Representing a spike in enforcement, FDA reported 178 import refusals for cosmetic products in August 2022 alone. FDA refused various cosmetic products including eyelash, eyeshadow, and eyebrow products, skincare preparation products, hair preparation products, and deodorant products, on grounds that products appeared to contain unsafe color additives and were adulterated, lacked proper labeling of the net quantity of contents statement and/or failed to comply with cosmetic labeling requirements and were misbranded, and/or that the product appeared to be a new drug without an approved New Drug Application.
While FDA does not “approve” cosmetic products prior to their marketing in the U.S., and cosmetics are more loosely regulated of the FDA product categories, color additive violations are a common reason for detaining imported cosmetic products offered for U.S. entry. Color additives are subject to strict approval under U.S. law and failure to meet U.S. color additive requirements causes a cosmetic to be adulterated.
Whether you are a contract manufacturer, importer, or distributor, the next time you see a pop of color in a cosmetic/personal care product, or any FDA regulated product for that matter, ensure that the color additives comply with FDA approval requirements including a substance’s use as a color additive, certification (i.e. batch certification), specifications, and use and restrictions, to avoid enforcement. And let the use of color continue to shine on, compliantly.
