“Mejora la movilidad y normal funcionamiento de las articulaciones.” (English translation: Improves mobility and normal functioning of joints.).

“Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.” (English translation: Benefits people suffering from degenerative processes such as arthritis and osteoarthritis.).

“Eficaz en problemas de articulaciones de lesiones deportivas.” (English translation: Effective for joint problems due to sports injuries.).

“Antiinflamatorio y analgésico.” (English translation: Anti-inflammatory and analgesic.).“Detiene el avance de deterioro en articulaciones.” (English translation: Stops the progress of joint deterioration.).“Combate la artritis.” (English translation: Fights arthritis.).“Altamente eficaz en la reconstruccion del cartílago.” (English translation: Highly effective in restoring cartilage.).“PROPRIEDADES” (English translation: PROPERTIES) 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.Įxamples of claims observed on the labeling of “Artri King Reforzado con Ortiga y Omega 3” that establish the intended use of this product as a drug include, but may not be limited to, the following: “Artri King Reforzado con Ortiga y Omega 3” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. The undeclared diclofenac ingredient in “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. 3, 4 NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. 2 Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). 1 FDA confirmed through laboratory analyses that the “Artri King Reforzado con Ortiga y Omega 3” purchased on contained the active pharmaceutical ingredient (API) diclofenac, which is not listed on the product label. 321(g)(1), was introduced or delivered for introduction into interstate commerce by Walmart via your Walmart Fulfillment Services. You can find the FD&C Act and FDA regulations through links on FDA’s home page at FDA purchased “Artri King Reforzado con Ortiga y Omega 3” through your website, The product, which is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C.

As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. Furthermore, this product is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C.

As discussed below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of this product, which is an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. This letter concerns your firm’s distribution of the “Artri King Reforzado con Ortiga y Omega 3” product that violates the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). Issuing Office: Center for Drug Evaluation and Research | CDER

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