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U.S. Department of Health and Human Services

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Enforcement Actions

Alistrol Health 6/26/12

  

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 

 

June 26, 2012
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
In reply refer to Warning Letter SEA 12-25
 
Mr. Steven Kalia
Dr. Stacey Miller, N.D.
Alistrol Health, Inc.
 
125A-1030 Denman Street
Suite 345
Vancouver, BC
V7G 2M6
CANADA
 
200 West Kellogg Rd.
Bellingham, Washington 98226
 
WARNING LETTER
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet addresses: www.alistrol.com, www.alistrol.net, www.drophighbloodpressure.com, www.highbloodpressure-treatment.net, www.naavudi.com, and www.depressionfighters.com in June 2012, and the promotional materials distributed with your products, and has determined that your “Alistrol,” “Naavudi,” “CLE Vitamin D3,” and “Depression Fighters” 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 websites and in the promotional materials 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.
 
Examples of some of the claims observed on your websites include:
 
On your websites, www.alistrol.com, www.highbloodpressure-treatment.net, and www.drophighbloodpressure.com:
 
On each of the homepages:
  • “Alistrol … is the number one choice for my patients suffering from high blood pressure.”
  • “Alistrol is widely used as a heart tonic, and to help regulate blood pressure.  It is also used to break down cholesterol and fat that may contribute to heart disease.”
 
On the webpage titled, “Product”:
  • “You may also continue to take Alistrol, if you so choose, after your blood pressure has returned to a healthy normal range.”
  • “Our ingredients are carefully combined, with precise-percentage accuracy, to counter high blood pressure as effectively as possible.”
 
On the webpage titled, “Benefits of CLE Vitamin D3”:
  • “Taking both Alistrol and CLE Vitamin D3 supplement is a double-barrelled attack on your high blood pressure.”
  • “It is believed to . . . be beneficial for sufferers from some autoimmune diseases and even some cancers.”
 
On the webpage titled, “Ingredients” under the heading, “Garlic Seed Extract”:
  • “It is used internally as supportive treatment of high blood lipids and for the prevention of age-related vascular changes - its cholesterol lowering effect. Garlic has also been found to reduce metabolism of glucose in diabetes, slow down the development of arteriosclerosis and lower the risk of heart attacks.”
 
On a webpage titled, “Clinical Research”:
  • “Alistrol is a truly different blood-pressure-reducing supplement - an all-natural approach to mitigating stubborn and dangerous high-blood-pressure conditions.”
  • “[A]listrol . . . clinical study was conducted . . . where subjects . . . had markedly lowered high blood pressure at the end of the study.  The highlights of the clinical study:”
  • “Lowered systolic blood pressure by 11.5 points”
  • “Lowered diastolic blood pressure by 10.1 points”
  • “Aistrol [sic] efficacy at 91%”
 
Your website also contains disease claims in the form of personal testimonials, including:
 
On a webpage titled, “Success Stories”:
  • “I started taking Alistrol a year ago and I've had phenomenal results!  I have completely weaned myself off of my prescription medication and my blood pressure is at a normal level.”
  • “Within six weeks I saw my blood pressure revert back to normal!”
  • “By week three my blood pressure was down from 170/105 to 133/75, amazing!”
  • “Within the first two weeks my blood pressure went from 160/100 to 140/90. By week ten I was 133/75!  . . . With no headaches and sleeping through the night.”
  • “With Alistrol, after six weeks of use, my blood pressure is where it should be.”
  • “Since I’ve taken Alistrol, I don’t need my prescription medication.”
  • “After one month of taking 6 [Alistrol] capsules straight, my blood pressure was in control.”
  • “After 4 weeks my hypertension is normal.” 
 
On your website, www.alistrol.net:
  • “Finally a solution to the leading cause of heart attack and stroke!”
  • “The only natural compound clinically proven to lower blood pressure!”
  • “Cutting-edge breakthrough is clinically proven to permanently reverse the cause of high blood pressure”
  • “[A]listrol is the safe, powerful, state-of-the-science, clinically-proven solution that not only helps lower blood pressure . . . it reverses the underlying causes of high blood pressure in as little as a few weeks.”
  • “In a double-blind, placebo-controlled study . . . Alistrol was shown:”
  • “To be effective for managing mild to high hypertension in as little as 2-4 weeks”
  • “To help lower systolic blood pressure by 11.5 points”
  • “To help lower diastolic blood pressure by 10.1 points”
 
On your website, www.naavudi.com:
On the homepage:
  • “Naavudi is a herbal dietary supplement . . . that has helped many to manage their diabetes.”
  • “The nine ingredients work together synergistically to markedly lower blood-glucose sugar . . ..”
  • “Its core component, Epicatechin, is believed to . . . directly reduce blood-glucose sugar.”
 
On the webpage titled, “Success Stories”:
  • “After taking NAAVUDI for one month, I lowered my blood sugar 40 points.”
  • “I’ve been on NAAVUDI for 6 months now and my blood sugar has stabilized around 90!”
 
