private Limited · 99-39 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For Quantum Naturals India Private Limited · 99-39 · INDIA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is INDIA; product is ZenAlc Capsules- Herbal Supplement | ZenRex Capsules -Herbal Supplement | ZenJoy Capsules-Herbal Supplement | Zen Hab Capsules- Herbal Supplement | ZenFlex Capsules- Herbal Supplement | Zen Fem Capsules- Herbal Supplement | Zen Hab Capsules- Herbal Supplement | Zen Fem Capsules- Herbal Supplement | ZenAlc Capsules- Herbal Supplement | ZenFlex Capsules- Herbal Supplement | ZenJoy Capsules-Herbal Supplement | ZenRex Capsules -Herbal Supplement; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 01/18/2017; address is 42 Plot No , Gurgaon, Haryana INDIA, verified against its source on 2026-09-16.

- **Firm:** Quantum Naturals India Private Limited _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** 42 Plot No , Gurgaon, Haryana INDIA _(verified: appears in the quote below)_
- **Date published:** 01/18/2017 _(verified: appears in the quote below)_
- **Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** ZenAlc Capsules- Herbal Supplement | ZenRex Capsules -Herbal Supplement | ZenJoy Capsules-Herbal Supplement | Zen Hab Capsules- Herbal Supplement | ZenFlex Capsules- Herbal Supplement | Zen Fem Capsules- Herbal Supplement | Zen Hab Capsules- Herbal Supplement | Zen Fem Capsules- Herbal Supplement | ZenAlc Capsules- Herbal Supplement | ZenFlex Capsules- Herbal Supplement | ZenJoy Capsules-Herbal Supplement | ZenRex Capsules -Herbal Supplement _(verified: each item appears in the quote below)_
- **FDA 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 _(verified: each item appears in the quote below)_

## What the source says

> Quantum Naturals India Private Limited Date Published : 01/18/2017 42 Plot No , Gurgaon, Haryana INDIA 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: 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: 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. 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: 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. 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: 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. 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: 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: 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).