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WARNING LETTER

Nature's Treasures MARCS-CMS 513202 —

Product:
Animal & Veterinary
Recipient:
Nature's Treasures

United States

Issuing Office:
Los Angeles District Office

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

 

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 17, 2017
WL # 23-17
Nature’s Treasures, Inc.
Attention: Raya Shanazarian
3600 N Verdugo Blvd.
Suite #207 
Glendale, CA 91208
 
Dear Ms. Shanazarian:                                                                                          
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.mynaturestreasures.net in February 2017 and has determined that you take orders there for the products KR22 Oxicell, Dysbiocide, Colostrum LD®, FC-Cidal, Diabend, Matcha Tea and NeurO2. Based on our review of your product labeling, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
Unapproved New Drugs/ Misbranded Drugs
 
The claims on your website establish that the products KR22 Oxicell, Dysbiocide, Colostrum LD®, FC-Cidal, Diabend, Matcha Tea and NeurO2 are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 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 website claims that provide evidence your products are intended for use as drugs include:
 
On the webpage titled “KR22 Oxicell”:
  • “Oxicell is the best choice for Liver Disease or Cancer”
  • “…[P]owerful anti-inflammatory…”
  • “If you (or your pet) are suffering from liver problems, cancer, arthritis, kidney disease or other inflammatory conditions, this product can really help.”
On the webpage titled “Dysbiocide”:
  • “…used for urinary tract disorders including kidney disease…as a potential medication against breast cancer…as an antibacterial, antifungal, antimalarial…antiviral…used for…dysentery…osteoarthritis…in the treatment of cancers…as a unique antimicrobial agent against drug-resistance [sic] bacteria.”
  • “…treat patients suffering from stomach parasites.”
  • “…used for centuries to treat dysentery and malaria.”
  • “…effective cure for bacterial and amoebic dysentery.” 
On the webpage titled “Colostrum LD® Capsules”:
  • “Eliminate harmful pathogens and fight infection”
  • “For anyone whose has compromised health situation, GI or digestive health issues, auto-immune conditions, inflammatory conditions, cancer, heart disease, is recovering from an injury, wants to get rid of allergies, or detects a cold or flu coming on, 4 capsules (1 tablespoon powder) twice a day are recommended.”
On the webpage titled “FC-Cidal 100 Capsules”:
  • “alleviate symptoms of dysentery”
  • “antifungal and antiviral” 
On the webpage titled “Chi’s Enterprise Diabend”:
  • “…[R]esearch shows incredible results using this for diabetes, especially type II.”
On the webpage titled “NeurO2”:
  • “…[S]upport during neurodegenerative states, hypoxia states, stroke recovery, brain injury recovery…”
We also note a claim made on your Facebook page, accessible at https://www.facebook.com/mynaturestreasures, with a link to your website where your products are offered for sale.
 
In a November 9, 2016 post:
  • “Art of making matcha green tea. Benefits…fights cancer. To purchase yours, please go to www.mynaturestreasures.net”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drug” 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), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products KR22 Oxicell, Dysbiocide, Colostrum LD®, Diabend, Matcha Tea and NeurO2 are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, KR22 Oxicell, Dysbiocide, Colostrum LD®, Diabend, Matcha Tea and NeurO2 fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
 
Unapproved New Animal Drug
 
Furthermore, the claims on your webpage establish that your KR 22 OxiCell product is also an unapproved new animal drug within the meaning of section 201(g)(1)(B) of the Act, [21 U.S.C. § 321 (g)(1)(B)] because it is intended for use in the cure, mitigation, treatment, or prevention of disease in animals. As mentioned above, your webpage for KR 22 OxiCell contains the following claim:
  • “If you (or your pet) are suffering from liver problems, cancer, arthritis, kidney disease or other inflammatory conditions, this product can really help.”
Your KR 22 OxiCell product is a new animal drug, as defined by section 201(v) of the Act [21 U.S.C. § 321(v)], because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Moreover, the product is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the product is unsafe within the meaning of section 512(a) of the Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)]. The introduction or delivery for introduction into interstate commerce of this adulterated drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Adulterated Device
 
Additionally, based on our review of your website, your firm, Nature’s Treasures, Inc., is marketing a telethermographic system (thermographic camera) without marketing clearance or approval, in violation of the Act. We note that on your www.mynaturestreatsures.net website disclaimer, you state that your “products are not intended to diagnose, treat, cure or prevent any disease.” However, notwithstanding this disclaimer, the claims made on your website for your thermographic camera product demonstrate that the product is a device under section 201(h) of the Act, 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. 
 
