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.
If you are exporting products to a country with different requirements for cosmetics, your exported product may not comply with the U.S. Federal Food, Drug, & Cosmetic Act or Fair Packaging and Labeling Act. However, there are several things you need to do to prevent your products being labelled and misbranded or adulterated:
- Make sure it meets the foreign purchaser’s requirements
- Make sure the product does not conflict with the laws of the country it is being exported to
- Label the outer shipping package to make it clear the product is intended for export
- Do not offer the product for sale in U.S. domestic commerce
It is the exporter’s responsibility to make sure that products are compliant with the regulations of the destination country. For information on a country’s regulations, you can contact embassies, regulatory agencies, or regulatory consultants in that country. You should also make sure that other U.S. government agencies do not have additional requirements related to trade sanctions or hazardous material shipment.
Exporters will often be required by the destination country to provide an export certificate. Although issuing export certificates is a service the FDA offers, they are not required to do so. The FDA will not issue a certificate for products manufactured outside the U.S., or for raw/bulk materials. The issuing of an export certificate does not constitute FDA approval of a product.
You can apply for a cosmetic export certificate online or request a paper form through the Center for Food Safety and Applied Nutrition. Export certificates can only be issued for products that are solely intended to be used as a cosmetic. Products intended to alter the structure or function of the body or have a therapeutic effect are not considered to be cosmetics. Intended use of a product is based on claims made on the label and promotional material, consumer perception, and ingredients.
The FDA does not issue certificates of free sale for cosmetic products and does not notarize certificates. You may request a product specific, or general certificate. Not all importing countries will accept a general certificate. The certificate package includes a cover letter, certificate(s), “To Whom it may Concern” letter(s), and an invoice. There is a $10 fee per certificate to be paid after the receipt of the invoice.
Export certificate requests may take several weeks to process depending on the form of the application, type of product, and regulatory workload. The FDA recommends obtaining an export certificate from the state or local health department, trade board, or trade association if this will be accepted by the importing country.
The importing country may require that the export certificate is authenticated. The exporting company can request an apostille/authentication form the U.S. Department of State or a foreign government official can verify this independently.
If you require any assistance with U.S. or Canadian 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.