October 12, 2010
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903

TO: support@rx-drugs-support.com
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: October 8, 2010

WARNING LETTER

The United States Food and Drug Administration (FDA) recently reviewed your websites (listed in the table located at the bottom of this letter) and has determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), and 505(a) of the FFDCA [21 U.S.C. §§ 331(a), 331(d), and 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.

Unapproved New Drugs

Certain products you offer for sale through your websites are drugs within the meaning of section 201(g) of the FFDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These products are also new drugs as defined by section 201(p) of the FFDCA [21 USC § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. No approved applications pursuant to section 505 of the FFDCA (21 USC § 355) are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 505(a) and 301(d) of the FFDCA [21 USC §§ 355(a) and 331(d)].

As a few examples, your firm offers for sale through your websites “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “Cialis Professional,” and “Viagra Soft.” “Viagra” and “Cialis” are the names of FDA-approved drugs well-known for their intended use(s) to treat disease. Similarly, Acomplia (rimonabant) is well-known as the name of a drug previously approved in the European Union. It has never been approved by FDA, and in June 2007, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Including drug names such as “Viagra,” “Cialis,” and “Acomplia” causes products such as “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “Cialis Professional,” and “Viagra Soft” to be subject to regulation as drugs under Section 201(g) of the FFDCA because they are intended for use in the diagnosis, cure, mitigation treatment, or prevention of disease. As stated above, no approved applications pursuant to section 505 of the FFDCA (21 USC § 355) are in effect for these products. Your offering these products for sale without approved applications violates the FFDCA.

Misbranded Drugs

Your websites offer prescription drugs – some of which include controlled substances, particularly concerning because of their potential for abuse and dependency – for sale without
requiring that the drugs be dispensed only upon a prescription from a practitioner licensed by law to administer such drugs. Therefore, the drugs are misbranded under section 503(b)(1) of the FFDCA [21 U.S.C. § 353(b)(1)].

Additionally, because the above mentioned drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FFDCA [21 U.S.C. § 352(f)(1)]. Because your products, such as “Viagra Professional,” “Cialis Super Active,” “Female Viagra,” “Acomplia,” “Cialis Professional,” and “Viagra Soft,” lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the FFDCA.

In addition, your websites offer Accutane (isotretinoin) for sale. Accutane is a potentially dangerous prescription drug that should only be taken under the close supervision of a healthcare professional and pharmacist. Because isotretinoin has serious risks, FDA-approved drugs containing isotretinoin are available in the U.S. only under specially created safety controls. More specifically, among other requirements, patients and their doctors and pharmacists are required by FDA to register with the iPLEDGE program in order to receive this medication. These safety controls are bypassed when this drug is purchased from foreign sources or over the Internet, placing patients who use this drug at risk. The Accutane product offered for sale on your websites is misbranded within the meaning of section 502(f)(1) of the FFDCA [21 U.S.C. § 352(f)(1)] in that labeling for the drug fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of misbranded products violates section 301 of the FFDCA (21 U.S.C. § 331).

* * *

FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for new drug approval and labeling review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.

This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the FFDCA and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.

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Sincerely,

/S/
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research

cc:
Rx-Promotion
Marianne Knowles
Suite 2, Portland House
Glacis Rd, GI

Alex James
Internet Marketing Pro’s LLC
domain486@gmail.com
3422 Old Capitol Trail
Wilmington, DE 19808-6192

Annette Goldi and Annette Cirino
domain486@gmail.com
Landerbrook Drive
Cleveland, OH 44023

Hardy, Anthony
anthonythardy@aol.com
11306 Kettering Terrace
Largo, MD 20774

Nexton Limited
Ryabov Sergey
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Scherbakova st., 6-38
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Aiden Aibo
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219 Macquarie Street
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Brian Tracy
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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
• 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 http://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
• 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
• 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

October 12, 2010
WARNING LETTER
Via UPS

Dr. Rhonda Henry
247 La Costa Ave.
Dayton, NV 89403

Dear Dr. Rhonda Henry:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address www.drhenry.com in July 2010 and has determined that the products, “Pure Heart,” “Melatonin,” “Flaxseed Meal,” “DHEA” and “Cardio Chelate (H-870)” 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 website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  The marketing of the products with these claims violates the Act.

