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:
 
A table that describes conditions that are “Reported to respond to noni” and the “% [people] Helped”:
 
Under the subsection “Anti-inflammatory & Joint Mobility”:
 
“Anti-Inflammatory”
 
“Joint Mobility”
 
-    80% decrease in arthritic type symptoms in Noni treated patients
-    Reduction in pain, swelling and stiffness”
Under the subsection “Immune Support Effects on Immune System”
 
-    Cancer exposed mice lived 4 times longer with Noni treatment”
-    Noni . . . turned pre-cancer cells back into normal cells”
Under the subsection “Analgesic Treatment of Pain and Headaches”:
 
Under the subsection “Adaptogen Normalizing function”:
 
- 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:
 
Your web site also contains disease claims in the form of personal testimonials, including:
Colloidal Silver
 
Examples of some of the claims observed under the product category titled "Colloidal" include the following:
 
“Colloidal Silver Testimonials”
Under the heading “Colloidal Silver Frequently Asked Questions”
 
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

This page was posted on January 24, 2019.

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