PLANTAS MEDICINALES DE MEXICO · 99-39 · MEXICO

Product code, Product and FDA notes

54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/19/2019 Desc: Ajo King Brand Vision Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which ingredient in the product is derived,as per 21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Mujer Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Rinon Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Presion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Nervios Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Mejora Tu Vision Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Jengibre Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Higado Vesicula Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Gastritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Diabetes Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Curcuma Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Circulacion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/25/2021 Desc: Ajo King Artritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/29/2020 Desc: Ajo King Brand Mujer Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 01/10/2020 Desc: Ajo King Brand Colesterol Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients,and they are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36.Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived,as per 21CFR101.4(h)(1).Section 403(y) of the Act[21U.S.C.§343(y)] in that the BLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/27/2019 Desc: Ajo King Brand Glucosamina Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English-21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name-21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL-21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients-21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived-21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LBB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer-21CFR101.93(b) and that a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer. 60 - - - -- Human and Animal Drugs Date Published: 01/29/2020 Desc: Ajo King Brand Mujer Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 65 - - - -- Human and Animal Drugs Date Published: 01/29/2020 Desc: Ajo King Brand Mujer Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Artritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Mujer Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Rinon Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Presion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Nervios Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Mejora Tu Vision Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Jengibre Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Higado Vesicula Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Gastritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Diabetes Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Curcuma Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 65 C - - 99 Nutrient/Tonic N.E.C. Date Published: 01/25/2021 Desc: Ajo King Circulacion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 66 - - - -- Human and Animal Drugs Date Published: 08/19/2019 Desc: Ajo King Brand Vision Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which ingredient in the product is derived,as per 21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer. 66 - - - -- Human and Animal Drugs Date Published: 08/27/2019 Desc: Ajo King Brand Glucosamina Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English-21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients and are not declared on the LBL by the common/usual name-21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL-21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients-21CFR101.36. Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived-21CFR101.4(h)(1). Section 403(y) of the Act[21U.S.C.§343(y)] in that the LBB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement. Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer-21CFR101.93(b) and that a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer. 66 - - - -- Human and Animal Drugs Date Published: 01/10/2020 Desc: Ajo King Brand Colesterol Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of: Section 403(f) of the Act[21U.S.C.§343(f)] in that all required statements on the LBL are not in English,as per 21CFR101.15(c)(1). Section 403(i)(2) of the Act[21U.S.C.§343(i)(2)] in that the article is fabricated from two/more ingredients,and they are not declared on the LBL by the common/usual name,as per 21CFR101.4/21CFR101.36. Section 403(q)(1)(A) of the Act[21U.S.C.§343(q)(1)(A)] in that the serving size on the LBL is incorrect.Serving size is the maximum amount consumed per eating occasion as recommended on the LBL,as per 21CFR101.9(b)/21CFR101.12(b). Section 403(q)(5)(F) of the Act[21U.S.C.§343(q)(5)(F)] in that the presentation of the nutrition information on the LBL does not comply with 21CFR101.36. Sections 403(s)(2)(A)(ii)(I)/403(q)(5)(F) of the Act[21U.S.C.§343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the LBL label fails to include the amount by weight per serving size of all ingredients,as per 21CFR101.36.Section 403(s)(2)(C) of the Act[21U.S.C.§343(s)(2)(C)] in that the LBL fails to identify the part of the plant from which each ingredient in the product is derived,as per 21CFR101.4(h)(1).Section 403(y) of the Act[21U.S.C.§343(y)] in that the BLB fails to bear a domestic address/ phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.Section 403(r)(6) of the Act[21U.S.C.§343(r)(6)] in that the LBL make structure function claims but fail to bear the required disclaimer,as per 21CFR101.93(b).Under section 403(r)(6) of the Act,a dietary supplement may bear certain claims,generally called "structure/function claims," on its LBL provided that the firm has substantiation that the claim is truthful/not misleading; the firm has notified FDA within 30 days of marketing the product bearing the claim and the claim includes a mandatory disclaimer 66 - - - -- Human and Animal Drugs Date Published: 01/29/2020 Desc: Ajo King Brand Mujer Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to be misbranded within the meaning of:; Section 403(f) of the Act [21 U.S.C. §343(f)]-all required statements on the LBL are not in English, as by 21 CFR 101.15(c)(1). Section 403(q)(5)(F) of the Act [21 U.S.C. 343 (q)(5)(F)]-presentation of the nutrition information on the LBL does not comply with 21 CFR 102.36. Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)]-LBL fails to identify the part of the plant from which each botanical dietary ingredient in the product is derived, as by 21 CFR 101.4(h)(1). Section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)]-it is a dietary supplement, but the LBL fails to include a statement of identity as a "dietary supplement, as by 21 CFR 101.3(g). Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]-LBL is false and misleading in that the two bottles contained in the outer box appear to have different contents but, are not labeled as such. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]-LBL fails to declare the common/usual names of each ingredient, as by 21 CFR 101.36 and 21 CFR 101.4. ; Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. §§343(q)(5)(F) and 343(s)(2)(A)]- LBL fails to list the name of each ingredient of the dietary supplement product that is described in section 201(ff) and its quantity. Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)]-serving size declared on the bottle 1 and bottle 2 LBL is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the LBL, as in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. ;Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the LBL fails to bear a domestic address/ phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Artritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Circulacion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Curcuma Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Diabetes Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Gastritis Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Higado Vesicula Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Jengibre Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Mejora Tu Vision Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Nervios Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Presion Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Rinon Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/25/2021 Desc: Ajo King Mujer Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but does not repeat all the required information in both languages