Lime Crime: FDA Followup

Wednesday, September 02, 2015


I received the following from the FDA in regards to the Lime Crime warning letter.

This message is being sent in response to the following submitted inquiry:

We have received multiple inquiries regarding the warning letter that FDA sent to the cosmetic's firm, Lime Crime, Inc., about their Velvetines Liquid Matte Lipstick (red velvet). The following provides additional information about FDA's action and the safety of this product.

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC) has prepared a response for case number 00054075.

Response: In general, because FDA is a law enforcement agency, we restrict comment on an article and its labeling to persons responsible for its manufacture and/or distribution. As background, the Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under this law, cosmetic products and ingredients are not subject to premarket approval by FDA, with the exception of color additives. However, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use. Companies and individuals who manufacture or market cosmetics are legally responsible for making sure their products comply with the law. FDA can and does take action against cosmetics that do not comply with the laws we enforce and against firms and individuals who market them. For more information about FDA’s role in regulating cosmetics, you may wish to refer to FDA’s Cosmetics Web page, at http://www.fda.gov/Cosmetics/default.htm.

In the current case, the Lime Crime product label declared the color additives ferric ferrocyanide and ultramarines, which are only permitted for use in coloring externally applied cosmetics. The term “externally applied cosmetics” means cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane. These products were not tested by the agency; therefore, it is unknown whether or not the product actually contains the non-permitted color additives. However, if the ingredients are different from those listed in the labeling, the product is misbranded, which is also a violation of the law. We are currently working with the firm to determine whether the product only contains approved color additives and that the firm declares their presence appropriately on the product label.

Thank you for contacting FDA’s FCIC.

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