Lime Crime – FDA Warning Letter

The FDA issued a Warning Letter to Lime Crime, Inc. on July 29, 2015, regarding their Velvetines Liquid Matte Lipstick (red velvet) product. The FDA determined this product is a cosmetic under Section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act).

The product was found to be adulterated under Section 601(e) of the Act because it contains color additives, ferric ferrocyanide and ultramarines, which are unsafe for their intended use. These color additives are only permitted for externally applied cosmetics, as per 21 CFR § 73.2299 and 21 CFR § 73.2725, respectively. FDA regulations (21 CFR § 70.3(v)) define "externally applied cosmetics" as those applied only to external parts of the body, not to the lips or mucous membranes. Therefore, their use in a lip product is not in conformity with the regulations.

Alternatively, if the product does not contain these color additives, it is misbranded under Section 602(a) of the Act due to false labeling. Introducing or delivering adulterated or misbranded cosmetics into interstate commerce violates Section 301(a) of the Act.

Lime Crime, Inc. was requested to take prompt action to correct these violations and notify the FDA in writing within fifteen working days of receipt of