FDA Sends Warning Letter to Joanne O’Donnell Be Natural Organics, LLC.

Joanne O’Donnell
Be Natural Organics, LLC.
3976 S. Pine Center Street
West Bloomfield Township, MI 48323

Dear Ms. Joanne O’Donnell:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.benaturalorganics.com/ in April 2017 and has determined that you take orders there for the products Calendula Cream Soap, Chamomile Balancing Mist, CoQ10 Eye Protection Cream, Gentle Face Lotion, Amaretto Body Scrub, Pomme D’Or Anti-Aging Crème, Daily Botanical Enzyme Peel, Squalane Serum, and Sea Kelp Moisturizer. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § § 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

 

 

 

 

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Calendula Cream Soap:

• “…Calendula is known to be antiseptic, anti-inflammatory, and immune stimulating. These properties are suitable for treating various types of dermatitis such as eczema.”

Chamomile Balancing Mist:

• “Chamomile, lemongrass, edelweiss and milk thistle [(ingredients in your product)] calm irritated skin with anti-inflammatory properties, …”
• “Calming and anti-inflammatory”
• “Chamomile Hydrosol- Just as chamomile tea can soothe the stomach and nerves, topically applied chamomile hydrosol has great skin soothing benefits. It has anti-inflammatory and anti-allergenic properties that can help reduce the redness and irritation of sensitive or damaged skin.”
• “Rose [(an ingredient in your product)] Distillate – … roses have anti-inflammatory and antibacterial properties.”
• “Lactobacillus/Kelp Ferment Filtrate [(an ingredient in your product)] -… Reduces inflammation.”
• “Calendula [(an ingredient in your product)] – Contains flavonoids for anti-inflammatory activity…Calendula also promotes skin healing and brightening and cell regeneration. It is noted for its ability to soothe eczema, psoriasis, diaper rash, acne and burns”

CoQ10 Eye Protection Cream:

• “CoenzymeQ10 (aka Ubiquinone) -… is used by the cells to make ATP which provides energy to carry out their metabolic functions at an optimal rate”
• “Aloe Vera Leaf Juice [(an ingredient in your product)] – Research has shown aloe vera’s unique ability to regenerate cellular membranes and boost the production of fibroblast cells (responsible for collagen production) six to eight times faster than the rate of normal cellular function.
• “Shea Butter [(an ingredient in your product)] -…chemical constituents offer anti-inflammatory…benefits.”

Gentle Face Lotion:

• “Rose Flower Water [(an ingredient in your product)] -… roses have anti-inflammatory and antibacterial properties.”
• “Witch Hazel Distillate [(an ingredient in your product)] –… benefits include the reduction of inflammation and promotion of wound healing.”
• “Acai Fruit Extract [(an ingredient in your product)] -… acai berries to be one of the most beneficial natural ingredients for the treatment of hyperpigmentation (darkening of the skin).”
• “Edelweiss Extract [(an ingredient in your product)] – ….anti-inflammatory… properties.”

Amaretto Body Scrub:

• “Boosts circulation and helps drain lymph nodes by increasing blood flow to the skin’s surface”

Pomme D’Or Anti-Aging Crème:

• “Stimulates new healthy cell production and growth”
• “Squalane [(an ingredient in your product)] -… it is antibacterial and has been scientifically proven to clear up difficult skin problems (eczema, dermatitis, rashes, etc.).”

Daily Botanical Enzyme Peel:

• “Decreases hyperpigmentation from age spots and acne…”
• “Stimulates new skin cell production; increases collagen and elastin production”
• “Helps destroy acne causing bacteria”
• “Stimulates blood flow, …”
• “Rooibos Tea Extract [(an ingredient in your product)] – Helps prevent skin disorders like acne and rashes. Also possesses strong antibacterial properties.”

Squalane Serum:

• “It also has antibacterial properties and helps to prevent the formation of brown age spots. Research has shown that squalane is beneficial for clearing up difficult skin problems such as eczema, dermatitis, rashes and certain types of acne.”

