Ray’s Vitamins
FDA issued a warning letter to Rene Gonzalez, owner of Ray's Vitamins (Whittier, CA), regarding the sale of 'Yeicob Ácido Hialurónico,' a product marketed as a dietary supplement for joint and arthritis support. Laboratory analysis confirmed the product contained undeclared active pharmaceutical ingredients diclofenac (an NSAID) and dexamethasone (a corticosteroid), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made drug-intended-use claims without FDA approval, and the failure to disclose the undeclared ingredients poses serious consumer health risks. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.
Flagged claims (1)
How This Supplement Can Help You: Supports ligament and tendon function, lubricating and cushioning joint areas. Provides nutrients for joint health, including the cartilage [sic] and menisci. Helps adjust moisture absorption in the skin, preventing dehydration. Often used for joint or muscle pain related to arthritis.
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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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