mel33t
Well-known member
...http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm456525.htm hboy:
...http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm456525.htm hboy:
*cough* Karma *cough*
Thank you for posting this here! Fortunately, I never purchased this shade, however, I was considering possibly doing so in the future. I see that this was issued to her on the 29th of last month but it is still for sale on the website. Once she received this notice, she should have taken it down immediately and put a notice on her site and social media accounts warning people about how one of the ingredients in the product is not safe for use on the lips. That way, customers who currently have the product can choose to not use it anymore on their lips or use it at their own risk. Shame on her for not informing her customers by now!
Well, glad I never bought that shade.
Darn I've had this colour for a looong timehttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm456525.htm hboy:
WFH. I guess I need to throw mine out. I won't be wearing the Lime Crime Red Velvet again.
Food and Drug Administration [TR]
[TD] [/TD]
[TD] 5100 Paint Branch Parkway
College Park, MD 20740 [/TD]
[/TR]
WARNING LETTER
JULY 29, 2015
VIA OVERNIGHT DELIVERY
Ms. Doe Deere, CEO
Lime Crime, Inc.
20501 Ventura Blvd Ste. 220
Woodland Hills, CA 91364
Re: CMS#461005
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[email protected].
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Courtesy of @MissElle12
Same here! If I were her, I would have yanked that shade immediately off of the site upon receipt of that letter.Well, glad I never bought that shade.
I should be surprised she still has it available, but I'm not.
Exactly. I'm guessing she will not notify her customers of this warning.Same here! If I were her, I would have yanked that shade immediately off of the site upon receipt of that letter.
Omg the scent is awful on those! And I've worn red velvet and haven't died (yet) :lmao:Oh no ^^^ I don't have that shade though! But this apart I have always wondered who ,if any one , approves the formulas of a lot of these Instagram based companies (yes paranoia at its best lol) !! La splash is the only brand I think I have tried apart from lime crime and I don't use those at all because of the strong chemical scent!! :sigh:
The scent on those makes me a little nervous too, especially the Lip Coutures (I don't find the other two formulas nearly as bad). I still use them because I like the colors/wear and I haven't experienced any sort of irritation, but I do wonder what's in them that makes them smell like industrial cleaning products.But this apart I have always wondered who ,if any one , approves the formulas of a lot of these Instagram based companies (yes paranoia at its best lol) !! La splash is the only brand I think I have tried apart from lime crime and I don't use those at all because of the strong chemical scent!!
Yeah the US is super anal about shit like that. I'm not worried. I'll still wear it and my BU.As far as I know [COLOR=333333]ferric ferrocyanide and ultramarines are lip-safe in the EU so I'm not that bothered tbh. Strange that the product is still available on the site though.[/COLOR]
Same here. The average person probably ingests far more awful stuff than some pesky pigments during the course of the day lol.Yeah the US is super anal about shit like that. I'm not worried. I'll still wear it and my BU.
Did they actually respond like that on IG??Well, this is a little surprising. I'm almost done with my Red Velvet and I may or may not get another one. I just hate how the company's MO is to lie about things rather than admitting any fault and offering a resolution. Do the products have ingredients not approved by the FDA? No, no, we just misprinted the ingredients list to make you think they did. And yet some people on Instagram are being called bullies and haters for asking legitimate questions.
Just saw their responses SMH.Did they actually respond like that on IG??
Indeed. It really really irritates me. No matter what happens, they simply deny it and then it goes away. I know the obvious thing is not to buy from them, I just find the lying to be incredibly unethical.Just saw their responses SMH.