In the United States, cosmetic products must comply with specific labeling requirements mandated by the Food and Drug Administration (FDA) and other regulatory bodies. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These guidelines ensure consumer safety and provide transparency regarding the product’s identity, origin, and contents. This information was mandatory prior to the Modernization of Cosmetic Regulation Act (MoCRA) enforcement and remain valid, alongside new requirements introduced with the MoCRA.
Currently, there are no regulations or requirements under current United States law that require cosmetic manufacturers to print expiration dates on the labels of cosmetic products, but cosmetic firms have a responsibility for the safety of their products.
Labelling Requirements
- Statement of Identity
The statement of identity refers to the name that identifies the cosmetic product. It can be a common or usual name, a descriptive title, or even a fanciful name that is easily understandable by consumers. Additionally, illustrations that depict the intended use of the product may be used. However, the statement should not reference a specific ingredient unless it’s clear that other ingredients are also present. This statement must be prominently displayed on the main display panel, visible to consumers when placed on a retail shelf.
- Net Quantity Declaration
The declaration of net quantity must appear on the principal display panel. For solid, viscous, or aerosol products, the net weight should be listed, while for liquids, the volume is required. Imperial system (ounces, pounds) is mandatory and the metric system (grams, liters) could be used, reported in brackets.
- Ingredients List
The list of ingredients must be reported with the International Nomenclature of Cosmetic Ingredients (INCI) names. Ingredients are listed in descending order based on their weight, except for those below 1% and colorants. Similar to the European Regulation, could be used the generic name Fragrances and the term “may contain” followed by a color name for products with different shades, such as make-up products. Colorants must be FDA-approved, and some may require a batch certification before use.
- Warnings and Usage Instructions
Labels must include clear and comprehensive warnings to ensure safe usage. The FDA has specific warning requirements for particular products, while products containing ingredients that have not been proven safe may need additional warnings according to CFR 21.
- Manufacturer, Packer, or Distributor Information
The label must provide the full name and address of the manufacturer, packer, or distributor. This information identifies the “Responsible Person” for the product in case of inquiries or issues.
- Country of Origin
The U.S. Customs and Border Protection (CBP) requires that the country of origin be indicated on the label. This should be the country where the product underwent substantial transformation. In some cases, abbreviations like “PCR” for “People’s Republic of China”, are not accepted.
- Placement of Information
Labelling requirements vary between primary and secondary packaging. On the outer package, the product name, statement of identity, any warnings, and the net quantity must be on the principal display panel, that part of the label that is most likely to be shown or examined under customary conditions for retail sale. Other information, such as usage instructions and ingredients, can be placed on the information panel. For inner packaging, the name and optional statement of identity may be listed on the front, while other mandatory details go on the information panel. For the inner container, ingredient lists are not always required.
- Claims and Product Classification
Cosmetic labeling must be truthful and not misleading. Claims made on cosmetic labels play a crucial role in determining product classification. If a claim implies that a product can affect the body’s structure or function, it may be classified as an OTC drug, even if it contains no active pharmaceutical ingredients. Cosmetics are defined as products intended to cleanse, beautify, or alter appearance, and only claims that imply these functions are accepted
MoCRA Updates
- Professional-use products
The Modernization of Cosmetics Regulation Act introduces new requirements, particularly for professional-use products, adverse event reporting, and fragrance allergen declarations. Professional-use products must clearly state that they are for use by authorized professionals only.
- Adverse event reporting
By the end of 2024, manufacturers must include a contact method for reporting adverse events, such as a U.S.-based address, phone number, or an electronic contact. Phone number must be available during office hours and the person answering must be trained to handle adverse event reporting.
- Allergens
The FDA will publish a draft guidance on fragrance allergens by late 2024, with a final implementation likely in late 2025 or early 2026.
In conclusion, compliance with U.S. cosmetic labeling laws is critical for product safety and transparency. By following the FDA’s requirements and staying informed of regulatory updates, manufacturers can avoid common errors and ensure their products meet legal standards.
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