| Public Health Service Food and Drug Administration |
5100 Paint Branch Parkway |
Department of Health and Human Services
WARNING LETTER
AUG 22 2011
VIA OVERNIGHT-DELIVERY
RETURN RECEIPT REQUESTED
Mr. Mike Brady, CEO
GIB, LLC dba Brazilian Blowout
6855 Tujunga Avenue
North Hollywood, CA 91605-6312
Re: 207094
Dear Mr. Brady:
The U.S. Food and Drug Administration (FDA) has reviewed the regulatory status of your product, Brazilian Blowout Acai Professional Smoothing Solution (Brazilian Blowout). As Brazilian Blowout 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, Brazilian Blowout is adulterated within the meaning of Section 601 (a) of the Act [21 U.S.C. § 361 (a)] and is misbranded within the meaning of Section 602(a) of the Act [21 U.S.C. § 362(a)]. 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.
Adulterated Cosmetic
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. Brazilian Blowout is an adulterated cosmetic because it bears or contains a deleterious substance that may render it injurious to users under the conditions of use prescribed in your labeling. Specifically, based on FDA sample analysis, Brazilian Blowout contains methylene glycol, the liquid form of formaldehyde, which, under the conditions of use prescribed in the labeling, releases formaldehyde when hair treated with the product is heated with a blow dryer and then with a hot flat iron. Methylene glycol is a deleterious substance, which at the levels present in this product, may harm users under the conditions of use prescribed in the labeling thereof. FDA analysis of approximately 50 mg samples of Brazilian Blowout confirmed the presence of methylene glycol, the liquid form of formaldehyde, at levels ranging from 8.7 to 10.4%.
The primary route of exposure to formaldehyde, when using Brazilian Blowout under the conditions of use prescribed in the labeling, is through inhalation. Formaldehyde is a highly reactive chemical that readily reacts with biological tissues, particularly the mucous tissues lining the respiratory tract and the eyes. Adverse events have reported the following injuries associated with Brazilian Blowout: eye disorders (irritation, increased lacrimation, blurred vision, hyperaemia); nervous system disorders (headache, burning sensation, dizziness, syncope), and respiratory tract (dyspnea, cough, nasal discomfort, epistaxis, wheezing, rhinorrhea, throat irritation, nasopharyngitis). Other reported symptoms included nausea hypotrichosis, chest pain, chest discomfort, vomiting, and rash.
Brazilian Blowout is targeted primarily for use by salon professionals in a salon setting. The product may also be used in home salon settings as Brazilian Blowout is also available for purchase in beauty retail stores and via the internet by the general public.
Misbranded Cosmetic
In addition, under Section 602(a) of the Act [21 U.S.C. § 362(a)], a cosmetic is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)] provides that, in determining whether a product's labeling or advertising is misleading "there shall be taken into account (among other things) the extent to which the labeling or advertising fails to reveal facts material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual."
Brazilian Blowout is misbranded because its label and labeling (including instructions for use) makes misleading statements regarding the product's ingredients and fails to reveal material facts with respect to consequences that may result from the use of the product. Specifically, Brazilian Blowout contains the liquid form of formaldehyde, methylene glycol; however, the product label declares that the product contains "No Formaldehyde" or is "Formaldehyde Free." This declaration renders your product misbranded because it is a false and misleading statement. In addition, the failure to include information about the release of formaldehyde into the air during the heating process on the product's label or labeling makes your product misbranded because you fail to reveal material facts with respect to consequences that may result from the use of your product under the conditions of use prescribed in the labels or labeling.
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 as a manufacturer to ensure that the products your firm markets are safe and otherwise in compliance with all applicable legal and regulatory requirements.
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action without further notice, including, but not limited to, seizure and/or injunction.
Please advise this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented.
Please direct your written reply to Rob Genzel Jr., Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
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