Labelling is part of the identity of a cosmetic product, so it is an essential part of the development and marketing of a cosmetic product. However, in this regard, beauty brands shall also ensure that labelling meets the regulatory requirements.
A label is any wording, prints, or graphics on the outer packaging and container of a cosmetic product. The term label also refers to leaflets, inserts, and other promotional material accompanying the product.
In the United States, labels of cosmetic products must comply with the Federal Food, Drug, and Cosmetic (FD&C) Act, MoCRA, the Fair Packaging and Labeling (FP&L) Act, and any other relevant legislation. Non-compliance with labelling requirements makes those products misbranded, with various consequences, including denial of placing them on the US market and requested recalls or injunctions.
Here is our guide to help you avoid any possible compliance issues for your cosmetic products in the United States.
Mandatory elements on cosmetics labels
The US legislation establishes requirements on the placement, size, and language of the mandatory information to appear on the labelling of a cosmetic product.
According to US law, each label has a principal display panel (PDP), namely the part of the label that a consumer sees on shelves or at the time of purchase. Generally, the PDP is the front panel of the outer packaging, or the inner packaging for products sold without the outer packaging. The packaging parts that are not the PDP are called information panels.
The PDP must include the following information:
- Identity of the cosmetic product, i.e., commercial name and function (intended use)
- Net quantity in US units of measurement
- The warning “The safety of this product has not been determined” for products without adequate safety substantiation
Information panels must bear the following elements:
- Directions for safe use
- Warnings and precautions
- Name and place of business of the manufacturer, packer, or distributor. If the details are not that of the manufacturer, the name must be preceded by the appropriate wording, such as “Manufactured for” and “Distributed by”
- Ingredients list except for trade secret ingredients
Plus, some information requested by MoCRA:
- An address, phone number, or electronic contact information in the United States for reporting adverse events to appear by December 29, 2024
- Fragrance allergens (once the FDA determines the list — It has time until June 29, 2024, to issue its proposal)
- For professional products, a statement that they can only be administered or used by licensed professionals
The same information must also appear on the inner packaging.
If a product is, at the same time, a cosmetic and a drug, it should comply with labelling requirements for both categories. For example, the ingredients list shall include first the drug ingredients and quantity, the kind and proportion of any alcohol, and then the remaining ingredients.
Other labelling requirements
US law provides that labelling information must be prominent and conspicuous so it is easily readable and understandable by consumers. Therefore, there are fonts and size requirements for major elements. At the same time, graphics cannot obscure information, and there must be sufficient contrast with the background.
Moreover, labelling information must be in English unless products are sold solely in Puerto Rico or another Territory of the US where the predominant language is not English.
Labelling requirements are complex, but we are here to assist you. If you choose Obelis as your US Agent or regulatory consultant, we will review your product labels, ensuring they meet all relevant regulatory requirements. Our team of experts will work closely with you in all stages of the development and marketing of your products.
Don’t let regulatory challenges hold your business back. Contact us today to hear how we can help you place your cosmetic products on the US market!
Francesca Santacatterina
Publications Department
21.06.2023
References:
- FDA. (2022). Cosmetics Labeling Guide. Retrieved on 21.06.2023
- FDA. (2016). How FDA Evaluates Regulated Products: Cosmetics. Retrieved on 21.06.2023