Examples of some of the claims observed on your website include:

On a webpage at the Dr. Rhonda’s Health Store entitled, “Lose Weight Permanently By Eating”:

Pure Heart

• “[T]here is a completely safe … therapy that can prevent and even reverse heart disease”
•  “The results showed a superior clinical improvement in the Pure Heart group including:

o Decrease of LDL cholesterol
o Increase of HDL cholesterol
o Moderate to Dramatic decrease in angina
o Increase in total blood flow through previously occluded vessels
o Improvement in feeling of depression
o Recovery of myocardial function in previous ischemic and necrotic areas
o Reduction in tachycardia upon stress exercise”

• “The ingredients in Pure Heart appear to be capable of partially or completely reducing ischemia.”

•  “Pure Heart was created to help prevent the changes in the blood vessels which result in heart disease.”

Melatonin

• “Melatonin boosts the immune system reducing the likelihood and severity of infectious diseases, it is a super antioxidant that protects cells from free radical damage, slows the growth of tumors, regulates blood pressure, wards off heart disease, prevents cancer….helps control Parkinson’s Disease, stops or delays the formation of cataracts….”

Flaxseed Meal

• “The dynamic health benefits [of Flaxseed Meal] include: lowered blood pressure … and anti-cancer benefits.”

DHEA

• “Research has found DHEA to have significant anti-obesity … anti-cancer effects.”
• [L]ow DHEA levels correlate to increased risk of cancer, heart disease, osteoporosis, obesity, diabetes …”
• “Scientific research has linked increased levels of DHEA with reduced risk of most degenerative diseases ….”

Cardio Chelate (H-870)

• “Oral Chelation Formula Removes Plaque that Clogs and Hardens Arteries.”
• “Ayurvedic Herbs Work on the Cause of Heart Disease.”
• “This balanced herbal formula displays the following properties:

o “Pushkarmul and kut have beta blocking like activity.”
o “Arjuna has antihypertensive calcium channel blocker activity.”
o “Gugul has hypolipidemic and antithrombic properties.”
o “Shankhpushpi, arjuna and jalneem are … antihypertensive.”
o “Kut has antidiabetic properties.”
o “Gugul decreases obesity … ”

• “[B]romelain, an enzyme from pineapple, and Papain … cleanse the arteries.”
• “These enzymes break down fibrin, inhibit clotting and promote normal healing of surface lesions.”

Your website also contains disease claims in the form of personal testimonials. The following are excerpted from a webpage entitled “Dr. Rhonda Henry’s Health Test”:

•  “Recently, an excruciatingly painful arthritis flare up in my knees …. Dr. Rhonda heard of my pain, she came in like an angel, bearing a bag of supplements ….  Within 24 hours, my condition turned around.  The inflammation left, the mobility increased.”
• “8 years ago, I was a very sick person.  I had battled colitis, diverticulitis, Epstein-Barr virus and low blood sugar.  I spent thousands of dollars on tests and doctor bills trying to find an end to all my health problems.  I picked up parasites in the Yucatan Peninsula …. I was down 93 pounds, couldn’t digest food, and was weak
• and dizzy all the time … I now eat and digest my food, lift weights 3 times a week, and have energy to spare.”

The claims quoted above are supplemented by the metatags used to bring consumers   to your website through Internet searches.  The metatags include “diabetes”, “arthritis”, “depression”, “menopause”, “peri-menopause”, “Candida”, “digestive disorders”, “osteoporosis”, and “infections”.

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.

