Tag: Global Keratin

Van Tibolli Beauty Corp Issued Warning Letter AKA “GK Hair Taming System with JUVEXIN®”

~ Joseph Kellner
 THE REAL HAIR TRUTH
WARNING LETTER
FLA-15-31
September 2, 2015
Mr. Van Tibolli, CEO
Van Tibolli Beauty Corp.
4800 NW 15th Avenue, Unit E
Fort Lauderdale, FL 33309-3781
THE REAL HAIR TRUTH
Dear Mr. Tibolli:
The United States Food and Drug Administration (FDA) has reviewed the regulatory status of your products, the GK Hair Taming System with JUVEXIN® Curly and GK Hair Taming System with JUVEXIN® Resistant hair smoothing products.  The GK Hair Taming System Curly and Resistant products are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, therefore these products are 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, the GK Hair Taming System with JUVEXIN® Curly and GK Hair Taming System with JUVEXIN® Resistant hair smoothing products are adulterated within the meaning of Section 601(a) of the Act [21 U.S.C. § 361(a)] and are 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 Cosmetics
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.  The conditions of use in the product labeling fail to include instructions to: (1) use these products in a facility with adequate ventilation, (2) avoid direct eye and skin contact, and (3) avoid unnecessary repeated use.
The GK Hair Taming System with JUVEXIN® Curly and Resistant products are adulterated cosmetics within the meaning of Section 601(a) of the Act, 21 U.S.C. § 361(a) because they bear or contain a deleterious substance that may render it injurious to users under the conditions of use prescribed in your labeling. Specifically, based on product labeling and FDA sample analysis, the GK Hair Taming System with JUVEXIN® Curly and Resistant products contain methylene glycol, the liquid form of formaldehyde, which, under the conditions of use prescribed in the product 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, under the conditions of use prescribed in the current labeling.  FDA analysis of approximately 50 mg samples of the GK Hair Taming System with JUVEXIN® Curly and Resistant confirmed the presence of 3.9 % and 4.85% methylene glycol, the liquid form of formaldehyde, respectively.
FDA notes that the primary route of exposure to formaldehyde, when using the GK Hair Taming System with JUVEXIN® Curly and Resistant products 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.  Formaldehyde is a recognized carcinogen. For example, adverse events have reported the following injuries associated with formaldehyde containing hair smoothers: 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.
Misbranded Cosmetics
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.” Specifically, the GK Hair Taming System with JUVEXIN® Curly and Resistant products are misbranded because the product labels and labeling, including instructions for use, fail to reveal material facts with respect to consequences that may result from the use of the product.
FDA notes that the product labels for the GK Hair Taming System with JUVEXIN® Curly and Resistant declare the following:
  • “INSTRUCTIONS: Shampoo client’s hair twice using GKhair pH+ Shampoo.  Apply, then massage product ¼ inch from the root.  Comb for even distribution.  Blow dry client’s hair straight and smooth until 100% dry.  Flat iron to seal cuticle.  For detailed instructions visit http://www.GKhair.com.”
  • “WARNING: Product releases formaldehyde.  Information on the physical and health hazards, and the safety data sheet, may be obtained from Van Tibolli Beauty S.a.r.l.  This product must be applied by hair professionals only.  If you are nursing or pregnant do not use the product without first consulting your physician.  If skin contact occurs, wash immediately.  If ingestion or eye contact occurs, call a physician immediately.  Salon professional and client must wear protective clothing.  Keep out of reach of children.  Store in a cool and dry place.”
Although the GK Hair Taming System with JUVEXIN® Curly and Resistant product labels bears a warning statement, the warning statement and product labeling are inadequate. Specifically, they fail to reveal facts material with respect to consequences that may result from this use of these products under the conditions of use as follows:
1.    They fail to inform the user of the adverse effects that may result from the release of formaldehyde into the air during the heating process, which can have both short term and long term health effects (e.g., eye and throat irritation, headache, dizziness, burning sensations, breathing problems, nosebleeds, chest pain, skin irritation and certain cancers), particularly for those who are sensitive to formaldehyde.  Long term exposure may potentially cause certain cancers.
2.    They fail to inform users that concurrent uses of these products in the same facility may increase the concentration of formaldehyde in the air, which could increase the risk of adverse effects.
We also note that while the GK Hair Taming System is targeted primarily for use by salon professionals in a salon setting, the product may also be used in home salon settings as the GK Hair Taming System with JUVEXIN® Curly and Resistant hair smoothing products are also available for purchase in beauty retail stores and via the internet by the general public. Consequently, we recommend that Van Tibolli Beauty Corp. work with its distributors to ensure that GK Hair Taming System with JUVEXIN® Curly and Resistant products are labeled in accordance with the requirements of the Act.
The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist in connection with your products. 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.
Your response should be sent to:
Salvatore N. Randazzo, Compliance Officer
555 Winderley Place, Suite 200
Maitland, Florida, 32751
Refer to the Unique Identification Number 451478 when replying. If you have any questions about the content of this letter please contact: Salvatore N. Randazzo at (407) 475-4712.
Sincerely,
/S/
Susan M. Turcovski
District Director
Florida District Office