Sea Kelp Moisturizer:

• “Aspen Bark Extract [(an ingredient in your product)] -…treating burns to reducing fevers to relieving eczema. The bark is rich in salycin, which is considered to be analgesic, anti-inflammatory, calming and healing.”
• “Red Raspberry Seed Oil [(an ingredient in your product)] – natural SPF properties (especially against UVB rays). It enhances the barrier function and repair of the outer layer of each cell…”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

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 all violations associated with your products, including the violations identified in this letter. If you do not believe 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.

Your firm’s response should be sent to:
Dr. Byron Ho, Compliance Officer
U.S. Food and Drug Administration
300 River Place, Suite 5900
Detroit, MI 48207

Busted we win! Unilever for breach of warranty, violation of consumer fraud and deceptive trade practices pays up!

realhairtruth.comI love it, I love it. Busted for whatever the lawyers could get, they got in full from Unilever!. According to documents filed Friday in Illinois federal court, Unilever United States Inc. has agreed to pay $10.2 million to settle a class action lawsuit accusing it of marketing and selling a Suave-brand hair treatment that causes significant hair loss.  The Suave Keratin class action lawsuit was initially filed in August 2012 on behalf of a class of consumers who purchased or used Suave Professionals Keratin Infusion 30-Day Smoothing Kit, a product that was recalled in May 2012. The plaintiffs alleged that the product included dangerous ingredients that caused injuries, and that Unilever failed to properly inform consumers about the proper way to use the product to avoid injury.  During this time frame we at the “Real Hair Truth/Jotovi Designs Inc.” watched closely all the litigations that went forward with this class action lawsuit.  And passed along any and all emails we received from consumers to the appropriate law firms representing the clients involved.  Jotovi Designs Inc. was also used as a avenue for any and all complaints within the professional beauty industry, working hand in hand with consumers and professionals directing them to the proper law firms involved with the plaintiffs.  Now trust me my friends that is just penny’s to them not even nickels or dimes at all. They are a large corporation will it hurt them, “NO” not at all.  These large manufacturers are always in court. Look at L’Oreal, the mother of all lawsuits does it hurt them “No”. They always find a way to push the envelope, this is just a part of there corporate lives. No biggy to them.  The consumer and professional are the ones who get hurt. And trust me the so-called professional beauty industry does not care to inform there industry of these deviate practices. They will actually support these company’s. Basically because they need there money to survive. They cannot do it on there own.

On the Unilever website the company claims that. “Our brands play a major part in helping us achieve our sustainable living aims of helping more than a billion people improve their health and well-being; halving the environmental footprint of our products and sourcing 100% of our agricultural raw materials sustainably”.  Really?

Unilever is a major force in the beauty/cosmetics industry with household names as, Dove, Axe, Lux, Pond’s, Sunsilk, Tresemme, and who could also forget the beauty industry TONI&GUY that you can buy anywhere and beauty professionals will hail the product. Knowing full well they have no exclusive of the product what so ever. But they will sell it in there salons. And buy there tickets to there hair shows supporting TONI&GUY. But that’s another story in itself. The Suave Keratin class action lawsuit asserted claims against Unilever for breach of warranty, violation of consumer fraud and deceptive trade practices statutes and unjust enrichment arising from the manufacture, advertising and sale of the Suave Keratin Infusion smoothing kit. According to the plaintiffs’ motion supporting preliminary approval of the class action settlement, between 225,000 and 260,000 smoothing kits were sold.

Under the terms of the proposed Suave Keratin class action settlement, Unilever will pay $10 million to establish two settlement funds: a reimbursement fund and a personal injury fund. The $250,000 reimbursement fund will be available to Class Members who purchased a Suave Professionals Keratin Infusion 30-Day Smoothing Kit, providing a $10 refund for the past purchase of the product.

The class action settlement injury fund will provide relief to Class Members who suffered bodily injuries to their hair or scalp as a result of using the Suave keratin treatment. Class Members who incurred expenses for hair treatment but who no longer have receipts for their expenditures will be eligible to receive up to $40 per claimant. Class Members who have receipts from their treatments will be eligible to receive up to $800 per claimant for their expenses. Class Members who suffered significant bodily injury to their hair or scalp will be eligible to receive up to $25,000 per claim.

real hair truth.comDuring the filming of my next documentary “The Beautiful Lies”, I received numerous emails for consumers who used this product. Writing to me the causes, and health hazards they experienced with this product.

