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U.S. Department of Health and Human Services

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Enforcement Actions

Pharmaterra, Inc. 7/15/13

  

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 Ave SE, Suite 210
Bothell, WA 98021
Telephone: 425-302-0340
FAX: 425-302-0402 

 

July 15, 2013
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 13-23 
                                                                            
Robert Adamowski, Chairman
PharmaTerra, Inc.
3440 W Mercer Way
Mercer Island, Washington 98040
 
Dr. Mike Baker, Vice President
PharmaTerra, Inc.
15615 Bel Red Road, Suite C
Bellevue, Washington 98008
 
WARNING LETTER
 
Dear Mr. Adamowksi and Dr. Baker,
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www.pharmaterra.com in July 2013, and has determined that you take orders there for the product, “ProBeta,” which the website promotes for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].  The therapeutic 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 into interstate commerce for such uses violates the Act.
 
Unapproved New Drugs
 
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
 
On your homepage, an article entitled “ProBeta®: A Natural Blood Sugar Balancer”: 
 
“ProBeta® is the world’s most extensively researched and clinically tested Gymnema sylvestre product….we published ground breaking research on GS4, our fourth extract, in a paper entitled the Antidiabetic effect of a leaf extract from Gymnema sylvestre in non-insulin-dependent diabetes mellitus patients …”
 
On a webpage, under the heading “Our Research”:
 
 “Type I Diabetics: Key Results from ProBeta® after six months
 
34% reduction in fasting blood glucose
22% reduction in HbA1c
14% reduction in external insulin requirement”
 
The graphs/slides on this page are also evidence of intended use to treat disease because they represent that ProBeta augments the effects of exogenous insulin which is a drug.
 
 “Half of the patients treated were able to reduce their daily insulin dosage during treatment with ProBeta®. In fact, patient 6, who had been diagnosed with Type I diabetes for only six months, was able to eliminate insulin administration all together following three months of treatment with ProBeta®. All patients experienced significant reductions in fasting blood glucose and glycosylated hemoglobin levels during treatment with ProBeta®, which are indicative of more effective glucose metabolism.”
 
 “Type II Diabetes: Key Results from ProBeta® after four months
 
 “23% reduction in fasting blood glucose 
 “15% reduction in HbA1c”
 “Treatment with ProBeta® resulted in significant reductions in fasting blood glucose levels in all cases.”
 
 “Most patients were able to decrease their other hypoglycemic drugs while on ProBeta® therapy”
 
Pre-Diabetics: Key Results from ProBeta® after four months”
 
  “30% reduction in fasting blood glucose”
 
 “Treatment with ProBeta® resulted in significant reductions in fasting blood glucose levels in all cases.”
 
 Type I Diabetics: Blood profile after six months on ProBeta®”
  “Reduction in cholesterol … were observed. C-peptide levels increased significantly during ProBeta® therapy, indicating an increase in the production of endogenous insulin in Type I diabetic patients.”
 
 Type II Diabetics: Blood profile after four months on ProBeta®”
 
 “Significant reductions in cholesterol … were observed, and were accompanied by an increase in postprandial insulin levels.”
 
Under the heading, “Research” sub-heading “Key results from ProBeta®”
 
 34% reduction in fasting blood glucose in Type I diabetics, in six months
 
 22% reduction in HbA1c in Type I diabetics, in six months
 
 23% reduction in fasting blood glucose in Type II diabetics, in four months
 
 15% reduction in HbA1c in Type II diabetics, in four months
 
 30% reduction in fasting blood glucose in pre-diabetics, in four months
 
On a webpage, under the heading “Order Online”, sub-heading “Product Description”:
 
 “We recommend that individuals who develop elevated blood glucose levels during adulthood take ProBeta®. Individuals at risk of developing elevated blood glucose levels may take up to one half the normal dose to decrease risk.”
 
 “Our studies show that individuals taking ProBeta® regularly typically experience improvement in blood glucose control, decreased glycosolated hemoglobin typically measured as HbA1c, mildly decreased blood cholesterol…”
 
Your website also contains evidence of intended use in the form of testimonials recommending or describing the use of this product for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials, under the sub-heading, “Product Reviews”, and as part of the scrolling testimonials on your homepage, include:
 
 “It does work…ProBeta did drop my blood sugar about 30 points after 2 months. I check my blood sugar 8-10 times a day and keep a log. You can clearly see it going down. The only change was ProBeta.”
 
 “ProBeta has brought my morning blood sugar to 106. Before, it was at 161... I have type 2 diabetes. I’m 77yrs old and this is working very well.”
 
 “It works. My blood sugar dropped.”
 
 “From 8.1 sugar fasting to 5.8.  From "pre-diabetic" to healthy levels…”
 
 “I’m on the lowest dose that I can be for metformin, because I take ProBeta as an enhancer.”
 
 “My mother has diabetes. She's elderly and we don't want her on meds because we don't think she'll be able to handle them. ProBeta works for her. She's been on it for years. Even her doctor is impressed. Whenever we go to the clinic for her checkup, her blood sugar, HbA1c and other indicators are in good shape. She's completely off her medications.”
 
 “Blood sugar dropped…After a few weeks it really started to take strong effect.… ProBeta works for me… I've lowered my medications and that's absolutely incredible.”
 
 “It lowered my son’s blood sugar…My son has Type I diabetes and needs a lifelong treatment. He’s been using ProBeta for 10 years and it has always worked.”
 
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. 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:
 
  “Use of Gymnema sylvestre leaf extract in the control of blood glucose in insulin-dependent diabetes mellitus.” Journal of Ethnopharmacology, Volume 30, Issue 3, October 1990, Pages 281-294. E.R.B. Shanmugasundaram, et al
 
 “The insulinotropic activity of Gymnema sylvestre, R.Br. an indian medical herb used in controlling diabetes mellitus.” Pharmacological Research Communications, Volume 13, Issue 5, May 1981, Pages 475-486. K. Radha Shanmugasundaram, et al.
 
The claims quoted above are supplemented by the metatags used to bring consumers to your webpages through Internet searches. Examples of some of the metatags include:
 
 Diabetes
 Fasting blood sugar
 Hblac
 
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 ProBeta is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use the product safely for its intended purposes.  Thus, this product 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)].
 
Misbranded Dietary Supplements
 
Even if your product, ProBeta, did not have therapeutic claims that caused it to be a drug, it would be misbranded within the meaning of section 403(q)(1)(A)(i) of the Act because the label does not list the serving size for a dietary supplement as described in 21 CFR 101.9(b)(1) and (2) and 101.12(b) Table 2. The serving size should be the maximum amount consumed per eating occasion. Your ProBeta product label is also misbranded within the meaning of section 403(q)(1)(B) because the “servings per container” are not listed on the label as required by 21 CFR 101.36(b)(1)(ii).
 
The above violations are not meant to be an all-inclusive list of deficiencies in your products or 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 the date by which each such item will be corrected.
 
If you need additional information or have questions concerning any products distributed through your website, please contact FDA.  You may respond in writing to Jessica L. Kocian, Compliance Officer, U.S. Food and Drug Administration Seattle District Officer, 22215 26th Ave SE, Suite 210, Bothell, Washington 98021. If you have any questions concerning this letter, please contact Jessica Kocian, Compliance Officer at 425-302-0444.
 
Sincerely,
/S/ 
Charles M. Breen
District Director
 
cc: Claudia Coles, Food Safety Program Manager
      Washington State Department of Agriculture
      Food Safety Program
      P.O. Box 42560
      Olympia, Washington 98504-2560