Allergic reaction caused by contact with or consumption of allergens is a common issue. It can range from a mild rash to anaphylaxis that can even be fatal. Currently, there are extensive guidelines for labelling allergens in the food and beverage industry to protect consumers. Nevertheless, the use of cosmetics can also lead to allergic reactions. Thus, making the need for cosmetic labelling requirements vital for consumer safety. Hence, the FDA authorities are strictly enforcing FDA cosmetics labelling requirements. Thus, cosmetics manufacturers are obliged to comply with FDA cosmetics labelling guidelines and regulations.

With the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), the FDA is strictly implementing regulations for labelling cosmetics, especially the allergens in it. Hence, cosmetics companies will need to update their product labels to comply with new MoCRA cosmetics labelling requirements. Hence, we have created this guide to give cosmetics manufacturers an overview of the FDA cosmetics labelling guidelines. Understanding the FDA cosmetics labelling requirements is essential for regulatory compliance and consumer safety.

FDA list of allergens in cosmetics products

FDA has identified certain allergens that cause most allergic reactions due to the use of a cosmetic product. The Fair Packaging and Labeling Act (FPLA) grants FDA the authority to mandate an ingredient declaration on the label of retail cosmetic products. The FDA has categorised allergens into 5 classes:

1. Metals
2. Preservatives
3. Dyes
4. Fragrances
5. Natural rubber

MoCRA regulations: Changes in FDA cosmetics labelling guidelines

The new MoCRA aims to strengthen the regulatory guidelines for cosmetics products to protect consumer health. It has issued additional regulatory requirements for marketing cosmetics products in US. As per MoCRA guidelines, cosmetics companies will be required to submit a statement for each cosmetic product to be marketed in US. Among other details, the statement must contain information on the cosmetic’s ingredients and applicable warnings.

The changes in FDA cosmetics labelling guidelines aim to enhance transparency and consumer safety. Therefore, manufacturers producing cosmetic products with potential fragrance allergens will need to update their product label with fragrance allergens present. Thus, cosmetics manufacturers will have to implement this along with other cosmetic labelling requirements to comply with new MoCRA guidelines.

Understanding new FDA cosmetics labelling guidelines: MoCRA requirements

MoCRA has introduced new requirements for cosmetics product labels. Hence, compliance with the new FDA cosmetics labelling guidelines is mandatory for cosmetics manufacturers. The cosmetics product label should have a properly declared statement of identity and net quantity of contents (net weight). Additionally, it should mention the cosmetics product ingredient list with the names of each ingredient properly declared. Furthermore, the business name and address, country of origin, and any required warning/cautionary statement should be included on the label. Compliance with labelling guidelines is vital, as incorrect labelling can be interpreted as misbranding of products. Notably, in addition to the label content, the guidelines dictate the label placement, type size, and prominence.

New FDA cosmetics labelling guidelines: Key points to keep in mind

We have highlighted some major points to keep in mind while labelling your cosmetics products.

• The cosmetic product label should be large enough that the required information will be prominently displayed in a type size that is easily legible.
• The product ingredients should be listed in weight order, from the heaviest to the lightest. Additionally, they should be mentioned in the most commonly accepted industry standard names.
• The products that require a cautionary warning and/or directions for safe use must have that information presented in a noticeable and prominent manner.
• In case there is more than one label, the basic required information should be mentioned on the principal display panel.
• The FDA has not defined and does not regulate the terms, “natural” or “organic.”. However, your products should not be misleadingly or incorrectly labelled.
• As per guidelines, the necessary label content that should be mentioned include the name of the product and net quantity. Additionally, the directions for safe use, any warnings or caution, and an ingredient list should be provided. Furthermore, the business information should be provided.

Your guide to FDA cosmetics labelling guidelines

This guide will give you an idea of the FDA cosmetics labelling guidelines. It will help you ensure your product is providing consumers with the necessary information, as per regulatory requirements, they need to stay safe.

What are the guidelines for listing ingredients on the cosmetics product label?

In accordance to the MoCRA guidelines, the FDA has laid down the following rules for listing ingredients on cosmetics product labels:

• Nomenclature for the ingredients: Use of International Nomenclature of Cosmetic Ingredients (INCI) names is recommended when available.
• Order: The product ingredients must be mentioned in descending order of their predominance as per their weight.
• Placement of the label content: The ingredient list must be visible prominently on the cosmetics product’s information panel. This is usually on the back or side of the packaging.
• Color additives: Colour additives used must be declared using specific names as approved by the FDA.
• Allergens: Fragrance allergens present in the product must be listed according to the FDA regulations as per MoCRA guidelines.
• Fragrance and flavour: The fragrance and flavour used in the product can be listed collectively on the label without specifying each component. However, the allergens will need to be disclosed separately on the label.
• Threshold levels: Ingredients present in the product at less than 1% can be listed in any order after those present at greater than 1%.

What product ingredients do not have to be listed on the cosmetics product label?

Although MoCRA has introduced stringent requirements for labelling cosmetics products, certain ingredients may still be exempt from listing requirements.

• Incidental product ingredients: Those product ingredients that have no technical or functional effect in the finished product and are present at negligible levels need not be listed.
• Fragrance and flavour components of the cosmetics product: The fragrance and flavour product components may be collectively listed as “fragrance” or “flavor.” However, the specific allergens must be flagged separately.
• Trade secret ingredients: Certain product ingredients and components considered trade secrets may be omitted from listing in the label, if they satisfy the FDA criteria and justification.

What are the FDA cosmetics labelling requirements?

The updated FDA cosmetics labelling requirements are as follows:

• Product identity statement: The cosmetics product’s identity, such as “shampoo” or “moisturizer,” should be clearly mentioned on the principal display panel.
• Net quantity of contents: The amount of product in the package, expressed in weight or numerical count, should be mentioned on the product label.
• Ingredient declaration list: List of all ingredients used in the product must be mentioned in the descending order of predominance on the information panel. Moreover, fragrances and colour additives should also be included in the list.
• Name and place of business: The name and address of the manufacturer, packer, or distributor should be mentioned on label.
• Warnings and directions for use: Necessary warning or cautionary statements and directions for safe use of the product should be mentioned.
• Fragrance allergen disclosure: Any fragrance allergen present in the cosmetic product must be listed on the product label.

In this blog, we have provided an overview of the FDA cosmetics labelling guidelines. For detailed information on the FDA cosmetics labelling requirements, feel free to contact us. Our team of experts has in-depth knowledge of the MoCRA regulations for cosmetics industry. We will help you achieve MoCRA compliance in a smooth and hassle-free manner. Simply drop an email at [email protected] or call/Whatsapp on 9996859227 and our team will get back to you.