Why the World Can’t Get Enough of Korean Beauty—and What That Means for U.S. FDA Compliance

April 25, 2025

The global beauty industry is undergoing a quiet revolution—and it’s being led by Korean beauty, or “K-beauty.” From skin-plumping essences to 10-step regimens and snail mucin serums, Korean beauty has gone from niche curiosity to global staple. It’s now a $7 billion global phenomenon, gaining popularity not just across Asia but also in the U.S., where mainstream retailers and Amazon storefronts are flooded with Korean products.

So what makes K-beauty so irresistible? It’s a perfect storm of innovation, affordability, and cultural influence. Korean beauty brands are known for their cutting-edge formulations, clean aesthetics, and skin-first philosophy. Combine that with the international popularity of K-dramas, K-pop stars, and social media virality, and it’s no wonder the rest of the world is obsessed.

But for Korean beauty brands and U.S.-based importers, there’s one crucial element that often gets overlooked: FDA compliance.

U.S. Entry = FDA Accountability

K-beauty brands eyeing U.S. distribution need to be aware that the U.S. cosmetic regulatory landscape is shifting. With the Modernization of Cosmetics Regulation Act (MoCRA) now in effect, all cosmetics marketed in the U.S.—including imported ones—must follow stricter guidelines. This includes facility registration, product listing, adverse event reporting, and updated labeling standards.

Common Pitfalls for K-Beauty Brands

Some of the biggest compliance issues we see with Korean beauty products include:

• Non-compliant ingredient names: INCI names must be used on the label, not localized or translated names.

• Missing Responsible Person: Under MoCRA, a U.S.-based responsible person must be designated and listed on the label.

• Structure/function claims: Some K-beauty products make claims that verge into drug territory, like “anti-aging” or “skin regeneration,” which could trigger FDA scrutiny.

• Eye-area products: MoCRA eliminates small business exemptions for any product used near the eyes—this includes eye creams, serums, and masks.

Bridging Innovation and Regulation

As a consulting firm specializing in FDA cosmetic compliance, we help K-beauty brands enter and succeed in the U.S. market. Whether you're a U.S. importer working with Korean manufacturers, or a Korean brand preparing to launch stateside, aligning with MoCRA requirements is essential.

Pro Tip: If you’re selling on Amazon, you’ll also need to meet platform-specific requirements in addition to FDA standards.

Want to bring your K-beauty brand to the U.S. the right way? Contact us for a compliance review or email us to get started with a quote.

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