The above violations are not meant to be an inclusive list of deficiencies in your products and their labeling.  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. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the 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.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Juliane K. Jung-Lau, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502.  If you have any questions regarding any issues in this letter, please contact Ms. Jung-Lau at 510-337-6793.

Sincerely,

/S/

Barbara J. Cassens
Director
San Francisco District

October 12, 2010

WARNING LETTER
VIA UPS NEXT DAY

W/L 03-11

Kids Chelat Heavy Metal Chelator

District Director

October 12, 2010
W/L 04-11

Mr. Richard D. Brooks
Ms. Joan R. Campbell
Hormonal Health, LLC
357 West 2nd Street Suite 1A
San Bernardino, California  92401

Mr. Richard D. Brooks
Ms. Joan R. Campbell
Hormonal Health, LLC
1213 Goldfield Avenue
Carson City, Nevada  89701

Dear Mr. Brooks and Ms. Campbell:

This letter concerns your firm’s marketing of its Kelatox suppository product and its METALDETECTOR Instant Toxic Metals Test, on your websites:

• www.kelatox.com
• www.kelatoxpro.com
• www.chelationhealthproducts.com

This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

According the labeling, Kelatox is intended to affect the structure or function of the body of man or other animals and/or intended to cure, mitigate, treat, or prevent disease conditions.  Statements documenting these intended uses include, but are not limited to, the following:

• “Kelatox . . . removes a wide range of toxic metals including Mercury, Lead and Aluminum from the body.”

• “Kelatox® uses Calcium Disodium EDTA . . . recommended . . . for lead poisoning and other toxic heavy metal conditions . . . as far ranging as decreased circulation, degenerative diseases such as Alzheimer’s, diabetes, decreased adrenal gland function and Autism. ”

• “The primary cause of endothelial dysfunction is the build up of heavy metals in this [endothelial] lining . . . .  The EDTA in Kelatox will remove heavy metals from the endothelium helping it to produce nitric oxide thereby allowing the blood vessels to relax increasing the blood flow.”

• “We have seen changes in patients with chronic fatigue, fibromyalgia, neurological diseases, depression, skin problems, headaches, and many more conditions.  This product is beneficial to help your patients heal.”

• “My husband was diagnosed with Parkinson’s Disease recently. . . .  Kelatox was ordered and started.  Within weeks, he was feeling better.  In eight weeks his massage therapist noticed a difference in his overall body . . . She was giving him massages for years and was never able to work “deep in his muscles” until he took Kelatox.”

• “I . . . have been taking IV EDTA since 1998 for macular degeneration.  I’ve recently switched to EDTA chelation suppositories. . . .  Because they are working so well, I am planning on dropping IV EDTA and solely using the chelation suppositories.”

• “I suffer from Peripheral Neuropathy and had lost all feeling in my legs. . . .  One month after I started Kelatox, I regained the sense of feeling completely in my right leg and partially in the left.”

Your firm markets Kelatox as a dietary supplement.  Because this product is a suppository and not intended for ingestion, it is not a dietary supplement as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).  Rather, this product is a drug, as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended to affect the structure or function of the body and/or intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.

Moreover, Kelatox is a “new drug” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling.  Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.  Your sale of Kelatox suppositories without an approved application violates these provisions of the Act.

Furthermore, Kelatox is offered for conditions such as, but not limited to, lead poisoning, Alzheimer’s disease, autism, endothelial dysfunction, Parkinson’s disease, macular degeneration, and peripheral neuropathy, which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners.  Therefore, adequate directions cannot be written so that a layman can use Kelatox safely for its intended uses.  Thus, the labeling of Kelatox suppositories fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).  Kelatox is not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that its labeling bear adequate directions for use because Kelatox lacks an approved application.  The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §331(a).

