Microbial Testing Is Not Enough: 5 FDA Risks Cosmetics Exporters Must Check [GeXPs26-0626EN]
Microbial Testing Is Not Enough: 5 FDA Risks Cosmetics Exporters Must Check FDA Import Alert 53-17 has highlighted the serious consequences of microbiological contamination in cosmetic products. However, passing a final-product microbial test does not by itself ensure that a cosmetic is ready for the U.S. market. Imported cosmetics may be examined at the time of entry. Products that appear to be adulterated or misbranded may be detained, required to be brought into compliance, re-exported, destroyed, or refused entry. For global beauty brands, contract manufacturers, and OEM/ODM companies, U.S. market readiness requires more than a laboratory report. Regulatory and quality teams should review the following five connected risk areas before shipping cosmetic products to the United States. 1. Microbial Control Beyond Final-Product Testing Relying only on a negative microbial result from a finished batch may leave important risks unaddressed. Contamination can arise from raw mate...