FDA Cosmetic Labeling Requirements

Updated May 1, 2023

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.

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. 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 means cosmetics companies will need to update their products’ labeling to include declaration of fragrance allergens.

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists can help review your product’s label for FDA compliance.

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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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, cosmetic labeling regulations 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.

California Reporting Requirements

While allergen-related regulations for cosmetics is not found at the federal level, products marketed in California will be subject to additional requirements of which manufacturers and distributors should be aware.

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

MoCRA requires 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. 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 FDA compliance.

Registrar Corp’s Regulatory Specialists can help you register your cosmetic facility with FDA.

For more information about FDA Registration, 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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Don’t wait! Renew your
FDA registration today.

Registrar Corp will help you re-register with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.


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