| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7114 FAX: (612) 334-4142 |
Department of Health and Human ServicesOctober 12, 2010
WARNING LETTER
Refer to MIN 11-01
OVERNIGHT MAIL via UPS
Kevin Raymond
Jay Hoogenakker
Cardio Renew, Inc.
15050 Cedar Avenue, #116-315
Apple Valley, Minnesota 55124
Dear Messrs. Raymond and Hoogenakker:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.cardiorenew. com, www. cardiorenew. org, www.cardio-renew.com, www.cardiorestore.com and www.oralchelationblog.com and has determined that the products "Cardio Renew" and "Cardio Restore" 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 therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your websites include:
Cardio Renew (cardiorenew.com. cardio-renew.com. cardiorenew.org):
On the Home pages of www.cardiorenew.com and www.cardiorenew.org:
• "EDTA [an ingredient in your product] Chelation Promotes: ... Normalized Blood Pressure ... Normalized Cholesterol Levels"
Your webpage titled "Benefits of EDTA Chelation Therapy" states, "Cardio Renew is 100% pure liquid EDTA chelation therapy that will ... increase[] blood flow.... If your blood flow is restricted due to blockage, your body is not receiving the proper nourishment, which causes poor health conditions. Now, if you reduce the blockage and increase circulation, your body receives the proper blood rich in oxygen and nutrients which can allow it to recuperate, regenerate and operate normally once again." Below this statement, your webpage discusses many diseases in specific detail. Some of the listed diseases and more specific claims include:
• "Alzheimer's disease: ... In mixed dementia, Alzheimer's and vascular dementia (reduced blood flow to parts of the brain) occur together. Increasing circulation with liquid chelation therapy brings blood rich in oxygen and nutrients to all parts of the body, increasing energy and alertness."
• "Angina: Chest pain or discomfort that occurs when the heart does not get enough blood due to build up in the coronary arteries. ... Reducing blockage and increasing circulation through EDTA chelation therapy can help the body function closer to normal."
• "Arteriosclerosis:. " Reducing blockage and increasing circulation through EDTA chelation therapy, can assure a healthy blood flow with oxygen to the heart."
• "Atherosclerosis"
• "Bursitis: ... Poor circulation can increase inflammation. Increasing circulation through chelation therapy can help the body function closer to normal."
• "Cardiac Arrhythmia"
• "Cardiovascular Disease"
• "Cholesterol Reduction: ... By increasing blood flow by removing mineral deposits and heavy metals from the body; liquid EDTA chelation treatment can assist in reducing blockage in the arteries and veins. Read more about how you can reduce your cholesterol with chelation therapy."
• "Coronary Artery Disease"
• "Diabetes Mellitus"
• "Diabetic Neuropathy"
• "Diabetic Retinopathy"
• "Elevated Blood Fats (Hyperlipidemia)"
• "Erectile Dysfunction"
• "Fibromyalgia: ... There are multiple physiologic abnormalities in someone with FM, including low levels of blood flow to the thalamus region of the brain. Increasing circulation through oral chelation can help the body function closer to normal."
• "Gangrene"
• "Heart Failure: ... Reducing blockage and increasing circulation through chelation therapy, can assure a healthy blood flow with oxygen and nutrients to the heart."
• "Heavy Metal Poisoning: ... EDTA chelation removes heavy metals and excessive minerals from the body, reducing the risk for overload or toxicity."
• "High Blood Pressure"
• "Intermittent Claudication: The pain is due to insufficient blood flow in the legs (caused by blocked arteries) It is the most prominent symptom of PAD (Peripheral
Artery Disease). Reducing blockage and increasing circulation through oral EDTA chelation, can assure a healthy blood flow throughout the body."
• "Ischemia: A condition in which the blood flow (and thus oxygen) is restricted to a part of the body.... Reducing blockage and increasing circulation through oral chelation therapy, can assure a healthy blood flow throughout the body."
• "Macular Degeneration"
• "Multiple Sclerosis"
• "Osteoarthritis: ... Poor circulation can increase inflammation.... Increasing circulation through EDTA chelation therapy can help the body function closer to normal."
• "Parkinson's Disease"
• "Peyronie's Disease"
• "Psoriasis"
• "Raynaud's Disease: ... It's a disorder of the blood vessels that supply blood to the skin, these arteries narrow, limiting circulation to affected areas. Increasing circulation with liquid chelation therapy brings blood rich in oxygen and nutrients to all parts of the body."
