FDA Warning – Rx-promotion

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
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11306 Kettering Terrace
Largo, MD 20774

Nexton Limited
Ryabov Sergey
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Scherbakova st., 6-38
Saint-Petersburg, 197375
RU

Aiden Aibo
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219 Macquarie Street
Sydney 2000
AU

Brian Tracy
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Baloboo 13-66
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US

Roman Vozhev
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Said Umarik
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Smartsol Inc.
Jorge Smark
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FDA Warning Letter – Cardio Renew Inc

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

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

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

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

 

FDA Warning Letter – Dr. Rhonda Henry

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

FDA Warning – Evenbetternow

October 12, 2010

WARNING LETTER
VIA UPS NEXT DAY

W/L 03-11

Mr. Donald Nichols
Ms. Andrea Nichols
Evenbetternow, LLC
447 W. Silvertip Road
Oro Valley, AZ 85737
Evenbetternow, LLC
1870 W. Prince Road, Suite 54
Tucson, AZ 85705
Re: Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and Heavy Metal Screen Test
Dear Mr. and Ms. Nichols:
This letter concerns your firm’s marketing of several products, including but not limited to, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay, and Heavy Metal Screen Test on your websites:
These (and other) products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
According to the products’ labeling, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, and Natur-Leaf are intended to cure, mitigate, treat, or prevent disease conditions. Statements documenting these intended uses include, but are not limited to, the following:

Kids Chelat Heavy Metal Chelator

• “Guaranteed to remove heavy metal ions from the body . . . Kids-ChelatTM contains EDTA, an amino acid that is so effective at removing unwanted minerals and metals from
the body, that is has been the standard FDA approved treatment for lead, mercury, aluminum and cadmium poisoning for more than 50 years.”
• “I recently ordered the Kids Chelat™ and Kids Clear clay baths for my 10 year old son. The results were astounding. My son was able to transition out of his special education classroom at school and he needs his classroom assistant much less.”
• “The Kids Chelat™ totally changed my autistic son from a hand flapping hyper kid to a sweet mellow angel.”
Bio-Chelat Heavy Metal Chelator

• “As a preventative measure, Bio-Chelat™ keeps any unbound heavy metals ions from being absorbed (or re-absorbed) by the body . . . whether it be metal ions from food, amalgams, or the environment. Bio-Chelat™ has its greatest value for sub-acute or chronic heavy metal toxicity.”
• “My son Anthony is 5 years old and has behavioral and developmental challenges . . . Within a couple of weeks of using Bio-Chelat™ on Anthony. . . his speech returned at a higher level than his usual immature echolaic-type dialogue.”
• “[D]iagnosed as autistic . . . . He started taking Bio-Chelat™ . . . . He became quieter, and his speech improved . . . . Also, he demonstrated improved social response.”
• “I take Bio-Chelat and it has really helped with my neuropathy which creates a burning, stabbing pain throughout my body.”
• “I suffered from heavy pollen allergies . . . However, soon after I started with the product I was almost completely free of any symptoms.”
Behavior Balance DMG Liquid

• “My grandson is reading outloud from books. After being on the spectrum for 3 years and had lost his speech at 3 yrs. we are delighted at his progress! Behavior Balance- DMG™ contributed to this important development.”
AlkaLife Alkaline Drops

• “Flush Out Harmful Acid Waste & Reverse Aging, Illness and Disease!”
• “I have suffered with acid reflux for the past 6 years, and have taken prescription medication (proton pump inhibitors) . . . . Since using the alkalizing drops . . . I have been finally able to get off all the medicines.”
• “I was diagnosed with IC [interstitial cystitis] . . . . I purchased your product, AlkaLife drops . . . . [T]his product . . . will lead me to better pain management, if not a cure.”
NutriBiotic Grapefruit Seed Extract

• “A powerful anti-bacterial and anti-fungal agent.”
Natur-Leaf
• “We have seen patients who have irritable bowel syndrome, spastic colons, abdominal cramping, rheumatoid arthritis, cystis [sic], fibromyalgia, hay fever, asthma, allergies to foods and medications, benign prostate hypertrophy and acne, have their symptoms completely reverse and the patients return to normal health.”
In addition to the above-listed products that you market as supplements, your firm also markets Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay. According to product labeling, Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay are intended to cure, mitigate, treat, or prevent disease conditions or to affect the structure or function of the body. Statements documenting these intended uses include, but are not limited to, the following:
Kids Clear Detoxifying Clay Baths

