Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA confirmed through laboratory analysis that a sample of your “Umary” contains undeclared diclofenac and omeprazole.
Passage 2The labeling for “Umary” does not declare that the product contains the drug ingredients diclofenac and omeprazole. The failure to disclose the presence of diclofenac and omeprazole in the product’s labeling renders “Umary” misbranded under section 502(a) of the FD&C Act.
Passage 3No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Passage 4“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."