FDA Receives Complaints Associated with the Use of Brazilian Blowout

The FDA has been notified by some state and local organizations of reports from salons about problems associated with the use of Brazilian Blowout, a product used to straighten hair. Complaints include eye irritation, breathing problems and headaches. State and local organizations with authority over the operation of salons are currently investigating these reports.

To date, FDA has not received any official adverse event reports on Brazilian Blowout. FDA has, however, recently received a number of inquiries from consumers and salon professionals concerning the safety of this product and similar “professional use only” hair care products.

Although FDA does not have authority over the operation of salons, the Agency does have certain authority over hair straighteners and similar cosmetic products. FDA is working with state and local organizations, as well as the Occupational Health and Safety Administration (OSHA) to determine whether the products or ingredients would be likely to cause health problems under the intended conditions of use. The composition of the products and the labeling, including use instructions and any warning statements, will be key factors in this determination.

From our understanding of how this type of hair straightening product is used, there appears to be the possibility for formaldehyde to be released into the air after the product has been applied to the hair and heated. Workplace safety in general, including air quality issues, is regulated by OSHA. Salons are generally subject to state and local authorities as well, which may specify safety practices such as assuring proper ventilation. Some information regarding workplace exposure to formaldehyde is available on OSHA’s website (view here). The National Institute for Occupational Safety and Health at the Centers for Disease Control and Prevention also has published resources on formaldehyde on its website (view here).

Consumers and salon professionals are urged to report adverse experiences to FDA in either of the following ways:

1) Reporting to the nearest FDA district office. Phone numbers for their complaint coordinators are posted on FDA’s website and in the Blue Pages of the phone book, generally under United States Government/Health and Human Services.

2) Reporting to MedWatch, click here to email.

FDA will continue to monitor this problem and will report on any new developments.

The Power of 3

In the March 2009 Salon Today cover story entitled “Flat-out Truth About Brazilian Keratin Treatments,” internationally known scientific expert, Doug Schoon, provided us with answers to the recent Hair Smoothing Controversy. In the article, Doug explains how there is no formaldehyde in Brazilian Keratin Treatments and explains why proper ventilation is still required when performing these services.

The article explained the importance of first ventilating the breathing zone of the stylist and client, using a chemical source capture system. Next, ventilate the work station air with a salon room air purifier. Finally, utilize a special filtration system for the building’s HVAC, designed to also remove chemical vapors.

Three Zone Ventilation is now being ushered into the salon industry by Aerovex Systems (www.aerovexsystems.com). 3 percent of all Chemical Source Capture System sales until November 21, 2010 will go to Susan G. Komen for the Cure. Susan G. Komen for the Cure is the global leader of the breast cancer movement. It has become the largest source of nonprofit funds dedicated to the fight against breast cancer in the world.

Exposing the Formaldehyde Myth

By Doug Schoon
Chief Scientific Advisor
Creative Nail Design, Inc.

An unfortunate misunderstanding is happening globally concerning many cosmetic products, including some nail products. Some groups are incorrectly claiming that “formaldehyde” is an ingredient in cosmetics. Advocacy groups are even loudly proclaiming that formaldehyde is a known carcinogen and are demanding manufacturers remove this cancer-causing ingredient from cosmetics. Actually, if these groups understood formaldehyde’s basic chemistry, they would see their claims are absolutely wrong. They’d also know that formaldehyde is not a cosmetic ingredient and never has been!

Advocacy groups incorrectly claim that formaldehyde is an ingredient found in nail hardeners, nail polish and preservatives used to prevent bacterial and fungal growth in products such as lotions, creams and shampoos. How can I be so sure about that formaldehyde has never been a cosmetic ingredient? Because formaldehyde is a gas, not a liquid or a solid. A gas cannot be added to cosmetics as an ingredient, since it would rapidly escape from the product. Interestingly, formaldehyde is a naturally occurring gas that must be kept absolutely bone dry. In the presence of even tiny amounts of moisture, it instantly transforms into completely different substances. This is why it quickly breaks down and doesn’t accumulate in the environment. As you can imagine, this is yet another reason why formaldehyde can’t be used in cosmetics; it wouldn’t be stable for more than 1000th of a second after contact with moisture.

