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U.S. Department of Health and Human Services

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Enforcement Actions

Matrix Health Products 5/16/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
Telephone:      425-302-0340
FAX:    425-302-0402

 

May 16, 2013
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 13-21
 
Steven L. Kravitz, President
Matrix Health Products, Inc.
dba Earth’s Bounty
9700 NE 126th Avenue
Vancouver, Washington 98682-2304
 
WARNING LETTER
 
Dear Mr. Kravitz:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your firm’s website at the Internet address: www.earthsbounty.com on May 15, 2013. Based on this review, FDA has determined that your Earth's Bounty and Colloidal Silver, Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice and Hawaiian Noni Juice Capsules products are promoted for conditions that cause these products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You may find the Act and FDA’s regulations through links on FDA's home page at www.fda.gov.
 
Examples of some of the claims observed on your website www.earthsbounty.com include the following:
 
Noni Products
 
Examples of some of the claims observed related to your Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice and Hawaiian Noni Juice Capsules products include the following:
 
Under the product category titled “Noni,” under “Benefits,” a pie chart with the following categories:
 
  • “Anti-inflammatory . . . ”
  • “Analgesic – for pain and headaches”
 
A table that describes conditions that are “Reported to respond to noni” and the “% [people] Helped”:
 
  • “Cancer, lessened symptoms”
  • “Heart disease, decreased symptoms”
  • “Stroke”
  • “Diabetes, Types 1 and 2”
  • “Obesity, lost excess weight”
  • “High blood pressure, decreased”
  • “Smoking, stopped”
  • “Arthritis, lessed [sic] symptoms”
  • “Pain, including headaches, decreased”
  • “Depression, lessened symptoms”
  • “Allergy, decreased symptoms”
  • “In some situations, noni can allow other medications to act more efficiently. You should tell your health professional that you are taking noni as your physician might want to decrease the dose of the medication prescribed.”
 
Under the subsection “Anti-inflammatory & Joint Mobility”:
 
“Anti-Inflammatory”
 
  • “Reduction of pain and swelling in injuries─bruises . . . burns”
  • “Muscular conditions─arm, leg, neck and back pain”
 
“Joint Mobility”
 
  • “In a study of 673 arthritis patients:
-    80% decrease in arthritic type symptoms in Noni treated patients
-    Reduction in pain, swelling and stiffness”
  • “Dramatic disappearance of age-related joint pain . . . ”
 
Under the subsection “Immune Support Effects on Immune System”
 
  • “Effective with colds and other infections”
  • “Directly fights viruses, bacteria, fungi”
  • “Univ. of Hawaii, ‘Proceedings of the Amer. Assoc. for Cancer Research’
-    Cancer exposed mice lived 4 times longer with Noni treatment”
  • “Keio Univ., Japan, ‘Cancer Letters, 1993’
-    Noni . . . turned pre-cancer cells back into normal cells”
  • “Noni reported to stimulate T-cells and NK cells in our immune systems”
  • “Improvements in AIDS patients”
 
Under the subsection “Analgesic Treatment of Pain and Headaches”:
 
  • “Noni has a reputation as the ‘pain & headache tree’ ”
  • Effective with migraine and tension headaches”
  • “Physician survey of 3700 pain patients – 87% reported decrease in symptoms”
  • “Significant dose-related analgesic activity in treated mice”
  • “These findings validate the traditional analgesic properties of Noni”
  • “Valuable risk-free addition to any pain treatment program”
 
Under the subsection “Adaptogen Normalizing function”:
 
  • “Isolation of new compound from Noni called scopoletin:
- Lowered blood pressure . . .
- Reduced inflammation
- Killed bacteria and fungi
- Prevented growth of tumors”
 
In addition, when publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(C), a citation of a publication or reference in the labeling of a dietary supplement is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following are examples of publications that are used to market your product for disease treatment and prevention on your website and are thus evidence of your product’s intended use as a drug:
 
  • “ ‘New studies show this juice . . . soothes even the worst aches and pains . . . ’ Woman’s World Magazine, 5/9/00”
  • “ ‘Proponents say that (Noni) stimulates the immune system, helping the body fight off cancer and bacterial infections.’ Natural Health Magazine,10/10”
  • “ ‘Scientific research now shows that constituents in Noni fruit have the ability to . . . regenerat[e] damaged cells and inhibiting tumor growth.’ Delicious Living Magazine, 05/01”
  • “ ‘. . . Noni’s ability to reduce colds and flu can easily be demonstrated.’ Terry Willard, CLH, Ph.D., Vitamin Retailer Magazine, 5/00”
Your web site also contains disease claims in the form of personal testimonials, including:
 
