# DONG TIAN YANG INDUSTRIAL CO., LTD · 66-41 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For DONG TIAN YANG INDUSTRIAL CO., LTD · 66-41 · CHINA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is CHINA; product is Whitening Mask | Aloe Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Powder Soft Mask Vitamin C Whitening | Whitening Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Aloe Mask | Whitening Mask | Aloe Mask | Powder Soft Mask Vitamin C Whitening; product code is 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 - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C; date published is 01/29/2020; address is Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** DONG TIAN YANG INDUSTRIAL CO., LTD _(verified: appears in the quote below)_
- **Import alert:** 66-41 _(verified: appears in the quote below)_
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 01/29/2020 _(verified: appears in the quote below)_
- **Product code:** 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 - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) | 53 L - - 08 Paste Masks (Mud Packs) (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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Whitening Mask | Aloe Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Powder Soft Mask Vitamin C Whitening | Whitening Mask | Aloe Mask | Whitening Mask | Powder Soft Mask Vitamin C Whitening | Aloe Mask | Whitening Mask | Aloe Mask | Powder Soft Mask Vitamin C Whitening _(verified: each item appears in the quote below)_
- **FDA notes:** The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' | The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. _(verified: each item appears in the quote below)_

## What the source says

> DONG TIAN YANG INDUSTRIAL CO., LTD Date Published : 01/29/2020 Town, Nanhai , Lishui; Dachong Industrial District , Foshan, Guangdong CHINA 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 08 Paste Masks (Mud Packs) (Skin Care Preparations) Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/11/2020 Desc: Whitening Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): 'It can reduce the face skin pigments.'; '[H]elp the skin improve activates cells, repair skin thoroughly, endows skin with elasticity and firmness.'; 'It also strengthens skin blood circulation.'; '[M]akes skin recover its luster and elasticity.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/11/2020 Desc: Aloe Mask Notes: The product appears to be an unapproved new drug as the product labeling includes claims such as (not an all-inclusive list): '[D]iminishes inflammation, and resists allergy.'; '[I]mprove grease exudation.'; 'Aloe Vera essence heals wounds.'; '[R]egrowing capability for skin deep cells.'; 'It can accelerate skin metabolism, ... anti-aging, lightening colour spots, whitening skin.' 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 01/29/2020 Desc: Powder Soft Mask Vitamin C Whitening Notes: The product appears to be an unapproved new drug and is promoted in labeling to meet the definition of a cosmetic under section 201(i), and a drug under section 201(g) of the Federal Food, Drug and Cosmetics Act (FD&C Act or the Act) in that it is intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure of any function of the human body. Therefore, the product must meet the regulatory requirements of both a cosmetic and a drug. 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)]. The product 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)]. Powder Soft Mask Vitamin C Whitening is subject to DWPE under Import Alert # 66-41. Shipments of this product appear to have been transmitted under various product codes to FDA; therefore, please verify the true identity of product shipments from this firm offered for entry into the US.

## 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/).