U.S. FDA Registration & Labeling Compliance Assistance

FDA Cosmetic Labeling Review

Proper cosmetic labels and claims are critical to the import and commercial success of cosmetics in the United States. Labeling issues are often the primary cause of delays in customs release or FDA import detentions. It is critical that your cosmetic ingredients are permitted by FDA and labeled accordingly. A common violation of FDA regulation is an improper therapeutic claim on a cosmetic product. The differences between a cosmetic claim and a drug claim can be very subtle, and failure to appreciate these can result in enforcement actions by the FDA.

Here are some of the label design elements to be considered:

• Format, Font Size and the Order of Declarations of Information
• Principal Display Requirements
• Product Identity and Health Claims Statements
• Ingredients Requirements
•  Cross Checking Ingredients vis-a-vis FDA Cosmetic Ingredients Dictionary
• Warning Statement Requirements
• New Quantity & Place of Business Requirements

FDA Listing Inc. cosmetic labeling experts will first review your products to make sure they meet the general requirements of packing and labeling defined by the US Fair Packing and Labeling Act- FPLA- and Uniform Packing and Labeling Regulations- UPLR. Other aspects of review include;

Review of each specific claim, health related or otherwise, to make sure they don't fall into the drug category as defined by the FDA drug regulations. We review all aspect of either direct or indirect claims, to see if they seem substantiated and truthful, and make interpretations and recommendations for changes as required.

Review of your ingredients for proper listing and cross-checking them with the FDA's available cosmetic ingredient resources of.

Lastly,  not only we look at the individual regulatory aspect of your label, but also from the US customer perspective. We may provide you with suggestion for proper wordings based on common American English, and design implications and interpretations in the eyes of an average American customer.

If interested to get a free evaluation of your current label please fill up the form by clicking the start button.