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U.S. Department of Health and Human Services

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Enforcement Actions

Neuliven Health 7/15/13

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                            
 
 
WARNING LETTER
 
 
July 15, 2013
 
WL # 47 - 13
 
Neuliven Health, Inc.
Attn: Lee Zhong, M.D., Ph.D.
10171 Pacific Mesa Blvd.
Suite # 302
San Diego, CA 92121
 
Dear Dr. Zhong:
                                                                             
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website, www.glucocil.com in April 2013 and has determined that you take orders there for the product, Glucocil, which the website promotes for conditions that cause this 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(g)(1)]. The claims on your website establish that this 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.
 
Unapproved New Drugs
 
Examples of the claims noted on your website include the following:
 
On the homepage “Glucocil’s ingredients help you naturally and safely:”
 
•  “Lower fasting blood sugar levels up to 29%”
  “Lower A1c levels significantly”
 

“Since using Glucocil, my blood sugar level has been under control.” 

“Glucocil helps stabilize your blood sugar all day, without adding a drug!” 

“The average decrease I see in my patients’ glucose spike at 45 minutes is 50-75 points. With that kind of decrease in the glucose spike, the blood glucose levels are much easier to control.” 

“Glucocil has the natural and safe ingredients clinically proven to help manage blood sugar levels.” 

“After trying many natural remedies to lower and stabilize blood sugar levels, I have found Glucocil to be the only product that performs remarkable results.”

 
On the webpage titled, “How it Works”:
 

“Glucocil is a natural supplement specifically designed to help prediabetics and type 2 diabetics: 

› Lower blood sugar & A1c levels …”

“Clinical studies show that Glucocil ingredients:

               Lower fasting blood sugar levels up to 35% …
               Lower A1c levels up to 21%”
 
On the webpage titled, “Ingredients”
 

“Cinnamon Bark Powder…Cinnamon has been shown to reduce fasting serum glucose … and total and LDL-cholesterol concentrations in patients with type 2 diabetes. More specifically, studies have found that cinnamon powder not only reduces fasting blood sugar levels up to 29%, but also significantly reduces A1c levels.” 

“Fish Oil… It is also known that a high fish intake can delay the development of diabetes in glucose-intolerant individuals.”

“Vitamin D… Studies suggest that high levels of vitamin D helps reduce the risk of developing cardiovascular diseases by 33 percent, type 2 diabetes by 55 percent …”
 
On the webpage titled, “Questions”:
 
““Is Glucocil effective immediately or does it take a while to work? The natural ingredients in Glucocil … can lower your fasting blood sugar in as little as two weeks.”
 
Most people take natural supplements with their medications. In fact, 60% of Glucocil users are taking blood sugar management medications. Of course, we recommend that you consult your physician before taking Glucocil with—or in place of—your medications.”
 
Your website also contains evidence of intended use in the form of testimonials recommending or describing the use of Glucocil, for the cure, mitigation, treatment, or prevention of disease including. Examples of such testimonials, on the webpage titled, “Stories from Real Glucocil Users”, include:
 
 "I have type 2 diabetes and have seen my A1c numbers climb up and up. My doctor has wanted me to start Insulin injections, which is a very scary thought because I simply hate needles of any kind. Since taking Glucocil, my A1c dropped by 3 and my doctor has agreed to let me continue taking oral medication only.”
 
 “I had a heart attack in 2011. My blood sugar shot up and it didn't seem to want to come done. They put me on metformin and that about killed me. Then they put me on Januvia, I was allergic to it, then they put me on Glipizide, I almost lost my eyesight with it. I started doing research on natural things that would help blood sugar.... I saw an ad for Glucocil.... Didn't take long to try it and has seemed to bring my blood sugar down and stabilize it…My blood sugar runs between 105 and 150. That is within what my doctor wants.”
 
 “In Nov 2011 I was diagnosed pre diabetic, with A1c just over 6, added to existing high blood pressure & heart disease. (Open heart surgery in 2008.) Since then, with the use of Glucocil as directed, I have lost 35 lbs & contained my blood sugar levels with no other diabetic medications.”
 
 “My fasting number was 134. I read about the medication on the internet. After reading about the side effects, I refused to pick it up from the pharmacy. I found the Glucocil website and decided to try a natural way first before using medication. After 6 weeks on Glucocil my fasting number was down to 125.”
 