On your website, www.depressionfighters.com:
On the homepage:
  • “Depression Fighters is a natural herbal anti depression dietary supplement that will provide relief to your depression and anxiety disorders.”
  • “Depression Fighters was developed as a safe, all-natural alternative to antidepressants”
  • “Improve mood, reduce anxiety and feelings of depression”
  • “Depression Fighters is my choice for patients to help win the battle with depression and anxiety.”
 
Your website also contains disease claims in the form of personal testimonials, including:
 
On the webpage titled, “Success Stories”:
  • “As someone with a complex diagnosis of depression  . . . After 30 days of being on the product, the anxiety was gone.”
  • “Depression Fighters had alleviated my depression and gone are the terrible side effects.”
 
Additionally, we note the following claims found on promotional materials that accompany the shipment of your “Alistrol” product:
 
On business cards with your website addresses and ordering information for your “Alistrol,” “Depression Fighters,” and “Naavudi” products:
  • “Lower Blood Pressure Naturally”
  • “Stop Depression Naturally”
  • “Stop Type 2 Diabetes Naturally”
 
On a pamphlet titled, “All Natural Alistrol” which includes your website addresses and ordering information for your “Alistrol,” “Depression Fighters,” and “Naavudi” products:
  • “At a recent conference sponsored by the World Heart Association in Geneva Switzerland, Alistrol was introduced as the leading natural herbal remedy to lower high blood pressure quickly without any known side effects . . .. ”
  • “Alistrol is the only exclusive formula that is proven to lower high blood pressure naturally quickly and effectively.”
  • In a graph titled, “RESULTS OF CLINICAL STUDY,” you provide data from a study in which, according to your graph, subjects who took your “Alistrol” product lowered their systolic blood pressure, on average, from 142.6 mmHg to 128.4 mmHg in six weeks.  The same graph indicates that on average, subjects who took your “Alistrol” product lowered their diastolic blood pressure from 91.5 mmHg to 81.6 mmHg during the same six week period.  These data, in conjunction with other claims found in your pamphlet, establish that your “Alistrol” product is intended for use to treat hypertension.
 
We also note claims found on your Facebook page accessed at http://www.facebook.com/pages/Alistrol/171767636213230?sk=wall. Several examples of these include the following:
  • In a post dated March 15, 2012, titled, “Reduce your blood pressure even faster with this powerful duo of natural remedies” which includes a link to an article titled, “Why Vitamin D and Alistrol Make a Great Team” that is posted on the blog on your website, www.alistrol.com.
  • In a post dated March 14, 2012, titled, “We’ve got proof that our products work.  Hear it straight from our customers!” which includes a link to the webpage titled, “Success Stories” on your website, www.alistrol.com. The post summarizes the link as follows: “Find a solution to high blood pressure, natural treatment to cure blood pressure using herbs. Natural supplements for lowering high blood pressure. Get Alistrol today.”
  • In a post dated February 23, 2012 titled, “Two natural remedies, when combined, will reduce blood pressure even faster.  Read all about it in today's blog post” which includes a link to an article titled, “Vitamin D and Alistrol Together Reduce High Blood Pressure More Quickly” that is posted on the blog on your website, www.alistrol.com.
 
In addition, these claims are supplemented by the metatags you use to bring consumers to your website. These metatags include:
 
For your website, www.alistrol.com:
  • “[H]igh blood pressure medication, High blood pressure remedies, Lower blood pressure, How to lower blood pressure, High blood pressure treatment, Natural treatment for high blood pressure, Natural remedies for high blood pressure, Natural blood pressure remedies, Natural remedy for high blood pressure, Controlling high blood pressure, Blood pressure remedies, Blood pressure treatment”
 
For your website, www.depressionfighters.com:
  • “AntiDepressants, best depression remedy, Anti Depression, depression natural treatment, anxiety depression treatment, treat depression naturally, depression management and treatment”
 
For your website, www.naavudi.com:
  • “Diabetes, Diabetes Supplement, Diabetes Medicine, Alternative Diabetes Medicine, Diabetes Treatment, Diabetes Management, Treatment diabetes, Diabetes symptoms, Diabetes diet…Blood sugar control, Diabetic Remedies, Natural Blood Sugar Control” 
 
Claims on your websites, promotional materials, and product labels establish that your products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  Your 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 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(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 above violations are not meant to be an all-inclusive list of violations in your products and their labeling. 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 websites, 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. If you do not respond or if we find your response inadequate, we may take further action.  For instance, we may seize your products(s) under section 304 of the Act [21 U.S.C. § 334], enjoin your firm from operating under section 302 of the Act [21 U.S.C. § 332], and/or take further action to refuse admission of any of your products that are imported under section 801(a) of the Act [21 U.S.C. § 381(a)], including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry.  DWPE information may be conveyed in FDA's Import Alerts.  For your information, an example of an Import Alert that conveys information specific to foreign firms that market or promote unapproved new drugs is Import Alert #66-41.  This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert_190.html.
 
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 Lisa Althar, Compliance Officer, Food and Drug Administration, Seattle District Office, 22215 26th Avenue SE, Bothell, Washington, 98021. If you have any questions regarding any issue in this letter, please contact Ms. Althar at (425) 302-0427.
 
Sincerely,
/S/ 
Charles M. Breen
District Director