The OTC System That Let Safety Risks Linger for a Decade — And the FDA’s Quiet Move to Fix It

In 2023, more than 300 children died across multiple countries—Gambia, Uzbekistan, and Cameroon—after taking contaminated cough syrup. The syrups were tainted with diethylene glycol and ethylene glycol, the same chemicals found in antifreeze. Their kidneys failed. No warning came in time.

The U.S. was spared that crisis. Not by luck—but because the FDA had already started rewriting how it oversees nonprescription drugs. That overhaul began in 2020, under a quietly revolutionary framework known as OMUFA: the Over-the-Counter Monograph User Fee Act. Now, that program is up for reauthorization. And the choice facing Congress is stark: fund a modern system that works—or risk falling back to a regulatory playbook that let problems fester for decades.

A System Designed for a Slower Era

The old OTC monograph system—created over 50 years ago—was built on the idea that most nonprescription drugs were simple, stable, and unlikely to change. Regulators created “monographs,” essentially rulebooks that defined what ingredients and dosages could be used in different therapeutic categories. If a company followed the recipe, it could go straight to market—no FDA pre-approval required.

But updating that recipe? That required formal rulemaking. Years of public comments. Administrative delays. And little room for urgent action. So even when science evolved—or when risks emerged—the FDA was handcuffed. One official described the system as “once and done,” a framework that assumed innovation wouldn’t come and safety wouldn’t shift.

That assumption didn’t hold. Take acetaminophen, for example. The FDA first issued a warning to the public about its rare but potentially severe link to skin reactions in 2013. But it wasn’t until 2024—over a decade later—that the agency proposed new labeling language to reflect that risk. Why the delay? Under the monograph process, updating a single warning label required the same complex procedure as drafting new legislation.

The result was a public health system unable to keep pace with the very market it was regulating.

OMUFA I: A Rebuild from the Ground Up

In 2020, Congress passed the CARES Act. Buried inside was a provision that quietly restructured how nonprescription drugs would be regulated moving forward.

Gone was the sluggish rulemaking process. In its place: a streamlined administrative order system, enabling the FDA—or industry—to propose changes based on new science, safety concerns, or innovation. That new framework became section 505G of the FD&C Act.

To make it work, Congress also authorized the FDA to collect user fees under a five-year agreement, known as OMUFA I.

The results came fast. By 2025, the agency had issued 33 final administrative orders establishing up-to-date conditions for various OTC drug categories. It launched the first centralized IT portal for tracking and submitting monographs. It published multiple guidance documents clarifying how to submit new ingredient requests, label changes, or safety updates.

But most critically, the FDA began to act on long-standing concerns. In 2024, it issued a proposed order to revise labeling on all OTC acetaminophen products, finally aligning warnings with risks the agency had flagged over a decade earlier.

That same year, the FDA moved to remove oral phenylephrine as an approved decongestant ingredient—after an advisory committee unanimously found it to be ineffective. The agency also initiated the first proposed changes to the sunscreen monograph in years. And in an unexpected milestone, the FDA received its first industry-submitted request to add a new sunscreen ingredient—something that would have been practically impossible under the previous system.

Dr. Jacqueline Corrigan-Curay, Acting Director of the Center for Drug Evaluation and Research, emphasized in congressional testimony that these reforms were not just about efficiency. They were about restoring the FDA’s ability to act when science, safety, or innovation demands it.

OMUFA II: The Next Phase of Protection

The reauthorization proposal for 2026–2030, known as OMUFA II, is now before Congress. It’s not just a funding bill. It’s a roadmap for what comes next. The plan includes a projected $206.8 million in funding over five years, with modest inflation adjustments. It enables the FDA to hire eleven additional full-time employees, thereby enhancing its capacity to review safety data, monitor global manufacturers, and issue timely regulatory orders.

But funding alone isn’t the story. OMUFA II also commits the FDA to modernizing its inspection model—prioritizing facilities based on real-world risk factors like failure to pay fees or past GMP violations. It promises greater transparency around industry compliance, including public reporting on registrants, monograph exclusivity timelines, and facility status.

And it addresses one of the industry’s long-standing frustrations: lack of clarity. Under OMUFA II, the FDA will provide earlier notice for relevant advisory committee meetings, release additional guidance on OTC monograph order requests, and host public webinars to help companies understand how to navigate the system. Manufacturers won’t be left guessing what’s required—or blindsided by a last-minute regulatory expectation.

Corrigan-Curay indicated that these changes weren’t imposed unilaterally. They were developed through 25 stakeholder negotiation sessions, public meetings, and input from consumer groups, pharmacy associations, and academic experts. “We heard the calls for predictability and fairness,” she said. “OMUFA II is our answer.”

What Happens If Congress Says No?

Without reauthorization, FDA officials warn that planned safety initiatives could stall for years. That includes pediatric-specific dosing guidelines for acetaminophen, updated pregnancy labeling for NSAIDs, risk reevaluations for benzocaine and codeine in children, and broader access to child-friendly formulations.

In some cases, delays could stretch over a decade—bringing the U.S. back to the same place it was before 2020: waiting for rulemaking while patients remain exposed to outdated or incomplete drug labels. And for the American public, the consequences would be invisible—until they weren’t. Just like the hundreds of families who bought children’s cough syrup abroad, never knowing it contained a silent poison.

The FDA caught that risk in time. However, this was only because the infrastructure built under OMUFA was already in place.

The Real Stakes

The fight over OMUFA II isn’t about monographs. It’s about what kind of public health system the U.S. wants to maintain.

It’s about whether innovation in the OTC space will be met with regulatory clarity—or uncertainty. Whether safety risks will be addressed with urgency—or buried in procedure. And whether the next crisis will be caught early—or explained after the fact. Dr. Corrigan-Curay didn’t mince words in her testimony. The agency, she indicated, is ready to lead. But without congressional action, it won’t have the tools to do so.