Real Hair Truth Cosmetic/Beauty Product Injury Lawsuits

~ Joseph Kellner

the real hair truth

Injuries from cosmetic products can come in a wide variety of forms — from allergic reactions to infections and other complications. There are two main legal theories that a person injured by a cosmetic product (the plaintiff) could sue under: product liability and breach of warranty. This article discusses what a plaintiff in a cosmetic injury suit must prove under either theory, cases specifically related to allergic reactions, and the possibility of class action lawsuits.

Product Liability: The Basics

The most likely theory to be used in a lawsuit involving cosmetic product injuries is product liability. An injured plaintiff can sue both the manufacturer and/or the seller (the defendant) of the cosmetic product if his or her injury was caused by a defect, a defective design or improper labeling. Most states follow what is called the “strict product liability” rule, although a few still use traditional negligence rules.

A plaintiff suing under a strict liability theory simply needs to prove:

  • that he or she was the kind of consumer that the defendant intended to use the product
  • that the defect did not occur after the product was sold, and
  • that the plaintiff was injured.

This kind of theory is called “strict liability” because many of the requirements in a standard negligence case, like proof of a specific duty of care owed to the plaintiff, are not included. Most states adopted strict liability for mass-marketed consumer products because, among other things, the manufacturers needed to be financially responsible for their products, and not be allowed to escape liability simply because of the difficulty plaintiffs faced trying to prove negligence claims.

In a negligence case (in those few states that still use this theory for consumer products), the plaintiff will need to prove:

  • that he or she bought the product from the defendant
  • that the defendant should have known that the product could be dangerous if unaccompanied by proper warnings, or that the product had a defect
  • that the failure to warn the plaintiff, or the defect or defective design, injured the plaintiff, and
  • that the plaintiff didn’t do anything to cause the injury.

Breach of Warranty

A cosmetic product injury case based on a breach of warranty theory will be the same as other standard breach of warranty cases.

An injured plaintiff could sue for breach of an express warranty if the seller or manufacturer made specific guarantees that a product would have specific effects that the product did not have (note that this theory might not fit with most cases involving an actual injury).

The plaintiff could also sue for breach of an implied warranty that the cosmetic product was fit for normal use, i.e. the implied guarantee that no normal cosmetic product would cause an injury if used properly.

Finally, the plaintiff could sue for breach of an implied warranty that the product was fit for a specific purpose, i.e. that the defendant knew the plaintiff wanted to use the product for a specific purpose, but the product caused an injury when the plaintiff tried use it.

There are many state and federal laws controlling breach of warranty claims. Some breach of warranty claims may not be appropriate when the plaintiff is suing for physical injuries, if the law only allows compensation for the money lost on the product (what is called “economic damages”).

Some warranty laws, however, do allow a plaintiff to sue for physical injuries. Perhaps more importantly, proving a breach of warranty can help prove a strict liability or negligence claim. A plaintiff is not limited to suing under one theory, so including a breach of warranty claim in a cosmetic injury lawsuit will generally help a plaintiff’s case overall.

