Tag: FDA

Loreal Always In Trouble

~ Joseph Kellner

logos-loreal

FEB 12, 2015

WARNING LETTER

VIA OVERNIGHT DELIVERY
Brigitte Liberman, President Active Cosmetics Division
L’Oréal USA
575 Fifth Avenue
New York, NY 10017
Re: CMS # 440851
Dear Ms. Brigitte Liberman:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.laroche-posay.us in December 2014. Based on this review, you take orders there for your products “Rosalic AR Intense” and “Mela-D Pigment Control,”  which appear to be promoted for uses that cause the products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(C)]. The claims on your website indicate that the products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the claims on the website http://www.laroche-posay.us, that provide evidence that your products are intended for use as drugs include:
Rosaliac AR Intense:
  • “Localized Redness Intensive Serum”
  •  “RECOMMENDED FOR: Redness-prone skin, experiencing overall redness, flushing and sensations of discomfort”
  •  “Reduces visible redness and sensations of discomfort”
  • “[F]ormula combining 3 effective ingredients to help reduce redness with a long lasting efficacy”
  • “I have rosaceaon my neck when I get warm or under stress. This product really works to keep it under control!!!”
  • “I have broken capillaries and generalized redness on several areas of my face. I was told laser treatment was the only fix. Then…the miracle of Rosalic AR!”
  • “With powerful Ambophenol [0.5%] to visibly reduce redness”
Mela-D Pigment Control:
  • “Concentrated Dark Spot Correcting Serum”
  • “Use to treat dark spots and discolorations”
  • “Recommended For: Hyperpigmentation and Dark Spots”
  • “With 2% Kojic Acid to visibly reduce the intensity of dark spots”
Your “Rosalic AR Intense” and “Mela-D Pigment Control” products are not generally recognized as safe and effective for the above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. A description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.
Furthermore, your “Rosaliac AR Intense” product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The Real HAIR TRUTH
This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. 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 review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.
We request that you take prompt action to correct the violations cited in this letter. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
THE REAL HAIR TRUTH
You should direct your written reply to Dehlia Young, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions regarding this letter, you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
Sincerely,
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition

Retail Regulation In The Cosmetic Industry

~ Joseph Kellner
real hair truth
The $71 billion personal care product industry in the United States is largely unregulated, and retailers are stepping up to fill the void.

When retailers adopt policies on the safety of the products they sell, it’s called retail regulation.

