FDA Cosmetic Labeling Requirements
Importance of Proper Cosmetic Labeling
- Accurate and FDA-compliant cosmetic labels and claims are essential for achieving commercial success in the United States. Adhering to FDA cosmetic labeling requirements ensures compliance with FDA standards, helping cosmetic manufacturers, packagers, labelers, and brand owners avoid legal consequences, such as FDA enforcement actions. This safeguards US consumer safety, maintains supply chain stability, and strengthens a cosmetic brand’s long-term reputation.
- Labeling issues are often the leading cause of delays in U.S. customs release or FDA import detentions. Incorrect or incomplete labeling can cause significant delays, disrupt supply chains, and increase costs. Accurate cosmetic labeling is essential to avoid these problems and ensure smooth import and distribution.
FDA Cosmetic Labeling Requirements
The FDA defines cosmetics as products applied to the human body to cleanse, enhance attractiveness, or change appearance without impacting the body’s structure or functions. Based on this definition, an improper therapeutic claim on a cosmetic product violates the FDA regulation. The differences between a cosmetic claim and a drug claim can be very subtle, and failure to understand the distinction can result in enforcement actions by the FDA.
Here are the key elements to consider in cosmetic label design:
● Format, Font Size, the Order of Information● Principal Display Requirements● Product Identity and Health Claims Statements● Ingredients Listing Requirements● Warning Statement Requirements● Quantity & Place of Business Requirements● Adverse Event Reporting Contact
Here are the key elements to consider in cosmetic label design:
● Format, Font Size, the Order of Information● Principal Display Requirements● Product Identity and Health Claims Statements● Ingredients Listing Requirements● Warning Statement Requirements● Quantity & Place of Business Requirements● Adverse Event Reporting Contact
New Cosmetic Labeling Requirements under MoCRA
Recent FDA cosmetic regulations, such as the Modernization of Cosmetics Regulation Act MoCRA, have set new cosmetic labeling requirements. These include incorporating a Responsible Person’s contact information and a domestic address, declaring specific information about products for professional use, and detailing fragrance allergens.
Cosmetic ingredients must be listed according to the widely accepted International Nomenclature Cosmetic Ingredient (INCI). When formulating a cosmetic product, a manufacturer must avoid using harmful ingredients listed on the FDA’s Prohibited & Restricted Ingredients list. Cosmetics cannot include active medicinal ingredients, so any claims made about the product must be toned down to be purely cosmetic.
Furthermore, using concise and easy-to-understand language on the cosmetic label is critical, as technical terms or complex wording could confuse or mislead consumers. Given the available surface area, complying with the minimum font size requirements on the cosmetic label is vital. Cautions and warnings are another indispensable part of the cosmetic label; specific precautionary measures such as preliminary skin tests or self-pressurized container warnings are good examples.
Cosmetic ingredients must be listed according to the widely accepted International Nomenclature Cosmetic Ingredient (INCI). When formulating a cosmetic product, a manufacturer must avoid using harmful ingredients listed on the FDA’s Prohibited & Restricted Ingredients list. Cosmetics cannot include active medicinal ingredients, so any claims made about the product must be toned down to be purely cosmetic.
Furthermore, using concise and easy-to-understand language on the cosmetic label is critical, as technical terms or complex wording could confuse or mislead consumers. Given the available surface area, complying with the minimum font size requirements on the cosmetic label is vital. Cautions and warnings are another indispensable part of the cosmetic label; specific precautionary measures such as preliminary skin tests or self-pressurized container warnings are good examples.
How We Can Help
When you engage with FDA Agent Pro, a cosmetic labeling expert will review your product to ensure it meets the general packing and labeling requirements known as the Fair Packaging and Labeling Act (FPLA).
Next, we conduct a comprehensive review of each specific health-related claim to ensure it will not fall into the drug category as defined by the FDA drug regulations. Our thorough approach leaves no stone unturned, examining all aspects of direct or indirect claims to see if they seem substantiated and truthful and making interpretations and recommendations for changes as required.
We further review your ingredients for proper listing and cross-check them with the FDA’s available cosmetic ingredient resources. Lastly, we look at your label from the individual regulatory and US customer perspectives. We provide suggestions for proper wordings based on standard American English and design implications and interpretations in the eyes of an average American customer, ensuring your product resonates in the US market. Please feel free to call or email us if you need assistance to comply with FDA cosmetic labeling requirements.
Next, we conduct a comprehensive review of each specific health-related claim to ensure it will not fall into the drug category as defined by the FDA drug regulations. Our thorough approach leaves no stone unturned, examining all aspects of direct or indirect claims to see if they seem substantiated and truthful and making interpretations and recommendations for changes as required.
We further review your ingredients for proper listing and cross-check them with the FDA’s available cosmetic ingredient resources. Lastly, we look at your label from the individual regulatory and US customer perspectives. We provide suggestions for proper wordings based on standard American English and design implications and interpretations in the eyes of an average American customer, ensuring your product resonates in the US market. Please feel free to call or email us if you need assistance to comply with FDA cosmetic labeling requirements.
Cosmetic Label Review Process Cost: $594
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to collect additional company and product label details
Step 3
We analyze and review Principal Display Panel PDP, Health Claims Review, Product Direction & Warnings
Step 4
Ingredient Nomenclature Review, Responsible Party & Adverse Event Contact Information
Step 5
We ensure your label meets the general packing and labeling requirements known as the Fair Packaging and Labeling Act (FPLA)