The Crime in Plain Sight

On November 14, 2024, Brandon Miller walked into his local pharmacy in Fresno County, California, and purchased a bottle of Optase Dry Eye Intense Drops. He was looking for relief from chronic dry eye symptoms. What he got instead was an unapproved drug that federal regulators say should never have been on the shelf in the first place.

Miller’s purchase was legal under California law. The problem is that Scope Health, Inc., the company that manufactured and sold the product, was breaking both federal and state drug laws every single day it kept OPTASE products in the supply chain. And according to a class action complaint filed in the U.S. District Court for the Eastern District of California, Scope Health knew it.

The 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. Under the Federal Food, Drug, and Cosmetic Act, introducing unapproved new drugs into interstate commerce is illegal. Under California’s Sherman Food, Drug, and Cosmetic Law, selling those same drugs within the state is also illegal.

Scope Health did it anyway.

This is not a dispute over labeling technicalities. This is not a disagreement about marketing language. 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 selling them.

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 medical conditions. People who suffer from them are in pain. They need relief. And they trust that when they walk into a pharmacy and purchase an over-the-counter treatment, that product has been vetted by federal regulators to ensure it is safe and effective.

That trust is the foundation of the entire over-the-counter drug market. Scope Health exploited it.

The company used therapeutic language in its marketing. It made claims about treating disease. Under the Federal Food, Drug, and Cosmetic Act, that makes OPTASE products drugs, not cosmetics or supplements. Drugs require FDA approval. OPTASE products never received it.

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.” That determination triggers a legal requirement: before these products can be sold, Scope Health must submit a New Drug Application to the FDA and receive approval.

Scope Health never did that. 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 “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 are not GRASE. If a drug is not GRASE and does not have an approved New Drug Application, it is an unapproved new drug. Selling it is illegal.

Scope Health sold them anyway. For years.

The Non-Financial Ledger

Brandon Miller is not suing because OPTASE Dry Eye Intense Drops gave him an allergic reaction. He is not suing because the product didn’t work. He is suing because Scope Health sold him a product that was unlawfully marketed and sold in the first place.

The harm is not just financial. It is dignity. It is betrayal.

Miller suffers from dry eye symptoms. He went looking for relief. He found a product on a reputable platform, sold by a company that positioned itself as a legitimate pharmaceutical brand. He paid money. He used the product. And 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. 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 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 is thousands of people. Possibly tens of thousands. All of them 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 loss of trust. 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 does not issue warning letters lightly. Warning Letter No. 695085, issued to Scope Health on July 9, 2025, is a formal notification that the company is in violation of federal law. It is the regulatory equivalent of a flashing red light. It says: stop what you are doing, fix the problem, or face enforcement action.

Here is 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.”

These are not allegations. These are findings of fact by a federal regulatory agency with the statutory authority to make those determinations. The FDA reviewed the products. The FDA reviewed the marketing. The FDA made a determination. The products are illegal.

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—that are not permitted active ingredients for OTC ophthalmic demulcent drug products.”

For Dry Eye Intense Drops, the FDA found the product “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 circumvents the FDA approval process, it does not just harm the individual consumers who purchase the product. It undermines the entire regulatory framework designed to ensure drug safety and efficacy.

Dry eye disease is not a trivial condition. It 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 companies 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.

The FDA approval process exists for a reason. It 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 is the only way to ensure that the products patients rely on actually work.

Scope Health skipped that process entirely. The result is that thousands of California consumers used OPTASE products without the assurance that those products had been subjected to the rigorous testing required by law.

Economic Inequality

Pharmaceutical fraud disproportionately harms low-income and working-class consumers. These are the people who cannot 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 a company like Scope Health sells unapproved drugs at premium prices, it extracts wealth from the very consumers who can least afford to lose it. The 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 are looking at potentially millions of dollars in revenue extracted through unlawful sales.

That money is gone. It went into Scope Health’s coffers. And the consumers who paid it received products that were never vetted for safety or effectiveness by the FDA.

The complaint seeks restitution, but restitution does not undo the harm. It does not give back the time consumers spent using products they believed were lawful. It does not 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. When unapproved drugs are recalled or consumers dispose of them after learning they are unlawful, those products often end up in landfills or wastewater systems.

OPTASE products contain active ingredients like sodium hyaluronate, trehalose, and tea tree oil. When these substances enter the waste stream, they can contribute to pharmaceutical pollution in waterways, 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 that should never have been manufactured in the first place.

The “Cost of a Life” Metric

What Now?

The lawsuit is in its early stages. Scope Health has not yet filed a response. The court has not yet certified the class. But the legal and factual foundation of the complaint is strong.

The FDA has already made its determination. The OPTASE products are unapproved new drugs. Some are misbranded. Scope Health does not dispute that it sold these products in California. The only remaining questions are: how many people were harmed, and what is the appropriate remedy?

The complaint seeks injunctive relief to stop Scope Health from continuing to sell the products unlawfully. It seeks restitution to return to consumers the money they spent on products that should never have been sold. And it seeks corrective advertising to inform the public of the violations.

Those are reasonable demands. Scope Health sold products that federal regulators determined were unlawfully marketed. It profited from those sales. Now it must be held accountable.

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

If you work in pharmaceutical distribution, retail pharmacy, or regulatory compliance, this case is a warning. The FDA’s willingness to issue public warning letters and the plaintiffs’ bar’s willingness to pursue class actions means that unapproved drug sales are no longer flying under the radar. Get your house in order.

If you are a consumer who believes you were harmed by an unapproved or misbranded drug, you have rights. Document your purchases. Keep your receipts. Contact a consumer protection attorney. The system failed you, but you do not have to accept that failure quietly.