Injuries Caused by Allergies

If a manufacturer knows, or should know, that a product might cause an allergic reaction in some people, injured plaintiffs could potentially sue the manufacturer for failing to warn about the allergic reaction under a strict liability or negligence theory. A breach of warranty theory might also be possible if the allergic reaction is not extremely rare, i.e. the product was not fit for cosmetic use because some percentage of the population was allergic.

Class Actions for Cosmetic Product Injuries

If a cosmetic product causes many or all of its users the same kind of injury, then a class action may be possible. In a class action case, multiple plaintiffs with the same kind of injury from the same source sue the defendant in one lawsuit.

If someone is injured by a cosmetic product, they or their attorney should research whether there is already a class action case or a settlement fund for people injured by the product. Often, even though the case has settled, there will be a fund to pay those who were not a part of the original case.

Real Hair Truth what makes a cosmetic misbranded?

~ Joseph Kellner

The Beautiful Lies

The film “Beautiful Lies” release date will be in 2014

In our beautiful world cosmetics hold a strong life in the world of personnel beauty. According to the U.S Government this is a definition of what is “Misbranded”.  Realize my friends that in this day and age government is in everything you do, and with the past and current behavior of the U.S Government would you even take there word on just about anything. Politicians cannot even agree on anything anymore, there life span as a senator, congressman, house representative is for life. Your freedom of speech is going down the drain. So why would you take the word of the FDA. According to the United States Food and Drug Administration (FDA), its responsibilities include “protecting the public health by assuring that foods, cosmetics are safe, wholesome, sanitary and properly labeled.” This responsibility entails regulating a large number of companies producing this nation’s food, making appointments to the high-level positions within the agency very important.  Most high-level FDA employees have a background in either medicine or law, but one of the largest private-sector sources is the Monsanto Company. Over the past decades, at least seven high-ranking employees in the FDA have an employment history with the Monsanto Company.

Well aware of its accused ‘revolving door’ connection with the FDA and other government agencies, Monsanto has issued several press releases denying collusion with the government. In fact, it posted on its official website that collusion theories relating to these agencies, including the FDA, “ignore the simple truth that people regularly change jobs to find positions that match their experience, skills and interests.  ”

Monsanto’s statements help shed light on the balancing act regularly occurring on Capitol Hill when appointments to these top agency positions arise. The importance of the food, cosmetic industrys cannot be overstated and, therefore, the pending question remains: Do Americans want industry insiders regulating it, or those from the academic realm?

What makes a cosmetic misbranded?

Section 602 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered misbranded:

“A cosmetic shall be deemed to be misbranded–

  • (a) If its labeling is false or misleading in any particular.
  • (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.
  • (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
  • (d) If its container is so made, formed, or filled as to be misleading.
  • (e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 721. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).
  • (f) If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.

Note that under the FD&C Act, the term “misbranding” applies to–

  • False or misleading information,*
  • Lack of required information,
  • Conspicuousness and readability of required information,
  • Misleading packaging,
  • Improper packaging and labeling of color additives, and
  • Deficiencies where the Poison Prevention Packaging Act requires special packaging.

*Note: According to the FD&C Act, a determination that labeling is “misleading” includes considering both what the label says and what it fails to reveal:

“If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or 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” (FD&C Act, sec. 201(n); 21 U.S.C. 321(n)].

In addition, a cosmetic marketed in violation of the FPLA or any regulations issued under its authority is considered misbranded within the meaning of the FD&C Act [15 U.S.C.1456(a)]. For cosmetics offered for sale as consumer commodities, the FPLA–

  • requires further label information, such as the product’s identity [15 U.S.C.1453], and
  • authorizes the implementation of regulations to specify the proper presentation of required label information, require an ingredient declaration, and prevent deceptive packaging [15 U.S.C.1454 (c)]

The FPLA defines a consumer commodity, as it applies to FDA-regulated products, as:

“any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act …, and any other article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use.” [15 U.S.C.1459(a)]

Note that the FPLA defines a consumer commodity by the way it is marketed, not the way it is labeled. Labeling a product with words such as “For Professional Use Only” does not keep your product from being considered a consumer commodity under the FPLA.