There is a rich history of retailers using their purchasing power to effect positive market change.
In 2008, when Walmart—the world’s largest retailer—agreed to stop selling baby bottles, sippy cups and sports water bottles made with BPA, it forced manufacturers to reformulate in order to keep selling to this retail giant.
More and more retailers are adopting store wide policies governing the safety of their beauty products, with Whole Foods leading the way by implementing a basic chemical safety screening for all its personal care products and adopting a restricted-substances list made up of more than 400 chemicals prohibited from products bearing its premium standards labels.
In 2008 CVS stepped up to the plate by adopting a store-wide policy prohibiting the use of certain
toxic chemicals in their store-brand baby products. Walgreen’s and Target followed suit in 2013 by
announcing they would develop and adopt comprehensive cosmetic safety policies to govern the
safety of the private-label and national brands they carry.
The following goals should guide retailers’ policies and practices to improve the safety of personal
care products sold in their stores:
•
Expand the sale of safer cosmetics and personal care products (products free of chemicals
linked to cancer, birth defects, developmental harm and other health concerns).
•
Adopt a list of chemicals that are banned from use in private-label and national brands sold
in their stores, and ensure that toxic chemicals are replaced with safer alternatives.
•
Reformulate private-label products to eliminate chemicals of concern.
•
Practice the highest level of transparency by sharing the company’s safe-cosmetics policy,
practices and progress on websites and in corporate responsibility reports.
•
Strive for continuous improvements in policies and practices by monitoring scientific
research regarding emerging chemicals of concern.
Federal Regulations
Major loopholes in federal law allow the cosmetics industry to put virtually any chemical into a
cosmetic or personal care product with no pre-market FDA safety testing or review, no monitoring
of health effects, and inadequate labeling requirements. Most of us assume the FDA regulates
these products just as it does food and drugs to assure safety. In fact, cosmetics are one of the least
regulated consumer products available to the public. To make matters worse, contaminants in a
finished cosmetic product that occur as by-products of the manufacturing process, by law, don’t
have to be listed on the product label. That means chemicals like PFOA can hide in a cosmetic or
personal care product without consumers knowing.
The Federal Food, Drug and Cosmetics Act (FFDCA) includes 112 pages of standards for food and
drugs, but just a single page for cosmetics. The cosmetics title of the FFDCA, which has not been
amended significantly since it was enacted more than 77 years ago, provides virtually no power to
perform even the most rudimentary functions to ensure product safety in an estimated $71 billion
cosmetic industry.
Fortunately, for the first time in 77 years, Congress could close the gaping holes in our outdated
federal law and give the FDA the statutory authority and resources it needs to effectively regulate
the safety of cosmetics and personal care products. Currently, Congress is considering two bills to
regulate cosmetics ingredients.
The Senate
On April 20, 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the
Personal Care Products Safety Act of 2015, an important bill with the potential to give the cosmetics
industry a desperately needed makeover. Many strong provisions in the bill would advance the
FDA’s ability to protect consumers from unsafe chemicals in cosmetics and personal care products:
•
Requiring companies to register their facilities, products and ingredients with the FDA;
•
Closing labeling loopholes by requiring full ingredient disclosure for professional salon
products and web-based sales of cosmetic products; and
•
Directing the FDA to assess the safety of a minimum of five cosmetics chemicals a year.
However, the bill falls short of what is needed. Ideally, federal regulation would put in place a robust
safety standard and elevate the rigor of ingredient safety reviews by the FDA and manufacturers to
ensure that cosmetics and personal care products are as safe as possible

Defective Products May Cause Serious Personal Injury

~ Joseph Kellner

The beautiful LiesYou can see the advertisements on television all the time—women running their fingers through their hair, happy because they have dyed their hair to a “brilliant” color. But what happens if the hair dye is a defective product? After all, hair dye contains chemicals that come in close contact not only with your scalp, but with your eyes, nose and mouth, creating the potential for a serious personal injury. Some women say they suffered severe burns after using hair products, including dyes and relaxers.

According to the FDA, some problems reported from hair dyes include hair loss, burning, redness, itchy or raw skin, swelling in the face and trouble breathing. Sometimes, the issue is an allergic reaction, and the FDA warns that such a reaction can occur even after years of using a hair dye product.

Some lawsuits have been filed against hair dye makers, alleging their product caused women to permanently lose their hair. In 2006, a lawsuit was filed against Procter & Gamble, alleging that Clairol “Nice ‘n Easy” hair dye left the plaintiff with chemical burns on her scalp and caused her hair to fall out.

Hair dye chemical burns do not just happen at home. In fact, lawsuits have been filed against salons alleging that clients suffered chemical burns during hair dye treatments. In 2014, a woman filed a $12,000 lawsuit, alleging she suffered a severe chemical burn to her scalp. Her lawsuit seeks expenses for medical care as well as damages for physical and mental pain and suffering.  An article in the FDA’s Consumer magazine notes that hair straighteners and hair dyes are among the agency’s Office of Cosmetics and Colors top consumer complaint areas. Although some complaints are caused by misuse of the product, others may be related to the product itself, and reactions vary from hair breakage to emergency room visits. According to the FDA article, there have been cases where products were labeled as “chemical free” when they actually contained ingredients that most people would consider “chemicals.” In those cases, the products were eventually removed from the market or had their labels changed.  Chemical burns can be incredibly painful and can have severe consequences for victims. They can take a long time to heal, putting patients at risk for infections. The recovery can be expensive, requiring various medicines, including steroids, to heal the burns and creams to stop the pain. Of course, there is also the emotional impact associated with such chemical burns. The scarring of the head and face can be emotionally traumatic for a person, leading to depression and anxiety.

In cases where a defective product has caused personal injury, it is possible to file a lawsuit to hold the company accountable for putting a defective product on the market.

