Sage Pharmaceuticals Inc. · 66-41 · TAIWAN
For Sage Pharmaceuticals Inc. · 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 | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Low S Oil | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Low S Oil | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Low S Oil | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream; 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
- Sage Pharmaceuticals Inc. verified
- Import alert
- 66-41
- Import alert name
- Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- Country
- TAIWAN verified
- Address
- 4 F , No. 1 Wugong 5th Rd.; Xinzhuang Dist. , New Taipei City, TAIWAN verified
- Date published
- 12/08/2021 verified
- 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. each item verified
- Product
- Low S Oil | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Low S Oil | Fifth Element Peptide Cream | Co Q-10 Topical Serum | Low S Oil | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Co Q-10 Topical Serum | Fifth Element Peptide Cream | Arbutin C & E Topical Serum | Low S Oil | Co Q-10 Topical Serum | Arbutin C & E Topical Serum | Fifth Element Peptide Cream each item verified
- 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)]. each item verified
What the source says
Sage Pharmaceuticals Inc. 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: 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: 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: 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 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: 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: 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: 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 - - 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 - - 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: 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: 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: 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: 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 - - 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 - - 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: 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 - - 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)].
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.