Public Health Service Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
JULY 29, 2015
VIA OVERNIGHT DELIVERY
Ms. Doe Deere, CEO
Lime Crime, Inc.
20501 Ventura Blvd Ste. 220
Woodland Hills, CA 91364
Dear Ms. Deere:
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.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
We request that you take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your product is in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at firstname.lastname@example.org.