Popular shampoos contain toxic chemicals linked to nerve damage

~ Joseph Kellner

real hair truthResearchers at the National Institutes of Health have found a correlation between an ingredient found in shampoos and nervous system damage. The experiments were conducted with the brain cells of rats and they show that contact with this ingredient called methylisothiazoline, or MIT, causes neurological damage.

Which products contain this chemical compound MIT? Head and Shoulders, Suave, Clairol and Pantene Hair Conditioner all contain this ingredient. Researchers are concerned that exposure to this chemical by pregnant women could put their fetus at risk for abnormal brain development. In other people, exposure could also be a factor in the development of Alzheimer’s disease and other nervous system disorders.

The chemical causes these effects by preventing communication between neurons. Essentially, it slows the networking of neurons, and since the nervous system and brain function on a system of neural networks, the slowing of this network will suppress and impair the normal function of the brain and nervous system.

These finding were presented December 5th at the American Society for Cell Biology annual meeting.

I have frequently warned readers about the dangers of using brand-name personal care products. The vast majority of these products contain toxic chemical compounds like MIT that contribute to cancer, liver disorders and neurological diseases. In fact, this chemical, MIT, is just one of dozens of such chemicals that are found in personal care products.

Why are these dangerous products allowed to remain on the market? Because the FDA, which is responsible for regulating these products, spends almost no time, money or effort actually investigating the safety of such products. Instead, the FDA spends the vast majority of its time approving new prescription drugs rather than protecting the public against the dangers from such drugs or personal care products like cleansers, shampoo’s, soaps, deodorants and fragrance products.

In fact, it may surprise you to learn that manufacturers can put practically any chemical they want into shampoos, even if it is a hazardous chemical listed in the RTECS database of toxicity and even if it is considered a toxic waste chemical by the EPA. The FDA allows all sorts of chemicals to be used in these products including chemicals that are known carcinogens and that contribute to liver failure and nervous system disorders. How’s that for protecting public health?

If you thought prescription drugs were dangerous, just take a look at the toxic chemicals found in personal care products used by virtually all Americans every single day. Americans bathe themselves in toxic chemicals and they do it by buying and using products made by brand name companies that have premier shelf positioning at convenience stores, grocery stores and discount clubs.

One of the more curious personal care products on the market is Herbal Essences Shampoo by Clairol. Personally, I think this product is a joke because it’s trying to exploit the word “herbal” to imply that the shampoo is healthy, even though it is primarily made with the same ingredients as other popular shampoos. The first three ingredients, for example, are: water, sodium laureth, and sodium laurel sulfate. Big deal, huh? You can find the same three ingredients in 99-cent shampoo at Wall-Mart. Plus, the product contains all sorts of other ingredients that I personally would never allow to touch my skin (like methylchloroisothiazolinone, if you can believe there’s actually a chemical with a name that long). Think the color of the shampoo is from the herbs? Think again. Three other ingredients in the shampoo are Yellow #5, Orange #4 and Violet #2.

In other words, this is a shampoo product purchased by naive consumers, in my opinion. People who really know herbs and natural products can only laugh at a product like this. Want a real shampoo? Buy Olive Oil Shampoo from Heritage Products, available at most natural health stores.

The bottom line to all of this, though, is that every week, it seems like we see a new announcement about some toxic chemical found in personal care products that is related to either cancer or neurological disorders. And yet week after week these products are being sold by retailers and consumed in large quantities by the American people who remain oblivious to the real damage these products are causing to their health.

Once again, the solution here is to protect yourself by learning the truth about these products and switching to products made with safe ingredients. There are safe shampoos, safe soaps, safe laundry detergents, dish washing liquids and even deodorant products. You don’t have to expose yourself to toxic chemicals to take care of personal hygiene, because whether you agree with it or not, these disease-causing chemicals are going to remain quite legal in the use of personal care products for many years to come. Why? You can bet that the manufacturers of these products will fight against any attempt to regulate or outlaw these toxic chemicals. That’s because the chemicals are convenient for such manufacturers. It’s much the same way in which food manufacturers use sodium nitrate in bacon and other packaged meats. It’s all about their convenience rather than protecting your health.

