K-Beauty FDA Compliance: Why 'Marketing' Is No Longer Enough in the U.S. Market

A fast-growing K-Beauty brand — call it Brand A — recently appeared in not one but two FDA public databases. First in CAERS, the FDA's cosmetics adverse event reporting system. Then in MAUDE, the medical device adverse event database.

No recall. No import alert. But showing up across two separate FDA systems at the same time? That kind of thing gets noticed.

Why an FDA Database Listing Is Never Just a Footnote

CAERS and MAUDE are fully public. No login required. Any consumer, healthcare professional, retail buyer, investor, or competitor can search by product name right now.

FDA doesn't treat these reports as simple complaints. They feed into a signal detection system — a way of identifying patterns and emerging risks before formal enforcement kicks in. A single report may not set off alarms. But when entries start stacking up across multiple systems, a brand moves from the background to the foreground of FDA's post-market surveillance.

A listing doesn't prove wrongdoing. But once something is in the public record, it stays there. And increasingly, how a brand manages what's in those databases shapes how the market perceives it.

What Changed After MoCRA — And What Too Many Brands Still Haven't Caught Up On

"Cosmetics don't need FDA approval." That's true. Cosmetics aren't subject to premarket approval in the U.S.

But that framing became a lot less reassuring once MoCRA — the Modernization of Cosmetics Regulation Act — took effect in 2022. Here are three things every brand selling in the U.S. market needs to have in order:

① Mandatory Adverse Event Reporting — 15 Business Days Companies must report serious adverse events to FDA within 15 business days of becoming aware of them. Not when asked. Proactively. The clock starts the moment the company has knowledge of the event.

② Facility Registration and Product Listing Any company marketing cosmetics in the U.S. must register its facilities and list its products with FDA. Selling without registration isn't a gray area — it's a violation.

③ Record Retention All adverse event records must be kept for a minimum of six years — three years for small businesses — and must be available to FDA upon request at any time.

"We haven't received a Warning Letter, so we're fine" is a riskier position than it sounds. By the time FDA moves formally, the market has usually already moved. Buyers, platforms, and investors aren't waiting for enforcement action. They're checking the databases.

FDA Compliance Is an Operating System, Not a Certificate

A lot of brands think of FDA registration as a box you check once. Get registered, move on.

That's not how it works anymore. Under MoCRA, compliance is an ongoing system — adverse event monitoring, proactive reporting, label management, responsible party designation.

These aren't one-time tasks. They're infrastructure that has to run in the background for as long as you're selling in the U.S.

And the stakes grow with the brand. The larger your footprint, the more surface area you're presenting to regulatory scrutiny. Growth doesn't reduce compliance risk — it amplifies it.

The next era of K-Beauty won't be won on product formulation or creative marketing alone. It'll come down to who builds the FDA compliance infrastructure to sustain that growth — in the world's most transparent market.

5 Things to Check Right Now — FDA Compliance Checklist for K-Beauty Brands

The U.S. market is genuinely compelling. It's also the market where everything is documented and anyone can look it up.

The brands that get ahead of an FDA database listing and those that scramble after the fact don't end up in the same place. Take a hard look at where your K-Beauty FDA Compliance stands today.

▶ Product Classification Is your product a Cosmetic, an OTC Drug, or a Medical Device under U.S. law? The answer isn't always obvious — and getting it wrong changes everything about how your product needs to be regulated, labeled, and marketed.

▶ Claims Review Does your website, Amazon listing, social media, or label include words like "treats," "regenerates," or "reduces inflammation"? A single phrase can reclassify your product and put you in a completely different regulatory lane.

▶ Adverse Event Response Process If a serious adverse event came in today, could your team actually execute a 15-business-day FDA report? Is the process documented and tested — or is it theoretical?

▶ U.S. Responsible Person Is your Responsible Person formally designated? Are they actually equipped to handle FDA communications if and when they come?

▶ Database Monitoring If a buyer searched CAERS and MAUDE for your brand right now, what would come up? Do you know?

If any of these feels uncertain, that uncertainty is the risk.

Provision Consulting Group is a U.S. FDA regulatory consulting firm

specializing in MoCRA compliance, adverse event reporting systems, product classification,

claims review, and CAERS/MAUDE monitoring for K-Beauty and global brands entering the U.S. market.

For inquiries or expert assistance, please contact us today.

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Email: ask@provisionfda.com