• “We highly recommend this product to any parent looking for a new and different way to combat Autism and the toxins that attribute to this disorder.”
• “Kids Clear™ Detoxifying Clay Baths not only draw out chemical toxins and pollutants from the body, they also assist in pulling out heavy metals that many doctors agree are a causative factor in the development of neurological and behavioral symptoms.”
• “After using clay baths, a number of parents of an autistic child have noticed dramatic improvement.”
• “What a change! Our almost 5 year old son who is on the spectrum is now doing great. After just the first bath, my husband and I saw results! He’ll turn to look at us (in the eyes) after calling his name only once! He’s using the right words to communicate, and in sentences!! And best of all, he’s smiling and laughing, and just seems happier!”
EBN® Detoxifying Bentonite Clay

• “EBN® Clay Baths assist in the removal of both metal and chemical toxins, such as food additives, preservatives, radiation toxins, formaldehyde, cigarette toxins, pesticides, and so on.”
• “In addition to being an excellent internal detoxifying agent, our clay can be very helpful for acute upset stomach, indigestion and diarrhea.”
• “Our clay was used in Malawi . . . to inhibit the incidence of diarrhea in infants and children.”
• “For many years I suffered from migraines . . . and after about 3 months there was a huge improvement.”
• Toxins play a major role in ALS [Amyotrophic Lateral Sclerosis] and other neurological disorders, so neutralizing these toxins is highly important. Two very easy, inexpensive and effective ways to do this is with EBN® Detoxifying Clay Baths and Bio-Chelat™ Heavy Metal Chelator.
Kids Chelat Liquid Chelation Drops, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, and Natur-Leaf are represented as dietary
supplements.
However, these products are drugs, as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. § 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay are also drugs under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because they are 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. We note that certain versions of Kids Clear Detoxifying Clay Baths and EBN Detoxifying Bentonite Clay represents these products as dietary supplements. To the extent that these products are not intended for ingestion, they are not dietary supplements as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).
Moreover, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, and EBN Detoxifying Bentonite Clay are “new drugs” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because they are not generally recognized as safe and effective for use and under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for them. FDA-approved applications are not in effect for these products. Thus, the sale of the above-listed products violates these provisions of the Act.
Furthermore, Kids Chelat Heavy Metal Chelator, Bio-Chelat Heavy Metal Chelator, Behavior Balance DMG Liquid, AlkaLife Alkaline Drops, NutriBiotic Grapefruit Seed Extract, Natur-Leaf, Kids Clear Detoxifying Clay Baths, EBN Detoxifying Bentonite Clay are offered for conditions, such as (but not limited to) autism, heavy metal poisoning, and interstitial cystitis, which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use them safely for their intended uses. Thus, your products’ 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). These products are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that labeling bear adequate directions for use because these products lack approved applications. Section 301(a) of the Act, 21 U.S.C. § 331(a), prohibits the introduction of a misbranded drugs into interstate commerce. Accordingly, the sale of the above-listed products violates these provisions of the Act.
In addition to the new drugs that you market and sell on your websites in violation of the Act, you also market and sell the Heavy Metal Screen Test in violation of the Act.  The Heavy Metal Screening 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 websites
state the following regarding the Heavy Metal Screen Test:
• “By taking a urine sample and mixing it with the test solutions . . . it determines immediately the presence of unbound heavy metal ions in your urine.”
• “The Heavy Metal Screen Test is a wonderful way to know if you have heavy metals in your body AND to show you the progress along the way as you use the Bio-Chelat and EBN Detox clay baths.”
• “The Heavy Metal Screen Test gives you a quick, reliable method for determining if electrically active heavy metal ions are present (ie. being excreted through the urine) at a high, medium, or low concentration, or not at all.”
• “This test is most useful in determining if your body’s detoxification pathways are compromised or not.”
The Heavy Metal Screen 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 Heavy Metal Screen 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 an all-inclusive statement of violations that exist in connection with your products and websites. 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 and any other violations you may have. Failure to promptly correct such 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. Additionally, if another firm manufactures the products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA   92612
If you have any questions about the content of this letter, please contact Dr. William Vitale, Compliance Officer, at 949-608-2919.
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 at
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 yours,
/S/
Alonza E. Cruse

District Director

Hormonal Health

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:

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

FDA Warning – Artery Health Institute

October 12, 2010
WARNING LETTER NYK-2011-02

VIA UPS

Howard Sousa
The Artery Health Institute, LLC
45 East 89th Street
New York, NY 10128

Dear Mr. Sousa:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website atwww.arteryhealthinstitute.com in June 2010 and has determined that your product “Advanced Formula EDTA Oral Chelation” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.

