# BEAUTY RIVER INTERNATIONAL CO LTD · 66-41 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

For BEAUTY RIVER INTERNATIONAL CO LTD · 66-41 · TAIWAN, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is TAIWAN; product is Low S Oil | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Low S Oil | Low S Oil | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Low S Oil | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum; product code is 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C; date published is 12/08/2021; address is 4 F; No. 1, Wugong 5th Rd. , Xinzhuang Dist. , New Taipei City, TAIWAN, verified against its source on 2026-09-16.

- **Firm:** BEAUTY RIVER INTERNATIONAL CO 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:** TAIWAN _(verified: appears in the quote below)_
- **Address:** 4 F; No. 1, Wugong 5th Rd. , Xinzhuang Dist. , New Taipei City, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 12/08/2021 _(verified: appears in the quote below)_
- **Product code:** 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 04 Eye Lotion (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 09 Skin Fresheners (Skin Care Preparations) | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. | 53 L - - 99 Other Skin Care Preparations, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Low S Oil | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Low S Oil | Low S Oil | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Low S Oil | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum _(verified: each item appears in the quote below)_
- **FDA notes:** products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. | products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. _(verified: each item appears in the quote below)_

## What the source says

> BEAUTY RIVER INTERNATIONAL CO LTD Date Published : 12/08/2021 4 F; No. 1, Wugong 5th Rd. , Xinzhuang Dist. , New Taipei City, TAIWAN 53 B - - 01 Bath Oils, Tablets and Salts (Bath Preparations) Date Published: 12/08/2021 Desc: Low S Oil Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 04 Eye Lotion (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 04 Eye Lotion (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 04 Eye Lotion (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 C - - 05 Eye Makeup Remover (Eye Makeup Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 01 Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Low S Oil Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Low S Oil Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 09 Skin Fresheners (Skin Care Preparations) Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/08/2021 Desc: Low S Oil Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/08/2021 Desc: Co Q-10 Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/08/2021 Desc: Fifth Element Peptide Cream Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 12/08/2021 Desc: Arbutin C & E Topical Serum Notes: products are not generally recognized as safe and effective for the above referenced use and therefore, the products are “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (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 articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act in that they appear to be new drugs within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].

## 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/).