FDA issues Scope Health warning letter over OPTASE ophthalmic products

In our latest reporting on recent FDA warning letters, Scope Health Inc. was also the recipient of a July 2025 letter issued following the federal agency’s review of the company’s product labeling for four over-the-counter (OTC) ophthalmic products.

The problem: Those products were deemed to be violating several regulatory criteria.

Hold up: Didn’t we just hear about FDA violations?

Indeed we did.

Scope Health’s violations piggyback off last week’s coverage of the FDA sending warning letters to three manufacturers regarding violations of the Federal Food, Drug, & Cosmetic Act (FD&C Act).

The subject of those violations: All three companies’ OTC eye drop products were found to be unapproved new drugs and misbranded products.

Gotcha. Now to this new situation.

To start: The FDA conducted a digital search of Scope’s OPTASE product website in August 2024.

Quick refresh: Launched in 2016, the OPTASE brand’s product lineup features dry eye management solutions that include eye drops, sprays, moist heat masks, eyelid wipes, and gels.

Following this review: The agency determined that several products listed on the website as OTC and available for sale in the United States were in violation of various sections of the FD&C Act by being:

Unapproved new drugs introduced or delivered for introduction into interstate commerce
Misbranded products

Let’s get into specifics—which products were called out?

The FDA noted the following OPTASE products as “drugs” intended for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

And their respective violations?

The FDA classified all products listed in the previous section as unapproved new drugs in violation of two sections within the FD&C Act.

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

See here for a look at each of these products’ marketing product label claims, as highlighted in the agency’s letter.

Any others?

Those three eye drops—Allegro Eye Drops, MGD Advanced Dry Eye Drops, and Dry Eye Intense Drops—as well as the HYLO Night Eye Ointment were also identified as being misbranded products under the FD&C Act.

Section 502(f)(2): Requires a drug’s labeling to include adequate warnings against unsafe dosage, methods, or duration of administration—and against its use in those pathological conditions where its use may be dangerous to health—as well as unsafe dosages, methods, or duration of administration for users’ protection of users.
- Applies to Dry Eye Intense Drops
  - See here for the FDA’s issues with this
Section 502(ee): Specifies requirements for including a drug’s established name and for listing its active/inactive ingredients on the label; also provides for certain exemptions from this requirement
- Applies to Allegro Eye Drops, MGD Advanced Dry Eye Drops, and HYLO Night Eye Ointment
  - See here for the FDA’s issues with these

As such, the FDA noted, “introduction or delivery for introduction of misbranded products into interstate commerce is prohibited."

Noted. Next up: Focus on this unapproved new drug issue.

The FDA determined all seven of these ophthalmic products to be “unapproved new drugs” based on criteria such as:

Not being generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling (referenced uses).

Plus: The ophthalmic products reportedly have “no FDA-approved applications in effect”—a notable requirement from the agency under the FD&C Act.

And what app would be needed?

An OTC monograph—specifically (in this case) the OTC Monographic M018, dubbed M018 for short.

See here for a rundown on what this is.
- And keep in mind: Nonprescription (OTC) drugs must meet all criteria mandated under this app in order to be legally marketed in the United States.

In Scope’s case: Four of its seven products are OTC drugs and, thus, require an M018:

Allegro Eye Drops
MGD Advanced Dry Eye Drops
Dry Eye Intense Drops
HYLO Night Eye Ointment

I’m getting some deja vu on all of this …

Unsurprising, considering those three similar warning letter situations we told you about from last week pertaining to three eye drop products.

In those cases, the products also required (but did not have) an M018 in effect because they were classified as “ophthalmic demulcent products” (read up on what this means).

Connecting them even further: The three OPTASE eye drops identified in Scope Health’s situation (Allegro, MGD Advanced, and Dry Eye Intense) were also classified as demulcent products—for the very same reason.

… and that reason is?

The FDA noted that all three OPTASE eye drops are “formulated with several active ingredients that are not permitted for OTC monographic ophthalmic demulcent drug products.”

For example:

Allegro Eye Drops
- Active ingredients: hydroxethyl cellulose and Ectoin
MGD Advanced Dry Eye Drops
- Active ingredients: glycerin, sacha inchi seed oil, trehalose, and sodium hyaluronate
Dry Eye Intense Drops
- Active ingredients: glycerin and sodium hyaluronate

Looking at the M018 list of permitted active ingredients for demulcent products (see page 3), those six ingredients are not mentioned—translating to their respective products being illegally marketed in the U.S.

**Hold up. All of those ingredients are labeled as inactive on the drops’ labels.**

That may be so. However, just as in those three other eye drop cases, the FDA reasoned that the products’ marketing materials tell a different story.

Specifically: “Statements on your website show that they are active ingredients in their respective products because they are intended to furnish pharmacological activity for the treatment of a disease or condition.”

See here for examples of these statements, as highlighted by the agency.

And what about that fourth product needing an M018?

You mean the HYLO Night Eye Ointment?

Unlike the OPTASE eye drops, the FDA classified this as an emollient product (intended for lubrication and moisture retention) formulated with Vitamin A as its active ingredient.

This is despite the product labelling listing Vitamin A as an inactive ingredient
The FDA’s reasoning: Statements on HYLO’s product website indicate Vitamin A is actually used as an active ingredient.

The issue with this: Vitamin A is not listed under the M018’s list (see page 4) of approved active ingredients for emollient products

Those are a lot of issues the FDA has raised …

It sure is. And, just as in previous warning letters, the federal agency requested a detailed response from Scope Health on how it intends to remedy the identified problems.

And did Scope respond?

We can indeed confirm that the company responded to the letter (within the requested 15-day timeframe).

To be more precise: In reply to Glance’s request for comment, Scope wrote (via email) that the company “provided a detailed response to the FDA addressing all points raised” and that the company expects “to resolve this matter promptly.”

Care to share what that response included?

Scope stated:

“We value the FDA's feedback and as part of our response, our team has already implemented updates to our website to remove the claims beyond those permitted by the FDA.”

Further: The company emphasized to customers and clinicians to be “rest assured” that the warning letter “does not call into question the safety of our products, and Optase product shipments will continue as normal.”

And what do these updates entail, exactly?

Great question, which we asked Scope for expansion on. The company’s response, in part:

“We have made the necessary updates to ensure our product performance claims are in line with FDA guidelines.”

Scope also reiterated that the FDA raised no safety concerns about its products.

*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.