ibeautistore.com
FDA issued a warning letter to ibeautistore.com (Dover Plains, NY) regarding its product 'Umary' (sold as 'New Hyaluronic Acid 850 mg Sealed 30 Caps'), which laboratory analysis confirmed contained undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and omeprazole. The product was marketed as a dietary supplement but constitutes an unapproved new drug under FD&C Act section 505(a) and is misbranded under section 502(a) due to failure to disclose these dangerous hidden drug ingredients. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within fifteen working days.
Flagged claims (2)
What is hyaluronic acid?It [sic] is a polysaccharide found naturally in skin and cartilage cells. This crystalline substance has the function of hydrating the skin and joints, as it attracts and retains water molecules.
As the body ages, the presence of hyaluronic acid in our body decreases considerably. This translates into an aging of the skin that is losing firmness and volume and, of course, in the appearance of dreaded wrinkles.
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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