Labelling requirements for cosmetic prodcts in the US: Before and after MoCRA

Cosmetic products marketed in the USA, whether domestically manufactured or imported, must comply with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act). The label elements required under the FD&C Act must be indicated on both the inside and outside container, while the FP&L Act requirements, e.g. ingredient list,  apply only to the outer container. Before MoCRA, the labelling requirements for cosmetic products in the USA included the requirement for an ingredient list, product name and the place of business of the manufacturer, packer, or distributor. However, the specific inclusion of fragrance allergens and Responsible Person (RP) contact details has not been mandatory until MoCRA.

The most important labelling requirements for cosmetic products including the MoCRA additions are indicated as follows:

Ingredient Declaration

• Cosmetic products must declare each ingredient in descending order of weight, while fragrance and flavour substances may be listed differently.
• The ingredient declaration must be easily readable at the time of purchase and may appear on any information panel of the package.
• New in MoCRA: Each fragrance allergen in a product must be indicated additionally on the label.

Language Requirements

• Cosmetic labels must be in English language unless distributed in regions where English is not predominant.
• If foreign language representations are used, all labeling statements in that foreign language must also appear in English for clarity.

Net Quantity Declaration

• The net quantity declaration provides information on the weight, measure or numerical count of a product’s components.
• The size of this declaration depends on the packaging size and should be easily visible to consumers.
• If the product is solid or semi-solid, it needs to have weight measure in pounds (lb) or ounces (oz).
• If the product is liquid, it needs to have US gallons, pints, quarts or fluid ounces. It can, but it does not have to include metric units.

Business Name and Distributor Statement

• The name and address of the manufacturer, packer, or distributor should be clearly indicated on cosmetic packaging to ensure traceability and accountability.
• Imported products must bear the country of origin (with its English name).
• New in MoCRA: Every new cosmetic product must bear the contact details of the Responsible Person, including address, phone number, or electronic contact information, which may include a website.

Professional Cosmetics

• Professional cosmetics products labels are required to include the same information as other cosmetic products
• New in MoCRA: Additionally, professional cosmetics must explicitly indicate to be used by licensed professionals only and comply with FDA regulations.

Cosmetic Claims

• Care must be taken with cosmetic claims to avoid misbranding products as drugs.
• If a claim implies treating or preventing disease or affecting human body functions, it may classify the product as a drug under FDA regulation.

Label Warnings

• Cosmetics that may pose hazards when misused must have appropriate label warnings and clear directions for use.
• These warnings should be prominent and conspicuous on products like aerosols, feminine deodorant sprays, and children’s bubble bath products.

Adulterated Cosmetic Products

• A cosmetic product is considered adulterated under the FD&C Act if it contains harmful substances, dirty, putrid, or decomposed materials, or if it is manufactured under unsanitary conditions that may lead to contamination or adverse health effects.
• Adulteration also includes the presence of unsafe color additives, excluding coal-tar hair dyes.
• New in MoCRA: Introduction of additional requirements such as safety substantiation, compliance with Good Manufacturing Practices (GMP), adverse event recording and reporting, and registration of products and facilities to prevent adulteration.

Misbranded Cosmetic Products

• A cosmetic product is considered misbranded if it does not comply with labelling requirements established by relevant laws.
• Misbranding occurs when labels contain misleading or false information, lack mandatory labelling elements displayed prominently for consumer understanding, fail to label colour additives correctly, or if the container’s design is misleading.
• The FD&C Act prohibits the distribution of cosmetics which are adulterated or misbranded
• The FDA can take regulatory actions against companies marketing affected cosmetics, including requesting voluntary recalls if products are reasonably suspected to be adulterated or misbranded.