Probeauty (PBA) Would Rather Buy Hair Shows Than To Do What Is Right For The Industry!

Jotovi Designs Inc

The women begin to arrive just before 8 a.m., every day and without fail, until there are thickets of young Asian and Hispanic women on nearly every street corner along the main roads of Flushing, Queens.

As if on cue, cavalcades of battered Ford Econoline vans grumble to the curbs, and the women jump in. It is the start of another workday for legions of New York City’s manicurists, who are hurtled to nail salons across three states. They will not return until late at night, after working 10- to 12-hour shifts, hunched over fingers and toes.

On a morning last May, Jing Ren, a 20-year-old who had recently arrived from China, stood among them for the first time, headed to a job at a salon in a Long Island strip mall. Her hair neat and glasses perpetually askew, she clutched her lunch and a packet of nail tools that manicurists must bring from job to job.

Tucked in her pocket was $100 in carefully folded bills for another expense: the fee the salon owner charges each new employee for her job. The deal was the same as it is for beginning manicurists in almost any salon in the New York area. She would work for no wages, subsisting on meager tips, until her boss decided she was skillful enough to merit a wage.

It would take nearly three months before her boss paid her. Thirty dollars a day.

Once an indulgence reserved for special occasions, manicures have become a grooming staple for women across the economic spectrum. There are now more than 17,000 nail salons in the United States, according to census data. The number of salons in New York City alone has more than tripled over a decade and a half to nearly 2,000 in 2012.

Real Hair Truth.com

But largely overlooked is the rampant exploitation of those who toil in the industry. The New York Times interviewed more than 150 nail salon workers and owners, in four languages, and found that a vast majority of workers are paid below minimum wage; sometimes they are not even paid. Workers endure all manner of humiliation, including having their tips docked as punishment for minor transgressions, constant video monitoring by owners, even physical abuse. Employers are rarely punished for labor and other violations.

Asian-language newspapers are rife with classified ads listing manicurist jobs paying so little the daily wage can at first glance appear to be a typo. Ads in Chinese in both Sing Tao Daily and World Journal for NYC Nail Spa, a second-story salon on the Upper West Side of Manhattan, advertised a starting wage of $10 a day. The rate was confirmed by several workers.

Lawsuits filed in New York courts allege a long list of abuses: the salon in East Northport, N.Y., where workers said they were paid just $1.50 an hour during a 66-hour workweek; the Harlem salon that manicurists said charged them for drinking the water, yet on slow days paid them nothing at all; the minichain of Long Island salons whose workers said they were not only underpaid but also kicked as they sat on pedicure stools, and verbally abused.

Last year, the New York State Labor Department, in conjunction with several other agencies, conducted its first nail salon sweep ever — about a month after The Times sent officials there an inquiry regarding their enforcement record with the industry. Investigators inspected 29 salons and found 116 wage violations.

Among the more than 100 workers interviewed by The Times, only about a quarter said they were paid an amount that was the equivalent of New York State’s minimum hourly wage. All but three workers, however, had wages withheld in other ways that would be considered illegal, such as never getting overtime.

The juxtapositions in nail salon workers’ lives can be jarring. Many spend their days holding hands with women of unimaginable affluence, at salons on Madison Avenue and in Greenwich, Conn. Away from the manicure tables they crash in flophouses packed with bunk beds, or in fetid apartments shared by as many as a dozen strangers.

Ms. Ren worked at Bee Nails, a chandelier-spangled salon in Hicksville, N.Y., where leather pedicure chairs are equipped with iPads on articulated arms so patrons can scroll the screens without smudging their manicures. They rarely spoke more than a few words to Ms. Ren, who, like most manicurists, wore a fake name chosen by a supervisor on a tag pinned to her chest. She was “Sherry.” She worked in silence, sloughing off calluses from customers’ feet or clipping dead skin from around their fingernail beds.

At night she returned to sleep jammed in a one-bedroom apartment in Flushing with her cousin, her cousin’s father and three strangers. Beds crowded the living room, each cordoned off by shower curtains hung from the ceiling. When lights flicked on in the kitchen, cockroaches skittered across the counter-tops.

