Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA confirmed through laboratory analysis that a sample of your “Artri King Reforzado con Ortiga y Omega 3” contains the undeclared active pharmaceutical ingredients diclofenac and dexamethasone, which are not listed on the product label.
Passage 2“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. 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.
Passage 3“Artri King Reforzado con Ortiga y Omega 3” is not generally recognized as safe and effective for its above referenced uses and therefore is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 4The labeling for “Artri King Reforzado con Ortiga y Omega 3” does not declare that the product contains the drug ingredients diclofenac and dexamethasone.