Claims Compliance Guide

Last reviewed: August 2026. Claims can change a product’s regulatory route. The same formula may be an ordinary cosmetic in one market and a drug, quasi-drug or functional cosmetic in another because of intended use and wording. This is a practical planning guide, not legal advice.

Why this matters before launch

Decisions in this area affect formula, claims, labeling, technical documentation and the selected country route. Review them before commercial artwork or production is locked.

Key concepts

Cosmetic claim

A claim about cleansing, beautifying, appearance or other permitted cosmetic positioning.

Therapeutic trigger

A disease-treatment, prevention or structure/function claim can change the route.

Claim substantiation

Evidence must support the final market-facing claim.

How to manage the work

1. Choose Market
2. Create Claims Matrix
3. Screen Classification
4. Collect Evidence
5. Review Artwork
6. Approve Copy

What the factory needs and does

The factory supplies the controlled technical evidence required for review.

• Provide efficacy and safety support relevant to the formula and claim.
• Flag claim-sensitive ingredients and product functions.
• Maintain controlled product and test records.

What the brand needs and does

The brand owns market position, final claims and market-facing approvals.

• Define all claims across pack, web and advertising.
• Approve evidence and local wording before artwork release.
• Keep marketing materials consistent with the selected route.

Core file checklist

• Claims matrix for pack, web and advertising
• Formula and efficacy-support evidence
• Final labels and product-page copy
• Market review notes and change records

Related market guides

• Product Classification
• United States
• Japan & South Korea

Official resources

• FDA — cosmetic, drug or both
• EU Cosmetics Legislation