U.S. LABEL COMPLIANCE CHECK

U.S. Cosmetic Label Compliance Check is the process of reviewing the labels of cosmetic products to be sold in the United States to ensure they comply with the regulations and standards set by the FDA (Food and Drug Administration). This process aims to ensure consumers are accurately informed, protected from misleading claims, and can use the products safely.

Legal Basis:

Cosmetic labeling is primarily regulated by two federal laws:

• Federal Food, Drug, and Cosmetic Act (FD&C Act): This law mandates that cosmetic products be safe and properly labeled.

• Fair Packaging and Labeling Act (FPLA): This law requires certain information to be included on labels to enable consumers to compare products and make informed choices.
  
  

Key Elements Reviewed in a Cosmetic Label Compliance Check:

• Statement of Identity: The name that clearly and accurately describes what the product is. For example, "Facial Cleansing Gel," "Moisturizing Lotion."

• Net Quantity of Contents: Accurate declaration of the amount of product in the package, in both metric (grams, milliliters) and/or U.S. customary units (ounces, fluid ounces).

• Ingredient Declaration: A list of all ingredients in the product in descending order of predominance by weight. Ingredient names should be listed using INCI (International Nomenclature of Cosmetic Ingredients) names.

• Name and Place of Business: The full name and business address of the responsible party (manufacturer, packer, or distributor). For foreign firms, the country name must be included in addition to the city, state, and postal code.

• Directions for Use: Instructions on how to use the product safely and effectively. Specifically, the steps necessary to achieve the expected results should be clearly stated.

• Warning/Caution Statements: Information about potential hazards associated with the use of the product and necessary precautions. For example, "Avoid contact with eyes," "Keep out of reach of children."

• Country of Origin: If the product is manufactured outside the United States, the country of origin must be indicated as "Made in [Country Name]".

• Claims: Claims made about the product's structure or function (e.g., "moisturizes," "reduces wrinkles") must be truthful and substantiated. Exaggerated, misleading, or drug-like claims ("treats," "cures") should be avoided.

• Language: All mandatory information on the label must be in English. Other languages may be added voluntarily.

• Font and Size: Information must be easily legible and of sufficient size. There are minimum font size requirements for certain information.

• Placement: Mandatory information may need to be placed on specific parts of the label (front panel, back panel, etc.).

Why is it Important?

• Legal Compliance: It is mandatory to comply with FDA regulations and avoid penalties.

• Consumer Confidence: Accurate and transparent labeling helps you gain consumer trust and loyalty.

• Brand Reputation: Inaccurate or misleading labels can seriously damage your brand image and reputation.

• Market Access: Non-compliant labels can cause your products to be held up at customs, prevent their sale, or lead to recalls.
  
  

Who Should Have It Done?

All companies that manufacture, import, pack, or distribute cosmetic products in the U.S.