 “I lost a few pounds before I took Glucocil and my blood sugar dropped about 15 points. Then I started taking Glucocil and it dropped between 85 to 110. I am a believer. That happened in one month. I ordered 3 more months supply. It is easy to take and I have been able to stop my metformin.”
 
 “My A1c level dropped over 2 points during the first two months of using Glucocil. So far, that has meant I do not have to take any other blood [sugar] control medicines.”
 
 “All my research kept leading me to Glucocil … In just a couple of weeks … I went to the doctor, and my A1c was 6.0 down from 10.6.”
 
 “Glucocil really does work. My A1c used to run 11 or higher. Since taking Glucocil, my A1c is under 7 and I'm taking less medication.”
 
 “This is a miracle. I used to take metformin and my blood sugar was still at 160, I am taking Glucocil now and my blood sugar is 90-105…”
 
 “I'm almost 30 days into my first try with Glucocil, and I couldn't be happier with the results thus far. I was skeptical at first, but decided to give it a try, My fasting glucose has dropped about 20 points thus far and has steadily decreased over the first 4 weeks!”
 
 “I figured I was wasting my money but I ordered the Glucocil anyway. I'm so glad I did. Within one week my blood sugar stabilized between 85 to 106 before bed and between 106 to 119 in the morning (fasting). Bottom line. Glucocil really works.”
 
 “Before taking this product, my blood sugar was averaging 135 - 150. Now on most recent tests, my sugar level is now below 95 - 100.”
 
  I found out about Glucocil doing research on the internet and gave it a try. Happy to say my levels are down to 120, still a little on the high side but I am excited about the results.”
 
 “I just received a call from my daughter, who has been using Glucocil for one week, and she told me that I have to try it. Her fasting blood sugar has dropped 40 points.”
 
 “I have been taking oral diabetes medication for 14 years and excercise [sic]every day. After taking Glucocil for three months and eating carefully, my fasting blood sugar has dropped about 25 points to about 105. It is the first natural supplement to really work for me. I am going to reduce my oral medication over the next few months.”
 
 “I suffered a stroke approx 2 years ago and it was my diabetic condition which caused my stroke … Since I started taking Glucocil, my blood sugar count has gone down to approx 75 - 95 and has really stabilized itself.”
 
 “This is a great product. My average fasting blood glucose before Glucocil was 148. Now it's 112.”
 
 “[Before Glucocil,] fasting was running about 130-135 and A1c was 7.1. My doctor was talking about putting me on insulin, which totally freaked me out! Fasting is now running 95-105!!! Last A1c was 6.1!”
 
 “I'm very happy with Glucocil; my sugars went down to 125. I recommend this product to everybody that has high sugars / type 2 diabetes.”
 
 “My fasting sugar reading in the morning was running around 140 most of the time. My wife started researching online for a natural product to help regulate my sugar levels. She discovered Glucocil and ordered it for me to try. Now my morning fasting readings are anywhere from 105 to 115 which is a big improvement for me.”
 
 “My doctor told me I was on the brink of type 2 diabetes ... My fasting glucose was 127-132 and my A1c was 6.5.  I asked him about natural ... supplements, and he told me that they were a waste of money ... [but I] started on Glucocil. Two months later I was tested and my glucose went down to 99 and my A1c went down to 6.1.”
 
On the webpage titled, “Glucocil in the News, under the subheading, “Glucocil Press Releases”:
 
On the webpage accessed through the link titled, “June 2008”:
 
 “BREAKTHROUGH NATURAL FORMULA GLUCOCIL™ UNVEILED TO HELP TYPE 2 DIABETICS ACHIEVE A HEALTHIER DIET AND LIFESTYLE”
 
 “ [T]o help those with type 2 diabetes …”
 
On the webpage accessed through the link titled, “July 2008”:
 
 “MAJOR STUDIES ON MULBERRY LEAF SHOW ITS SIGNIFICANT PROMISE FOR MILLIONS OF AMERICANS LIVING WITH TYPE 2 DIABETES”
 
 “Clinical trials conducted by researchers at University of Minnesota (VA Hospital) conclude that mulberry leaf extract may provide key nutritional health benefits to type 2 diabetics”
 
 “[S]tabilize blood sugar levels: One of these studies published in Diabetes Care, the most widely read diabetes journal ...”
 
