Walmart Inc. – FDA Warning Letter, Oct 28, 2022

On October 28, 2022, the FDA issued a Warning Letter to Walmart regarding its distribution of "Artri King Reforzado con Ortiga y Omega 3" via walmart.com and Walmart Fulfillment Services.

The FDA's laboratory analysis confirmed the product contains the undeclared active pharmaceutical ingredient (API) 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 product is deemed an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), because it is intended for disease treatment/prevention and is not generally recognized as safe and effective. Its introduction into interstate commerce without FDA approval violates sections 301(d) and 505(a).

Furthermore, the product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), as its labeling is false or misleading by failing to declare the presence of diclofenac, a material fact given its associated health risks. This misbranding constitutes a prohibited act under section 301(a).