Almost all of the workers interviewed by The Times, like Ms. Ren, had limited English; many are in the country illegally. The combination leaves them vulnerable.

Some workers suffer more acutely. Nail salons are governed by their own rituals and mores, a hidden world behind the glass exteriors and cute corner shops. In it, a rigid racial and ethnic caste system reigns in modern-day New York City, dictating not only pay but also how workers are treated.

Korean workers routinely earn twice as much as their peers, valued above others by the Korean owners who dominate the industry and who are often shockingly plain-spoken in their disparagement of workers of other backgrounds. Chinese workers occupy the next rung in the hierarchy; Hispanics and other non-Asians are at the bottom.

The typical cost of a manicure in the city helps explain the abysmal pay. A survey of more than 105 Manhattan salons by The Times found an average price of about $10.50. The countrywide average is almost double that, according to a 2014 survey by Nails Magazine, an industry publication.

With fees so low, someone must inevitably pay the price.

“You can be assured, if you go to a place with rock-bottom prices, that chances are the workers’ wages are being stolen,” said Nicole Hallett, a lecturer at Yale Law School who has worked on wage theft cases in salons. “The costs are borne by the low-wage workers who are doing your nails.”

Until more people realize that a $10.50 manicure or a $6.00 tee shirt cannot be the means to earn a living wage for its producer (just do the math)….I doubt this exploitation will end.

In interviews, some owners readily acknowledged how little they paid their workers. Ms. Ren’s boss, Lian Sheng Sun, who goes by Howard, at first denied doing anything wrong, but then said it was just how business was done. “Salons have different ways of conducting their business,” he said. “We run our business our own way to keep our small business surviving.”

Many owners said they were helping new immigrants by giving them jobs.

“I want to change the first generation coming here and getting disgraced, and getting humiliated,” said Roger Liu, 28, an immigrant from China, seated inside the salon he owned, Relaxing Town Nails and Spa in Huntington Station, N.Y. As he spoke last summer, an employee, a woman in her 50s, paced the salon, studying a scrap of paper scribbled with the steps of a pedicure, chanting them to herself quietly in Chinese.

It was her first week working in a salon, she said. Mr. Liu was not paying her.

More to come Next week on This Story!

What California Bill 1513 Means for Salons and Spas on Commission

The Real Hair Truth

About frigging time, say goodbye bye to free labor. People deserve to be paid. Especially for sitting there waiting for a customer. Time is money. The ol trick of hiring a professional and giving them a chair and telling them they have to build up there clientele when they answer a advertisement for employment will be gone. That old trick is history, and should teach salon owners labor is not free. Good for the industry this should keep the owners honest. The industry was built on free labor. Pay back time. How can a professional come to work worrying about rent, food, electric, transportation etc if they work on commission. Salon owners will say I can’t do that, then you shouldn’t have opened a salon. Now I will wait for all the know it all’s to reply. Please do I love debate. I have watch professionals I have worked with in my 33 years of this industry, ripped offed, taken advantaged of, and done so much wrong to they have gotten out of the profession. Its interesting how salon owners can come up and blame the professionals. And assume that with your words that all are alike. “Have to pay people to sit in the break room, on their cellphones, bitching about how they are not busy.” Well not everyone in this industry does what you say. I’m glad to see this, it should have happened along time ago. I love it! Boo Hoo for the salon owners, good for the employees. The employees are what make you. About time this happened, I love all the new ways and new roads the industry is changing. Be your own Boss everyone Don’t live other peoples dreams. You will have nothing in the end. Especially in the Beauty Industry!, Hah!

Note: Although CA employment attorneys were consulted when researching this article, we highly recommend that you contact a legal representative to discuss your rights and responsibilities on this topic. Strategies is not a legal counsel and the contents of this article should not be considered as such. We will be updating this post as more information is presented to us.

Commission salons and spas in California were just given the ultimate “Bad Hair Day”.

With the passage of California Bill 1513 “piece-rate legislation”, the rules have completely changed on how salon and spa owners can compensate their stylists and massage therapists.

For all intents and purposes, the traditional commission model is no longer compliant in California. Strict new laws now require salons and spas to drastically alter they way they compensate their commissioned employees.

And unfortunately, the potential financial impact of Bill 1513 on many salons and spas could be catastrophic. See the full bill here.

