Amazon.com, Inc.
FDA issued a warning letter to Amazon.com CEO Andy Jassy regarding Amazon's distribution of three products — 'Artri Ajo King,' 'Artri King Reforzado con Ortiga y Omega 3,' and 'Ortiga Mas Ajo Rey' — marketed as dietary supplements but found via laboratory analysis to contain undisclosed diclofenac, a prescription NSAID. The products bore disease-treatment claims (arthritis, osteoarthritis, joint deterioration) that caused them to be classified as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(a) due to failure to disclose the active pharmaceutical ingredient. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.
Flagged claims (12)
Osteoartritis
Gota
Detiene el avance de deterioro en articulaciones.
Antiinflamatorio y analgesico.
Mejora la movilidad y normal funcionamiento de las articulaciones.
Reumas
Combate la artritis.
Dolor de Artritis
Beneficia a personas que padecen de procesos degenerativos como artritis y osteoartritis.
Altamente eficaz en la reconstruccion del cartilago.
Eficaz en problemas de articulaciones de lesiones deportivas.
Ciatica
Required actions (2)
Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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