Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1With 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). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3.” Accordingly, introduction or delivery for introduction into interstate commerce of these products violates sections 301(d), 21 U.S.C. 331(d), and 505(a) of the FD&C Act.
Passage 2The labeling for “Kuka Flex Forte,” “Reumo Flex”, and “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 the presence of diclofenac in the products’ labeling renders “Kuka Flex Forte,” “Reumo Flex,” and “Artri King Reforzado con Ortiga y Omega 3” misbranded under section 502(a) of the FD&C Act.
Passage 3FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988. Given that diclofenac was not marketed as a dietary supplement or as food before Voltaren was approved, “Kuka Flex Forte” and “Reumo Flex,” which contain diclofenac, are excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act.