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# Unived Marketing Unapproved Drugs: FDA
- URL: https://www.fdaweb.com/unived-marketing-unapproved-drugs-fda/
- Published: 2021-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:57:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149245

FDA says that Unived Inc., Irvine, CA, is marketing several products that are considered to be drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. A just-released 4/7 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unived-inc-611569-04072021?ref=fdaweb.com) lists claims made on the firm’s Web site that provide evidence that the products are intended for use as drugs.

The letter says the products are not generally recognized as safe and effective for the intended uses and thus are considered to be new drugs. They also are misbranded because they don’t contain adequate directions for use.

Unived was told to respond with a list of specific steps it is taking to address the violations, with copies of related documentation and a timetable for completing the actions.