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

• “UNCLOG arteries and restore cardiovascular function”
• “This completely safe and natural therapy has been used successfully for over 50 years … Plaque is dissolved throughout your entire circulatory system. It can reverse atherosclerosis, lower cholesterol levels and blood pressure and help to prevent heart attacks and strokes!”
• “[P]atients … suffering from angina and coronary artery disease, symptoms dropped dramatically.”
• “Chelation therapy appeared to be a powerful antidote to- and preventative against-atherosclerosis, arthritis, kidney stones and otosclerosis ….”
• “EDTA chelation is one of the most effective, least expensive, and safest treatments for heart disease ever developed”
• “EDTA … REDUCES CHOLESTEROL”
• “By improving calcium and cholesterol metabolism EDTA can help to lower cholesterol, the principal component of atherosclerotic plaque.”
• “Garlic [an ingredient in Advanced Formula EDTA Oral Chelation] is believed to work by making blood less “sticky,” preventing the clinging of plaque to arterial walls…. [G]arlic may have more than a preventive effect and even possibly … ‘a curative role in arteriosclerosis therapy (plaque regression)’.”
• “Some dangerous heavy metals that are removed from your body using EDTA chelation therapy are:
o MERCURY: Some symptoms: … hyperactivity, migraines …
o LEAD: Some Symptoms: ADD, cardiovascular disease, impotence, liver
dysfunction
o CADMIUM: Some Symptoms: Arthritis, cancer, lung disease, kidney disease,
vascular disease, high cholesterol, cardiovascular disease
o ARSENIC: Some Symptoms: Liver dysfunction … chronic anemia
o ALUMINUM: Some Symptoms: liver dysfunction, neuromuscular disorders”
• “[C]onsistently observed a reduction of serum cholesterol by an average 20% or more in … patients who use oral chelation.”
Your website also contains disease claims in the form of personal testimonials from Dr. Garry Gordon, including:
• “I had a patient … who could never get her cholesterol below 500. Once she started taking 6 tablespoons a day of the EDTA-based chelation formula, she got down to 200. So this stuff can work wonders.”
• “The more chelation we give people, the less osteoporosis they have ….”

The disease claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include: “cardiovascular disease” and “clogged arteries.”

Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(P) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally 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 product is 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 purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the 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 deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Lillian C. Aveta, Compliance Officer, New York District Office, Compliance Branch, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions regarding any issue in this letter, please contact Ms. Aveta at 718-662-5576.
Sincerely,

/S/
Ronald M. Pace
District Director

FDA Warning – Maxam Nutraceutics

October 12, 2010
VIA UPS

In reply refer to Warning Letter SEA 11-01
WARNING LETTER

James G. Cole, CEO
Maxam Nutraceutics/Maxam Laboratories
1020-D Wasco Street
Hood River, Oregon 97031

Re: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test

Dear Mr. Cole:

This letter concerns your firm’s marketing of your products: PCA-Rx, PC3x, AFX, AD-Rx, AN-Rx, Anavone, AV-Rx, BioGuard, BSAID, CF-Rx, CreOcell, Dermatotropin, Endotropin, GTF-Rx, IM-Rx, Keto-Plex, Natural Passion, NG-Rx, NX-Rx, OR-Rx, Oxy-Charge, PN-Rx, Ultra-AV, Ultra Pure Yohimbe, and the Heavy Metal Screening Test on your website, www.maxamlabs.com. These products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.
According to labeling, your products are 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:

PCA-Rx

• “Try our oral chelation therapy called clathration for autism, Alzheimers, allergies, heavy metal detox and more.”
• “Removes heavy metals, toxins, mycoplasmas and cardio and cerebral vascular plaque.”
• “Some older users of PCA-Rx have remarked a definite improvement in thought process and recall ability ….”

• “Strong Relief For Uterine Fibroids … After 3 months of using PCA-Rx from Maxam, the growths resolved completely.”

PC3x

• “I have been giving this to a friend of mine that has lung problems from chemical exposure and had to use an inhaler to breath [sic] when out in the heat. After just two months of use … he showed a 51% increase in lung capacity.”
• “Aids in and accelerates the cellular detoxification process.”
AFX (Autism Factor)
• “Restructures and repairs all pathways, including the brain, nervous system, thyroid, growth hormone and immune function.”
• “Maxam constantly fine-tuned AFX to enhance its efficacy, addressing all aspects of Autism Spectrum/ADD/ADHD/RS or any other neural developmental disorders ….”

