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Proper labeling is an important aspect of putting a cosmetic product on the market. And this is a big topic in our next Documentary. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act4 (FD&C Act) and the Fair Packaging and Labeling Act5 (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices and to help consumers make informed decisions regarding product purchase.
It is illegal to introduce a misbranded cosmetic into interstate commerce, and such products are subject to regulatory action. Some of the ways a cosmetic can become misbranded are:
No. FDA does not have the resources or authority under the law for pre-market approval of cosmetic product labeling. It is the manufacturer’s and/or distributor’s responsibility to ensure that products are labeled properly. Failure to comply with labeling requirements may result in a misbranded product.
Before proceeding with a discussion of labeling requirements, it is helpful to know what some labeling terms mean:
No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA’s Voluntary Cosmetic Registration Program6 (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].
Be aware that promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body may cause the product to be considered a drug. FDA has an Import Alert in effect for cosmetics labeled with drug claims7. For more information on drug claims, refer to Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?)8.
If a product is an over-the-counter (OTC) drug9 as well as a cosmetic, its labeling must comply with the regulations for both OTC drug and cosmetic ingredient labeling [21 CFR 701.3(d)]. The drug ingredients must appear according to the OTC drug labeling requirements [21 CFR 201.66(c)(2) and (d)] and the cosmetic ingredients must appear separately, in order of decreasing predominance [21 CFR 201.66(c)(8) and (d)]. Contact the Center for Drug Evaluation and Research10 (CDER) for further information on drug labeling.
All labeling information that is required by law or regulation must be in English. The only exception to this rule is for products distributed solely in a U.S. territory where a different language is predominant, such as Puerto Rico. If the label or labeling contains any representation in a foreign language, all label information required under the FD&C Act must also appear in that language [21 CFR 701.2(b)].
The following information must appear on the principal display panel:
The following information must appear on an information panel:
Mr. Michael Brady
CEO, Oill LLC dba Brazilian Blowout
6855 Tujunga Ave.
Nortb Hollywood, CA 91605
Dear Mr. Brady,
The purpose of this letter is to alert you to an issue that has been brought to the attention of the Occupational Safety and Health Administration (OSHA). OSHA has become aware of your August 24, 2011, letter sent to salon owners. The letter states, and your website implies, that “all OSHA and independent air-quality tests conducted on the Brazilian Blowout Professional Smoothing Solution, as well as all others in this category, have yielded results well-below even the most stringent ofOSHA standards (AL, PEL, STEL).” Please be advised that we disagree with this statement.
Earlier this year, an OSHA inspection at a salon found that workers using Brazilian Blowout Acai Professional Smoothing Solution were exposed to formaldehyde levels that exceeded OSHA’s 15-minute short term exposure limit (STEL) of2 ppm. A citation was issued to the employer after OSHA inspectors conducted air sampling. This is only one example, but there are other instances where OSHA investigations have found exposures to formaldehyde exceeding legal limits in workplaces applying professional hair smoothing solutions. Further, OSHA’s laboratory performed analysis of bulk samples of your product, which revealed significant levels of methylene glycol (known to release formaldehyde) to be present. Pursuant to 29 CFR 1910.1048, the agency requires manufactures of products that contain or potentially release fomlaldehyde to include information about the chemical and its hazards on the label and in the material safety data sheets. Hazards associated with formaldehyde must be listed if it is present in the product at 0.1 % or more (as a gas or in solution) or if the product releases formaldehyde into the air above 0.1 parts per million.
It is improper to provide misleading information or make misrepresentations regarding OSHA, or to use the agency’s name to promote a private enterprise, product, or service. When such use comes to our attention, we insist that any and all implied or stated references to OSHA are discontinued immediately. Therefore, we request that you take the following corrective action:
Attached please find OSHA’s hazard alert on hair smoothing products that could release formaldehyde. Thank. you for your attention to this very important matter.
Sincerely,
Frank Meilinger, Director
Office of Communications
A Wonderful Bunch of Bastards in My Industry!
US Department of Labor’s OSHA cites Florida manufacturers and
distributors of hair products containing formaldehyde for health violations
Companies failed to protect workers, warn product users of hazards
ATLANTA – The U.S. Department of Labor’s Occupational Safety and Health Administration has cited two Florida manufacturers and two Florida-based distributors of hair products containing formaldehyde for 16 health violations involving alleged failures to protect their employees from possible formaldehyde exposure and to communicate with the products’ users, such as salons and stylists, about the hazards of formaldehyde exposure. Proposed penalties for the companies total $49,200.
