# NuEra Nutraceutical Inc · 99-39 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For NuEra Nutraceutical Inc · 99-39 · CANADA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is CANADA; product is REDSENOL-1 CAPSULES | REDSENOL-1 CAPSULES; product code is 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 08/16/2017; address is 12031 No. 5 Rd , Richmond, British Columbia CANADA, verified against its source on 2026-09-16.

- **Firm:** NuEra Nutraceutical Inc _(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:** CANADA _(verified: appears in the quote below)_
- **Address:** 12031 No. 5 Rd , Richmond, British Columbia CANADA _(verified: appears in the quote below)_
- **Date published:** 08/16/2017 _(verified: appears in the quote below)_
- **Product code:** 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** REDSENOL-1 CAPSULES | REDSENOL-1 CAPSULES _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) 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. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1). | The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) 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. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1). _(verified: each item appears in the quote below)_

## What the source says

> NuEra Nutraceutical Inc Date Published : 08/16/2017 12031 No. 5 Rd , Richmond, British Columbia CANADA 54 Y - - 04 Ginseng Unconventional Dietary Speciality for Humans or Animals Date Published: 08/16/2017 Desc: REDSENOL-1 CAPSULES Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) 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. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1). 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 08/16/2017 Desc: REDSENOL-1 CAPSULES Notes: The product appears to be misbranded within the meaning of: (1) Section 403(q)(1)(A) of the Act [21 U.S.C. §343(q)(1)(A)] in that the serving size is not an amount customarily consumed. (2) 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. (3) Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labeling does not include a statement of identity as a dietary supplement per 21 CFR 101.3(g). (4) Section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b). (5) Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because the supplement facts label is not in accord with 21 CFR 101.36. (6) Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient, i.e, Panax ginseng, in the product is derived, as required by 21 CFR 101.4(h)(1).

## 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/).