How did this misunderstanding begin? Sometime in the early 1900s formaldehyde manufacturers began mixing this gas with water to create a liquid substance called “formalin”. These manufacturers mistakenly assumed that the added formaldehyde was simply dissolving in the water, so this is how formalin was sold. They didn’t realize the truth; formaldehyde does not dissolve in water, but instead instantly reacts with the water to change into a completely new and different substance called methylene glycol. Not only is it completely different, methylene glycol belongs to an entirely separate chemical family. Formaldehyde is a gas and methylene glycol is a liquid with very different chemical properties.

Here’s what caused most of the confusion. United States, Canada, Europe, Australia and many other countries require labeling with ingredient name listed in the “INCI Dictionary”. INCI stands for “International Nomenclature of Cosmetic Ingredients”. This dictionary repeated the original misinformation and required cosmetic manufacturers using formalin to put the name “formaldehyde” on product labels. About 1.5% formalin is often in used nail hardeners and these labels carried the incorrect “formaldehyde” ingredient name for many years, even though they contain almost undetectable trace levels of true formaldehyde amounting to around 0.0010%. Manufacturers of these products had no reason for concern until it was discovered that inhaling relatively high concentrations of formaldehyde gas for long periods in rare instances may cause an unusual form of nasal cancer. Suddenly, advocacy groups began to erroneously claim that nail hardeners, polish and other cosmetics contain a dangerous cancer causing ingredient. They obviously did not realize that the label name was incorrect. When the Nail Manufacturer’s Council (NMC) discovered that nail technicians and their clients were being given incorrect information, we decided to clear up the situation once and for all. As Co-chair of the NMC, I worked with others in this industry group to officially correct the INCI naming error, which was finally approved in December 2008 and is now in effect. Manufacturers using formalin in nail hardeners can now use the correct name for this ingredient, “methylene glycol”. If you find “formaldehyde” on a cosmetic label, you will know this is an incorrect name and you can be sure that formaldehyde was NOT added to the product. You can also be sure that the formaldehyde related cancer risks claimed by these advocacy groups doesn’t apply to cosmetics.

Some advocacy groups also claim formaldehyde is a nail polish ingredient, which is also completely incorrect. Here are the facts: a major ingredient used in nail polish is called “tosylamide formaldehyde resin”. This resin is originally made using several substances, including formaldehyde gas, but the resin is totally different. It is very thick, sticky, doesn’t evaporate and has completely different properties from formaldehyde gas. This resin can contain tiny trace amounts of formaldehyde residuals, but those levels are well below those found in nature. Formaldehyde is created in many naturally-occurring processes. Yes, formaldehyde is a natural and organic substance that is normally found in many foods up to 0.0098%. Trace amounts naturally occur in even organically grown pears, apples, carrots and tomatoes. In nail polish, the trace formaldehyde residuals are about the same as what naturally occurs in some foods. Also, scientific studies done in salons have proven that nail products don’t increase levels of formaldehyde in the salon air, so why the concern? Unless these advocacy groups think organically grown apples and carrots are also dangerous, they must be greatly over exaggerating the health risks.

The third incorrect claim is that certain preservatives used in some lotions, creams, shampoos, body washes, etc. release so much formaldehyde gas that they can cause cancer. What is the scientific truth? The most effective preservative ingredients for these types of cosmetics will very slowly release even lower amounts of formaldehyde than what is found in foods. In general, they release about 100 times lower levels or about 0.0001%. As you now know, this will immediately mix with water in the product and instantly convert into methylene glycol, so there’s virtually no chance of inhaling harmful levels of formaldehyde gas. The same thing happens to the trace levels of formaldehyde that naturally occurs in food, which is why formaldehyde gas inhalation isn’t a problem with cosmetics. Remember, formaldehyde gas only rarely causes nasal cancer and when it does, these problems are only found in people who inhale significantly large dosages for long periods of time, e.g. formaldehyde manufacturing plant worker. These extremely beneficial preservatives can help ensure the safety of cosmetic products, so it’s important to not to unfairly slander them. These preservative may occasionally cause skin irritation and allergic sensitivity in a small percentage of the population, but show no adverse effects for the overwhelming majority of people who use products protected by these important ingredients.