“Employers are responsible for identifying the risks associated with producing and using these hair products, as well as for taking appropriate measures to ensure that they protect their own employees and other workers who may be using their products, such as stylists, from any potential hazards,” said Cindy Coe, OSHA’s regional administrator in Atlanta.
OSHA’s inspections were initiated based on a referral by Oregon’s Occupational Safety and Health Division, which tested more than 100 product samples at 50 salons using hair smoothing or straightening products. Some products causing formaldehyde exposure were traced back to the Florida manufacturers and distributors. Formaldehyde can irritate the eyes and nose, and cause coughing and wheezing. It is a sensitizer, which means that it can cause allergic reactions of the lungs, skin and eyes, such as asthma, rashes and itching. It also has been linked to cancer.
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 there is substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known.
Pro Skin Solutions Inc. in Orlando, a manufacturer of keratin-based products used for hair straightening, has been cited for five serious violations with penalties of $15,000. Violations include failing to establish a written respiratory protection plan, provide an emergency eyewash station, develop appropriate procedures to protect employees in the event of an emergency and develop or implement a written hazard communication program. The company also failed to address formaldehyde exposure and inhalation hazards, including possible cancer-causing effects, on material safety data sheets for the formaldehyde-containing products.
Additionally, Pro Skin Solutions has been cited for two other-than-serious violations with no monetary penalties for failing to maintain air sampling records and provide written procedures for evaluating chemical hazards. An other-than-serious violation is one that has a direct relationship to job safety and health, but probably would not cause death or serious physical harm.
Keratronics Inc. in Coral Springs, a manufacturer of keratin-based products used for hair straightening, has been cited for three serious violations with penalties of $9,000 for failing to provide an eyewash station for employees using corrosive products, evaluate the hazards of keratin-based products for development of the material safety data sheets, and develop or maintain a written hazard communication program on handling chemicals such as timonacic acid, formalin, acetic acid and hydrolyzed keratin.
All manufacturers, importers and distributers are required by OSHA standards to identify formaldehyde on any product that contains more than 0.1 percent formaldehyde, either as a gas or in a solution that can release formaldehyde at concentrations greater than 0.1 part per million. The material safety data sheet that comes with the product also must include this information, as well as explain why the chemical is hazardous, what harm it can cause, what protective measures should be taken and what to do in an emergency. The sheets are used by employers to determine products’ potential health hazards and methods to prevent worker exposure.
Federal OSHA issued a hazard alert earlier this year to hair salon owners and employees about potential formaldehyde exposure resulting from working with some hair smoothing and straightening products. It can be viewed at http://www.osha.gov/SLTC/formaldehyde/hazard_alert.html.
In addition, the U.S. Food and Drug Administration recently issued a warning letter to GIB LLC in North Hollywood, Calif., doing business as Brazilian Blowout, concerning misbranding relating to formaldehyde. That letter is available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm270809.htm.
Keratronics, M&M International and Copomon Enterprises were inspected by OSHA’s Fort Lauderdale Area Office, 1000 S. Pine Island Road, Suite 100, Fort Lauderdale, Fla. 33324; telephone 954-424-0242. Pro Skin Solutions was inspected by OSHA’s Tampa Area Office, located at 5807 Breckenridge Parkway, Suite A, Tampa, Fla. 33610; telephone 813-626-1177. To report workplace incidents, fatalities or situations posing imminent danger to workers, call the agency’s toll-free hotline at 800-321-OSHA (6742).
The companies have 15 business days from receipt of the citations and proposed penalties to comply, request a conference with OSHA’s area director or contest the findings before the independent Occupational Safety and Health Review Commission.
Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance.
Mr. Kellner, I thank you immensely for sharing this research and so unbiasedly. You did more than a stellar job in presenting this education and now I’m already working on the many ways I can insure that what I use and recommend to any guest that finds themselves in my design chair is not only treated with the utmost respect (which I always do) but that they are NEVER misled or given erroneous advice just because a manufacturer sends me free products or offers classes.
You DID hit the nail on the head. You are truly THE MAN!!!
Manufactures that divert…you’re history in my book. Every salon client deserves much better than this. Your greediness and your self proclamations will soon be your demise.
The Real Hair Truth 
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