Department of Health and Human Services' logo Department of Health and Human Services

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

October 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:


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:

On your webpage titled "Angina Symptoms:"


On your webpage titled "Hypertension and Blood Pressure:"


On your webpage titled "Peripheral Artery Disease (PAD):"


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:"

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:

Your webpage titled "Chelation Therapy Health Conditions" states, "Below are conditions that Chelation Therapy has helped improve" followed by a list including the following:

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:"

On your web page titled "Common Questions and Answers:"

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:

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

This page was posted on October 16, 2010.

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