• "Rheumatoid Arthritis: ... Because EDTA acts as a good anti-inflammatory, along with the chelation process increasing blood flow, oral chelation therapy can help relieve pains and conditions caused by arthritis."
• "Scleroderma"
• "Senile Dementia"
• "Strokes: An injury to the brain due to the interruption of the blood supply when an artery becomes blocked, or a blood vessel breaks.... Increasing circulation and reducing blockage with liquid EDTA chelation therapy brings blood rich in oxygen and nutrients to all parts of the body."
• "Thrombophlebitis: The swelling of a vein caused by a blood clot, due to diminished blood flow.... Reducing blockage and increasing circulation through EDTA chelation therapy can help the body function closer to normal."
• "Transient Ischemic Attack (TIA): ... TIA's occur when a blood clot temporarily clogs an artery and part of the brain doesn't get the blood it needs. EDTA chelation reduces the viscosity or 'stickiness' of the blood, improving blood circulation throughout the entire body."
On your webpage titled "Angina Symptoms:"
• "Treatment for Angina and Chelation Therapy ... Cardio Renew's oral liquid EDTA chelation therapy can assist in angina relief."
On your webpage titled "Hypertension and Blood Pressure:"
• "Chelation therapy from Cardio Renew can help you relieve hypertension.... [R]eturn your blood pressure to a healthy level."
On your webpage titled "Peripheral Artery Disease (PAD):"
• "Cardio Renew can assist in relieving Peripheral Artery Disease symptoms."
In addition, your websites www.cardiorenew.com, www.cardio-renew.com and www.cardiorenew.org contain disease claims in the form of personal testimonials. The following are excerpts from a webpage entitled "EDTA Chelation Therapy Testimonials:"
• "I just returned from the doctor after taking this product [Cardio Renew] for two months. I am 58 and for 3 years I've had a partially [sic] blocked carotoid left artery and blood pressure hovering between 130 and 150/90. The doctor recently ordered a MRl and MRA which showed NO blockage and my blood pressure was 116170!! The ONLY thing I've been doing differently is taking the EDTA."
• "I was diagnosed with PAD [Peripheral Artery Disease] and was finding it more and more difficult to walk .... I've been on Cardio Renew for 3 1/2 weeks now .... I can WALK!!!!!! ... I've managed to avoid the procedures that the doctors wanted to do on me."
• "I have been using Cardio Renew for two years after two by-pass operations and just got a clearance from my heart doctor that I will not need a third by-pass... , My arthritis is gone .... It seems that cleaning out all my arteries has given my body a chance to regenerate all organs.... I am now using it for AMD [Age-related Macular Degeneration], the dry type ... it should unplug the veins in my eye."
• "I have been suffering daily severe chest pains [hyperlink to "Angina Symptoms" webpage] and breathing problems. I started your basic Cardio Renew program on August 30, 2008, and am 3 weeks into the program. NO MORE CHEST PAINS AT ALL, my breathing has gotten 200% better .... I am also a diabetic, with severe foot and hand pains and numbness. I have just about eliminated [sic] the pains and the numbness is gone."
• "[M]y results with Cardio Renew were pretty amazing! My total cholesterol on 10-7-05 was 291 .... LDL [bad cholesterol] was 197! ... I took it [Cardio Renew] for 4 weeks .... I went back for another blood test on 2-16-06. My total cholesterol was 225!!! My bad cholesterol was down to 1431"
• "I was in constant pain, left arm and shortness of breath. I've just finished my forth [sic] week [taking Cardio Renew]. The pain in my left arm is gone...."
• "I have been taking Cardio Renew less than two weeks '" ! No angina, ... and have cut the prescription BP [Blood Pressure] medication out. Reduced the diabetes medication to half."
• "I had such tremendous results in just a few days [of taking Cardio Renew] for my arthritis ...."
Furthermore, videos posted on your websites www.cardiorenew.com, www.cardio-renew.com and www.cardiorenew.org include testimonials and other claims that establish the intended use of Cardio Renew as a drug.
Examples of claims found on the videos include, but are not limited to:
"News Report: Oral EDTA Chelation":
• "This is the alternative to drugs.... EDTA could be the key to unlocking the mystery of heart disease."
• "My health is so many times better than before Cardio Renew. I have no symptoms of plaque buildup...."
