MexHealth LLC d/b/a Al Natural E-Shop
FDA issued a warning letter to MexHealth LLC d/b/a Al Natural E-Shop (Travis Bunch, La Mesa, CA) regarding their product 'Ossos-Sans,' marketed as a dietary supplement. Laboratory analysis confirmed the product contained undeclared diclofenac (an NSAID) and methocarbamol (a muscle relaxant), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made numerous disease-treatment claims (arthritis, osteoporosis, fractures, etc.) without FDA approval, and failed to disclose the presence of active pharmaceutical ingredients. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (11)
Calambres
The labeling for "Ossos-Sans" does not declare that the product contains the drug ingredients diclofenac and methocarbamol.
Inflamacion
Fracturas
Reumos
Regeneración de cartílago
Artritis
Golpes
Osteoporosis
Osteoartritis
Dolores Musculares
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 injunction.
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