Reference Source

KUKAMONGA · 54-16 · MEXICO

For KUKAMONGA · 54-16 · MEXICO, import alert is 54-16; import alert name is "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"; country is MEXICO; product is KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex); product code is 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs; date published is 08/14/2026; address is Av De Ka Patria 288-1 J , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO, verified against its source on 2026-09-16.

Firm
KUKAMONGA verified
Import alert
54-16
Import alert name
"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"
Country
MEXICO verified
Address
Av De Ka Patria 288-1 J , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO verified
Date published
08/14/2026 verified
Product code
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) | 55 - - - -- Pharm Necess & Ctnr For Drug/Bio | 56 - - - -- Antibiotics (Human/Animal) | 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs | 60 - - - -- Human and Animal Drugs | 61 - - - -- Human and Animal Drugs | 62 - - - -- Human and Animal Drugs | 63 - - - -- Human and Animal Drugs | 64 - - - -- Human and Animal Drugs | 65 - - - -- Human and Animal Drugs | 66 - - - -- Human and Animal Drugs each item verified
Product
KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) | KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) each item verified
FDA notes
FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. | FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

KUKAMONGA Date Published : 08/14/2026 Av De Ka Patria 288-1 J , Col. Jardines De La Patria, Zapopan , Zapopan, Jalisco MEXICO 54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human) Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 55 - - - -- Pharm Necess & Ctnr For Drug/Bio Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 56 - - - -- Antibiotics (Human/Animal) Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 58 - - - -- Human and Animal Therapeutic Biologic and Biosimilar Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 60 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 61 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 62 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 63 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 64 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 65 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act. 66 - - - -- Human and Animal Drugs Date Published: 08/14/2026 Desc: KUKA FLEX CBD 100 MG (Glucosamine flex green chondroitin hyaluronic acid msm green flex) Notes: FDA’s Health Fraud Branch has determined that “KUKA FLEX CBD” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. FDB explained that “KUKA FLEX CBD” is labeled as being a dietary supplement.1 However, this product is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.2 In addition, the sample of “KUKA FLEX CBD” was purchased from eBay, where the listing described it as being for “Joint Support, Pain Relief & Inflammation Support.” “KUKA FLEX CBD” appears to be a new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “KUKA FLEX CBD.” Thus, the introduction or delivery for introduction into interstate commerce of this product appears to violate these provisions of the FD&C Act.

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