Foreign manufactured products make up key sectors of virtually every industry. In cosmetics, consumer demands for international products are largely driven by trends, and multicultural beauty needs. Whether you are importing cosmetics into the U.S., or exporting U.S. cosmetics to another country, you want to make sure that your products don’t get held up at the border. Here are a few tips to help make sure everything goes smoothly.
The FDA works with U.S. Customs and Border Protection (CBP) to monitor cosmetic imports. Foreign cosmetics are subject to examination at time of entry into the U.S. by CBP. Products that are adulterated or misbranded can be refused entry and future products from the same importer may be targeted for examination. The most common problems with non-compliant cosmetic imports include:
- therapeutic claims that would class the product as an unapproved new drug
- labelling violations
- microbial contamination
- use of prohibited or restricted ingredients
- color additive violations
Products that are refused entry must be brought into compliance, destroyed, or re-exported. All these options cost time and money so it is better tomake sure that your cosmetic products are compliant before they get to the U.S. border.
Although cosmetic products and ingredients (other than color additives) do not require pre-approval from the FDA, they must be safe when used as directed and labelled appropriately. This is the responsibility of the product manufacturer or marketer and the regulations for both imported and domestic products are the same. You do not require a product registration number for importing cosmetics to the U.S. but establishments are encouraged to register their products under the Voluntary Cosmetic Registration Program. The data collected by this program is used to evaluate products on the market and to assist the Cosmetics Ingredient Review (CIR) in assessing ingredient safety and determining priorities for ingredient safety review.
All labelling of cosmetic products must be in English, unless it is solely marketed in Puerto Rico where it must be labelled in Spanish. If some labelling information also appears in an additional language, all required label information must also appear in that language. Common names must be used to identify botanical ingredients and CI numbers may only be used in parenthesis following the U.S. color additive name.
Cosmetics may be imported without labelling and then labelled and marketed in the U.S. under certain conditions. The person introducing the import must be the operator of the repackaging/labelling establishment or there must be a written and signed agreement between the establishment operator and person introducing the shipment. This agreement must be available customs officials at time of entry. This exemption is void if the products are moved from the establishment without compliant labelling.
If you require any assistance with U.S. Regulations for cosmetic products, please contact Focal Point Research Inc. We are industry leading Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.