Naturista Store LLC
FDA issued a warning letter to Naturista Store LLC (Downey, CA) for selling 'ADVANCE KING,' a product marketed as a dietary supplement but found via laboratory analysis to contain undeclared pharmaceutical ingredients dexamethasone, diclofenac, and methocarbamol. The product was marketed with disease-treatment claims for conditions such as sciatica, osteoarthritis, gout, and joint pain, making it an unapproved new drug under the FD&C Act. FDA also flagged eight additional similarly named products sold on the website as posing serious safety concerns based on prior analyses of comparable products. The agency demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure and/or injunction.
Flagged claims (8)
Osteoartritis
Advance King es un suplemento totalmente natural para todos, desde atletas competitivos hasta jubilados que disfrutan de sus años dorados. Nuestra fórmula natural, puede ayudar potencialmente a fortalecer tus huesos, reducir el dolor articular, la rigidez articular y el deterioro del cartílago.
Arteriosclerosis
Hierbas medicinales para CALMAR el DOLOR
Ciática
Fortalece y recupera la MOVILIDAD y FLEXIBILIDAD de tus articulaciones
Ácido Urico
Gota
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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