Cosmetic products distributed in the US must comply with FDA labeling regulations under the FD&C Act and the FPLA.
“Labeling” includes the product label and any written or graphic information accompanying the product.
Our regulatory team can assist you with compliance in the following areas:
- Ingredient and color additive compliance
- Cosmetic product name and identity
- Marketing statements, claims, and taglines
- General FDA cosmetic labeling requirements
At Liberty Management Group, our specialists conduct a detailed review, identify deficiencies, and deliver corrected, ready-to-use FDA-compliant cosmetic labels accurately and efficiently.
Frequently Asked Questions (FAQs)
1. What does FDA cosmetic label compliance mean?
It means the product’s labeling meets all applicable FDA requirements related to product identity, ingredient declaration, mandatory warnings, and formatting.
2. Does the FDA approve cosmetic labels before products are sold?
No. The FDA does not preapprove cosmetic labels. Manufacturers are fully responsible for ensuring compliance before marketing.
3. What information is required on a cosmetic product label?
- Product identity (what the product is)
- Net quantity of contents
- Manufacturer, packer, or distributor name and address
- Ingredient list
- Required warning statements
- Proper label formatting and placement
Example: Non-compliant vs. Corrected Label
4. Do cosmetic ingredients need to follow a specific naming convention?
Yes. Ingredients must follow the name designated by the Commissioner or names published in the most current edition of the CTFA/INCI.
5. Are cosmetic claims regulated by the FDA?
Yes. Certain claims may cause a cosmetic to be classified as a drug, triggering additional regulatory requirements.
6. Does the FDA review cosmetic labels during facility registration?
No. Registration and listing do not involve label approval. Compliance responsibility remains with the company.
7. What are the consequences of non-compliant cosmetic labels?
Non-compliant labels may result in warning letters, import detention, product recalls, or import alerts.
