US FDA Cosmetics Labeling Requirements and Regulations

UPDATE! The Modernization of Cosmetics Regulation Act (MoCRA) creates several important new requirements for cosmetics. Read about these new requirements here!

 

FDA defines a cosmetic as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance of the body. The definition excludes “soap” so technically, FDA does not regulate soap. However, FDA has very specific conditions for a product to be considered a “soap”, and so most soaps on the market do in fact fall under FDA’s jurisdiction.

A common misconception is that FDA does not regulate cosmetics. While FDA does not have premarket approval requirements for cosmetics and cosmetic ingredients (except that there are premarket approval requirements for color additive ingredients), FDA does in fact regulate cosmetics to ensure the products are not adulterated (i.e. contaminated) or misbranded (e.g. mislabeled.)

FDA can take regulatory actions against adulterated or misbranded cosmetics and the companies that market those products. For example, there are currently over ten import alerts covering cosmetic products. Below are actions cosmetic companies should take to avoid such regulatory actions.

Cosmetic Facility Registration

U.S. law now requires FDA registration of cosmetic manufacturers and processors! Under the Modernization of Cosmetics Regulation Act (“MoCRA”), these facilities must be registered by the following deadlines:

• Facilities that manufactured or processed cosmetics for distribution in the United States on December 29, 2022 must be registered by December 29, 2023.
• Facilities that first manufactured or processed cosmetics for distribution in the United States after December 29, 2022 must be registered by February 27, 2024 or within 60 days of manufacturing or processing the cosmetics, whichever is later.

FDA requires that the registrations be renewed every two years. Foreign registrants require a US Agent.

Note: Registration of cosmetic manufacturers and processors was previously voluntary, and submissions could be made through FDA’s Voluntary Cosmetic Registration Program (VCRP). As this registration is now mandatory, FDA has discontinued the VCRP. Any companies that registered through the VCRP must register again under FDA’s mandatory registration requirements.

Cosmetic Product Listing

FDA requires that all companies declared as the manufacturer, packer, or distributor on the label of cosmetic products to list each cosmetic they market in the United States. When a product is listed, it is assigned a listing number.

Submissions for cosmetic product listings must be submitted by the following deadlines:

• Cosmetic products that were marketed in the United States on December 29, 2022: December 29, 2023.
• Cosmetic products first marketed in the United States after December 29, 2022: 120 days of marketing the product or within 120 days of December 29, 2023, whichever is later.

Note: Information in any Cosmetic Product Ingredient Statements (CPIS) filed through FDA’s voluntary program will not be transferred to the mandatory listings.

FDA Ingredient and Product Safety

The company must be able to substantiate that each ingredient is safe under the labeled or customary conditions of use. In addition to substantiating the safety of each ingredient, some toxicological testing is usually needed for the formulated product to ensure the product is safe.

Also, each batch of certifiable color additives used in the product must be certified.

• For products containing animal-derived ingredients, determine whether the Animal and Plant Health Inspection Service (APHIS) allows those ingredients to be imported and whether the shipment must be accompanied by a Veterinary Services permit. The permit requirements depend on the animal source of the ingredient, the country of origin, and other factors.
• Determine whether the product contains any ingredients subject to Bovine Spongiform Encephalopathy (BSE) restrictions.

CITES Permit

Know if any of the product’s ingredients are prohibited by the US Fish and Wildlife Service (FWS) due to being derived from an endangered species or if any ingredients require a Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) permit for importing an endangered species.

FDA Label Requirements

Ensure the product label complies with all federal labeling requirements such as having a properly declared statement of identity, net quantity of contents (net weight), ingredient list with names of each ingredient properly declared, business name and address (manufacturer, distributor, or packer), country of origin, any required warning/caution statements, and other labeling requirements.

Manufacturing Conditions

While FDA does not have mandatory Good Manufacturing Practices (GMPs) for cosmetics, the products must not be manufactured under conditions that may lead to adulteration (i.e. contamination) of the products. FDA provides cosmetic manufacturing guidelines which can be found at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-cosmetic-good-manufacturing-practices.

FDA Cosmetics Labeled as Organic

Any organic labeling must meet USDA’s organic labeling and certification requirements.

California Proposition 65

For products marketed in California (including packaging), Proposition 65 requires businesses to provide warnings to the consumers about any substances in the products that California believes causes cancer or reproductive harm including birth defects. California lists these substances in its “Prop 65 list” ( https://oehha.ca.gov/proposition-65/proposition-65-list). If the products contain any of those listed substances, companies can usually meet the Prop 65 requirements by placing the appropriate warning statement on the product’s label.

Note that FDA does not require registration for cosmetic facilities. However, FDA has a voluntary registration program (VCRP) under which companies can voluntarily register their facilities and file statements for their products. FDA uses the VCRP to obtain cosmetic data and assess priorities for reviewing ingredient safety. Again though, companies are not required to do this.