Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“Artri King Reforzado con Ortiga y Omega 3” is not generally recognized as safe and effective for the above referenced uses and therefore is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for “Artri King Reforzado con Ortiga y Omega 3.” Introduction or delivery of this product into interstate commerce without an approved application violates sections 301(d), 21 U.S.C. 331(d), and 505(a), 21 U.S.C. 355(a) of the FD&C Act.
Passage 2The labeling for “Artri King Reforzado con Ortiga y Omega 3” does not declare that the products contain the drug ingredient diclofenac. As discussed earlier, diclofenac can lead to adverse cardiovascular events, such as heart attack and stroke, or serious gastrointestinal damage, including bleeding, ulceration, and fatal tears of the stomach and intestines, or liver toxicity including liver failure that can cause the need for a liver transplant or death. The failure to disclose this ingredient in the product’s labeling renders “Artri King Reforzado con Ortiga y Omega 3” misbranded under section 502(a) of the FD&C Act.