Top 5 Cosmetic Labeling Mistakes to Avoid After MoCRA Compliance

5 Common Cosmetic Labeling Mistakes Revealed by FDA Warning Letters

As K-Beauty continues its surge in popularity in the U.S. cosmetic market, FDA labeling regulations have also become stricter following the implementation of MoCRA. Simply registering or submitting a CPIS isn't enough anymore; even a single phrase on your product label can become a major hurdle for entering the U.S. market.

In fact, the FDA has recently issued numerous Warning Letters to imported cosmetic products, citing reasons such as "false or misleading claims," "misleading drug claims," and "omission of required information." We've analyzed these cases to summarize the key points you absolutely need to know.

1. Using "FDA Approved" Claims

Many brands use "approved" terminology to build consumer trust, but this is a clear regulatory violation. The FDA does not "approve" cosmetic products, and such statements are considered false advertising, leading to immediate warning actions.

❌ Examples to avoid: "FDA approved," "FDA certified"

2. Claims of "Treating or Mitigating Diseases"

In the U.S., cosmetics are solely intended for aesthetic improvement. Any claims related to the diagnosis, treatment, or mitigation of diseases will classify your product as an Over-the-Counter (OTC) drug. If your product uses such claims without FDA registration as an OTC drug, it could be denied entry.

❌ Examples to avoid: "Acne treatment," "Eczema healing balm," "Psoriasis relief cream"

3. Emphasizing Active Ingredient Content

If you highlight the specific percentage or concentration of an ingredient, you must have scientific data to substantiate that claim. The FDA requires scientific evidence, and if the actual content differs or if supporting data isn't provided, it will be considered a false claim.

✅ Instead, simply state the ingredient's presence: "with retinol" (rather than emphasizing a specific function or percentage without substantiation)

4. Missing Country of Origin or U.S. Contact Address

Following MoCRA implementation, all cosmetic labels must clearly state the country of origin and the name and address of the U.S. Responsible Person. Failure to disclose the country of origin or omission of the U.S. contact information will lead to customs clearance refusal by both the CBP (Customs and Border Protection) and the FDA.

✅ Example: "Made in Korea / Distributed by [U.S. Company Address]"

5. No Usage Warnings or Directions

The absence of warning statements for specific areas of use (e.g., around the eyes, sensitive areas) or missing directions for use are frequently cited issues, especially for products like peel-off masks or those containing chemical ingredients. Warning statements are considered mandatory for U.S. consumer protection, and their absence on the label can result in product rejection.

✅ Examples to include: "For external use only," "Avoid contact with eyes," "Not for use on damaged skin"

For companies exporting to the U.S., cosmetic labeling is far more than a design exercise. While many K-beauty brands successfully complete MoCRA facility and product registration, they still face import holds and FDA enforcement due to labeling non-compliance.

Think of your label as more than marketing—it’s a regulatory communication tool. It must speak not only to your customers, but also to FDA reviewers. A compliant label protects your brand, ensures market access, and builds long-term consumer trust.

Read more : After MoCRA, What's Next for Global Beauty? Find the Answer at the ACI Forum.

Provision Consulting Group is a specialized consulting firm focused on FDA regulatory approvals and FDA inspection readiness. We are committed to supporting and partnering with

Korean companies to ensure successful entry into the U.S. market.

If you have any questions or need assistance, please feel free to contact us.

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