Labeling regulations are very complex. Detailed information on cosmetic labeling is available in FDA’s Cosmetic Labeling Manual and the labeling regulations themselves [21 CFR 701].

2013 In Review For the Real Hair Truth Organization/Jotovi Designs Inc

~ Joseph Kellner

TheRealHairTruthLogo (1)mediumsize

The blog (The Real Hair Truth)/organization (Jotovi Designs) did well this past year.  The “TRUTHFUL”  voice for the industry will always be here on this page. The truth of the industry will always be written and told by me. Even though you will not find it in Modern Salon, PBA, Salon Galaxy,  Hairbrained.me, ETC.  And my films will voice the truth of the industry, ‘The Real Hair Truth, The Beautiful Lies”. Thank you everyone for your support the last 7 years. We have did it on our own without the help of industry magazines, websites, or cosmetic brands.

Jotovi Designs Inc.

We have funded our books and films on our own and will continue to do so.  Jotovi Designs Inc. is not looking for any help financially from any beauty/cosmetic industry brands and will continue to do so!  The organization continues to help professionals in the industry and will continue to do so! This year will be the release of the second documentary called “Beautiful Lies”.  I thank everyone for their continued support and may all have a wonderful New Year!

Best Regards

Joseph Kellner

Here’s an excerpt:

The concert hall at the Sydney Opera House holds 2,700 people. This blog was viewed about 19,000 times in 2013. If it were a concert at Sydney Opera House, it would take about 7 sold-out performances for that many people to see it.

Click here to see the complete report.

L’Oréal Hair Product Class Action Lawsuit Settlement. Burn In Hell!!

~ Joseph Kellner

TheRealHairTruthLogo

As usual in our industry, See no Evil, Hear no Evil, Speak no Evil. None of the So-called industry websites, comic books, or fan clubs will do no reporting against no major manufacturer in my industry. It is common knowledge for manufacturers to supply the latest and greatest to the industry sheep. For the purpose of increasing the financial pyramid for themselves. No longer is there a honest approach of informing the beauty industry of news about class action lawsuits for the betterment of the industry. WHY YOU SAY? Because industry giants sustain the beauty industry and give financial backing to the comic books, websites and fan clubs. If one of the three prior mentioned “bite” the hand that feeds them there would be no existence for that website, or magazine or organization.  So in general you will not know who, what, where in this industry. You will be led unless you do any investigative work by yourselves.

REALHAIRTRUTH

L’Oréal USA Inc. has reached a class action lawsuit settlement over claims it falsely marketed shampoo, condition and styling products under the Matrix, Kérastase, Redken and Pureology brand names.Under the proposed settlement agreement, L’Oréal will modify the labels of these products to remove certain misleading language.

The L’Oréal settlement will resolve a class action lawsuit (Richardson v. L’Oréal USA Inc.) that alleges L’Oréal misled consumers into believing they could only purchase the Matrix, Kérastase, Redken and Pureology products exclusively in professional salons, when consumers can purchase the products in major retail outlets.

REAlhairtruth.com

L’Oréal denies any wrongdoing, but has agreed to a class action lawsuit settlement to resolve the litigation.

Class Members of the L’Oréal class action settlement include all consumers nationwide who purchased the L’Oréal products for personal, family or household use on or after August 30, 2008. There is no monetary benefit for Class Members. Instead, L’Oréal has agreed to remove from the labeling of these hair products the following “claims”:

  • “for sale only in professional beauty salons”;
  • “exclusive salon distribution”;
  • “exclusive to Kérastase consultant salons”;
  • “only professional”;
  • “only in salon”;
  • “sold exclusively in salons”;
  • “available only at fine salons and spas”;
  • “available only at fine salons”; and
  • similar claims in English or other languages which may be read as suggesting availability for purchase exclusively in professional salons.

Since there is no monetary benefit for Class Members, there is no claim filing deadline. If you wish to object to the L’Oréal product class action settlement, you must do so by September 11, 2013.

Will the industry inform you about this?

NO THEY WONT, MY FRIENDS.

THEY WILL NOT!

Because the industry is L’oreal, And they do not want you to know any wrong about these companies. God Forbid they would reach out to you and explain the particulars of this lawsuit and tell you how to apply for claims.