For a sinister Shakespearian brew to conjure spirits, you’re going to need to gather a variety of mystical herbs, like the scale of a dragon and the cool blood of a baboon (or maybe a spotted gecko). For eternal life, harvest a dead man’s toe and a newt’s saliva.
But if dry eye relief is all you seek, then the urine of a human fetus is what you’ll need—just don’t mention it to the Food and Drug Administration.
The regulatory agency posted a public safety notification warning people not to use eye drops with such ingredients—products more akin to hocus-pocus than modern medicine.
The eye drops are thought to contain amniotic fluid, the clear liquid that surrounds and cushions a human fetus as it incubates in a womb.
Generally, amniotic fluid contains a variety of maternal and fetal excretions and secretions, but after the 10th week of gestation, it is largely fetal urine, with fetal lung secretions being another significant component.
“[M]anufacturers are marketing and distributing amniotic fluid eye drops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns,” – FDA statement
Unapproved
Makers of these tinkly eyedrops claim they can treat eye conditions, namely dry eyes and inflammation.
Any such biologic-based product claiming to cure or treat a condition is regulated by the FDA under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.
As such, these products require an investigational new drug application (an IND) to be tested in humans and a full FDA approval before hitting the market.
This appears to have been news to at least two companies that the FDA sent warning letters to late last year.
The companies, Regener-Eyes and M2 Biologics, were illegally selling unapproved eye drops, which the FDA said contained amniotic-fluid, to treat dry eyes.