You can see that when the science behind this issue is examined, it becomes clear and obvious that the claims about formaldehyde in cosmetics causing cancer are not only incorrect; the entire issue has been dramatically exaggerated and overstated. Next time you hear that “formaldehyde” is a cancer causing ingredient in cosmetics, you’ll know this is NOT true! You’ll also know that whoever made this statement doesn’t understand the facts. Please set them straight. Save this article so you can give it to them. Educators, please share this information with your students. It hurts the entire beauty, cosmetic and personal care industry when misinformation like this goes uncorrected. We need to set the record straight and you can help.

The Hair Smoothing Controversy

Internationally Known Scientist/Chemist, Doug Schoon, Speaks Out About:
The Hair Smoothing Controversy
Ask Doug Schoon what he thinks about the recent Hair Smoothing controversy and he’ll say
the following, which may be freely quoted, posted or distributed:

“I’m a scientist and chemist that has been researching and writing about salon product safety for over 20 years and have studied the use of Formalin in cosmetics and personal care products. I’ve been researching Formalin containing hair smoothing products for almost two years and am considered a leading expert on this subject. In light of all of the misinformation, worry and confusion, I believe it is important to provide information that might help to clarify the situation.

The 15 things I believe the public should know about this controversy:

1. In general, “hair/keratin smoothing products” use Formalin as the functional ingredient. Formalin treatments provide the superior results and provides services that last up to three to four months.

2. Formaldehyde is a GAS, not a Liquid. Formalin is a generic name for a substance that contains 59% Methylene Glycol and 0.0466% Formaldehyde, mixed in water with a small amount of Methanol to prevent the Methylene Glycol (which is a Liquid) from converting into a solid polymer.

3. A change accepted in late 2008 and published in the International Nomenclature of Cosmetics Dictionary (INCI), 2010 edition, corrects the error in previous editions and now recognizes Formalin by its correct name, Methylene Glycol, making this the name manufacturers will be using to label cosmetic products containing Formalin.

4. Products containing 5% Formalin (or less) contain less than 0.0025% Formaldehyde. The reason Oregon OSHA (and others) quote a much higher percentages is: The test methods they use actually measure both Methylene Glycol and Formaldehyde together as though they were one chemical, and do not report them separately, or use their proper chemical names. A “10% Formaldehyde” report from Oregon OSHA would be scientifically correct if it reported 9.96% Methylene Glycol and 0.04% Formaldehyde instead.

5. Why is Oregon OSHA taking this stance? They cite regulations which repeat the 100+ year old misunderstanding that Formalin is nothing more than dissolved Formaldehyde, which is chemically and scientifically incorrect. Methylene Glycol is a unique and different chemical substance and Oregon OSHA knows this to be true, but is required by regulations to call Methylene Glycol by the incorrect chemical name, Formaldehyde.

6. Science has known about this chemical identity crisis for over 35 years. In 1972 the American Chemical Society gave Methylene Glycol and Formaldehyde two separate and unique registry numbers (CAS#) to recognize them as two different chemicals. Federal OSHA should require Methylene Glycol and Formaldehyde to be measured and reported separately, which would help avoid confusion and provide for a better understanding of these two separate and unique chemical substances.

7. Why do I believe this misunderstanding should be corrected? Confusion created by this long held misunderstanding is causing medical, environmental and other scientific researchers around the world to be misled. For example, researchers often perform scientific studies with 37% Formalin and are misled to believe it is 37% Formaldehyde, when in fact its 0.0466% Formaldehyde and mostly Methylene Glycol, Methanol and Water. This makes researchers more likely to report erroneous information and draw incorrect conclusions, which in turn, can prevent the proper study of Methylene Glycol.

