FDA Compliance

Ocean Tears brand is the industry leader when it comes to chameleon marketing.

If you wish us to appear FDA compliant, we can appear FDA compliant. If you wish us to appear nonconformist and unwilling to kowtow to either the FDA or industry norms, we can do that. And if you wish us to appear as a trusted brand manufactured in a spanking clean northern European factory, good enough that no one cares if they meet FDA standards for sale in the US, so long as they can be purchased conveniently, we can do that too.

We know every trick of this trade, including how to convince eye doctors that we are on the up-and-up. After all, the only people who understand how OTC drugs are regulated are regulatory consultants and Big Pharma’s lawyers. We are not afraid of the FDA. It will take them at least three years to do anything about us (unless someone does or goes blind, which hopefully won’t happen) and by then, hopefully, our offshore bank accounts will be well lined. If not, we’ll just move to another state and start back up under another name.

Helpful statements and disclaimers

Here are examples of language we use to exploit the trust and ignorance of consumers and physicians, and how we cater for the cupidity of potential resellers.

  • “Ocean Tears products are compliant with all FDA regulations.” Simple, sweeping lies generally go over very well.

  • “These statements have not been reviewed by the Food and Drug Administration.” This is a timeless disclaimer that will immediately make consumers feel reassured.

  • “….”

OTC Monograph drug listings

Fortunately, no one knows that the OTC drug listing system - which populates the drug database people can search online - is completely unpoliced. There is literally no human review. Anyone who has a DUNS number and the brains to figure out the FDA’s software can list pretty much anything they want. We should know - we did this for two of our products, OceanTears ™ and Mermaid Tears ™.

What’s really exciting about this is that we can make something that would otherwise be required to go through the drug approval process (and we all know that takes many years and millions of dollars) and simply create a OTC drug listing that can masquerade as an OTC drug!

Answering questions from doctors about biologic eye drops

We have found that the following bald-faced lies go over quite well with eye doctors:

  • Biologics are not regulated by the FDA.

  • Biologics are in a sort of grey area, like homeopathic eye drops.

  • This product is actually regulated as a cosmetic.

  • It’s a biologic, not a drug.

Press releases

There is truly no need for noncompliant, unsafe eye drops to lurk in dark corners of the internet or on eye doctors’ office shelves. We can boldly declare whatever we want. No one will call us out on our lies because no one understands the FDA.

Here’s an example of public statements that we have found quite effective with physicians and nonprofit organizations.

Mermaid Tears ™ was awarded an over-the-counter (OTC) drug indication to relieve dryness of the eye in April 2023.

Mermaid Tears ™ is regulated as an OTC drug that is registered and in full compliance with all FDA regulations.

This sounds beautifully official, almost like drug approval! And it’s excellent cover for those of us who have succeeded in working the OTC listing system to display our noncompliant products. Fortunately, only regulatory lawyers know that this is gibberish, since the FDA does not “grant” anything to OTC drugs.