The Professional entity’s of the Salon Industry (If there is any!) really need to take a look at the fluster of what is going on within their profession regarding the Smoothing products that contain the (preservative Formaldehyde). preservatives are used everyday in all types of cosmetic products. Is there a law against it NO! But mis-labeling and misbranding is a big No! to the federal government.
A letter was sent to the company Brazilian Blowout from the FDA. August 22, 2011
Mr. Mike Brady, CEO
GIB, LLC dba Brazilian Blowout
6855 Tujunga Avenue
North Hollywood, CA 91605-6312
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.gov1.
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,
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
I called this office on September 19, 20, and asked for a press officer and to my dismay no phone calls were returned to my office. I am not surprised. And with all this banter about these products I have not seen the PBA take a leadership role on the matter. The PBA claims it supports the industry and advertises itself as having a Government Affairs Committee but when you look at the staff page there is not one attorney on board just Salon Owners, Beauty Corporations and such. Would it not be imperative to have attorney’s on the staff who are experienced in legal and governmental issues? And not Salon owners and Beauty corporations!
This does not make sense to me. But if you look closer on the website they have a page that talks about Safe Cosmetics Act of 2011, H.R. 2359. But will advertise on their site Coppola.
Copolla has claimed little to no formaldehyde when tests show their products contain substantial amounts! But keeping the industry informed is the main idea here, especially when a product has been recalled in the following country’s, Australia, Ireland, Canada, France, Germany, Cyprus. And researching further in this I have come to find out also about a organization in the industry called.
They claim the Professional Keratin Smoothing Council . In the history of the professional beauty industry, the keratin smoothing category has emerged in the last five years as one of the fastest growing, and potentially one of the most lucrative categories to ever hit the industry. Professional Keratin Smoothing Council (PKSC) has been established to achieve the following key objectives:
A. To become the industry portal for accurate information about keratin hair smoothing products and applications, and related services, through policy analysis, legal advocacy, regulatory development, scientific testing, and education and innovation
B. To establish, maintain, and continuously develop appropriate, responsible, and rigorous testing and supporting regulatory regimes for professional and consumer safety, including standardization of testing, ensuring MSDS compliance with the international GHS mechanisms, and full disclosure of ingredients in keratin hair smoothing products and applications
C. To solicit the participation and comments of all interested parties on a fair, equitable and open basis.
Board members are Cadiveu USA, Keratin Complex, Marcia Teixeira, Aerovex Systems and SalonTech. Interesting to know that recently Marcia Texeira, Keratin Complex,were sited by OSHA for the following, Both M&M International Inc. in Delray Beach, a distributor of the straightening hair product “Marcia Teixeira,” and Copomon Enterprises in Boca Raton, a distributor of the keratin-based hair product “Keratin Complex Smoothing Therapy,” have been cited for three serious violations and fined $12,600 each for failing to ensure that material safety data sheets reflected the content of formaldehyde in the products or the hazards associated with formaldehyde exposure, as well as for failing to develop a written hazard communication program for their own employees.
A serious violation occurs when their is substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known. This was dated September 8, 2011. Just last week. But the owners, Marcia and Marcelo Teixeira, owners of M & M International of Delray Beach, FL, will write about there two treatments (SOFT TREATMENT ™ and SOFT CHOCOLATE TREATMENT™) are completely free of formaldehyde producing ingredients!
The president of the company states “Our Company is committed to clear and open communication in order to ensure product safety, education and client service” – Marcia Teixeira, President. And also states in a Modern Salon article, “to being free of formaldehyde producing ingredients, their policy of clear and open communication, M & M International provides comprehensive Material Data Safety Sheets (MSDS) for the entire Marcia Teixeira product line – both old and new.
And chairs a organization for the betterment of the industry. And this Organization is charging members for membership, Again read the OSHA REPORT. What is the PKSC charging for a membership for, I have called the PKSC several time to get information about the organization and I have not heard any responses from them. On their website they also claim if you join as a manufacturer you must disclose the following for membership.
- Full disclosure of ingredients
- Labeling on product disclosing ingredients, which is not required by FDA for professional products
- Proper labeling for consumer products
- Post test results on council website
- Compliant MSDS for all products under the brand name, in harmony with the GHS platform
- Education and training for salon professionals and consumers
- Use consistent, approved, methods of analysis
COME ON WHO KIDDING WHO HERE! There asking for this information when they cannot even comply themselves! The Professional Keratin Smoothing Council offers several categories of membership and encourages other manufacturers, distributors, stylists and students to get involved. Visit pksc.org for more information or a membership application. If you would like to laugh some more check out the report the BIR (Beauty Industry Report) Did on the PKSC.
In the next documentary of the REAL HAIR TRUTH, Our largest topic will be on Health and Welfare in the beauty industry. With interviews from OSHA, FDA, EWG, Chemists. A lot of these company’s will be getting free advertising from my documentary.!
Joseph Kellner
The Real Hair Truth 
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