Monat Class Action Lawsuit Already

 

A new class action lawsuit alleges that Monat Global Corp. promotes its hair-care products as being able to help growth, but consumers say they actually lost hair and experienced irritation after using the products.

Lead plaintiffs, Trisha Whitmire and Emily Yanes de Flores, allege in their class action lawsuit that they and others purchased Monat hair care products because they were promised aid in hair growth and health; however, say the plaintiffs, the chemicals in the products actually lead to increased hair loss. They say the misrepresentations are part of a scam by Monat to get consumers to purchase even more expensive products from them. Both plaintiffs allege that they experienced significant hair loss after investing substantial sums in Monat products. They say they brought their concerns to the company, but were told they were going through a “detox” process and would see healthier hair if they continued to use the Monat products. They say the company also pointed the finger at suppliers when they continued to complain.

“Shamefully, hair loss claims are met with unsubstantiated claims of a ‘detox’ period that will cause increased hair loss before the purported benefits of Monat hair care products accrue or worse yet, suggestions to spend more money on still more expensive Monat haircare products,” the Monat class action lawsuit states. Frustratingly, allege the plaintiffs, the hair loss does not stop, even after consumers stop using the Monat products. According to the Monat class action lawsuit, Monat advertises its products as “naturally-based” and “safe.” The plaintiffs say they were drawn in by claims that the hair care products were “suitable for all skin and hair types.”

Further, allege the plaintiffs, Monat claims that their products stop hair loss and aid in regrowth. The website, according to the complaint, touts chemicals used in Monat products as clinically proven to provide a “significant decrease in hair loss effect and increase in hair regrowth.”

“In fact, MONAT Hair Care Products use numerous harsh chemicals and known human allergens. As a result of the defective nature of the MONAT Hair Care Products, they were and are unfit for their intended use and purpose,” the Monat class action lawsuit claims. According to the class action lawsuit, many other consumers experienced the same problems and misleading responses from the hair care company; however, Monat, a multilevel marketing scheme, has scrubbed customer complaints from the internet. The Monat class action alleges that the wealthy family running the business has even sued a woman who set up a Facebook page for those who suffered hair loss after using Monat.The plaintiffs seek to represent Monat hair care users who purchased the products since Jan. 1, 2014. The plaintiffs are seeking damages as well as a court order stopping Monat from allegedly misrepresenting their product to the public.

The consumers are represented by Brian W. Warwick and Janet R. Varnell of Varnell & Warwick PA, Charles J. LaDuca and William H. Anderson of Cuneo Gilbert & LaDuca LLP, John A. Yanchunis of Morgan & Morgan PA, and Joel R. Rhine and Dara Damery of Rhine Law Firm PC.

The Monat Haircare Products Class Action Lawsuit is Trisha Whitmire, et al. v. Monat Global Corp., Case No. 1:18­-cv­-20636, in the U.S. District Court for the Southern District of Florida.

Terms You Should Know In The Beauty Industry.

 

