How K-Beauty Brands Can Comply with U.S. FDA MoCRA and Health Canada Regulations in 2025

Introduction

The global fascination with South Korea’s K-Beauty industry continues to grow — celebrated for its innovation, clean formulations, and trend-setting products. But exporting to Canada and the United States means navigating two of the world’s most rigorous cosmetic regulatory frameworks.

In 2025, new rules under the U.S. FDA’s Modernization of Cosmetics Regulation Act (MoCRA) and Health Canada’s Cosmetic Regulations are reshaping how foreign cosmetic brands, including Korean exporters, enter these markets.

Here’s what every K-Beauty exporter should know to stay compliant and competitive.

1. United States – FDA & MoCRA Requirements

The Modernization of Cosmetics Regulation Act (MoCRA) is now fully in effect, introducing the most significant updates to U.S. cosmetic law in over 80 years.

Key Requirements for Exporters

• Facility Registration: All manufacturing and processing facilities must register with the U.S. FDA. 
• Product Listing: Each cosmetic product must be listed with the FDA. 
• Safety Substantiation: Brands must maintain evidence demonstrating product safety. 
• Adverse Event Reporting: Reporting of serious adverse events is mandatory. 
• Good Manufacturing Practices (GMPs): Formalized GMP standards are coming into force soon. 
• De minimis Exemption Removed: Since July 2025, even small or sample shipments from Korea require full FDA declarations. 

✅ Tip for Exporters: Partner with an experienced regulatory compliance consultant to ensure FDA facility registration, product listings, and label reviews are completed before shipping.

2. Canada – Health Canada & NNHPD Oversight

In Canada, cosmetics fall under the Food and Drugs Act and Cosmetic Regulations, administered by Health Canada.

Key Compliance Steps

• Cosmetic Notification Form (CNF): Must be filed within 10 days of first sale in Canada. 
• Bilingual Labelling: Labels must be in English and French, listing ingredients by INCI names. 
• Regulatory Alignment: Health Canada is aligning its Natural Health Product (NHP) labelling framework, with a transitional period until 2028. While cosmetics are not NHPs, hybrid or “cosmeceutical” products may trigger overlapping requirements. 

✅ Tip for Exporters: Prepare bilingual packaging in advance and cross-check formulations against Health Canada’s Cosmetic Ingredient Hotlist to avoid restricted or prohibited substances.

3. Common Pitfalls for Korean Exporters

• Using Domestic K-Beauty Labels Without Adaptation: Korean-style labels often omit mandatory U.S. or Canadian elements. 
• Making Overlapping Claims: Claims such as “treats acne” or “heals skin” can reclassify the product as a drug or natural health product. 
• Ignoring Importer Responsibilities: In both the U.S. and Canada, local distributors or importers share legal accountability for compliance violations. 

✅ Tip: Choose your North American importer carefully — they play a key role in ensuring regulatory compliance.

Conclusion

The opportunity for K-Beauty brands in North America remains enormous, but so is the compliance burden. Staying ahead of evolving regulations like FDA MoCRA and Health Canada’s labelling requirements will determine which exporters succeed in 2025 and beyond.

💬 Need help navigating FDA or Health Canada cosmetic registration?
Fiducia Globus provides expert guidance for cosmetic, skincare, and NHP compliance — from product listing to bilingual label review.
👉 Contact us today to simplify your export journey.