I think this needs to be replaced with something that looks more like EDS approach (see issues at a glance)
We’re a nonprofit, by the way - Dry Eye Foundation. We didn’t set out to be a watchdog, but OTC eye drop safety issues are claiming our attention more and more.
It’s about eye drop safety.
Yes, this is an issues site, not an e-commerce site.
Companies are increasingly violating, manipulating, or just plain ignoring FDA rules and systems for OTC eye drops - causing an escalation of eye drop safety issues. We’re worried about the extent of risks that consumers don’t know about.
THIS PAGE NEEDS SOME CHANGES - I put it here because we have to have an “all-in-one'“ issues page - all visitors need the option of going straight to the bottom lines quickly.
Did we fool you about Mermaid Tears™?
We sure fooled the FDA’s over-the-counter drug listing software. They’re treating Mermaid Tears™ like a real drug.
If we can fool the system, eye drop manufacturers and distributors can too.
In fact, they have.
Why we made Mermaid Tears ™
The Mermaid Tears project was carried out to prove to the FDA that the Center for Drug Evaluation and Research’s electronic drug listing platform (called CDER Direct) can be misused by unscrupulous companies to obtain legal-looking OTC drug entries in the FDA’s public drug database.
CDER Direct also does not prevent ignorant manufacturers and distributors from listing and manufacturing a dangerous eye drop – a product which lacks an effective preservative, and is incorrectly packaged in a standard eye drop bottle.
CDER Direct has numerous internal checks to stop a company from submitting an OTC product listing that is incomplete, or not in compliance with the specific OTC Monograph that applies to their product class.
Despite these supposed fail-safes, CDER Direct does not truly protect consumers by blocking the listing of prescription-only eye drops as OTC, or by preventing the listing of an eye drop that requires a preservative but does not have one.
Our point: There is no human review of the FDA’s OTC eye drop listing process.
The success of the “honor system” depends entirely on the product knowledge and ethical behavior of companies that manufacture or distribute eye drops – whether as OTC products or as faux-prescription products.
There’s more: unlisted OTC eye drops
An imperfect OTC listing system is not our only worry.
A rapidly growing number of eye drops sold in the US are manufactured by companies that the FDA knows nothing about.
These companies, both domestic and international, are dodging the FDA requirements to identify themselves to the FDA and to register their OTC eye drops.
And unfortunately, e-commerce giants such as Amazon and Walmart are providing safe havens for suspicious sellers and products to blend right in.