FDA uses untitled letters for violations that do not meet the threshold of regulatory significance for a warning letter and to request correction of these violations. Unlike a warning letter, an untitled letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action.
April 16, 2015
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUIRED
Karen Behnke, CEO
Juice Beauty Inc.
711 Grand Avenue, Suite 290
San Rafael, CA 94901
Dear Ms. Behnke:
U.S. Food and Drug Administration’s (FDA) laboratory analyses of your Illuminating Eye Shadow (chocolate, cappuccino, and champagne shades) products found that these products contained the ocular pathogen Bacillus cereus. These eye shadow products are intended to be applied to the human body for beautifying, promoting attractiveness, or altering the appearance, and as such, they are cosmetics within the meaning of section 201(i) of the Act [21 U.S.C. 321(i)].Under Section 601(a) of the Act [21 U.S.C. 361(a)], a cosmetic is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Bacillus cereus found in your eye shadow products render these products injurious to health because bacillus cereus can cause rapidly progressive endophtalmitis, i.e., inflammation of the intraocular cavities (i.e., the aqueous and/or vitreous humor) internal coats of the eye that can lead to possible loss of vision or the eye itself. It is a violation of section 301(a) of the Act [21 USC 331(a)] to introduce or deliver for introduction into interstate commerce an adulterated cosmetic. You may find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
We acknowledge that you recalled and destroyed contaminated eye shadow product from retail facilities. However, we note that your recall was inadequate in that products purchased by consumers were not recovered and that no proof of destruction was provided to FDA.
Additionally, we note that Juice Beauty Inc. Illuminating Eye Shadow products are formulated with preservative systems other than the preservative systems listed under Appendix C of Compliance Program Guidance 7329.001 (available at http://www.fda.gov/downloads/Cosmetics/GuidanceRegulation/GuidanceDocuments/UCM208412.pdf). Cosmetics need not be aseptic, however, they must not be contaminated with microorganisms which may be pathogenic, and the density of non-pathogenic microorganisms should be low (see FDA’s Bacteriological Analytical Manual (BAM), “Chapter 23: Microbiological Methods for Cosmetics,” Section C-Interpretation). Because botanical and organic ingredients are particularly vulnerable to microbial contamination, these ingredients should be afforded increased scrutiny by cosmetic manufacturers prior to their use. Enforcement action against contaminated products, which may be caused by inadequate preservation, may be considered if FDA analytical data show the presence of microbial contamination at such levels that it may render the product injurious to users. Such products may be deemed adulterated under Section 601(a) of the Act.
FDA conducted an inspection of Gemdo Cosmetics, Inc., a contract cosmetic manufacturing facility that you use to manufacture your Juice Beauty cosmetic products, located 29151 Ave. Penn, Valencia, California, 91355 from December 8, 2014 through December 23, 2014 in response to the Class II Recall of your Juice Beauty Illuminating Eye Shadow products (chocolate, cappuccino, and champagne shades) that were found to be contaminated with the ocular pathogen, Bacillus cereus. Based on the contamination of the Juice Beauty eye shadow products manufactured by Gemdo Cosmetics, Inc. and observations during our inspection, FDA sent Gemdo Cosmetics, Inc. a warning letter informing Gemdo Cosmetics, Inc. that the Juice Beauty Illuminating Eye Shadow products it manufactured are adulterated within the meaning of section 601(a) of the Act. And that the Juice Beauty eye shadow products and other eye area products manufactured in its dry room are adulterated within the meaning of section 601(c) of the Act [21 U.S.C. 361(c)] in that these cosmetics were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
As stated earlier, it is a prohibited act to introduce or deliver for introduction into interstate commerce an adulterated cosmetic (section 301(a) of the Act). Although your firm may contract out certain cosmetic manufacturing operations, it cannot, contract out its ultimate responsibility to ensure that the cosmetics it places into commerce (or causes to be placed into commerce) are not adulterated (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (explaining that an offense can be committed under the Act by anyone who has a “responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)).
This letter is not an all-inclusive statement of violations associated with your products. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to develop a plan for preventing the recurrence of these violations or the occurrence of other violations, including oversight of contract manufacturing operations. We request that you take prompt action to correct the violations associated with your products.
We request that you reply in writing within thirty (30) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including your planned corrective actions. If the corrective action cannot be completed within thirty working days, we expect that you will state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be sent to:
Lawton W. Lum
Director, Compliance Branch
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference the CMS number 450537 in your response.
If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer at 510-337-6793.
Kathleen M. Lewis, JD
San Francisco District Director