One of the key factors in bringing a new cosmetic product to the market is ensuring that your labelling is compliant. In the United States, cosmetic labelling is regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C) and under the Fair Packaging and Labeling Act (FPLA). Some of the reasons that a product can be considered misbranded include: its labelling is false or misleading its label fails to provide required information its required label information is not properly displayed

Obligations d'étiquetage cosmétique aux États-Unis

What does cosmetic labelling include?

It is important to note that, in the United States, the term “labelling” does not just refer to the sticker on a package, or the box it may come in. A product’s labelling includes “all labels and other written, printed, or graphic matter on or accompanying a product.” This ranges from a product’s physical packaging to the content on the brand’s website.

What information must be on a cosmetic label?

The displayed portion of the label, or the Principal Display Panel (PDP), must have the following information:

  • Identity statement
  • Net Quantity of Contents

The remainder of the required cosmetic labelling information can be displayed on portions of the label other than the PDP; the Information Panels. The Information Panels must include:

  • Name and Place of Business
  • Distributor Statement
  • Material Facts
  • Warnings and Precautions
  • Ingredients

Product name or identity

The identity statement indicates the nature and the use of the product. This tells the consumer what your product actually does. The product identity can be expressed using a common name, a descriptive name, or if the nature of the cosmetic is obvious, a fanciful name.

Net quantity

The net quantity declaration provides a weight, measure, or a numerical count of the product’s contents. It should appear on the bottom 30% of the PDP. The net quantity declaration should be distinct, easily legible, and in boldface. The FDA also specifies the size of the declaration based on the size of the cosmetic packaging.

The net quantity declaration must be in terms of a fluid measure if the cosmetic is liquid and of a weight measure if the cosmetic is solid, semi-solid, viscous, or a mixture of liquid and solid. Fluid measures can be expressed in US gallons, quarts, pints, or fluid ounces. Weight measures can be expressed in avoirdupois pounds or ounces. Net quantity declarations can additionally include metric units. Products that list their contents by weight must use the term “net weight” or “net wt.” in conjunction with the net quantity declaration, while products that list their contents by fluid can optionally use the term “net contents.”

Business name and distributor statement

A cosmetic label should also include the name and business address of the manufacturer, packer, or distributor. The street address can be omitted if the company is listed in a current city or telephone directory. If the name and address is not that of the manufacturer, this must be expressed with phrases such as "Manufactured for ...", "Distributed by ...", or other appropriate wording. Finally, imported products must state the country of origin by its English name.

Material facts

A cosmetic label should include any additional material facts that the consumer should be aware of. This can include Directions for Safe Use. Failure to reveal key material facts can be considered misleading, and can thereby result in a product being deemed misbranded.

Warnings and precautions

A cosmetic label must have a warning statement whenever necessary to prevent a health hazard that could be associated with the product (21 CFR 740). A cosmetic that does not have an appropriate warning statement may be considered misbranded. A warning statement must be conspicuous compared to other statements or designs, such that a consumer is likely to read it. This should be done through boldface type on a contrasting background, and with a minimum character height of 1/16”.

logo ECHA

The safety of a cosmetic can be considered adequately substantiated if scientific experts can reasonably conclude from available data that the product is not a hazard to consumers under conditions of use and reasonably foreseeable conditions of misuse. A cosmetic that has not had its safety adequately substantiated must bear the following statement on its PDP:

“Warning –The safety of this product has not been determined.”

Finally, there are also specific regulations regarding warning statements for some specific products. These products include aerosols, feminine deodorant, foaming detergent, and coal-tar hair dyes.

Ingredient Declaration

A cosmetic label must include an ingredients declaration, with the ingredients listed in descending order of predominance. However, there are a few exceptions to this:

  1. If the cosmetic is also an Over-the-Counter drug, the active drug ingredient(s) must be declared before the cosmetic ingredients.
  2. Ingredients that are present at a concentration not exceeding 1% can be listed in any order after the ingredients present at more than 1%.
  3. Color additives can be listed in any order after the listing of other ingredients. Any color additives not found in all shade formulations can be listed after “May Contain”.
  4. The phrase “and other ingredients” can be listed in place of the name of an ingredient accepted by FDA as a trade secret.

Other details to consider

Expration dating

There is currently no requirement to list an expiration date on a cosmetic product. However, cosmetic companies have a responsibility for the safety of their product. In order to ensure that their cosmetic product is being safely used, many brands choose to list an expiration date.

Language

All required cosmetic labelling information must be in English. The only exception is for products that are distributed solely in Puerto Rico or a territory where the predominant language is one other than English. In these regions, the required information can instead be stated in the region’s predominant language. It is important to note that if the label contains any foreign language representation, then all statements required by regulation must also appear on the label in that foreign language.

State regulations

In addition to the Federal regulations that are outlined by the FDA, many states have their own individual cosmetic regulations that must also be adhered to.

Want to know more about cosmetic labelling in the United States?

For more information on EcoMundo's services and software for your compliance in North America, do not hesitate to contact our expert, Mr. Michaël Sommeil by phone at : +1 (514) 575-6085 or even send him an email at [email protected]

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