In addition to the new drug that you market and sell on your websites in violation of the Act, you also market and sell the METALDETECTOR Instant Toxic Metals Test in violation of the Act.  The METALDETECTOR Instant Toxic Metals Test is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.  Your website www.kelatox.com states the following regarding the METALDETECTOR Instant Toxic Metals Test:

• “Test for the presence of toxic metals in urine or water, with this quick and convenient in-home test.”

• “The METALDECTOR™ Instant Toxic Metals Test readily detects free, electrically-active heavy metal ions.”

• “For anyone who is serious about avoiding degenerative diseases facing the human race, getting tested for heavy metals is more important than ever before.”

The METALDETECTOR Instant Toxic Metals Test, used to detect heavy metals in human urine, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. §351(f)(1)(B), because an approved application for premarket approval (PMA) pursuant to section 515(a) of the Act, 21 U.S.C. §360e(a) or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. §360j(g), are not in effect for it.  The METALDETECTOR Instant Toxic Metals Test is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), in that it was manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. §360; not included in a list required by 510(j), 21 U.S.C. §360(j); and notification or other information respecting the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. §360(k).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product.  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 your firm complies with all requirements of federal law and FDA regulations.

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, including, without limitation, seizure and injunction.  Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.  Furthermore, please advise this office what actions you will take to address product that you have already distributed.  Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer.  If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.

Your response should be sent to:

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

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

A description of the new drug approval process can be found on FDA’s internet website athttp://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm.  In addition, information regarding approval or clearance for devices is described athttp://www.fda.gov/cdrh/devadvice/3122.html.  Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO51-2201, Silver Spring, Maryland  20993.

Sincerely,

/S/
Alonza E. Cruse
District Director

cc: Jay Salmon
World Health Products, LLC
12685 South 125 East
Draper, Utah  84020

Marv Bateman
1189 E. Pinion St.
Washington, Utah  84780

Zayin of Utah Corporation
1022 W Smithsonian
Apple Valley, Utah  84737

TRANSMITTED BY FACSIMILE

Brian J.G. Pereira, MD
President and Chief Executive Officer
AMAG Pharmaceuticals, Inc.
100 Hayden Avenue
Lexington, MA 02421
RE: NDA 020410, 022180
GastroMARK® (ferumoxsil, oral suspension)
Feraheme™ (ferumoxytol) Injection For Intravenous (IV) use
MACMIS #18355

WARNING LETTER

Dear Dr. Pereira:
As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed AMAG Pharmaceuticals, Inc.’s (AMAG) webpages for its drug products, GastroMARK® (ferumoxsil, oral suspension) (GastroMARK)¹ and Feraheme™ (ferumoxytol) Injection For Intravenous (IV) use (Feraheme).² Both the GastroMARK and Feraheme webpages omit risks associated with the drug products; in addition, the GastroMARK webpage omits important information about the approved indication for GastroMARK, and both webpages misleadingly suggest unapproved new uses for the drugs. Thus, the webpages misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a),(f)(1) & (n); 321(n), and FDA’s implementing regulations. See 21 CFR 201.100(c)(1); 201.128; 202.1(e)(3)(i);(e)(5) & (e)(6)(i). Furthermore, AMAG failed to submit a copy of the GastroMARK and Feraheme webpages to FDA under cover of Form FDA-2253 at the time of their initial publication, as required by 21 CFR 314.81(b)(3)(i).
These violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial evidence or substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience.

