Scope Health Sold Eye Drops the FDA Never Approved.

The Crime in Plain Sight

Brandon Miller walked into his local pharmacy in Fresno County, California on November 14th 2024, where he purchased a bottle of Optase Dry Eye Intense Drops. He was looking for relief from chronic dry eye symptoms. What he instead received was an unapproved drug which federal regulators say shouldn’t have ever been on the shelf in the first place!

Miller’s purchase was (unfortunately) legal under California law. The problem is that Scope Health, Inc., the company which manufactured and sold the eye drops, was breaking both federal and state drug laws every single day it kept OPTASE products in the supply chain. And Scope Health knew it, according to a class action legal complaint filed in California!

This case revolves around a simple but devastating fact: the U.S. Food and Drug Administration determined that Scope Health’s entire OPTASE product line consists of unapproved new drugs. Some of them are also misbranded. Thus, this action is illegal Under the Federal Food, Drug, and Cosmetic Act. On top of that, under (get it? I’m a funny punster lol) California’s Sherman Food, Drug, and Cosmetic Law, selling those same drugs within the state is also illegal.

Scope Health did it anyway.

The FDA’s position is unambiguous: Scope Health’s OPTASE products are drugs. They make disease claims. They lack the required approvals. And they should not be sold.

Scope Health’s response? Keep right on selling them, baby! Maximum profits here we come!!

How the Scheme Worked

Scope Health markets its OPTASE product line as treatments for dry eye disease, meibomian gland dysfunction, and blepharitis. These are real legitimate medical conditions that many people have! People who suffer from them are in pain and need relief. And they unfortunately trust that when they walk into a pharmacy and purchase an over-the-counter treatment, that product that they’re exchanging money for has already been vetted by federal regulators to ensure it’s both safe and effective.

That trust is the foundation of the entire over-the-counter drug market. Scope Health exploited this trust at all of our collective expenses.

Scope used therapeutic language in its marketing. They made claims about treating disease. Under the Federal Food, Drug, and Cosmetic Act, that actually makes OPTASE products classified as drugs, not mere cosmetics or supplements which exist in a much more lax space regulation-wise. Which is quite obviously, much easier for a predatory corporation like Scope Health to obtain.

According to the FDA’s July 2025 warning letter, the agency reviewed the labeling and marketing of the OPTASE product line and determined that the products were “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” This determination triggers an important legal requirement mandating that Scope Health must needs submit a New Drug Application to the FDA and receive approval before the products can be sold to common customers.

Scope Health never did that though! The FDA confirmed in its warning letter that “there are no FDA-approved applications in effect for any of the [OPTASE Products] identified.”

Even more damning, the FDA stated it was quote “not aware of any adequate and well-controlled clinical trials in the published literature” supporting the claim that these products are generally recognized as safe and effective for their labeled uses.

In regulatory language, that means the products aren’t GRASE. If a drug is not GRASE and doesn’t have an approved New Drug Application, it is an unapproved new drug. Selling it is illegal.

idk if I’ve driven the point in yet that these drops were illegal. Because they were illegal. Scope Health illegally sold illegal eye drops.

Scope Health sold them anyway. For years.

The Non-Financial Ledger

So like I said earlier, Miller suffers from dry eye symptoms. He went looking for relief and found a product on a reputable platform, sold by a company which positioned itself as a legitimate pharmaceutical brand.

He paid money with which he exchanged for with his labor for. He used the product but at no point was he informed that the product he was using had been classified by federal regulators as an unapproved drug that lacked the clinical evidence to support its safety or effectiveness.

He trusted the system but the system failed him.

Now multiply that experience by every consumer in California who purchased an OPTASE product in the four years prior to the filing of this lawsuit. The legal complaint defines the class as “all persons in California who, at any time from four years prior to the date of filing of this Complaint to the time a class is notified, purchased, for personal or household use, and not for resale or distribution, the Optase Products.”

That’s thousands of people. Possibly even tens of thousands! All of whom paid money for products that were unlawfully sold. All of them were deceived into believing they were purchasing a lawful, FDA-vetted treatment.

The complaint makes this clear: “Plaintiff and reasonable consumers purchasing over-the-counter ophthalmic products reasonably expect that those products are lawfully marketed and sold. Had Plaintiff and reasonable consumers known that the Optase Products were unlawfully marketed and sold in violation of federal and California law, they would not have purchased them or would have paid less for them.”

This is the true loss of trust alluded to earlier. This is the injury to dignity. You cannot put a dollar amount on the feeling of realizing that the system designed to protect you from corporate predators let one walk right through the front door.

Legal Receipts

The FDA doesn’t issue warning letters lightly. Warning Letter No. 695085, issued to Scope Health on July 9, 2025, was a formal notification that the company is in violation of federal law. It is the regulatory equivalent of a flashing red light which basically says “HALT! Stop what you are doing, fix the problem, or face enforcement action. Wee-oo-wee-oo.”

Here’s what the FDA said, verbatim, in its warning letter:

“FDA determined that Scope’s MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray were unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FDCA.”

