# Capital O2 Natural Health Company Ltd · 66-41 · GHANA — FDA import alert red lists: firms subject to detention without physical examination

For Capital O2 Natural Health Company Ltd · 66-41 · GHANA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is GHANA; product is Living Bitters Tonic | Living Bitters Tonic | Great Swedish Bitters Liquid | Great Swedish Bitters Liquid; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 66 M - - 99 Tranquilizer N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 11/30/2017; address is 6 Carcass Road , South Odorkor , South Odorkor, Greater Accra GHANA, verified against its source on 2026-09-16.

- **Firm:** Capital O2 Natural Health Company Ltd _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** GHANA _(verified: appears in the quote below)_
- **Address:** 6 Carcass Road , South Odorkor , South Odorkor, Greater Accra GHANA _(verified: appears in the quote below)_
- **Date published:** 11/30/2017 _(verified: appears in the quote below)_
- **Product code:** 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) | 66 M - - 99 Tranquilizer N.E.C. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Living Bitters Tonic | Living Bitters Tonic | Great Swedish Bitters Liquid | Great Swedish Bitters Liquid _(verified: each item appears in the quote below)_
- **FDA notes:** The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)]. | The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)]. | The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system." | The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system." _(verified: each item appears in the quote below)_

## What the source says

> Capital O2 Natural Health Company Ltd Date Published : 11/30/2017 6 Carcass Road , South Odorkor , South Odorkor, Greater Accra GHANA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 03/16/2020 Desc: Living Bitters Tonic Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)]. 54 K - - 08 Aloe (Herbal and Botanical (not teas) II (continued)) Date Published: 03/16/2020 Desc: Living Bitters Tonic Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a). Furthermore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Act in that it appears to be a drug within the meaning of Section 201(g) and the label lacks adequate directions for use [Misbranded, Section 502(f)(1)]. 66 M - - 99 Tranquilizer N.E.C. Date Published: 11/30/2017 Desc: Great Swedish Bitters Liquid Notes: The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system." 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 11/30/2017 Desc: Great Swedish Bitters Liquid Notes: The product appears to be an unapproved new drug. Examples of labeling claims, including claims on the www.capitalo2.com website, include but are not limited to the following. • "INDICATIONS: Herbal medicine for managing insomnia, promotes blood circulation and for strenghtening [sic] the immune system." • "G-Swedish Bitters® is a combination of a 26-potent herb formula that strengthens the heart and enhances blood circulation throughout the body. It assists in the prevention of and recovery from stroke, paralysis and high blood pressure, and manages hypertension, insomnia and boosts the immune system."

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.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/).