What you need to know

Piece-rate vs. commission compensation:

As per the Labor Code, compensation for salon/spa services is technically labeled as “piece-rate” work, and not commission. Confused? Let’s look at the Labor Code’s definition of each classification:

  • Piece-rate is defined as pay “based upon an ascertainable figure paid for completing a particular task or making a particular piece of goods.”
  • Commission employees are defined as anyone “involved principally in selling a product or service, not making the product or rendering the service, and their compensation must be a percent of the price of the product or service.”

Because stylists and massage therapist are rendering services and not just selling them, their work is considered “piece-rate.” Why does this labeling matter? Because Bill 1513 only applies to piece-rate work and not commission work. But again, the Labor Code’s definition of commission is not the same as the salon/spa industry’s.

Big game changer #1…

Effective January 2016, all “piece-rate” California salons and spas must track, report and pay their stylists or massage therapists for “non-productive” and “rest/recovery” time.

“Non-productive time” is defined as the time employees are required to be at work, but are not actively servicing clients. This includes time…

  • Waiting for the next client to arrive
  • Folding towels
  • Sweeping the floor
  • Assisting at the front desk
  • Attending meetings
  • Technical training’s

“Rest/recovery times” is defined as time…

  • On break and meals

In other words, every minute that services providers are in the salon/spa and are not either servicing a client or on break, needs to be tracked, reported and compensated for.

The “non-productive” and “rest/recovery” pay rates must be at least the California minimum wage.

Big game changer #2…

And it’s a biggie…

The law states compensation for “non-productive” and “rest/recovery” time must be a separate pay rate from the rate paid for when services are being produced.

This means you are no longer allowed to average the total dollars paid by the total hours worked and let that cover both “productive” and “non-productive/rest” hours.

Previously, as long as the averaged hourly rate equaled or surpassed minimum wage, all was good.

This is no longer the case.

Big game changer #3…

In addition to aforementioned restrictions, Bill 1513 also contains one final crippling blow for California-based commission salons and spas:

  • Employers are required to calculate and pay back wages for all “non-productive” and “rest/recovery” hours worked dating back to July 1, 2012. And yes, employees have started filing lawsuits demanding back wages for this time period.
  • Or… choose the Safe Harbor option: Valid until July 1, 2016, Employers may choose to pay each employee 4% of their total earnings dating back to July 1, 2012. The state must be notified by July 1, 2016 that this option is being pursued, and full payment would be due by December 15, 2016. Doing so will also make them immune from any future employee lawsuits specifically related to Bill 1513.

An Example…Salon Sacramento

  • Open since 2006
  • $800,000 in gross service sales every year
  • 10 full-time stylists, each paid 50% commission
  • Each stylist works 40 per week, and is 75% productive.
  • California minimum wage as of 1/1/16: $10.00 per hour

Now let’s do some math…

  • $800,000 / 10 stylists = $80,000/yr gross revenue generated per stylist
  • $80,000 @ 50% commission = $40,000/yr gross pay for each stylist
  • If each stylist works 40 hour per week and is 75% productive, this means that 30 hours are spent servicing clients, and 10 hours are “non-productive” or “rest/recovery” hours.
  • 10 “non-productive” hours per week for 52 weeks is 520 “non-productive” hours for per year, per stylist

How this scenario would look under Bill 1513…

  • In addition to the $40,000 paid to each stylist for their commissions on services, they would each be due an additional $5,200 in compensation for their 520 “non-productive” hours worked at the minimum wage rate of $10 per hour.
  • This brings each stylist’s pay to $45,200/yr, the equivalent of 56% commission.
  • Multiplied by 10 stylists, this is a $52,200 increase in total salon payroll.

Salon Sacramento’s back wages due on all “non-productive” hours since July 1, 2012

  • We’re going to round our numbers to 3 years for clarity-sake
  • $52,200 x 3 = $156,600 due to employees if paid in full without using the Safe Harbor Clause
  • Or, if Salon Sacramento chooses to use the Safe Harbor Clause and pay the 4% penalty on all wages paid since 7/1/12, the amount due by December 15, 2016 would be as follows:
    • $40,000/yr x 10 stylists x 3 years = 1,200,000 / .04 = $48,000

Compensation alternatives for California salons & spas

So where do commission-based California salons and spas go from here? One thing is clear, the days of easily calculating 50% for them and 50% for the house are gone.

