NEWS & BLOGS

One Sunscreen Could Land You on FDA's Blacklist — Have You Checked Your OMUFA FY2026 Status?

Provision Consulting Group
1 minute ago
2 min read

"Our product is a cosmetic — it just has an SPF rating." "Anti-dandruff shampoo is regulated as a drug?"

If these questions sound familiar, your facility may already be at risk.

You May Be Selling a Drug Without Knowing It

The FDA classifies the following products not as cosmetics, but as OTC (over-the-counter) drugs:

Sunscreens with SPF claims
Acne products containing salicylic acid or benzoyl peroxide
Anti-dandruff shampoos containing zinc pyrithione or selenium sulfide
Topical analgesics containing menthol or lidocaine

Products that are considered cosmetics in other markets are often classified as OTC drugs in the U.S. And any facility that manufactures or distributes OTC drugs is subject to OMUFA — the OTC Monograph Drug User Fee program. In November 2025, OMUFA was officially reauthorized through FY2030.

1,377 Facilities Have Already Been Publicly Listed

The FDA publishes an Arrears List — a public record of facilities that have failed to pay their OMUFA fees. In plain terms, it's a blacklist.

As of June 2025, 1,377 facilities appear on that list. The moment your facility is added, every OTC monograph drug product you manufacture is automatically deemed misbranded — meaning it cannot legally be sold in the U.S. It doesn't matter if the products themselves are perfectly compliant. One unpaid fee is enough to shut down your entire product line.

Miss the deadline by more than 20 days, and you also lose the ability to submit an OMOR or request an official FDA meeting.

What's Changed for OMUFA FY2026

Applicable period: October 1, 2025 – September 30, 2026.

Tier	Fee
Tier 1	$587,529
Tier 2 (small businesses)	$117,505

*Qualifying small businesses can apply for Tier 2 — but it requires a separate application. If you're eligible and haven't applied, you're paying Tier 1 by default.

*Paper check payments were eliminated as of October 2025. Only ACH, credit card, and wire transfer are accepted. Some facilities have already missed deadlines simply because they weren't aware the payment method had changed.

Four Things to Verify Right Now

Does your product qualify as an OTC monograph drug?
Is your FDA facility registration current and accurate?
Are you subject to FY2026 OMUFA fees?
Have you applied for Small Business status?

OMUFA and MoCRA are two separate regulatory frameworks. Staying compliant with one doesn't cover the other.

PCG supports OTC drug manufacturers and distributors through every step — from determining OMUFA applicability and reviewing facility registrations to navigating the fee payment process.