# YDIK NATURE CARE PRODUCTS · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For YDIK NATURE CARE PRODUCTS · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Kulo Cough Syrup | Varman's Moor Health Syrups | Varman's Moor Health Syrups | Kulo Cough Syrup | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Kulo Cough Syrup | Varman's Moor Health Syrups; product code is 31 K - - -- Tea | 31 K - - -- Tea | 31 L - - -- Tea, Decaffeinated | 31 L - - -- Tea, Decaffeinated | 31 P - - -- Tea Substitutes | 31 P - - -- Tea Substitutes | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 12/09/2021; address is Rambhai Estate, Block # 944 , Aslali , Ahmedabad, Gujarat INDIA, verified against its source on 2026-09-16.

- **Firm:** YDIK NATURE CARE PRODUCTS _(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:** INDIA _(verified: appears in the quote below)_
- **Address:** Rambhai Estate, Block # 944 , Aslali , Ahmedabad, Gujarat INDIA _(verified: appears in the quote below)_
- **Date published:** 12/09/2021 _(verified: appears in the quote below)_
- **Product code:** 31 K - - -- Tea | 31 K - - -- Tea | 31 L - - -- Tea, Decaffeinated | 31 L - - -- Tea, Decaffeinated | 31 P - - -- Tea Substitutes | 31 P - - -- Tea Substitutes | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 E - - 99 Herbals & Botanical Teas, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd | 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. _(verified: each item appears in the quote below)_
- **Product:** Kulo Cough Syrup | Varman's Moor Health Syrups | Varman's Moor Health Syrups | Kulo Cough Syrup | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Varman's Moor Health Syrups | Kulo Cough Syrup | Kulo Cough Syrup | Varman's Moor Health Syrups _(verified: each item appears in the quote below)_
- **FDA notes:** Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. | Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. _(verified: each item appears in the quote below)_

## What the source says

> YDIK NATURE CARE PRODUCTS Date Published : 12/09/2021 Rambhai Estate, Block # 944 , Aslali , Ahmedabad, Gujarat INDIA 31 K - - -- Tea Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 31 K - - -- Tea Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 31 L - - -- Tea, Decaffeinated Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 31 L - - -- Tea, Decaffeinated Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 31 P - - -- Tea Substitutes Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 31 P - - -- Tea Substitutes Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 E - - 99 Herbals & Botanical Teas, N.E.C. Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 J - - 10 Moringa Oleifera (Herbal and Botanical Teas II, (continued) Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 12/09/2021 Desc: Kulo Cough Syrup Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 12/09/2021 Desc: Varman's Moor Health Syrups Notes: Products appear to be drugs as defined by section 201(g)(1), 21 U.S.C. 321(g)(1), of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. Products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), a new drug may not be legally marketed in the United States without an FDA-approved new drug application. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

## 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/).