Background
GastroMARK
According to its FDA-approved product labeling (PI), GastroMARK is indicated as follows:
GastroMARK is indicated in adult patients for oral use with magnetic resonance imaging to enhance the delineation of the bowel to distinguish it from organs and tissues that are adjacent to the upper regions of the gastrointestinal tract.
GastroMARK’s usefulness in the lower gastrointestinal tract and retroperitoneal region is limited (by transit time and dilution).
GastroMARK is not recommended for iron supplementation.
GastroMARK is contraindicated in patients with known or suspected intestinal perforation or obstruction, and in patients with known allergy to its active or inactive ingredients.
The PI for GastroMARK includes the following Warnings:
The ingestion of GastroMARK may cause abdominal pain, diarrhea, nausea and vomiting. In 78/256 (30%) of patients and normal volunteers, gastrointestinal adverse events occurred within the first 2 hours after ingestion of GastroMARK. In 30 (12%), gastrointestinal events had their onset within 30 minutes. In 63/256 (24%), diarrhea occurred within 24 hours.
Vomiting can be associated with aspiration. Precautions should be taken to avoid aspiration.
The effects of GastroMARK on human peritoneal tissues are not known. In animal studies, intraperitoneal injection of GastroMARK was associated with a foreign body reaction that persisted for at least 30 days.
Additionally, the PI contains numerous Precautions, including the possibility of increased severity of nausea, vomiting, diarrhea, and abdominal cramping in patients who have these symptoms prior to GastroMARK administration; “This could confound the ability to distinguish adverse effects of GastroMARK from the signs and symptoms of obstruction or perforation, and from the pre-existing conditions.” In addition, studies have not been conducted in patients who have a current or recent history of hiatal hernia, esophageal reflux, nausea, vomiting, or abdominal pain; or to describe the effects of drugs that increase or decrease gastrointestinal transit time on the GastroMARK image quality or gastrointestinal adverse events. GastroMARK should be given with caution to patients who cannot tolerate large fluid shifts, who are on specific fluid intake requirements, and who have disorders associated with iron overload (e.g., hemosiderosis, chronic hemolytic anemia with frequent blood transfusions, or chronic iron replacement). Furthermore, the safety of GastroMARK in patients with inflammatory bowel disease has not been well studied.
Feraheme
According to its PI, “Feraheme™ (ferumoxytol) Injection is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).”
Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and anemia not caused by iron deficiency.
Feraheme is associated with other serious risks. The PI includes Warnings and Precautions regarding the following (emphasis in original):
. . . HYPERSENSITIVITY REACTIONS
Feraheme may cause serious hypersensitivity reactions, including anaphylaxis and/or anaphylactoid reactions. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. Observe patients for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and only administer the drug when personnel and therapies are readily available for the treatment of hypersensitivity reactions. . . .
. . . HYPOTENSION
Hypotension may follow Feraheme administration. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor patients for signs and symptoms of hypotension following Feraheme administration. . . .
. . . IRON OVERLOAD
Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. . .

In the 24 hours following administration of Feraheme, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Feraheme complex.
. . . MAGNETIC RESONANCE (MR) IMAGING
Administration of Feraheme may transiently affect the diagnostic ability of MR imaging
. . . . Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. . . .
Feraheme will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission tomography (SPECT), ultrasound or nuclear medicine imaging.