” Dear Mr. Kellner, I too used this product and fried my hair…4 haircuts later still having issues with dry hair and itchy scalp. Any ideas on what I need to do to promote good hair health?”

” Dear Joseph Kellner,I found this email when reading about the horrible suave keratin product. I haven’t developed any health issues that I know of but my hair continues to fall out. I have had at least 10-12 inches cut off in the last 5-6 months and my hair used to be thick and is now just so thin and horrible feeling. Anything that can be done?”

“I bought the treatment on 3/23/12 from Wal-Mart and I used it a week later.  I have previously used Sally’s brand about 8 months prior so I knew what I was doing and I read the directions correctly.  Not even a week after I used the Suave brand, my hair got considerably lighter, which has never happened and my hair started to fall out.  Even now, every time I was my hair, more of it breaks and I am losing it by the handfuls.  I only use the treatments because after I had my daughter, my hair got wavy and thicker only in the back and I wanted an easier way to maintain my hair.  The treatment I used before worked wonders and seeing as Sauvé’s was a whole lot cheaper, I took a chance.  I know it is not supposed to make it straight, but it is supposed to make it easier to straighten, and this did not do as it was supposed to.  I saw the recall at my local CVS and wanted to know what I am supposed to do from here?  Thanks for your time.”

“I used this kit twice the first time my tightly curled hair was soft shiny the second time at first  I didn’t see any change in my then a couple of weeks after my hair started coming out by the handfuls it took me three years to get the growth I had now all Ivan do is cut it all off and do intensive conditioning treatments .something should be done to suave for the damage it has done to my hair.”

“I to had a bad experience with this product. My hairdresser called their 1800 # to let them know the damage that their product had done to my hair. It’s taken 6 months to get it back to almost normal. This has cost me a lot of money. Another dissatisfied customer”.

“I just used this product a few days ago and my hair is also fried. And when I went to the store to try to find a deep renewing conditioner the product was still on the shelf! I don’t know what to do with my hair at this point. I’ve been trying to nurse it back to life with coconut oil and mayonnaise but it still isn’t enough. Help?!”

Help it has been 4 months for my hair and it continues to break off and is fried.  It seems like it is getting worse not better.  I have spent over $2000 and yet I am still struggling.  No one is responding to my letters Unilever, Suave or Kroger. I tried to join a class action lawsuit with Wasserman, Comden, Casselman& Esensten but they have not contacted me back yet either.  The $12 is not sufficient and my current professional stylist believes it will be at least another year before my hair is back to normal if ever.  I can not afford this!! Is there any hope we will get some resolve from the company.  Please someone help!! This is truly a nightmare and not only has it ruined my hair but my personal life, my professional life and my personal well-being have all been severely compromised. Any information that you might have regarding where I might go next would be greatly appreciated.”

The Suave Keratin settlement will also resolve several similar class action lawsuits that were filed in Kentucky and California.

The Suave Keratin class action settlement agreement was reached after nearly 18 months of litigation and lengthy mediation sessions with former U.S. District Judge Wayne Andersen. According to the court documents, the plaintiffs believe that the settlement agreement is “fair, reasonable, adequate and in the best interests of the Named Plaintiffs and the putative Settlement Class. Unilever, denying wrongdoing of any nature and without admitting liability, has agreed to the settlement terms in order to address claims brought by consumers of Unilever products, and in order to avoid the burdens of continuing discovery expenses and litigation.”

The plaintiffs are represented by Marvin A. Miller, Lori A. Fanning and Andrew Szot of Miller Law LLC; Peter Safirstein, Christopher S. Polaszek and Elizabeth S. Metcalf of Morgan & Morgan PC; and Jana Eisinger of Law Office of Jana Eisinger PLLC.

The Suave Keratin Infusion Class Action Lawsuit is Sidney Reid, et al. v. Unilever United States Inc., et al., Case No. 1:12-cv-06058, in the U.S. District Court for the Northern District of Illinois.