FDA WARNING_LETTER - Amazon.com, Inc. - October 28, 2022

The FDA issued a Warning Letter to Amazon on October 28, 2022, concerning the distribution of "Artri Ajo King Reforzado con Ortiga y Omega 3," "Artri King Reforzado con Ortiga y Omega 3," and "Ortiga Mas Ajo Rey" products via www.amazon.com and its Fulfillment by Amazon service.

FDA laboratory analyses confirmed these products contain undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID). Diclofenac poses serious health risks, including increased risk of cardiovascular events (heart attack, stroke) and severe gastrointestinal damage (bleeding, ulceration, fatal perforation), and can interact with other medications.

The products are marketed as dietary supplements but are excluded from this definition under section 201(ff)(3)(B)(i) of the FD&C Act because diclofenac was approved as a new drug (Voltaren, 1988) before being marketed as a dietary supplement or food. Furthermore, due to their intended use for arthritis treatment, these products are considered unapproved new drugs under sections 201(g)(1) and 201(p) of the FD&C Act. Introducing them into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the FD&C Act.

Additionally, the products are mis