  • Free From~ This statement has become the mantra for large commercial brands, with the smaller brands following suit as a way to convey that their product is somehow safer than their competitors.
    • Danger of Claim: It can reinforce the idea that if something is “free from” a certain ingredient, that the missing ingredient is somehow “dangerous.”  And what was once part of the formula has since been removed, when it may have never been in the product in the first place.  This is marketing to the consumer that has been led to believe natural is better and everything else will kill them. Example: Parabens, sulfates, etc. get a bad rap, when there is actually scientific data that shows these are perfectly safe for personal care use in the recommended dosages within the cosmetic formula.  Or if it is a leave on or rinse off product will also determine ratios.  Any chemical in its full strength has the potential for causing harm, yet these are not offered to the end user, ever.
  • Chemical Free~ Another claim that bears no reality in truth or common sense.  Nothing formulated can be without chemicals as all things are chemical…natural or synthetic, makes no difference, it is just the manner in which they are derived or created.  Again, shamelessly used for SCARE tactic marketing.
    • Danger of Claim: This connotes the idea, all things chemical are hazardous to our health…..think of water, essential oils, olive oil, etc…..these appear to be benign now don’t they? However, from the point of view of the overstated 60% absorption claim, these are all potential penetration enhancers.  This claim also overlooks the fact of what the product is packaged in.  There is no getting around the chemical processes that goes into creating the packaging, such as a jar or tube, technically.
  • Hypoallergenic or Noncomedogenic~ These terms are not even recognized by the FDA and there actually isn’t any proven data in clinical trials, and has yet to be tested by the US Food and Drug Administration as to the validity of such terms.
    • Danger of Claim: Any ingredient could cause a problem for any individual and this connotes that it won’t cause a problem….sorry, but trial and error only, unfortunately.  Up to 10% of the population can and will have a reaction to something the majority of the population won’t have.  This includes a developed allergy after using an ingredient for years.  Our bodies are ever changing.  Those with acne may have a similar reaction. What won’t cause acne on one individual may be horribly occlusive to another.
  • Dermatologist / Clinically Tested~ This is a claim that can be made based on a single doctor trying it out on themselves or a patient.  Based on this perception it is theorized by the end user, it must be a proven product. A clinical study performed by the manufacturer on a small number of people will not constitute nationally, what can occur if millions use the product.
    • Danger of Claim: Gives the perception that it must be safe and work because a doctor or a clinical study said so, but is not necessarily the reality. Safety and efficacy data will change as high volume of users join the pool, and this is PURE marketing! 
  • Anti-aging Formula~ This ties into penetration enhancers being utilized within a skin cream and are designed to assist beneficial ingredients in penetrating into the otherwise impermeable surface layers of the skin to restore soft, supple skin with more elasticity.
    • Danger of Claim: EWG and Campaign for Safe Cosmetics have underscored this message as a penetration enhancer being the carrier of chemicals to the blood stream.  When in reality, penetration enhancers for the purpose of cosmetics are only skin deep and are not geared toward penetration through the dermis layer into the blood brain barrier as would be the desired effect with a topical drug.  Permanent change does not occur with any cosmetic, and only maintains the skin as long as the product is being used.
  • Non Toxic / Harmful Chemicals~ What does this even mean?  Who and what entity is deciding what is toxic or not?  This is yet to be determined and will continue to be debatable since EWG and CFSC think anything, other than naturally derived, is toxic to our bodies.  The majority of scientific research does not support the validity of this marketing claim.  Plus, too much of anything natural or synthetic can cause issues for some.
    • Danger of Claim: This statement plays into the fears of the consumer and reinforces the CFSC’s campaign rhetoric against beauty industry leaders and their products.  Such as lead being added to lipstick which is categorically FALSE and is considered a contaminant, which is found also in drinking water and the foods we eat that are grown in the ground.
  • 100% Pure / Natural / Organic~ This connotes that only natural chemicals are safe for the body and that synthetic chemicals are the bane of our existence and will give us cancer or worse. There is no human scientific data to support this claim.  And animal studies do not extrapolate to humans despite how hard watchdog groups try to convince us.
    • Danger of Claim: Beauty products labeled as natural are less tested and scrutinized than are synthetic products and pharmaceuticals. In fact, most compounds as they exist in their natural state cannot be formulated into skin care products. They first must be chemically altered before they can be incorporated into cosmetics, thereby negating the claim of being pure and natural.
  • FDA Approved ~ This marketing claim gives the unwitting consumer the idea the product is endorsed by the FDA, and the product must have been tested by the FDA to show proof of the companies claim of safety and / or efficacy.
    • Danger of Claim: This is outright FALSE and is actually in violation of FDA regulation.  FDA does not approve any finished product for the end user in the cosmetic and beauty industry.  Only prescription and OTC drugs and medical devices are FDA approved for their intended purpose.
  • Does Not Contain Fillers~ This marketing claim is designed to intimate that their product is formulated with nothing but pure and essential ingredients only, and that no fillers are used to create a less than desirable product, supposedly.
    • Danger of Claim: This insinuates that somehow a filler ingredient is cheap and makes another product substandard.  Unfortunately, this bears no weight in actual truth.  Those that claim their ingredients are the ultimate and then claim fillers as bad, are also ingredients that are used as filler.  Mica for instance is not only an essential ingredient to the formulation of the majority of mineral makeup, but it is also a FILLER ingredient.  By definition a filler ingredient is used for finish of product, bulking agent, or any ingredient utilized for the desired effect for smooth application.  There is no actual separation of the two.  Water can be considered a filler ingredient, since it is not typically essential but makes up the bulk of many skin care products.
  • Non Irritating~ This gives the end user of a product the assurance that their otherwise sensitive skin, will not have any problem with the product.  This expands on item 3.
    • Danger of Claim: The problem with this claim is everyone’s skin is different.  There are ingredients that have a long standing history of safety and efficacy, yet there will be the small percentile that will have irritation when using it.  Mineral makeup for instance works well for the majority of women, Bismuth Oxychloride excluded, but for a small number, no matter how much they hope, they will always have an irritant reaction and can never wear minerals, no matter its’ popularity.  We disclose this fact, by using only ingredients with known lower irritant risk factors, but still, only the end user will determine what is right for their skin or how they’ll react through testing it on themselves. It may not be a single ingredient, but when used in combination with another or its presumed ratio, is where the problem lies.  So by not purchasing something because one may see a certain ingredient of concern, they may be missing out on what otherwise could be fantastic for their skin.   Always TEST…TEST…TEST the product for absolute certainty.

 

 

 

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