WARNING LETTER
Be Natural Organics MARCS-CMS 523615 —
- Recipient:
- Be Natural Organics
United States
- Issuing Office:
- Chicago District Office
United States
Chicago District Office | |
WARNING LETTER
FY17-HAFE6-02
July 19, 2017
UPS NEXT DAY
SIGNATURE REQUIRED
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
If you have any additional questions about the contents of this letter, please contact Compliance Officer Dr. Byron Ho at 313-393-8262, or by email at byron.ho@fda.hhs.gov.
Sincerely,
/S/
William R. Weissinger, MS
Chicago District Director
Office of Human and Animal Feed
Operations Division East 6