 “What is so exciting and promising about our research is that it shows the mulberry leaf, a simple natural ingredient derived from a tree, can nutritionally help improve the blood sugar levels in type 2 diabetics …”
 
On the webpage accessed through the link titled, “August 2008”:
 
 “One natural supplement in particular that Baker says she has been recommending to certain type 2 diabetes patients … is a product called Glucocil™, which has been shown to help reduce blood sugar levels … in type 2 diabetes patients ...”
 
On the webpage accessed through the link titled, “November 2008”:
 
 “Natural dietary supplements can also provide helpful nutritional support to type 2 diabetes patients, and some even help stabilize blood sugar levels naturally. One such product…is called Glucocil™, a natural dietary support formula specifically designed to help manage … in type 2 diabetes patients
 
Moreover, we note the following claims on social media accounts. On your Facebook page, which is accessible at http://www.facebook.com/Glucocil:
 
Under the “About Us” link:
 
 “Lower fasting blood sugar levels up to 29%”
 
 “Lower A1c levels significantly”
 
In a post dated, October 13, 2012:
 
 “Glucocil is made for type 2 and pre-diabetics, helps them to lower blood sugar levels by … improving insulin sensitivity and production. Try the natural Glucocil at www.Glucocil.com”
 
In a post dated, October 17, 2012:
 
 “Maria, whose fasting blood sugar dropped 47 points (from 150 to 103) after taking Glucocil, has this to say: ‘When my doctor told me that my sugar was a little high, I was devastated…. Then he told me to start taking metformin twice a day. I felt awful for about a week, and out of desperation, I decided to search for an alternative remedy. This is when I found Glucocil. What a difference! It …regulated my sugar … Give this wonderful alternative a try as you can still take it along with your prescription, because in just a few days, you will see a big difference …’Try Glucocil at www.Glucocil.com.”
 
In a post dated, November 5, 2012:
 
 “A1c Dropped 4 Points!”
 
 “Angela has this to say about Glucocil: "Glucocil really does work. My A1c used to run 11 or higher. Since taking Glucocil, my A1c is under 7, and I'm taking less medication…Try Glucocil at www.Glucocil.com”
 
On your Twitter account which is accessible at https://twitter.com/glucocil:
 
In a post dated, August 23, 2011 and titled, “GNC To Carry Glucocil™ Blood Sugar Stabilizer: A Natural Alternative for 80 Million Americans,” which links to the following press release of the same date, accessible at http://prweb.com/releases/2011/8/prweb8714808.htm and titled, “GNC To Carry Glucocil™ Blood Sugar Stabilizer” with the following claims:
 
 “Says Dr. Lee Zhong, M.D., Ph.D., of Neuliven Health, “…. People with blood sugar concerns—and healthcare providers—are grateful that Glucocil delivers “peace of mind without a prescription.”””
 
 “Since using Glucocil, my blood sugar level has been under control…”
 
 “After trying many natural remedies to lower and stabilize blood sugar levels, I have found Glucocil to be the only product that performs remarkable results.”
 
These same claims can be found on your website, on the webpage, “In the News” under the link, “August 2011.”
 
We also noted that internet advertisements with the following claim link back to your website, www.glucocil.com.
 
 “Naturally Reduce Blood Sugar Elevations by up to 44%!”
 
 “Reduce Blood Sugar 44% Safely & Naturally, www.glucocil.com”
 
Finally, we note the following claims on the product label and in promotional material that accompanied the sale of Glucocil:
 
On the product label:
 
 “Lowers Fasting … Blood Sugar Levels*”
           
In a letter to the consumer:
 
 “Glucocil will immediately begin helping manage your blood sugar levels…”
 
 “Glucocil helps stabilize your blood sugar levels throughout the day…”
 
 “By taking Glucocil, you can better maintain healthy fasting … blood sugar levels sunup to sundown, which also helps lower your A1c.”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, this 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, Glucocil, 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 purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that its 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)].
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory 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. 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 state the date by which the corrections will be completed.
 
Please send your reply to the attention of Dr. Raymond W. Brullo, Compliance Officer, Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612. If you have any questions regarding any issue in this letter, please contact Dr. Brullo at (949) 608-2918.
 
 
Sincerely,
/S/ 
Alonza Cruse, Director
Los Angeles District
                                                                       
 
cc: Litao Zhong
     7340 A Trade St,
     San Diego, CA 92121