Not legal for interstate sales

What is required, and where do Regenereyes and StimulEyes stand?

According to the Food and Drug Administration, biologic products require approval via a Biologics License Application prior to introduction to interstate sales.

To date, no biologic eye drop has applied for a Biologics License Application, including Regener-Eyes and StimulEyes.

To verify the accuracy of this statement, please contact the Center for Biologics Evaluation and Research at the FDA.

  • Health care professionals may reach out to them at 240-402-7912 or CBERProductJurisdiction@fda.hhs.gov.

  • Consumers may reach out to them at 800-835-4709 (or 240-402-8010) option 1, or ocod@fda.hhs.gov.

For more information from the Code of Federal Regulations and other references, please read:

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