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

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