The most common adverse reactions reported in ≥2% of Feraheme-treated patients with CKD were nausea (3.1%), dizziness (2.6%), hypotension (2.5%), and peripheral edema (2.0%). Diarrhea (4.0%), constipation (2.1%), and hypertension (1.0%) have also been reported. In clinical trials, adverse reactions leading to treatment discontinuation in ≥2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Omission of Risk/Indication Information
Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.
The webpages present numerous efficacy claims for GastroMARK and Feraheme, but fail to communicate any of the risks associated with the drugs (see Background section above). By omitting the most serious and frequently occurring risks associated with these drugs, the webpages misleadingly suggest that GastroMARK and Feraheme are safer than has been demonstrated and therefore place the public at risk. For example, the GastroMARK webpage omits the drug’s contraindication in patients with known or suspected intestinal perforation or obstruction. We note that there are links to “Download the GastroMARK® Package Insert” at the bottom of the GastroMARK webpage and to “Download the Feraheme Package Insert” buried in the second sentence of the Feraheme webpage. However, these links do not mitigate the complete omission of risk information from the GastroMARK and Feraheme webpages.
Furthermore, the GastroMARK webpage fails to present the complete indication for GastroMARK, including material limitations to the indication. The webpage includes the following claims:
GastroMARK® (ferumoxsil) is AMAG Pharmaceuticals’ oral gastrointestinal (GI) imaging agent for delineation of the bowel. . . . By more clearly identifying the intestinal loops, GastroMARK® enhances the ability to distinguish the bowel from adjacent tissues and organs in the upper gastrointestinal tract.
This presentation fails to include that GastroMARK is indicated only in adult patients, and that its usefulness in the lower gastrointestinal tract and retroperitoneal region is limited by transit time and dilution. The webpage also fails to reveal that GastroMARK is not recommended for iron supplementation.
Promotion of Unapproved Uses
The Feraheme webpage includes the following claims:
• “Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.”
• “Feraheme is being developed to treat iron deficiency anemia associated with other conditions and disease states including women with abnormal uterine bleeding, and patients with cancer and gastrointestinal diseases.”
• “Feraheme is also being developed as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. . . .”
The presentation of both approved and unapproved product information for Feraheme together in this manner is misleading because it implies that Feraheme is effective for unapproved uses. However, Feraheme is not approved to treat iron deficiency anemia in women with abnormal uterine bleeding, or in patients with cancer and gastrointestinal diseases. In addition, Feraheme is not approved as a diagnostic agent for vascular-enhanced magnetic resonance imaging for the detection of clinically significant arterial stenosis or occlusion in subjects with peripheral arterial disease.
Similarly, the GastroMARK webpage first presents the product’s U.S. indication (minus limitations), along with efficacy claims for the drug, but states near the bottom of the page that, “In Europe Gastromark® is approved for rectal administration to delineate the lower intestinal system” (emphasis added). This statement, presented within a webpage that appears to be targeted to a U.S. audience, is concerning, as it suggests to U.S. healthcare professionals that GastroMARK is effective for delineating the lower intestinal system and for rectal administration, when in fact, the drug is not approved for this use or method of administration in the U.S.; the U.S. PI for GastroMARK specifically states that “GastroMARK is indicated. . . for oral use. . . .” and that “GastroMARK’s usefulness in the lower gastrointestinal tract and retroperitoneal region is limited (by transit time and dilution).”
The above statements thus misbrand Feraheme and GastroMARK.
Failure to Submit on Form FDA-2253
FDA regulations require companies to submit any labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. Copies of the GastroMARK and Feraheme webpages were not submitted to DDMAC under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).
Conclusion and Requested Action
For the reasons discussed above, the webpages misbrand GastroMARK and Feraheme in violation of the Act, 21 U.S.C. 352(a),(f)(1) & (n); 321(n), and FDA’s implementing regulations. See 21 CFR 201.100(c)(1); 201.128; 202.1(e)(3)(i);(e)(5) & (e)(6)(i). Furthermore, you failed to submit the webpages to FDA under cover of Form FDA-2253 at the time of their initial publication, as required by 21 CFR 314.81(b)(3)(i).
DDMAC requests that AMAG immediately cease the dissemination of violative promotional materials for GastroMARK and Feraheme, such as those described above. Please submit a written response to this letter on or before November 1, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for GastroMARK and Feraheme that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Because the violations described above are serious, we request, further, that your submission include a plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS #18355 in addition to the NDA numbers. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for GastroMARK and Feraheme comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.
Sincerely,
{See appended electronic signature page}
Thomas W. Abrams, R.Ph., M.B.A.
Director
Division of Drug Marketing,
Advertising, and Communications
CC: Russell D. Reed
Global Labeling Director
Mallinckrodt Inc.
675 McDonnell Boulevard
Hazelwood, MO 63042

¹ GastroMARK webpage, at http://www.amagpharma.com/products/gastromark.php (last accessed October 18, 2010).
² Feraheme webpage, at http://www.amagpharma.com/products/feraheme.php (last accessed October 18, 2010).
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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
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/s/
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THOMAS W ABRAMS
10/18/2010