The U.S. Food and Drug Administration (FDA) has reviewed your product, Lime Crime Velvetines Liquid Matte Lipstick (red velvet). As Velvetines Liquid Matte Lipstick is intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, it is a cosmetic within the meaning of Section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(i)]. As described below, your Velvetines Liquid Matte Lipstick (red velvet) product is adulterated within the meaning of Section 601(e) of the Act [21 U.S.C. § 361(e)]. It is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)] to introduce or deliver for introduction into interstate commerce any cosmetic that is adulterated or misbranded. You can find copies of the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
Under Section 601(e) of the Act [21 U.S.C. § 361(e)], a cosmetic is adulterated if it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a). Under section 721(a), a color additive is unsafe unless it is used in conformity with a regulation listing the additive for such use. Velvetines Liquid Matte Lipstick (red velvet) is an adulterated cosmetic because it bears or contains a color additive which is unsafe within the meaning of section 721(a). Specifically, according to your product label, Velvetines Liquid Matte Lipstick (red velvet) contains ferric ferrocyanide and ultramarines, which are only permitted for use in coloring externally applied cosmetics as prescribed in 21 CFR § 73.2299 and 21 CFR § 73.2725, respectively. Under 21 CFR § 70.3(v) “[t]he terms externally applied drugs and externally applied cosmetics mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane.” These color additives therefore may not be used in cosmetic lip products, because such use is not in conformity with the regulations that provide for the use of these additives. Alternatively, if your product does not contain ferric ferrocyanide and ultramarines, your product is misbranded under Section 602(a) of the Act [21 U.S.C. § 362(a)] because its labeling is false.