US FDA Cosmetic Labeling Compliance FDA labeling requirements for cosmetics

The FDA regulates the labeling of cosmetics and beauty products, to guarantee safety and accuracy for consumers. From ingredient lists to product claims, get up-to-date on the current labeling regulations with our FDA cosmetic labeling consultants.  Cosmetic products that are compliant with FDA labeling requirements can be sold in the United States. Learning the regulations and guidelines for cosmetic labeling from the FDA is essential for any cosmetics manufacturer looking to launch their product.

We are a cutting-edge platform, committed to offering Cosmetic Label Compliance solutions in the US and catering to Federal Food, Drug, and Cosmetic (FD&C) Act regulations and Fair Packaging and Labeling (FP&L) Act.

FDA Cosmetic Labeling Compliance

FDA governs and enforces regulations for cosmetic products in Canada. Whether products are manufactured or imported from abroad must stay in compliance with the labelling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act of FDA. Product labels must also comply with the act. Any cosmetic products in US are considered misbranded in the following situations.

  • Labelling is misleading or false
  • label does not include the name and address of packer, manufacturer or distributor
  • The net quantity of contents is missing
  • The required information is not stated prominently
  • The statement is not readable and understood by consumers

Understand the Cosmetic Product Labeling Requirements:

The labeling requirements for cosmetics apply to all product categories and types. Cosmetic labels must include the brand name, product type, designation of purpose and a list of active ingredients. Furthermore, if the cosmetic has color additives or contains any known skin sensitizers, their presence must be disclosed on the label. Additionally, cosmetics that make a claim about their performance or use must also be labeled with additional claims information.

Cosmetic Manufacturing Facility
Cosmetic Manufacturing Facility

Register Your Cosmetic Establishment with the FDA:

All cosmetic manufacturers, packagers, and distributors are required to register their establishments with the FDA. Companies selling cosmetics in the United States must provide a Consumer Commodity Initial Registration or Qualified Persons Certification (FDA-CFP-36) as proof of registration. Furthermore, foreign establishments offering cosmetic products for import into the U.S should submit a Cosmetic Establishment Registration form. These forms must be submitted prior to any product release and updated annually thereafter.

Become Familiar With Good Manufacturing Practices (GMPs):

The FDA’s Good Manufacturing Practice (GMP) requirements apply to all cosmetics sold in the United States. GMPs may include general hygiene guidelines, health and safety regulations, inspection procedures and packaging education for your employees. It is recommended that cosmetic manufacturers become familiar with the GMP regulations found in Part 211 of the Code of Federal Regulations (CFR). Compliance with these quality standards will ensure product safety, purity and efficacy.

Cosmetic Manufacturing Facility
Cosmetic Manufacturing Facility

Know Ingredients and Contaminant Limits Established by the FDA:

It is important to remain aware of the FDA’s specific regulations concerning allowable ingredients, levels and safe usage information in cosmetic products. Product safety depends on keeping all ingredient levels within the limits set by the FDA. In some cases, testing must be conducted to ensure that pathways for contamination have been identified and preventive controls have been implemented. These evaluations set limits from chemical contaminates – such as metals and impurities – which may enter into products during their manufacturing process or through packaging materials.

Develop Effective Quality Control Procedures for Cosmetics Products FDA Cosmetic Labeling Ingredients List:

Quality control for cosmetics manufacturers involves routine testing of raw materials and ingredients, assessing equipment performance, ensuring product consistency, testing products prior to release, examining packaging components and conducting microbial lab tests; all with the goal of guaranteeing retail products meet all industry standards. Quality systems must be adapted to guarantee that while all applicable national regulations are met, companies operating in different countries also comply with their local guidelines and regulations.

All cosmetics and beauty products sold in the United States must include an ingredient list on their labels. This list should provide clear and accurate information about what’s inside the product, including ingredients derived from animal sources, that are potential allergens, or that have been evaluated for safety by regulatory authorities. Consumers should be sure to always check the ingredient list before they purchase and use products.

FDA Cosmetic Labeling Requirements
FDA Cosmetic Labeling Requirements

Net Content and Supplementary Label Information

All labels for cosmetics and beauty products must include the net contents. This is the amount of product that a consumer can expect when they purchase it. The label should also include any additional information needed on a supplementary panel, like directions for use or warnings about possible skin sensitivities. A list of inactive ingredients may also be included on a secondary or supplementary label dependent upon FDA requirements.

Claim Substantiation & FDA Labeling Requirements

It is important that manufacturers adhere to the FDA’s claim substantiation and labeling requirements. Cosmetic product labels must not be false or misleading, exaggerate what products can do, or rely on testimonials. Claims must be backed up with reliable scientific evidence whenever claims are made about product performance. Packaging should also provide adequate space for listing ingredients and other relevant information.

FDA Cosmetic Labeling Requirements
FDA Cosmetic Labeling Requirements

Special Warnings/Claims & Qualifications

Additionally, special warnings or qualifiers may be necessary in certain cases to adequately inform potential buyers of any potential risks associated with the use of a product. For instance, cautionary language should appear on the label if the product can cause skin irritation, eye injury, ingestive toxicity, dermatitis, and other adverse reactions. Labels must include information on proper usage and any precautions consumers need to take when using a cosmetic product.

When manufacturing cosmetics, it is important to ensure that labels include clear and accurate information about the product for consumers in a way that is easily understood. Claims should be accurate and disclosed with adequate support. Furthermore, claims based on scientific opinion should also have acknowledged experts who can provide evidence to back them up. Additionally, specified warnings should also be included when necessary.

Get Expert US Cosmetic Label Compliance

Registering cosmetics is voluntary. The reporting system for this voluntary program is called the Voluntary Cosmetic Registration Program (VCRP). We offer two tiers of services. Our first tier reviews your artwork and provides comments (proofing).  Our second tier, design conversion solution whereby our graphic designer prepares a fully compliant, print-ready art file (you provide us with the images, logo and text. Our services include:

  • Assist with ingredient selection 
  • Help with new product formulations
  • Evaluate ingredients for safety and efficacy
  • Prepare full toxicology dossiers
  • Evaluate formulas and ingredients 
  • Complete all necessary scientific and medical writing
  • Develop compliant labels and offer translation services
  • Review labels for compliance
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