"Today's Health: Chelation Therapy":
• "If blockage is found ... some patients are trying an alternative therapy called EDTA chelation.... It is also believed by many that this process helps to reduce clogging in the arteries."
• "With chelation therapy, we find that patients who have angina pectoris ... improve -- the pain disappears, they're able to walk further"
The claims quoted above are supplemented by the metatags used to bring consumers to your website, www.cardiorenew.com. through Internet searches. These metatags include: "parkinsons disease ... heart disease ... fibromyalgia, hypertension, cardiovascular disease."
Cardiorestore:
On your home page:
• "L-Arginine [an ingredient in your product] can also help reduce the risk of vascular and heart disease, high blood pressure, strokes and high cholesterol levels."
• "N-Acetyl-Cysteine [an ingredient in your product] ... [can] help prevent influenza infection."
Your webpage titled "Chelation Therapy Health Conditions" states, "Below are conditions that Chelation Therapy has helped improve" followed by a list including the following:
• "Alzheimer's disease Angina ... Arteriosclerosis ... Autoimmune disease ... Bursitis ... Cardiac Arrhythmia Cardiovascular Disease (CVD) ... Coronary Artery Disease ... Diabetes Mellitus ... Diabetic Neuropathy ... Diabetic Retinopathy ... Erectile Dysfunction (ED) / Impotence ... Fibromyalgia ... Gangrene ... Glaucoma ... Heart Failure ... Heavy Metal Poisoning ... Hypertension/High Blood Pressure Multiple Sclerosis Osteoarthritis Parkinson's disease ... Raynaud's Disease Rheumatoid Arthritis Scleroderma Stroke prevention."
In addition, your website www.cardiorestore.com contains disease claims in the form of personal testimonials. The following are excerpts from a webpage entitled "Customer Testimonials:"
• "My son ... is now using it [Cardio Restore] and in two weeks his blood pressure has gone down to normal.."
• "I was told by my doctor that 1 had over 80% blockage in my left Carotid Artery and 60% in my right .... I ordered your Chelation Plus Program [a package that includes Cardio Restore] and began the process.... I completed the program and then got checked out again and the blockage in both of my Carotid Arteries had decreased each by 35%."
• "I started taking Cardio Restore about a month ago for my Angina. Not only is the angina gone...."
On your web page titled "Common Questions and Answers:"
• "Cardio Restore's EDTA helps keep the stent from accumulating plaque and removes mineral build up that has formed around it, this keeps it clean.... [A] lot of our clients have avoided stent implantation. EDTA chelation removes the unwanted minerals and metals causing blood to flow easier, reducing the need for a stent."
• "Does chelation treatment benefit arthritis?
Yes, EDTA ... helps reduce inflammation in the joints.... Chelation therapy may be helpful for rheumatoid arthritis patients...."
• "Does chelation treatment benefit diabetes?
Yes, EDTA has shown to be effective in preventing complications of diabetes.... It has been reported that patients who have received chelation therapy have less amputations, less blindness, less renal dialysis, and other diabetes complications, than those on conventional treatments."
The claims quoted above are supplemented by metatags used to bring consumers to your website www.cardiorestore.com through Internet searches. These metatags include: "unblocked arteries, unclogging arteries, artery blockage, artery plaque...."
Oralchelationblog:
In addition, your website www.oralchelationblog.comincludes many of the claims found on your other websites and cited above as well as direct links to www.cardiorenew.com. Examples of claims include the following:
• "If you are currently living with heart disease, high blood pressure, senile dementia, or macular degeneration, look into chelation therapy.... For a full list of diseases and illnesses that benefit from EDTA, click here [hyperiink to the "Benefits of Chelation Therapy" list of diseases found on www.cardiorenew.com)...
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, because your products "Cardio Renew" and "Cardio Restore" are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)). The introduction of a misbranded drug into interstate commerce is a violation of § 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. The unlawful disease treatment and prevention claims on your website are too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, 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. Failure to do so may result in enforcement action without further notice. Sections 302 and 304 of the Act [21 U.S.C. §§ 332 and 334] authorize the seizure of illegal products and injunctions against manufacturers and distributors of those products.
Please notify this office, in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to, Tyra S. Wisecup, Compliance Officer, U.S. Food and Drug Administration. If you have any questions regarding any issues in this letter, please contact Ms. Wisecup at the address on the letterhead or (612) 758-7114.
Sincerely,
/s/
Gerald J. Berg
Director
Minneapolis District
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