SoloVital – FDA Warning Letter, Jun 14, 2024

The FDA issued a Warning Letter to Mr. German Alegre regarding the product "Umary," also called "Umary Hyaluronic Acid," sold on https://www.solovital.com/. An FDA review in June 2024 and subsequent sample analysis confirmed "Umary" contains undeclared diclofenac and omeprazole.

Diclofenac, an NSAID, carries risks of cardiovascular events and gastrointestinal damage. Omeprazole, a PPI, can cause serious skin reactions, mask stomach issues, and interact with other medications. Both are active drug ingredients.

The product is deemed an unapproved new drug under sections 505(a) and 301(d) of the FD&C Act, as it's intended for disease treatment/prevention or to affect body function, and lacks FDA approval. Diclofenac's prior approval as a drug (Voltaren, 1988) excludes "Umary" from dietary supplement definition per section 201(ff)(3)(B)(i) of the FD&C Act.

Furthermore, "Umary" is a misbranded drug under section 502(a) and 301(a) of the FD&C Act because its labeling is false/misleading by failing to declare the presence of diclofenac and omeprazole.

The letter requires a written response within fifteen working days detailing corrective