Cosmetic products imported into the United States are subject to the same laws and regulations as those produced in the United States. They must be safe for their intended uses and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico). All color additives must be approved by FDA; many cannot be used unless certified in FDA’s own laboratories. If the product has an intended use that causes it to be considered a drug, it must comply with the requirements for drugs, including establishment registration and drug listing.

Cosmetic firms are encouraged to register their establishments and file Cosmetic Product Ingredient Statements with FDA’s Voluntary Cosmetic Registration Program (VCRP). However, firms importing products considered to be solely cosmetics in the United States are not required to register with FDA, and a registration number is not required for importing cosmetics into the United States.

Voluntary Cosmetic Registration Program (VCRP)

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States. It contains two parts:

1)Registering cosmetic manufacturing establishments. Cosmetic manufacturers or packers whose products are in commercial distribution in the United States should register their establishments. Only manufacturers and packers should register, not distributors. FDA assigns a registration number to each manufacturing establishment registered and sends you a receipt.

2)Filing Cosmetic Product Ingredient Statements (CPIS). A cosmetic manufacturer, packer, or distributor should file a statement for each product the firm has entered into commercial distribution in the United States. With the distributor’s permission, a private labeler or packer also may file these forms.
The VCRP applies only to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics. It also does not apply to hotel samples or free gifts or cosmetic products you make in your home to sell to your friends.

Caution: Registration of a cosmetic product establishment or assignment of a registration number does not mean FDA in any way denote has approved of the firm or its products. So you may not make any representation on product by the Food and Drug Administration. Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number. This kind of labeling may be will be considered “misleading” resulting in the cosmetic being “misbranding” and subject to refusal of admission at importation. 21 C.F.R. § 710.8.

Related Downloads

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