Tag: FDA

Statement on FDA Investigation of WEN by Chaz Dean Cleansing Conditioners 2017

~ Joseph Kellner

FDA previously announced that it is conducting an investigation of adverse event reports for WEN by Chaz Dean Cleansing Conditioner products, including reports of hair loss, hair breakage, balding, itching and rash. FDA has received and continues to receive reports of adverse events, as the investigation is still ongoing. In the course of its investigations, the FDA is looking at all sources of information, in order to better understand the consumer reports of adverse events. There are many potential causes of hair loss, including, for example, certain illnesses, medications, hormonal changes, rapid weight loss or gain, anemia, and high-stress life events, and these factors are being taken into account as the FDA continues to investigate these reports. If you experience hair loss, you should contact your healthcare provider. As with any cosmetic product, if you experience an adverse event that you think may be related to use of WEN by Chaz Dean Cleansing Conditioner, you should also cease using the product and report the event to the FDA.

The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash reported to be associated with the use of WEN by Chaz Dean Cleansing Conditioner products. While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.

As of November 15, 2016, the FDA had received 1,386 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners. We also are investigating more than 21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC that we learned of during inspections of manufacturing and distribution facilities.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.

The FDA will provide additional updates as new information becomes available.

 

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

~ Joseph Kellner

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

Leave it to the professionals! … Statement on FDA Investigation of WEN by Chaz Dean Cleansing Conditioners

~ Joseph Kellner

The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash reported to be associated with the use of WEN by Chaz Dean Cleansing Conditioner products. While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.

FDA previously announced that it is conducting an investigation of adverse event reports for WEN by Chaz Dean Cleansing Conditioner products, including reports of hair loss, hair breakage, balding, itching and rash. FDA has received and continues to receive reports of adverse events, as the investigation is still ongoing. In the course of its investigations, the FDA is looking at all sources of information, in order to better understand the consumer reports of adverse events. There are many potential causes of hair loss, including, for example, certain illnesses, medications, hormonal changes, rapid weight loss or gain, anemia, and high-stress life events, and these factors are being taken into account as the FDA continues to investigate these reports. If you experience hair loss, you should contact your healthcare provider. As with any cosmetic product, if you experience an adverse event that you think may be related to use of WEN by Chaz Dean Cleansing Conditioner, you should also cease using the product and report the event to the FDA.

The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.

Terms You Should Know In The Beauty Industry.

~ Joseph Kellner

 

  • 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.

 

 

 

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