Here are four employee-based compensation structures for California salons and spas moving forward:

  • Continue to pay commission/piece-work. The big challenge presented here is how will salons and spas be able to afford paying for “non-productive” and “rest/recovery” hours on top of the commission rates they are already paying? Yes, commission rates that fluctuate or are averaged based on weekly sales could be used, but these methods would also introduce substantial increases in bookkeeping responsibilities. They also may spawn confusion and resentment from service providers.
  • Hourly pay: Putting service providers on a fixed hourly rate is a sure-fire way to meet all California compensation requirements, as long as the hourly rate is at minimum wage or higher. However, if salons and spas don’t have the systems and leadership to drive sales and keep staff motivated, issues may arise.
  • Hourly plus commission: Keeping close to the current commission structure, employers could elect to pay service providers a set hourly wage (such as minimum wage), and then add a reduced-rate commission for each service rendered.
  • Team-Based Pay: Converting to a Team-Based Pay (TBP) structure not only meets all Bill 1513 requirements, but also offers growth and cultural benefits far beyond traditional salon/spa compensation models. TBP is an hourly and/or salary program with a team bonus that is tied the achievement of critical numbers (e.g., revenue, gross margin, client retention, productivity, pre-booking, retailing, net profit). Individual growth is tied to overall performance – not just the employee’s ability to generate revenue. A TBP system is designed to reward the right behaviors and performance – those that support the business’s goals and culture. RELATED: To learn more about the benefits and structure of Team-Based Pay, download Strategies’ free Team-Based Pay white paper report here.

As counter-intuitive and debilitating Bill 1513 is to the California salon/spa landscape, it is not something not to be taken lightly. If you are not pro-active in making the necessary changes now, you could be facing state fines, employee lawsuits for back wages or both.

Where can you get help?

Your first step should be to talk to a legal representative to learn what your legal rights and responsibilities are with Bill 1513. They will also have a very firm understanding of the bill as more details and cases are presented.

Your next step should be to restructure your pay structure to meet all compliance standards. If you would like one-on-one help from our team of Certified Strategies Coaches to quickly execute the restructuring of your compensation system to Team-Based Pay, click the link below. Not only will we ensure you meet all Bill 1513 guidelines, we will help you implement a pay program that can increases sales and profits, motivate your staff to grow the business, and provide world-class customer service.

Click here for hands-on help from a Strategies compensation expert.

Note: We highly recommend that you contact a legal representative to discuss your rights and responsibilities on this topic. Strategies is not a legal counsel and the contents of this article should not be considered as such. We will be updating this post as more information is presented to us.

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

 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

Loreal Always In Trouble

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

Illegal Cancer-Causing Chemicals Found in Nearly 100 Shampoo Brands! Oh My Lawd!

The Real Hair Truth

Cocamide Diethanolamine (cocamide DEA), a controversial ingredient found in body care items, has landed four personal care manufacturers with a lawsuit in California.

The Center for Environmental Health filed the suit after discovering the presence of cocamide DEA, the foam stabilizer and voluminous, in shampoos and soaps. In the state of California, Proposition 65 requires manufacturers to warn consumers over the risks of certain substances. Cocamide DEA is on that list because it is a suspected carcinogen. It was banned in the state last year after a study found it caused cancer in laboratory animals.

Some of the products that contain high levels of the illegal chemical are sold under well-known companies such as Colgate Palmolive, Paul Mitchell, and Prell. Lab tests also found the carcinogen in children’s products, such as a store brand bubble bath from Kmart, and a shampoo/conditioner from Babies R Us. Other store brand products that contain the carcinogen came from Trader Joe’s, Walmart, and Kohl’s.

Unfortunately, manufacturers can put any toxic chemical they want into shampoos because  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?  NADA it won’t change? Get over it! I guess profit is more important to them than the health of their customers. After all, it’s safe to say that many of these CEOs and top executives have ties to Big Pharmaceutical stock, so the fact that their products make people sick is a real win-win for their bank accounts.