FDA requires compliance with all US FDA regulations prior to the exportation of a cosmetic product that will be introduced into the US market. FDA and US Customs and Border Patrol (CBP) work jointly to ensure compliance with products crossing the border. FDA will review labels to ensure all mandatory statements appear on the label. FDA will review the ingredients to ensure the ingredients used are permitted and the color additives are in compliance with FDA regulations.
FDA will also review any claims on the labels and/or websites if there is a shopping cart associated with the website. Most product detentions and/or refusals for cosmetic products are based on the claims. FDA will also review for adulteration in certain circumstances.
In the event the cosmetic is found to be in violation of FDA regulations there is a possibility the product and the manufacturer are placed on FDA's blacklist or Import Alert. The result is that each time that manufacturer's products come through CBP the products will be automatically held and it is the manufacturer and/or importer of record's obligation to prove that the shipment does comply with the regulation.