FDA sends warning letters to three eye drop manufacturers

At the beginning of July 2025, the FDA issued warning letters to executives from three manufacturers regarding violations pertaining to each of their respective over-the-counter (OTC) eye drop products.

These manufacturers:

Where to start?

First up: iVIZIA. Available as part of Théa’s line of iVIZIA products, the iVIZIA eye drops are formulated with povidone 0.5% (the active ingredient) and several other inactive ingredients.

Its purpose:

For temporary relief of:
- Burning and irritation due to eye dryness
- Discomfort due to minor irritations of the eye
For use as a protectant and lubricant against further irritation or to relieve eye dryness

The drops are also reported to provide "instant and long-lasting relief of dry eye symptoms for up to 8 hours.”

And what are the issues the FDA has called out?

Per a July 9 warning letter sent to Théa’s President Susan K. Benton, the federal agency stated that a review of iVIZIA’s product labeling noted that the iVIZIA drops are:

An unapproved new drug in violation of two sections of the Federal Food, Drug, and Cosmetic (FD&C) Act
A misbranded product under one section of the FD&C Act

Start with those unapproved new drug violations.

Based on its review, the FDA referred to the iVIZIA drops as an “unapproved new drug introduced or delivered for introduction into interstate commerce” and in violation of the following FD&C Act sections:

Section 505(a): Pertains to the approval of new drugs and details the submission process for market approval based on safety and effectiveness
Section 301(d): Prohibits the introduction of misbranded or adulterated drugs into interstate commerce

And notably: The agency determined the iVIZIA drops to be a “new drug” and, therefore, cannot be introduced into interstate commerce (for commercial use) without an approved application from the FDA.

So what application is needed?

That would be an OTC monograph, which would enable a nonprescription (OTC) drug such as the iVIZIA drops to be generally recognized as safe and effective (GRASE) for its suggested labelling use, not misbranded, and—as a result—legally marketed.

Notably: This enables an OTC drug to be marketed without an approved drug application.

In this case: The iVIZIA eye drops would need to meet all of the conditions outlined under the FDA’s OTC monograph: Ophthalmic Drug Products for OTC Human Use (dubbed M018), which applies to ophthalmic drugs reserved for topical administration.

The FDA’s finding: The product did not.

Why not?

Based on acceptable M018 criteria, the iVIZIA drop is considered a “demulcent product” with a purpose of topical application to the eye to protect and lubricate irritation to relieve dryness and irritation.

To note: Under M018, ophthalmic demulcent products are permitted to include only specific active ingredients in their formulations—no others are allowed.

In the case of iVIZIA: The FDA noted that its formulation includes hyaluronic acid [HA] and trehalose—both of which are not listed (and therefore not permitted) under the OTC monograph for demulcent products.

But aren’t those two ingredients marketed as inactive ingredients?

They are … however, the FDA reasoned that the product’s marketing materials on the iVIZIA product website imply that both HA and trehalose provide therapeutic benefits—translating to them acting as active ingredients.

See here for examples of this verbiage.

Because of this: The FDA determined the iVIZIA drops to be an unapproved drug, and therefore, cannot be legally marketed.

Yikes. And what about this misbranding?

The misbranding follows from the FDA identifying the iVIZIA drops as an unapproved new drug.

What this means is that the iVIZIA drops have been deemed by the FDA to be a nonprescription drug subject to regulation, and therefore cannot be marketed without an approved application—which iVIZIA does not have.

So how does this situation compare to the other two products?

Similar to Théa and its iVIZIA drops, Covalent Medical and Revitalize Energy received warning letters in which the FDA identified their respective eye drop products as unapproved new drugs and misbranded products under the FD&C Act.

Also in common: The agency noted that “introduction or delivery for introduction of such products into interstate commerce” (in other words: for commercial sale and distribution) is prohibited.

Plus: Both nonprescription OTC eye drops were also classified as ophthalmic demulcent (lubricant) drug products that contain active ingredients not permitted under M018 criteria.

Talk specifics.

According to the FDA: In the case of Revitalize’s Energizing eye drops—intended to temporarily relieve burning and irritation due to eye dryness—and Covalent Medical’s FOCUS PI Post-Injection Eye Drops—distributed by Focus Vitamins and intended for use as a lubricant to prevent further irritation or to relieve eye dryness—the products:

Cannot be considered GRASE
Do not have an approved application (in accordance with the FD&C Act) in effect that would enable it to be distributed for commercial use
In the case of Revitalize’s drops: Contain non-M018-permitted ingredients in the formulation: menthol, camphor, caffeine, and taurine
- Similar to iVIZIA, though these are listed as inactive ingredients, the FDA reasoned that they are “intended to furnish pharmacological activity for the treatment of a disease or condition” based on marketing claims—making them active.
Contains product labeling uses not permitted under M018 (see here for Revitalize’s drops)

Uh oh. And what did the FDA ask of each company?

The companies were asked to respond to their respective July 9 warning letters within 15 business days with details on the specific steps they’ve taken to correct the violations—including an explanation for each step as to how they will prevent future violations.

If a company believes its products are not in violation of the FD&C Act, the agency requested that it explain its reasoning (with supporting documentation).

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction,” the FDA wrote.

So … have the company responded to these letters yet?

Glance reached out to representatives from each of the aforementioned companies.

According to Revitalize and Théa, the companies did indeed respond to the FDA’s warning letters.

At the time of publication, Covalent Medical has not yet responded to our request for comment.

And what steps have been taken to address the violations?

In an email to Glance, Revitalize wrote that “Revitalize Energizing Eye Drops was designed, intended, and patented to be within the FDA Monograph M018 and GRASE.”

The company further stated that its product “is an OTC vasoconstriction and demulcent product with patented Opti-boost technology involving our proprietary blend of active and inactive ingredients.”

As for any actions taken to address the FDA’s letter, Revitalize stated: “Any potential pharmacological claims or benefits surrounding any individual ingredients classified as inactive has been removed.”

How about Théa?

In response to Glance’s request for comment, the company requested the following statement be published in its entirety:

“Thea Pharma Inc. takes regulatory compliance seriously and we are committed to ensuring that all our products fully comply with FDA requirements. We are actively working with the agency to address their observations. iVIZIA Sterile Lubricant Eye Drops remain on the market and continue to meet all applicable manufacturing and safety standards.”

*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.