YDIK NATURE CARE PRODUCTS · 66-41 · INDIA

Product code, Product and FDA notes

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 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 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: 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 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. 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 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 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: 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 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.