So, here’s the idiot test for today: if I was standing on a street corner with a bottle of colored liquid, and I told you that liquid contained a toxic chemical that caused neurological disorders, Alzheimer’s disease and birth defects, would you buy that product from me and scrub it into your scalp under warm water?

Of course not. But if you’re buying these popular shampoo products, that’s exactly what you’re doing right now. Such is the power of brand marketing in America.

THE SMARTPHONE OF HAIRCOLOR IS HERE….COURTESY OF B’ORÉAL OF PARIS.

~ Joseph Kellner

THE REAL HAIR TRUTH.COM

I often wonder why salon owners and booth renters will buy from B’Oreal, WHY? But as soon as I think about it hairdressers are not left brain and right brained at the same time. Business is not taught in beauty schools. And if there is a business class in the hair shows it is to dump on one brand and try to sell you there’s.

So who do you want to partner with, the company that teaches consumers that they can do your job & discredits you or the ones that support the professional hairdresser? And the professional(?) Hairdresser will buy from companies such as Boreal, Paul Mitchell, Redken, TIGI, etc. knowing they do not have a EXCLUSIVE with the company. Because they are in competition with the manufacturer. The manufacturer will make a cosmetic line for the consumer and also for the professional(?). Trust me in other professions a true professional would not do this stupid mistake.
THE SMARTPHONE OF HAIRCOLOR IS HERE….COURTESY OF B’ORÉAL of PARIS.
L’Oreal Paris Mousse Absolue
At-home hair dye always seems like a fine idea until you find yourself trying to mix several different foul-smelling chemicals in the right ratio while unfolding a manual the size of a roadmap for planet Earth. But, though it may be less than ideal, for many women, an expensive hours-long trip to the salon isn’t an option anymore.
It’s something that’s been in the works for over a decade, according to Luc Maelstaf, packaging designer for B’Oreal of Paris. “Everybody always dreams of a product where you push a button and a machine does the work for you,” he says. “This device does just that: It makes the hair color mix without the consumer even noticing that it’s happening.”

Maelstaf says that B’Oreal of Paris used Japanese technology to develop the packaging of the product, which is what makes the automatic, reusable qualities possible. Two separate aerosol cans are held together in a sleek plastic sleeve. One can contains the colorant; the other, the oxidant. “The reaction to create hair color only happens when you have a mix of those two things,” says Sophie Bodelin, the head of hair color labs for the France headquarters of B’Oréal of Paris. “But now you don’t have to mix it yourself. The mix is complete as soon as the product comes out of the bottle.”

But in my industry they will buy the products from Boreal and use them in there salon. And what you have to listen to now is when the customer asks you what are you using on there hair. They will ask you. And then go home and find it on the internet. Thank you internet you gave the manufacturers a ndew3 way to sell there products. And that goes like wise for the entrepreneur. A entrepreneur will have a lot of hard times in the beauty industry. Manufacturing a beauty product is not easy and it takes money from start to finish to packing. What’s left for the beauty industry entrepreneur. The internet. Cosmetics company’s have never dreamed there sales would sky rocket like they have since the birth of the internet.
So for the Entrepreneur. 
 IT’S SIMPLE AND THEY HAVE SEEN THE MAJOR MANUFACTURERS DO IT SO THEY ARE ALREADY SCHOOLED on the vast uses of the internet. And also IN THE KNOWLEDGE OF NO VALUE AND NO EXCLUSIVE FOR THERE FELLOWS IN THE INDUSTRY. That would be too much to ask for especially in day and age when EX-Monsanto employee’s run the FDA.  Why go door to door anymore to sell your product. Don’t put a face on it, don’t take any responsibility for it. When you can just plant your packaged (Soap) on the internet. And dear Lord don’t get to know your customers, because they will soon find out your product is just a private label just like the many entrepreneurs have in the beauty industry. I have a gentleman in my next film “The Beautiful Lies” who sells hair color. Since I have used his hair color I get nothing but calls from the company wanting to tell me of there newest and latest and greatest product. That I should try and mind you buy also. They never heard of having samples to give to there good clients. And if a company in my so called professional beauty industry wants to tell you the horrors of a major manufacturer it is for there goodness. They just want you to buy there shit.
LOSERS!