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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Nutrient Synergy, Inc 6/25/13

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

June 25, 2013
 
WARNING LETTER
 
 
UPS Overnight
 
Don Stattine
Judy Stattine
Nutrient Synergy, Inc.
1724 Trevor Ct.
Longmont, CO 80501
 
Ref:  DEN-13-16-WL
 
Dear Mr. and Ms. Stattine,
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the internet address www.nutrientsynergy.com in June 2013 and has determined that you take orders there for the product Nepretin, which the website promotes for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(b)(1)(B)]. In addition, FDA reviewed a product label for Nepretin, which also promotes your product for conditions that cause it to be a drug. The therapeutic claims on your website and the product label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act. You can find copies of the Act and related regulations through links in FDA's home page at http://www.fda.gov.
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
 
The website link to your product: http://www.nutrientsynergy.com/diabetic-retinopathy.htm, which references a disease.
 
Under the heading “Nepretin”:
 
  • “Nepretin, a revolutionary treatment for diabetic retinopathy and nephropathy.”
  • “Nepretin is designed to control complications of diabetes …”
  • “Symptoms of diabetic retinopathy were dramatically slowed, stopped, or even reversed … when Nepretin was taken orally on a daily basis.”
  • Nepretin is an all-natural supplement designed to slow, stop, or reverse diabetic retinopathy.”
  • Treatment for diabetic retinopathy is now available!”
  • Nepretin may also be used as a preventive strategy for a large percentage of the diabetic population …”
 
Under the heading “DRAMATIC RESULTS FROM CLINICAL TRIAL”:
 
  • “The trial studied the effects of Nepretin in slowing, stopping, or reversing the symptoms of diabetic retinopathy in human patients with Type I diabetes with low or medium eye grades. Approximately 70% of the patients who started the study with a grade level above one either slowed, stopped, or reversed their diabetic retinopathy grade level during the course of the 24 months.”
  • “Nepretin may also be effective in lowering blood sugar and blood pressure readings …”
  • “The following improvements were experienced:
 
o   Improved the final eye grade in at least one eye
o   Improved glycohemoglobin rates
o   Improved albumin excretion rates...
o   Improved systolic and diastolic blood pressure values
o   Lessened total insulin needed”
 
Examples of some of the claims observed on the Nepretin product label include:
 
  • NEPRETIN Diabetic Retinopathy and Nephropathy Formula”
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Nepretin for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
  • In March 2009 I ordered Nepretin for my mother who has advanced diabetes, with all the renowned conditions that diabetes causes. … Thank you. Your product has had done what it advertised to do. My mom’s advancing eye disease stopped, and slightly reversed, and her kidney improvement is amazing.
  • While searching for a way to help my husband save his eyesight (he has diabetic retinopathy and cataracts in both eyes) I came upon your website. … He was going blind right before my eyes and I felt helpless. Your product offered a glimmer of hope to stabilize his eyes long enough for the surgery [for cataracts]. …We were so excited! Now after one year taking the Nepretin he got the best Christmas present ever; the cataracts have been removed from both eyes!! Every week his eyesight is improving … We thank God and Nepretin every day.
  • I was diagnosed with Type II Diabetes two years ago. 12 months later my vision was affected and I was diagnosed with diabetic retinopathy. … I started taking Nepretin four weeks ago and now my vision is much clearer. … Thank you for Nepretin.
  • My husband has been a Type II Diabetic for 15 years. Four years ago his eyes were starting to have problems. … I am so glad I found your website. My husband has been taking Nepretin for one year and his eyes are NO LONGER BLEEDING at all. … Thank you so much for saving my husband’s eyes.
  • I just wanted to let you know that my husband has been on the (Nepretin) formula for the past two months and is doing wonderful!! He has diabetic retinopathy, but his vision has improved enough that with a new prescription for glasses he has been able to see a lot better. … Also his glucose readings have gone down – he is able to better stabilize his sugars.
 
These referenced citations and other claims quoted above are supplemented by metatags used to bring consumers to your websites through Internet searches. The metatags are “diabetes nephropathy treatment,” “diabetes retinopathy supplements,”  “diabetes nephropathy supplements,” “diabetes retinopathy treatment,” “supplements for diabetes,” and “treatment for diabetes.”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 product is 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 this drug safely for its intended purpose. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the 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. § 331(a)].
 
This letter is not intended to be an all-inclusive review of your website and products your firm markets.   It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  You should take prompt action to correct the above violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and injunction.

During our June 6, 2013 conference call, FDA representatives from the Center for Food Safety and Nutrition (CFSAN), Office of Enforcement, and Denver District informed you that you promote Nepretin for conditions that cause the product to be a drug, and that distribution of the Nepretin product is in violation of Section 301(a) of the Act. At that time, you committed to contacting your customers via letter to inform them that your product is not intended to prevent, treat, or cure diabetic retinopathy or nephropathy, and to sharing the letter with FDA prior to sending it to your customers. In addition, we are in receipt of your letter dated June 10, 2013 written in response to the conference call. That letter indicates that you had cancelled your agreements with both Google and Yahoo for website placement, so that a search of “diabetic retinopathy” would no longer lead to your website and that you were not seeking new customers.  However, as discussed above, your website continues to take orders for this product and to promote the product for conditions that cause the product to be a drug. In addition, you have not sent us any customer notification letter.
 
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 each such item will be corrected.
 
Please send your reply to: U.S. Food & Drug Administration, Denver District, 6th Avenue & Kipling Street, Building 20 DFC, P.O. Box 25087, Denver, CO 80225-0087, Attn: Nancy G. Schmidt, Compliance Officer. If you have any questions regarding any issue in this letter, please contact Ms. Schmidt at 303.236.3046.

                                                           
Sincerely,
/S/
LaTonya M. Mitchell
Director, Denver District