Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations

Why FDA issued it

Note: The revision of this Import Alert (IA) dated 11/17/2023 updates the reason for alert, guidance, agency contacts, charge code language, product description, PAF, PAC. Changes to the import alert are bracketed by asterisks (***). This Import Alert was created to address cosmetics that ***appear to be adulterated and/or misbranded cosmetics due to color additive violations.*** ***Section 201(t) of the Food, Drug, and Cosmetic Act (FD&C Act) defines "color additive," as any substance that, when applied to a food, drug or cosmetic or to the human body or any part thereof, is capable of imparting color thereto, with certain exceptions. Some color additives are soluble organic dyes and insoluble pigments, while others are plant extracts and mineral compounds. Color additives are subject to a strict system of approval under the FD&C Act. Pre-approval by FDA is required for color additives

Quoted from the “Reason for Alert” section of the FDA page for 53-06, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.