8. When Formalin containing hair smoothing products are heated, they can release low levels of Formaldehyde gas. The limited salon studies I have performed over the last 18 months have indicated that inhalation exposure levels are within the Federal OSHA safe limits. Even so, sensitive individuals may experience acute (short term) symptoms such as irritated eyes or skin, headaches, difficulty breathing, sore throat and/or nausea, even at levels considered safe by Federal OSHA guidelines. Safe and proper use largely depend on the salon ventilation, as well as, cosmetologists’ product control and application procedures. Cosmetologists sometimes apply far too much product to the hair, which unnecessarily increases inhalation exposure, while wasting product and money.

9. The safety of these types of products and services is currently being examined by the FDA and OSHA. They will look at the results obtained by monitoring cosmetologists’ and clients’ exposure to Formaldehyde gas in salon air. This type of testing is proper and accurate and will address the real issue: What are the levels of exposure for clients, cosmetologists, and other salon workers? This information is needed before any final conclusions can be reached. I have great respect for OSHA, their mission and work. I am convinced that they will provide valuable information to help determine if levels of Formaldehyde in salon air are safe. I would expect this information to be released over the coming weeks.

10. Yes, there is a Safe Level for exposure to Formaldehyde and this substance is NOT automatically harmful at any concentration. Both Methylene Glycol and Formaldehyde is a natural, organic substance normally found in trace amounts in many foods, e.g. pears, apples, tomatoes, radishes, cabbage, carrots, green onions, meat, fish and shellfish. They are also naturally found in human blood and breath and both can be found naturally in organically grown foods and traces of Formaldehyde exists even in the purest mountain air.

11. In general, one or two, or even a million molecules aren’t likely to cause harm, since the potential for harm is caused by prolonged and/or repeated overexposure to unsafe levels; usually over an extended period of time. Less frequent exposures are less likely to result in harm or injury. Controlling the amount of exposure, e.g. proper ventilation, lowers exposure, lessens the risks and improves safety. Even so, persons with a previous history of allergic sensitivity to Formalin or Formaldehyde may adversely react with one exposure. Therefore, individuals who have or suspect allergic sensitivities should NOT receive or perform these services.

12. My (limited) experience with testing the air in salons over the last 18 months leads me to believe that a well-ventilated salon, performing two or three hair smoothing treatments per day will not exceed the Federal OSHA safe levels for Formaldehyde gas.

13. Cosmetologist and client safety can further be improved by using proper ventilation. The most useful type is called “chemical source capture” or “local” ventilation, meaning these devices pull much of the vapors into an overhanging hood, down a flexible tube, and through at least a 3 inch bed of activated charcoal to absorb a sizeable amount of Formaldehyde and lower exposure. Such systems can also be designed to safely ventilate to the outdoors.

14. Even salons that do not perform these types of hair smoothing treatments should still always use proper ventilation. Other services also create vapors, mists and dusts which must be controlled. I have evaluated and recommend the source capture system sold by Aerovex Systems, Inc. I suspect that similar systems on the market may also be effective, but I haven’t evaluated them.

15. Cosmetologists should always wear impervious gloves, e.g. nitrile gloves, to help avoid the potential for adverse skin reactions from accidental skin contact to Formalin containing products. Safety eye protection equipment should be worn to prevent accidental eye exposure. Read and understand ALL warnings provided by the manufacturer, including the Material Safety Data Sheet (MSDS) and call to ask the company questions.

Fair Disclosure: I do not have any commercial interest in selling products containing Formalin (Methylene Glycol), nor do I derive any profit from the sale of Formalin containing products. I provide scientific assistance to many cosmetic/personal care/beauty companies, some of whom sell Formalin containing products, as well as work with governments, associations and advocacy groups on cosmetic/personal care related matters.

This document is not intended to be a complete or comprehensive guide. If you experience significant problems which you believe may be related to these treatments, you should seek the advice of a qualified medical doctor. “

Scientist Responds to Misleading Claims by Oregon OSHA

Internationally known Scientist, Doug Schoon, responds to misleading claims by
Oregon OSHA that “Methylene Glycol” is a synonym for “Formaldehyde”.

Ask Doug Schoon why Oregon OSHA confuses Methylene Glycol with Formaldehyde and he’ll reply,
“Oregon OSHA is quoting the “regulations”, but their scientists know the regulations are contrary to
the scientific facts and have recently told me this!