“FDA further determined that the Optase Products were not generally recognized as safe and effective (GRASE) for their labeled uses and therefore constituted new drugs under the FDCA. Specifically, FDA explained that it was not aware of any adequate and well-controlled clinical trials in the published literature supporting a determination that the products were GRASE for their intended uses.”

“There are no FDA-approved applications in effect for any of the [Optase Products] identified above.”

The complaint also quotes specific violations for individual products. For MGD Advanced Dry Eye Drops, the FDA determined the product “did not conform to the applicable OTC ophthalmic monograph because it contained active ingredients -including sacha inchi seed oil, trehalose, and sodium hyaluronate- which were not permitted active ingredients for OTC ophthalmic demulcent drug products.”

For Dry Eye Intense Drops, the FDA found the product quote “did not conform to the applicable OTC monograph because it contained sodium hyaluronate as an active ingredient, which is not permitted under the monograph.” The multi-use bottle was also misbranded because “its labeling omitted the required warning: ‘If solution changes color or becomes cloudy, do not use.'”

For Allegro Eye Drops, the FDA determined that “Ectoin® functioned as an active ingredient but is not a permitted active ingredient for OTC ophthalmic demulcent products.”

For HYLO Night Eye Ointment, the FDA found that “vitamin A functioned as an active ingredient but is not a permitted active ingredient for OTC ophthalmic emollient drug products.”

These are regulatory violations with legal consequences. The Federal Food, Drug, and Cosmetic Act makes it unlawful to introduce misbranded or unapproved drugs into interstate commerce. California’s Sherman Law incorporates those federal requirements and makes it independently unlawful to sell such products within the state.

Scope Health violated both.

Societal Impact Mapping

Public Health

The public health impact of unapproved drugs is systemic. When a pharmaceutical company like Scope Health circumvents the FDA approval process, it undermines the entire regulatory framework designed to ensure drug safety and efficacy.

Dry eye disease causes chronic pain, impaired vision, and reduced quality of life. Patients who suffer from it deserve access to treatments that have been rigorously tested and proven effective.

When Evil Corporations like Scope Health flood the market with unapproved alternatives, they create confusion, erode trust in legitimate treatments, and potentially delay patients from seeking evidence-based care that would actually help them.

The FDA approval process exists for a reason! They requires manufacturers to submit data from controlled clinical trials demonstrating that a drug is safe and effective for its intended use.

That process is expensive and time-consuming, but it’s the only way to ensure that the products patients rely on actually work!

Economic Inequality

Pharmaceutical fraud disproportionately harms low-income and working-class consumers. These are the people who can’t afford to see a specialist every time they need relief from a chronic condition. They rely on over-the-counter treatments because those treatments are affordable and accessible.

When an evil company like Scope Health sells unapproved drugs at premium prices, they’re quite literally extracting wealth from the very consumers who can least afford to lose it.

The legal complaint does not specify the exact price Miller paid for his OPTASE Dry Eye Intense Drops, but over-the-counter ophthalmic treatments routinely cost between $15 and $30 per bottle. Multiply that by thousands of purchases over four years, and you’re looking at potentially millions of dollars in revenue extracted through unlawful sales.

The lawsuit seeks restitution, but unfortunately for us, restitution doesn’t undo the already-caused-harms. It doesn’t give back the time consumers spent using products they believed were lawful. It doesn’t restore the trust that was broken when they learned the truth.

Environmental Degradation

The environmental impact of pharmaceutical waste is an underreported dimension of corporate misconduct in the drug industry. These products often end up in landfills or wastewater systems when unapproved drugs are recalled or consumers dispose of them after learning they are unlawful and potentially hazardous.

OPTASE products contain active ingredients like sodium hyaluronate, trehalose, and tea tree oil.

These substances can contribute to pharmaceutical pollution in waterways when they enter the wastestream, which has been linked to endocrine disruption in aquatic life and contamination of drinking water supplies.

Scope Health’s decision to sell unapproved products created a secondary environmental harm: the disposal of products which shouldn’t have been manufactured in the first place.

The “Cost of a Life” Metric

What Now?

The FDA has already determined that OPTASE products are unapproved new drugs (and not cosmetic products). Some are misbranded. Scope Health doesn’t dispute that it sold these products in California, which is the state in which the class action was filed. The only remaining questions are how many people were harmed, and what the appropriate remedy for those victims would be.

The complaint seeks injunctive relief to stop Scope Health from continuing to sell the products unlawfully. The complaint is ultimately seeking restitution to return to consumers the money they spent on products that should never have been sold, while also seeking corrective advertising to inform the public of the violations going forward.

Those are reasonable demands in my extremely humble opinion! Scope Health sold products that federal regulators determined were unlawfully marketed. It profited from those sales. So thusly, Scope Health must needs be held accountable for the harms they’ve caused.

If you purchased any OPTASE-branded product in California between 2022 and 2026, you may be a member of the class action! Contact the law firms representing Brandon Miller: Fitzgerald Monroe Flynn PC or Furia Law, LLC. Their contact information is in the complaint PDF linked below. Or you can just Google their name lol

If you are a consumer who believes you were harmed by an unapproved or misbranded drug, just know that you have rights! Document your purchases. Keep your receipts. Contact a consumer protection attorney. This late stage economic system has failed you, but you don’t have to roll over and accept that failure quietly.