The purpose of this project was to evaluate the Food and Drug Administration’s (FDA) Field inspection findings for cosmetic manufacturing firms in order to assist in setting inspection priorities. Since FDA does not have pre-market review authority for cosmetics or cosmetic labeling, exercising our inspectional authority under the FD&C Act is especially important in the regulation of cosmetic products. Thus, the inspections and samples required under this program are necessary to help ensure that the industry is producing cosmetics that are both safe and properly labeled before they reach the market. The evaluation involved the review of FDA’s “Field Accomplishments and Compliance Tracking System” (FACTS) database for Fiscal Year 2004 (FY04) “cosmetic establishment inspections.” Data reviewed included numbers of inspections, inspection classifications, product types, and sample collections. 14 FDA District Offices conducted 120 inspections under the Domestic Cosmetics Compliance Program in FY04.
Inspections covered a broad range of cosmetic products. Inspections were classified as follows: 69 percent “No Action Indicated,” 23 percent “Voluntary Action Indicated,” six percent “Official Action Indicated,” and two inspections were not classified. The number (seven) and reasons (mainly microbiological and colors related) for recalls in FY04 did not diverge significantly from the number and reasons for recalls as the previous three fiscal years. Eighty-five samples were collected during these inspections. Two inspections involved samples for potential microbial contamination (shampoo and hair styling products), one inspection collected samples of tattoo inks for which multiple adverse events were reported to the agency, and one inspection involved the collection of decorative, non-vision-correcting contact lenses (for label review and to determine if the lenses were distributed without the involvement of a qualified eye care professional). Overall, the objectives of the Domestic Cosmetics Compliance Program (CP 7329.001) appear to have been met and remain as valid objectives for the FY05 cosmetics program. The program evaluation data indicated that program objectives could be enhanced through increased inspectional coverage of eye area cosmetic products, sampling for microbiological analysis, and the submission of the bovine-derived tissue questionnaire per program directions. Additional coverage is suggested for establishments that produce solely cosmetic products (e.g., firms that do not also produce drug products), and of products marketed as cosmetics but that bear drug claims.
PIC ID: 8245; Agency Sponsor: FDA-CFSAN, Center for Food Safety and Applied Nutrition; Federal Contact: Lambert, Lark A, 301-436-1143; Performer: FDA, Center for Food Safety and Applied Nutrition, Washington, DC