FDA to M2Biologics: Not lawful to market StimulEyes

FDA’s 11/17/22 Letter

See Untitled Letter to M2 Biologics from FDA’s Biologics Internet Surveillance division about StimulEyes amniotic fluid eye drops.

The FDA’s biologics enforcement division is indeed kicking into gear after a long pandemic during which illegal regenerative medicine businesses proliferated in defiance of the FDA’s reminder that their 3.5-year grace period had expired.

This letter is different from the one they sent to Regener-Eyes for various reasons. It focuses on M2’s use of testimonials to show that they are marketing their product (StimulEyes) as a drug and therefore, since it is a biologic, they have to first prove that it’s safe - among other things.