FDA cosmetic compliance
Legal overview
In the United States, cosmetics are regulated by the Food & Drug Administration (Food & Drug Administration; The Drug Administration (FDA) regulates, but companies and individuals who sell cosmetics are legally responsible for ensuring the safety of the cosmetics they produce/sell. Under U.S. law, cosmetics and most ingredients do not require FDA approval before they are marketed, with the exception of color additives (with the exception of coloring materials used in coal tar hair dyes), which must be approved by the FDA before they can be used in cosmetics. At the same time, the U.S. Cosmetic regulations provide the option to register cosmetics with the FDA through the Voluntary Cosmetic Registration Program (VCRP). The ingredients and labeling claims of any cosmetic product marketed in the United States must comply with the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the Code of Federal Regulations.
Mandatory registration of cosmetic factory facilities
Currently, cosmetic manufacturers/packers can register factory facilities with the FDA through the FDA's Voluntary Registration Program for Cosmetics (VCRP), but the FDA does not make this mandatory. After MOCRA goes into effect, all companies that sell cosmetics in the United States will be required to register their manufacturing facilities with the FDA and update their registration information every two years. Facilities outside the United States are also required to provide information on agents inside the United States.
Existing cosmetic facilities must register with the FDA within one year of the new rule, and new cosmetic facilities can register within 60 days of engaging in cosmetic processing and production.
Mandatory registration of cosmetic products
The current Voluntary Registration Program for Cosmetic Products (VCRP) also includes manufacturers/packers/distributors voluntarily submitting cosmetic product Ingredient Declarations (CPIS) to the FDA. After MOCRA came into effect, the filing of cosmetic products became mandatory. Cosmetic manufacturers/packers or distributors must submit specific information about each cosmetic product to the FDA for filing, including manufacturing location, ingredients, labeling, etc., and update it annually.
Existing cosmetic products must be filed with the FDA within one year of the new rule, and new cosmetic products can be registered within 120 days of being marketed.
Cosmetics definition and classification
Note: Some products meet the definition of both cosmetic and pharmaceutical products, which may occur when the product has two intended uses.
United States FDA cosmetics enterprise registration process
Confirm registration scope → Fill in the information questionnaire → Apply for VSCRP Enterprise account → Submit business registration information → FDA review → Obtain enterprise registration number
United States FDA cosmetics product filing process
Complete the registration of cosmetics enterprises → Fill in the information questionnaire → Submit cosmetic filing information → FDA review → Obtain CPIS number
The services we provide
- ○ FDA certification consultation and training;
- ○ FDA cosmetics company registration;
- ○ FDA cosmetic product filing;
- ○ FDA Cosmetics label/website information review;
COC REACH LIMITED specializes in product registration and compliance consulting services. Leveraging its professional expertise, diverse resources, and global network, it is committed to providing regulatory consulting and environmental compliance services to pharmaceutical and chemical companies, consumer goods manufacturers, and large multinational corporations. It addresses issues related to environmental health and safety laws, product quality standards, and other challenges faced by enterprises during production, sales, and global trade processes.
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