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# SoloVital Illegally Marketing Hyaluronic Acid: FDA
- URL: https://www.fdaweb.com/solovital-illegally-marketing-hyaluronic-acid-fda/
- Published: 2024-09-04T12:00:00.000Z
- Updated: 2026-09-14T14:40:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157708

FDA says its review of a Web site maintained by SoloVital in Chula Vista, CA, found that the company markets Umary Hyaluronic Acid, an unapproved new drug, in the U.S. An 8/27 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/solovital-688046-08272024?ref=fdaweb.com) says an FDA analysis determined that a sample of the company’s Umary contains undeclared diclofenac and omeprazole, both of which have been approved by FDA as active ingredients for use in human drugs.

The letter says Umary is labeled as a dietary supplement and reminds the company that under the law, if an article is an active ingredient in a drug product that has been approved by FDA or authorized by the agency for use in an IND, such products cannot legally be used in a dietary supplement.

FDA says it considers the Umary product to be a misbranded unapproved new drug. It says SoloVital should respond with a list of specific steps it has taken to correct violations and prevent their recurrence, with documentation of the steps, and a timetable for completing the corrections.