FDA WARNING_LETTER - Latin Foods Market - November 01, 2022

The FDA issued a Warning Letter to Latin Foods Market regarding their product "Artri King Reforzado con Ortiga y Omega 3," distributed via latinfoodsmarket.com. An FDA sample and laboratory analysis confirmed the product contains undeclared active pharmaceutical ingredients: diclofenac (an NSAID) and dexamethasone (a corticosteroid). These ingredients pose serious health risks, including cardiovascular events, gastrointestinal damage, impaired infection fighting, high blood sugar, muscle injuries, psychiatric problems, and adrenal suppression.

The product is deemed an unapproved new drug under sections 505(a) and 201(p) of the FD&C Act, as it is intended for disease treatment and affects body function, but lacks FDA approval. Its introduction into interstate commerce violates sections 301(d) and 505(a). Furthermore, it is a misbranded drug under section 502(a) because its labeling is false and misleading by failing to declare the presence of diclofenac and dexamethasone, which are material facts. This misbranding constitutes a prohibited act under section 301(a).

Latin Foods Market must submit a written response within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction.