FDA Cosmetic Labeling Requirements

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Importance of Proper Cosmetic Labeling

Accurate cosmetic labels and truthful claims are essential for marketing cosmetic products in the United States. Although the FDA does not generally pre-approve cosmetic labels or claims before marketing, manufacturers, packers, distributors, labelers, and brand owners are responsible for ensuring that products meet applicable FDA cosmetic labeling requirements. Proper labeling helps reduce the risk of a product being considered misbranded, supports consumer safety, and protects supply-chain continuity and brand reputation.

Furthermore, imported cosmetic products may be examined by U.S. Customs and Border Protection and the FDA upon entry. Incorrect, incomplete, or misleading labeling—including deficient ingredient declarations or missing required labeling information—may result in import delays, detention, refusal of admission, or the need to correct the product before distribution. Therefore, reviewing cosmetic labels before importation and U.S. distribution can help reduce avoidable compliance and supply-chain risks.

What are 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

What are the New Labeling Requirements under MoCRA ?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) introduced additional FDA cosmetic labeling requirements. These include providing domestic contact information for the Responsible Person to receive reports of serious adverse events and including certain information for cosmetic products intended only for professional use. Cosmetic businesses should also monitor FDA requirements regarding fragrance-allergen labeling as implementation continues to evolve.

Cosmetic ingredients must be listed according to the widely accepted International Nomenclature of Cosmetic Ingredients (INCI). When formulating a cosmetic product, a manufacturer must avoid using harmful ingredients listed on the FDA’s Prohibited & Restricted Ingredients list.

Cosmetic labels and claims must be carefully reviewed to ensure that the product remains within the cosmetic category. Under U.S. law, a product may be regulated as a drug or as both a cosmetic and a drug when its intended use includes treating or preventing disease or affecting the structure or function of the human body. Therefore, claims made on the product label, website, advertising, social media, and other promotional materials should remain consistent with the product’s intended cosmetic use.

It is important to note that the responsibility for product formulation lies with the manufacturer. This includes ensuring that all ingredients are permitted, that products do not contain substances on the FDA’s prohibited or restricted lists, and that overall product safety is established.

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 Can We Assist?

Please note that our label reviews focus solely on compliance with cosmetic labeling rules and do not replace product testing, safety evaluations, or legal certifications. When you engage with FDA Listing Inc., a cosmetic labeling expert will review your product to ensure it meets the general packaging and labeling requirements outlined in the Fair Packaging and Labeling Act (FPLA).

Next, we conduct a thorough review of each health-related claim to ensure it does not fall within the drug category as defined by FDA regulations. We will examine all aspects of direct or indirect claims to determine whether they appear to be substantiated and truthful, and provide interpretations and recommendations for any necessary changes. We will further review your ingredients to ensure they are properly listed on the cosmetic label, including appropriate INCI formatting where applicable.

Lastly, we examine your label from both a regulatory and U.S. consumer perspective. We provide suggestions for appropriate wording based on standard American English and design considerations, helping to ensure that the label is clear, appropriate for the U.S. market, and consistent with the product’s intended cosmetic use.

Please feel free to call or email us if you need assistance to comply with FDA cosmetic labeling requirements.

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