SoloVital
FDA issued a warning letter to SoloVital (Chula Vista, CA) on August 27, 2024, regarding their product 'Umary Hyaluronic Acid,' which laboratory analysis confirmed contained undeclared drug ingredients diclofenac (an NSAID) and omeprazole (a PPI). The product was marketed as a dietary supplement but is classified as an unapproved new drug under the FD&C Act because it contains approved drug substances not disclosed on the label, rendering it both an unapproved new drug and a misbranded drug. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (1)
Hyaluronic acid works as a cushion and lubricant in the joints and connective tissue. When joints are well lubricated they're less likely to grind together. It has been known to reduce knee discomfort.
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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