FDAImports recently assisted a cosmetics company in correcting a labeling issue and subsequently attaining release on their detained product. FDA had detained an entry of their cosmetics because the ingredient list named a color additive based on the Color Index name and not the established FDA name. The exporter and the importer were small businesses that were not in a position to re-label, and the goods arrived via an international carrier that would not release the goods for relabeling while FDA detained the entry. The FDAImports.com team worked with FDA to obtain a rare Release With Comment on the condition that the labeling error would be rectified after the release and future entries would use the proper name.
FDA Labeling Lesson: This case presents an important lesson – cosmetic label errors (or errors on food labels or any other products) are the easiest violation for FDA to detect. The violation is right in front of the FDA Inspector, and no FDA testing is required. From the FDA’s perspective, they represent inexpensive, fast, effective enforcement actions. From the manufacturer’s or importer’s perspective, they are costly, time-consuming, and frustrating problems to correct. But they are also one of the easiest FDA delay problems to prevent. The difference comes in having solid, detailed, and knowledgeable label reviews executed before product packaging ever goes to print. The FDAImports.com team regularly reviews and corrects its clients’ cosmetic labels, food labels, dietary supplement labels, and drug labels to ensure they are correct before export.
