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# Regener-Eyes Illegally Selling Dry Eye Product
- URL: https://www.fdaweb.com/regener-eyes-illegally-selling-dry-eye-product/
- Published: 2022-10-12T12:00:00.000Z
- Updated: 2026-09-14T18:02:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152949

The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Regener-Eyes, Palm Harbor, FL, established that the firm markets an “acellular biological product” that is composed of “placental-derived biomaterials” labeled as Regener-Eyes Ophthalmic Solution to mitigate or treat dry eye disease. A 10/5 [Notice of Violation](https://www.fda.gov/media/162219/download?ref=fdaweb.com) says the product is legally considered to be a drug, based on Web site statements describing its use. Drugs that are also biological products can only be marketed legally with a valid biologics license in place, FDA says, and there is no approved BLA or IND for this product.

Regener-Eyes was told to respond within 30 days.