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Enforcement Actions

BioNeurix Corporation 10/15/12

  

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
 

           
WARNING LETTER


VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED  
    


October 15, 2012


W/L 02-13


Benjamin Burack
BioNeurix Corporation
www.pharma-tree.com
5757 W. Century Blvd Ste 700
Los Angeles, CA  90045

Dear Mr. Burack:
                                                        
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at http://www.pharma-tree.com in July 2012 and has determined that your “Blood Sugar 360,” “Amoryn,” “Seredyn,” and “Mellodyn” products are promoted for conditions that cause the 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 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 can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.

On the homepage of your website, the link titled “Blood Sugar 360” opens to a page titled “Intro,” which includes various tabs on the left hand side.  These tabs link to pages with titles such as “How It Works” and “Testimonials.”  Examples of some of the claims for “Blood Sugar 360” and its ingredients in this section of your website include:

On the “Intro” webpage:

• “PharmaTree Blood Sugar 360 helps you control your blood sugar naturally.  The unique ingredients in Blood Sugar 360°™ have been proven … to reduce blood glucose levels and relieve the unwanted effects of elevated glucose.  Whether you have full-blown diabetes or simply a history of high blood sugar, PharmaTree Blood Sugar 360°™ is the natural solution…”

• “Reduce blood sugar levels”

• “Regulate insulin sensitivity

• “Normalize natural insulin production”

• “Decrease the chance of glucose-related nerve damage*”

On the “How It Works” webpage:

• “Chromium acts as an insulin potentiator, improving sensitivity to the body’s natural insulin.  People with diabetes become insensitive to insulin, causing excessive blood sugar levels”

• “By improving insulin sensitivity, chromium may help to interrupt or reverse this process.  In fact, studies show that chromium deficiency is common in people with Type II diabetes.”

• “Banaba helps improve the body’s natural process for reducing excessive blood sugar.”

• “Gymnema helps control blood glucose levels and restore normal insulin function….by improving the ability of the pancreas to produce insulin.”

• “Alpha lipoic acid (ALA) is an antioxidant that helps reduce blood sugar levels.  Numerous studies have shown that ALA may also help control certain complications of diabetes such as diabetic neuropathy (nerve pain/damage).”

• “Ginseng helps normalize blood sugar levels.  In one study, blood sugar levels in people with diabetes were lowered to healthy levels when taking ginseng….”

On the “Testimonials” webpage:

• “DECREASE IN HYPERGLUCOSE:  ‘I saw a decrease of my hyperglucose by starting at 10% [decrease] and now it is over 20% [decrease].… As I take the capsules, I see a decrease … keeping the same diet as before starting the capsules ….’
--Kenneth, Canada” (bracketed insertions in original)

• “AC1 REDUCED:  ‘Very happy with the results. My blood sugars have been much better and my AC1 has come down.’
--Carol, Florida”

On the “Directions” webpage under the heading “Dosage and Directions for Use”:

• “PharmaTree Blood Sugar 360 helps to lower blood sugar levels, stimulate insulin productivity, and increase insulin sensitivity within 30 minutes.”

On the “F.A.Q” webpage:

• “Will PharmaTree Blood Sugar 360 work for me?

PharmaTree Blood Sugar 360 contains ingredients shown to effectively lower and help normalize blood sugar for people with Type 1 and Type 2 diabetes.”

• “How quickly does PharmaTree Blood Sugar 360 take effect?

PharmaTree Blood Sugar 360 starts working to lower blood sugar levels after the first few doses.”
   
• “How long does a single dose of PharmaTree Blood Sugar 360 continue working?

[P]harmaTree Blood Sugar 360 will work all day to lower blood sugar and improve diabetic health….”
   
• “Can I take PharmaTree Blood Sugar 360 if I am currently taking a prescription diabetes medication?

Yes, PharmaTree Blood Sugar 360 is formulated to complement your diabetic medication with the possibility of being able to decrease your prescription dosage over time.”  

•“What are the possible side effects?

Since PharmaTree Blood Sugar 360 causes blood glucose levels to decrease, hypoglycemia is a potential side effect.  Also, if you’re taking insulin or insulin-like medications, monitor your blood sugar levels closely when taking PharmaTree Blood Sugar 360™, as adjustments to your medication may be necessary.”

In addition, when scientific 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)(iv)(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.  Your “Clinical Research” webpage describes studies that you claim “prove the efficacy of the ingredients in Blood Sugar 360” in preventing and treating diabetes and its complications, such as diabetic neuropathy.  Examples of your use of scientific publications to market “Blood Sugar 360” for prevention and treatment of diabetes and diabetic neuropathy on your website include:

• “Alpha Lipoic Acid Relieves Symptoms of Diabetic Neuropathy

A study2  in 2003 led by Mayo Clinic neurologist Peter Dyck, MD showed that Alpha Lipoic Acid is able to help decrease the symptoms of diabetic neuropathy such as pain, burning, and numbness.”

Reference:  “Ametov AS, Barinov A, Dyck PJ, Hermann R, Kozlova N, Litchy WJ, Low PA, Nehrdich D, Novosadova M, O'Brien PC, Reljanovic M, Samigullin R, Schuette K, Strokov I, Tritschler HJ, Wessel K, Yakhno N, Ziegler D; SYDNEY Trial Study Group.  The sensory symptoms of diabetic polyneuropathy are improved with alpha-lipoic acid: the SYDNEY trial. Diabetes Care. 2003 Mar;26(3):770-6.”

• “Chromium Demonstrates Improved Glucose and Insulin Levels for Diabetes Patients.”

One study3 tested Chromium’s ability to help control diabetes, using 180 participants with type 2 diabetes. … After two months patients taking the 500 microgram dosage showed significant Glycated hemoglobin (HbA1c) improvement and after 4 months, both groups taking the chromium supplement had lowered levels of HbA1c by up to 8.5%.”

Reference:  “Anderson R.A. Elevated intakes of supplemental chromium improve glucose and insulin variables in individuals with type 2 diabetes. Diabetes. 1997;46:1786–1791.”

Below the “Blood Sugar 360” link on your homepage is a link titled “Emotional Wellness.”  When clicked, this link goes to a page featuring products that are promoted for use in treating insomnia and mental health disorders.  Examples of some of the disease claims for these products include:

“Amoryn”

• “The main ingredient in AMORYN, hyperforin, is clinically proven to relieve depression….  After taking AMORYN for six weeks, 90% of people with depression…report positive results.”

“Seredyn”

• “[S]eredyn can help relieve … insomnia, and panic attacks.”

“Mellodyn”

• “Take MELLODYN every night for chronic insomnia…”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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 purposes.  Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(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. § 331(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.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  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 cited in this letter.  Failure to promptly correct these violations may result in legal 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 cited above and to assure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If you cannot complete all corrections within fifteen days, explain the reason for the delay and state the date by which the corrections will be completed.
   
Your response should be sent to:

Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.

Sincerely,

/S/

Alonza E. Cruse
District Director
Los Angeles District

 

Cc:  Ingeborg Small, Branch Chief 
      California Department of Public Health
      Food and Drug Branch
      1500 Capitol Avenue, MS-7602
      Sacramento, CA   95899-7413