Your thermographic camera is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. Your thermographic camera is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the Agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). 
 
Telethermographic systems intended for adjunctive diagnostic screening for detection of breast cancer or other uses are classified as class I devices under 21 CFR 884.2980(a), and require premarket clearance (510(k)) prior to marketing. Telethermographic systems that are intended for use alone in diagnostic screening for detection of breast cancer or other uses are classified as class III devices under 21 CFR 884.2980(b), and require approval of a PMA prior to marketing. Accordingly, cleared telethermographic systems are not for use alone in diagnostic screening of breast cancer or other uses. Use of such devices in diagnostic screening for detection of breast cancer and other uses constitutes a major change or modification in the intended use of the device (see 21 CFR 807.81(a)(3)(ii)) and would require premarket approval (see 21 CFR 884.2980(b)).
 
However, your firm’s promotion of its thermographic camera provides evidence that the device is intended for diagnostic screening for detection of breast cancer, including as a sole screening device. Examples include:
 
On the webpage titled “Breast-Cancer-Awareness”:
  • “[A]ll women 25 and older should get annual Thermography screenings…”
On the webpage titled “Mammography Vs Thermography”:
  • “[T]hermography looks for the body’s physiological response to cancer cells. These changes can often occur 8-10 years before the cells are large enough to be seen by a mammogram.”
  • “Thermography can detect the possibility of breast cancer much earlier…”
  • “Breast Thermography has: 99% Sensitivity, 90% Specificity, 90% Accuracy.”
  • “Thermography is far more sensitive than mammography.”
  • “Thermography benefits all women. They may be particularly useful for young women who want to monitor their breast health should start as early as possible.”
On the webpage titled “What is Breast Thermography”:
  • “As more and more women become knowledgeable in thermography they choose not to do mammography.”
  • “I myself have not done mammography since 2006, but have gone through the procedure of ultrasound twice.”
     
The webpage titled “What to Expect” discusses step-by-step how your firm uses the devices during an appointment. For example, Step 3 explains, “Your pictures will be sent out to our reading physician for analysis,” and Step 4 states, “We will set up an appointment to see you in ten days after your results have come back to us. You can share the report with your medical doctor and if he has further questions he can contact the doctor who read your report…”   Step 5 concludes that “You will be recommended when to do your second thermography by the reading doctor.” This discussion promotes the use of the thermographic system with a report provided based solely on the thermographic image.  
 
Furthermore, you also state on your website www.mynaturestreasures.net/thermography/what-is-breast-thermography/ that “Digital Infrared Thermal Imaging is approved by the F.D.A.” This statement is misleading in accordance with 21 CFR 807.97 because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Telethermographic systems have only been cleared by FDA with an intended use as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of differences in skin surface temperature changes. Thermography can be used to visualize, document temperature patterns and changes. FDA has never approved any telethermographic system for sole diagnostic screening a class III device under 21 CFR 884.2980(b).
 
Our office requests that Natures Treasures, Inc. immediately cease activities that result in the misbranding or adulteration of its telethermographic camera.
 
The above violations are not meant to be an all-inclusive list of violations in connection with your products or their labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. 
 
Please notify 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 the delay and the date by which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.
 
Your response should be sent to:
 
Kelly D. Sheppard, Director
Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
 
 
If you have any questions regarding this letter, you may contact Jessica Mu, Compliance Officer, at Jessica.Mu@fda.hhs.gov. 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
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