Author

Anna Benevente

Director of Labeling, Ingredient and Product Review

FDA Cosmetic Labeling Requirements

Jan 13, 2024

Allergic reactions are a common issue in the U.S., often occurring when someone comes into contact with a substance that their body perceives is harmful. This concern extends to cosmetics, making understanding US cosmetic labeling requirements crucial for consumer safety.

Whether the person is consuming an allergen through food or drink or contacting the substance with their skin, if the individual’s immune system attempts to fight the substance through releasing antibodies, a reaction is likely to occur. Allergic reactions can range from a mild rash to anaphylaxis, a severe and sometimes fatal reaction.

FDA regulates the declaration of allergens on food and beverage labeling extensively, but the same labeling regulations do not apply to allergens in cosmetics. Understanding cosmetic labeling requirements in the US is now more important than ever. With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA now has authority to create and enforce requirements for labeling allergens in cosmetic products.

Upcoming FDA cosmetic labeling requirements mean cosmetics companies will need to update their products’ labeling to include the declaration of fragrance allergens.

Do you need to list allergens on your cosmetic label? What sort of requirements must you meet in California? Keep reading to learn about current federal FDA and California state requirements.

Current Labeling Requirements for Cosmetic Products

Products that FDA regulates as food must bear a label that includes the common name of any “major food allergen” (as specified in the Food Allergen Labeling and Consumer Protection Act of 2004), either in the ingredients list or with a “contains” statement.

However, until FDA releases and enforces guidelines for labeling cosmetics allergens, this same requirement does not currently extend to cosmetics and personal care products.

FDA has determined the allergens that cause most allergic reactions due to use of a cosmetic product. These allergens are divided into 5 classes:

  • Preservatives
  • Metals
  • Fragrances
  • Natural rubber
  • Dyes

The Fair Packaging and Labeling Act (FPLA) gives FDA the authority to require an ingredient declaration on retail cosmetic products. However, certain ingredients that commonly contain allergens may be exempt from the declaration of the common name. For example, US cosmetic labeling requirements permit the labeling of “fragrance” and “flavor” without specifying the exact ingredient(s).

Although FDA requires an ingredient declaration on cosmetic labels, certain allergy claims are unregulated. For example, federal regulations do not govern or define terms like “fragrance-free” “hypoallergenic”, or “for sensitive skin”.

These are terms that the company manufacturing the product define, as FDA has not established any formal definitions or policies for their use. While these terms may provide a marketing advantage, FDA has stated that they may have very little meaning. Notwithstanding this, FDA has not imposed any specific restrictions on their inclusion on a label.

Understanding US cosmetic labeling requirements is essential for compliance and consumer safety.

California Reporting Requirements

While allergen-related regulations for cosmetics are not found at the federal level, products marketed in California will be subject to additional requirements of which manufacturers and distributors should be aware. Understanding US cosmetic labeling requirements is essential for companies operating in multiple states.

Under the California Safe Cosmetics Act of 2005, California established a list of ingredients suspected to cause cancer or reproductive harm, and mandates that products containing any of these ingredients be reported to the state.

The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) went into effect on January 1, 2022. CFFIRKA designates a subset of ingredients called “fragrance allergens” and specific ingredients that must be reported only if used as a fragrance ingredient (regardless of their function).

They must be reported by the company named on the label when present at a concentration of 0.01% (rinse-off cosmetics) or 0.001% (leave-on cosmetics).

Upcoming Changes in FDA Cosmetic Labeling Requirements

The new MoCRA regulations require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement must contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings.

Cosmetic products that contain fragrance allergens will need to update their label to list fragrance allergens. These upcoming changes to US cosmetic labeling requirements aim to enhance transparency and consumer safety. FDA must issue a proposed list of fragrance allergens within 18 months after the date of MoCRA’s enactment, with the final ruling issued no later than 180 days after the public comment period closes.

Get assistance with understanding and implementing US cosmetic labeling requirements for FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance, ensuring adherence to all US cosmetic labeling regulations.

For more information, call us at +1-757-224-0177, email us at info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/contact.

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FAQ: Understanding FDA Cosmetic Labeling Requirements

What are the FDA requirements for product labeling?

The FDA regulates cosmetic labeling to ensure consumer safety and transparency. With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the requirements have been updated and now include:

  • Identity Statement: Clearly states the product’s identity, such as “shampoo” or “moisturizer,” on the principal display panel.
  • Net Quantity of Contents: Indicates the amount of product in the package, expressed in weight, measure, or numerical count.
  • Ingredient Declaration: Lists all ingredients in descending order of predominance on the information panel. This includes fragrances and color additives.
  • Name and Place of Business: Provides the name and address of the manufacturer, packer, or distributor.
  • Warnings and Directions: Includes necessary warning statements and directions for safe use. This is crucial for products that could be hazardous if misused.
  • Fragrance Allergen Disclosure: Under MoCRA, any fragrance allergens present in the product must be listed on the label once the FDA issues its final rule on the required allergens.

How must ingredients be listed on cosmetic labels?

Under MoCRA and existing regulations, ingredients must be listed following these guidelines:

  • Descending Order: Ingredients should be listed in descending order of predominance by weight.
  • Common or Usual Names: Ingredients should be identified by their common or usual names.
  • Specific Naming for Certain Ingredients: Fragrances and flavors can be listed as “fragrance” or “flavor” without specifying individual components, though specific allergens will need to be disclosed.
  • Threshold Levels: Ingredients present at less than 1% can be listed in any order after those present at more than 1%.

What are the rules for listing ingredients on a label?

The FDA’s rules for listing ingredients on cosmetic labels under MoCRA and existing guidelines include:

  • Placement: The ingredient list must appear prominently on the product’s information panel, which is typically on the back or side of the packaging.
  • Order: Ingredients must be listed in descending order of their predominance by weight.
  • Nomenclature: Use INCI (International Nomenclature of Cosmetic Ingredients) names when available.
  • Fragrance and Flavor: Can be listed collectively without specifying each component, though allergens will need to be disclosed under new rules.
  • Color Additives: Must be declared using specific names as approved by the FDA.
  • Allergens: Fragrance allergens must be listed according to the forthcoming FDA regulations under MoCRA.

What kind of ingredients do not have to be listed on the label?

While MoCRA has introduced more stringent requirements, certain ingredients may still be exempt from individual listing:

  • Fragrance and Flavor Components: Can be collectively listed as “fragrance” or “flavor,” though specific allergens must be disclosed.
  • Incidental Ingredients: Those that have no technical or functional effect in the finished product and are present at insignificant levels may not need to be listed.
  • Trade Secret Ingredients: Rarely, some ingredients considered trade secrets can be exempt from listing if they meet specific FDA criteria and justification.

Author


Anna Benevente

Director of Labeling, Ingredient and Product Review

Highly regarded as a top expert on FDA labeling regulations, Anna Benevente continues to educate companies on existing regulations and updates from U.S. FDA for food and beverage, cosmetic, drug, and medical device products. She has researched thousands of products to determine whether they meet the FDA requirements for compliance. In addition, Ms. Benevente has conducted multiple seminars for trade and customs broker associations.

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