  • “ ‘. . . Noni . . . repairing . . . cell function and enhancing the body’s healing systems. . . .  Research indicates that Noni may help fight disease at a cellular level, aiding malfunctioning or ‘sick’ cells by helping them regain their normal function.’ Neil Solomon, M.D., Ph.D. Lecturer and Author, ‘Noni, Nature’s Amazing Healer’ ”
  • “ ‘. . . Noni has documented benefits as an analgesic, anti-inflammatory, . . . anti-microbial . . . ’ Stephen A. Center, M.D Physician and Lecturer Medical Director, Earth’s Bounty”
  • “ ‘In a large, multi-practice survey, 80% of 673 arthritis patients treated with Noni noted a decrease in joint pain . . . Besides a reduction of pain, decrease in swelling or edema was commonly noticed, as well as reduction in stiffness.’  Stephen A. Center, M.D Physician and Lecturer Medical Director, Earth’s Bounty”
  • “ ‘Research . . . describe[s] several newly discovered compounds in Noni that produce significant anti-bacterial activity. Many harmful bacteria, such as E. coli, Staph aureus, Salmonella typhae and Shigella paradysenteriae are killed by Noni . . . Many of these bacteria have developed drug-resistant strains, but Noni is still consistently effective . . . Noni was the most effective in preventing growth of tumors, and it may have turned pre-cancer cells back into normal cells.’ Stephen A. Center, M.D Physician and Lecturer Medical Director, Earth’s Bounty”
  • “ ‘In a survey of physicians who have treated and recorded the results of Noni on pain in over 3700 patients, 87% of patients reported a decrease in pain, including headache. Most of these patients experienced results within days or weeks.’  Stephen A. Center, M.D Physician and Lecturer Medical Director, Earth’s Bounty”
 
Colloidal Silver
 
Examples of some of the claims observed under the product category titled "Colloidal" include the following:
 
“Colloidal Silver Testimonials”
 
  • “Often called the ‘penicillin of alternative medicine,’ colloidal silver disables the enzymes that bacteria, parasites, viruses and fungi rely on to use oxygen. Unable to ‘breathe,’ the organisms die and are eliminated from the body.”
  • “Among the conditions colloidal silver has controlled are severe burns, . . . boils, . . . yeast infections, . . . digestive problems and colitis, ear and sinus infections, herpes, shingles, lupus, malaria, viral and fungal infections, blood parasites, rheumatoid arthritis, and ringworm.”
  • “It (silver) kills even antibiotic-resistant strains and also works on fungus infections, cures the most stubborn infections of all kinds and bacteria . . . ”
  • “Silver is emerging as a wonder of modern medicine.  An antibiotic kills some half-dozen disease organisms, but silver kills some 650 and resistant strain fails to develop.”
  • “Because silver has been found to exert anti-fungal properties, . . . silver supplementation in our diets could be vital in protecting our immune system.”
 
Under the heading “Colloidal Silver Frequently Asked Questions”
 
  • “Doctors and medical journals have long advocated the use of silver for infection, viruses, bacteria, fungus and a wide variety of disease organisms.”
  • “Silver has been shown to possess antiviral, antibacterial, and antifungal properties.”
  • “Silver has been used . . . because of its disease-resistant properties . . . Silver continues to be a versatile disease-fighting agent because it is effective against antibiotic-resistant bacteria and a much broader range of disease organisms than antibiotics.”
 
Your Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice, Hawaiian Noni Juice Capsules and Colloidal Silver products are not generally recognized as safe and effective for the above referenced conditions and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].  FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your Colloidal Silver, Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice and Hawaiian Noni Juice Capsules products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended uses. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(a)(1)], in that their labeling fails to bear adequate directions for use.  The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 221(a)].  
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling.  The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter. It is your responsibility to ensure that all of your products and labeling are in compliance with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.  
 
You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Within 15 working days of your receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
 
In addition to the above violations, we have the following comment.  We note that the image of the label for your Colloidal Silver product that you have posted on your website lists two ingredients, one (“Silver”) in the Supplement Facts panel and one (“Nanopure water”) under a “Suggested Use” heading above the Supplement Facts panel.  Under 21 CFR 101.4(g), ingredients must be listed immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label. These ingredients must be preceded by the word “Ingredients,” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d), in which case ingredients listed outside the nutrition label shall be in a list preceded by the words “Other ingredients.”
 
Your reply should be sent to the following address: Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 302-0427.
 
                                                                          
Sincerely,
/S/ 
Charles M. Breen
District Director
 
cc:   
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560