In reality, Methylene Glycol and Formaldehyde are very different, both chemically and physically!
Methylene Glycol is a liquid; Formaldehyde is a gas. Even so, Oregon OSHA has recently declared
that these are “synonyms”, yet these two substances have very different chemical compositions and
belong to different chemical families, the Aldehyde vs. Alcohols*.

Also in 1972, both Methylene Glycol and Formaldehyde were assigned different CAS registry
numbers indicating the American Chemical Society also believes these are different and unique
chemical substances. Chemists with an understanding of organic chemistry will agree, whatever
their opinion about these substances, that Methylene Glycol and Formaldehyde are two completely
different chemicals.

It is unfortunate that this world-wide misunderstand continues to propagating confusion and mislead
medical, environmental and other scientific researchers around the world. Confusion between these
two chemicals is wrongly affecting important scientific research and correcting this error is long
overdue. Scientific researchers and others should be educated to the facts; Methylene Glycol and
Formaldehyde are NOT the same chemical substance.

I have considerable respect for OSHA and very much appreciate the great work they do to improve
worker safety. Even so, OSHA should correct the regulations to be consistent with scientific facts.
They should consider Methylene Glycol and Formaldehyde as two unique and individual substances,
measure them as such and individually report their concentrations using correct chemical names.”

Protect Yourself From Airborne Toxins In Salons

Hair and nail salons can provide a great environment to relax and unwind. Customers enjoy leaving their worries at the door for a few hours while they do something special just for themselves. However, there may be something to worry about in many salon environments. Hair treatments such as perms, dyes, and straightening methods have been linked to health risks including respiratory problems and mucus membrane irritation.

Hair salon workers and frequent customers are exposed to formaldehyde and other toxic fumes from salon products like hairspray. Nail salons also harbor toxins in the air from nail polish and tiny particles released when manicures or pedicures are filed.

However, these dangers can be avoided by taking proper action. The Three Zone Ventilation System offers a way for salon owners to purify the air in their workplace and make it safe for customers and employees. “The One That Works” air purifier is a system designed to remove not only harmful fumes but also tiny particles like hair clippings and dust from nails. It will eliminate undesirable odors from cigarette smoke, acrylics, and styling products. It even removes bacteria and viruses from the air, promoting the health of customers and stylists alike. This lightweight, portable machine traps particles as tiny as one micron! It’s convenient to maintain, and you can run it all day long.

You pay a lot for cosmetic treatments, and you have a right to protection from airborne toxins. Salons are currently not regulated and required to meet safety standards. Therefore, it is up to the consumers to demand safety measures. A Chemical Source Capture System is the best way to ensure the safety and comfort of salon workers and their clients.

Busting The “Formaldehyde Free” Myth

Formaldehyde is often used as a preservative in household products such as glue and nail polish. Intense exposure can be irritating and cause severe reactions in the mucus membranes and respiratory system.

Contrary to popular belief, all Brazilian Keratin Treatments (also known as Brazilian Blowouts) contain formaldehyde or other “hydes” that are just as dangerous. Manufacturers and distributors have also started using formaldehyde substitutes, like Urea, that are just as toxic, but don’t have the stigma that is associated with formaldehyde.

In order for the straightening process to work, formaldehyde or a similar substitute is a requirement. This is the active ingredient which binds keratin to the hair, making it feel thicker and healthier. According to chemist Doug Schoon, of Schoon Scientific in Dana Point, CA, a chemical process is required to achieve the shiny, straight hair offered in these treatments.

Attempting to research the ingredients in Brazilian Keratin Treatments will yield poor results, as manufacturers use the excuse of protecting their “Secret Formula” as a way to deny you the right to know what is being applied to your hair. As long as a hair product is labeled “For Professional Use,” manufacturers are not required by the FDA to list the ingredients.

Taking proper precautions creates safer air quality in salons using Brazilian Keratin Hair Treatments. Installing a Three Zone Ventilation System ensures the safety of the hairstylists performing these treatments, as well as their clientele.