The story behind
Mermaid Tears™
How, when and why
this project became necessary
Part 1: Regener-Eyes
Part 2: EzriCare
Part 3: The Deluge
Part 4: Is Anyone in Charge?
Part 5: Making Mermaid Tears ™
Part 1: Regener-Eyes
Part 1: Regener-Eyes
January 2022
Some expensive eye drops were becoming increasingly popular. They were widely promoted for dry eye by eye doctors.
To our dismay, we found that they had no ingredient list and were packaged in the wrong bottle for preservative-free eye drops, leaving them vulnerable to bacterial contamination. Upon investigation, they turned out to be unapproved biologic drugs whose manufacturer was dodging the FDA’s biologics division and lying to doctors. When exposed, the company executed an astute - and astonishing - marketing pivot. By exploiting loopholes in the OTC drug listing software managed by a different division of the FDA, they were able to create an appearance of legitimacy even while under attack from another FDA division.
Another company mimicked their product, using similarly unsafe bottles, but feigning invisibility with the FDA.
Are there more companies like these?
Part 2: EzriCare
Part 2: EzriCare
January 2023
News breaks that someone has died of an infection that the CDC has linked to an artificial tear. Other people have been hospitalized and several have lost vision. Ezricare Artificial Tears had been sold on Amazon for quite some time, with a 4.5 average customer rating. We look at EzriCare’s OTC drug listing and find multiple discrepancies. We are particularly concerned that Ezricare, like Regener-Eyes, is packaged in an unsafe bottle that does not protect preservative-free eye drops from contamination. The FDA announces a recall of EzriCare, as well as an identical product and an eye ointment under a different brand name. All three were made in an overseas factory which had never been inspected.
Soon after, an unrelated made-in-the-USA eye drop (this one not listed with the FDA’s OTC system) is recalled, citing sterility concerns. The Ezricare body count and number of people blinded continues to rise.
Are there more eye drops like this?
Part 3: The Deluge
Part 3: The Deluge
December 2022 to present
A board member orders Bausch & Lomb eye ointment on Amazon and it turns out to be a clever counterfeit.
Another board member is alerted by an eye doctor to widely advertised drops claiming to change the color of your eyes.
Links to clones of popular eye drops Lumify and Theratears pop up on social media.
We begin regularly scanning Amazon eye drop listings and discover more, and more, and more eye drops that are not listed with the FDA’s OTC system at all. We begin assembling a collection. They include unregistered imports, eye drops with ingredients not allowed to be sold over the counter, and endless products attempting to tap popular demand for ‘natural’, ‘nutritional’, ‘homeopathic’, ‘holistic’ or ‘chemical free’ drugs.
No one knows where, or how they are made, or whether they are safe.
There are more eye drops like these.
Part 4: Who's in charge?
Part 4: Who's in charge?
Is anybody in charge
of OTC eye drops?
We have a safety problem.
And it’s escalating.
Companies are violating, manipulating or just plain ignoring the FDA’s OTC drug listing system.
Dry Eye Foundation has been trying for more than a year to get the attention of the appropriate people at the FDA, and they haven’t responded.
Finally, out of desperation, we took a drastic step to show the FDA - and anyone else willing to listen - just how easy it is for companies marketing unsafe eye drops to manipulate the OTC drug listing system to their advantage.
Part 5: Making Mermaid Tears™
Part 5: Making Mermaid Tears™
Mermaid Tears ™ is a fictitious product that will never be manufactured or sold.
It was invented by the Dry Eye Foundation because of the need to raise awareness about over-the-counter (OTC) eye drop safety problems.
Anyone can list an eye drop with the FDA.
Making Mermaid Tears
A funny and factual retelling of the story
Cast of characters
the fall guy, the chief scientist, the box art wizard
An OTC pretender with a mystery ingredient
In early 2022, the fall guy and the chief scientist discovered DailyMed, the National Library of Medicine’s public drug database. At the time we were primarily working on the patient safety issue of preservative-free eye drops incorrectly packaged in standard eye drop bottles.
On DailyMed we learned that Regenerative Processing Plant LLC, manufacturer of two of these eye drops, had somehow obtained OTC listings with the FDA.
The Regener-Eyes™ eye drops contain a mysterious – and highly marketable – “biologic” ingredient that cannot be found in the FDA's vast ingredient XL spreadsheet. Drugs that contain biologic ingredients require FDA approval as prescription drugs prior to marketing and sale.
Bold as a hunting orca, the mystery ingredient (initially d-MAPPS™, subsequently Tonicity Solution™) appears on both DailyMed labels. And the distributor, Regener-Eyes LLC, was everywhere on the internet describing the all-natural, preservative-free, biologic awesomeness of its eye drops.
How could these OTC listing have come to be?
Didn’t anyone at the FDA wonder what d-MAPPS™ was?
The chief scientist hypothesized that the FDA’s drug listing portal – called CDER Direct – was self-service and fully automated for OTC products. Using CDER Direct, anyone could make anything, on a very shaky honor system. Specifically, the portal could be used by an unscrupulous manufacturer to create a legal-looking DailyMed OTC drug listing for a not legal – that is, not approved – prescription drug. This has obvious marketing advantages.
We decided to test the hypothesis.
OceanTears™
First, the fall guy formed Ocean Tears LLC and registered it with the FDA.
Then, the fall guy and the chief scientist dreamed up OceanTears™, which contains a mystery biological substance of its very own: AmnioP™. The box art wizard designed an elegantly ocean-themed box.
Next, the chief scientist did battle with CDER Direct. This involved many hours and much profane commentary about the inscrutable CDER-speak of the error messages. God forbid the user should complete a Warnings & Precautions Section, when the product must have a Warnings Section.
Through repeated experimentation, the chief scientist conquered the error messages. After that, getting AmnioP™ into the drug label and onto the product box was simple. You can enter whatever you want in those free-text data fields. Really, anything.
OceanTears™ went live on DailyMed about three days after the listing was submitted. We celebrated.
Quod erat demonstrandum.
Mermaid Tears™
The chief scientist was on a roll. Why waste all that hard-earned knowledge of CDER Direct?
And sure, OceanTears™ was sufficient proof that CDER’s software had blind spots. But the OceanTears™ DailyMed listing seemed both boring and plausible, with standard language and one fine-print mystery ingredient that could be overlooked. Just like the Regener-Eyes™ labels, in other words.
The chief scientist decided to create a truly preposterous eye drop listing, complete with inscrutable biologic ingredient acronym and tattoo artist-style box art. Inside the chief scientist is a mad scientist, evidently. Want to know what BOPE™ is? It’s proprietary, we’re not telling.
And we didn’t forget the preservative, it’s preservative free. It says so on the box. There’s nothing wrong with the bottle, all the big drug companies have used it for years.
OceanTears™ took two weeks of intermittent but intense effort. The preposterous drop took about 40 minutes, half of it spent on creative writing and half on data entry. Words like aquarium, genome, and spontaneous + carbonation swam freely in the ocean of free-text data fields, unchallenged by any error message.
Secretly, the fall guy expected a call from the FDA asking what the hell we thought we were doing. Or at least an email with a really nasty error message.
Instead, Mermaid Tears™ went live on DailyMed about 3 days after the listing was submitted.
“Mermaid Tears™ proves to us — and the world — that there is no human oversight of the FDA OTC drug listing process whatsoever.”