AD-Rx

• “AD-Rx enhances serotonin (5-HT) function in the body.”
• “[N]atural treatment for mood disorders, anxiety, fatigue, insomnia, eating disorders, Post-Traumatic Stress Disorder (PTSD), Premenstrual Syndrome (PMS) and Obsessive-compulsive
disorder (OCD).”
AN-Rx (Pain Relief Anti-Anxiety Formula)

• “Relieves pain and anxiety, helps balance mood and has a calming effect.”
• “[H]elps with insomnia and interrupted sleep patterns.”

Anavone

• “Suppresses the catabolic hormone cortisol.”
• “[I]ncreases protein synthesis.”
• “Prevents muscle breakdown.”

AV·Rx


• “Diseases such as herpes, AIDS, the flu, mad cow disease and various types of cancer are all of viral or prion origin…. AV-Rx will help protect the body against diseases of viral or prion origin, as well assisting the body in the healing of these types of diseases.”
• “Herpes Relief – At Last!! … Within 24 hours of starting to take AV-Rx, Maxam Lab’s antiviral formula, her symptoms began to respond…. The client … even sprayed it externally on the vaginal membranes…. As a clinician, it is so wonderful to have clients get such an immediate response when the body has not been able to respond to any other treatment.”

BioGuard

• “Clean(s] and enhance(s] the immune system.”
• “Beneficial for intestinal bacteria and fungus, such as Candida yeast overgrowth.”

BSAID (Broad Spectrum Anti-Infective Disease)
• “Shown effective against latent residual viruses from old inoculations, measles, mumps, small pox, as well as HPV, EBV, CMV, HIV, etc.”
• “BSAID can also be used topically on areas of infection or injury.”
• “My son who is now 18 has had severe large clusters of cold sore breakouts since he was about 2 years old … I thought I would try BSAID for my son. IT WORKED WONDERS!!!He has not had a breakout in 2 years now.”
CF-Rx (Cellaflex Anti-Inflammatory Anti-Arthritic)
• “Anti-arthritic which stimulates regeneration and repair of all soft tissue, tendons, ligaments, muscle, skin (bruises). Cellaflex is also an anti-inflammatory which reduces pain in joint structures.”
• “[I]t is useful to nebulize the Cellaflex for lung diseases, especially asthma and other related pulmonary diseases.”
CreOcell (Creatinine Phosphokinase)
• “Enhances Endurance and Muscular Growth.”
• “Increased muscle nitrogen levels with lower protein intake, increased ATP level recovery and many of the positive benefits of a true anabolic compound without any of the negative side effects associated with toxic loading or anabolic steroid use.”
• “CreOcell is reported to give higher energy and endurance levels, harder more defined muscles, an increase in mental awareness and the most incredible “pump” users say they have ever experienced.”
Dermatropin
• “Dermatropin stimulates collagen, elastin regeneration, activates scar tissue repair, and reduces wrinkling and sun damage.”
Endotropin
• “Endotropin has been created to stimulate release of human growth hormone, stimulates full pituitary and hypothalamic function, luteinizing and follicle stimulating hormones, which, in turn, will stabilize estrogen and testosterone production.”

• “Endotropin will also stimulate adrenocorticotropic hormone (acth), which increases energy. Melanin, dopamine, serotonin, melatonin, and oxytocin are all stimulated as well…. Your entire endocrine system is covered. Endotropin may have just made growth hormone obsolete!”
GTF-Rx (Glucose Tolerance Factor)
• “GTF-Rx increases insulin sensitivity of cells, lowers insulin requirements, normalizes glucose levels, ameliorates symptoms of diabetes and accompanying chronic tissue degeneration.”
IM-Rx (Immune System Enhancement)
• “IM-Rx is an immune system modifier that down-regulates autoimmune dysfunction, to help alleviate symptoms of arthritis, lupus, multiple sclerosis and enhances T & B cell activity in response to infection.”

Keto-Plex

• “Increases Immunity/Assists in Weight Loss”
• “Keto-Plex … has measurable effects on increasing muscular density and hardness and promoting a defined, lean appearance. It also assists in weight loss and minimizes catabolism (break down) of muscle tissue.”
Natural Passion
• “Natural Passion Helps Increase:
o Libido
o Virility
o Sensitivity
o Desire for sexual intimacy”
NG-Rx (Neural Regeneration)
• “[D]esigned to … balance and correct the brain chemistry … and induce the formation and activation of neuro-pathways.”
• “NG-Rx … can help to reduce memory loss.”
• “It can stimulate your immune system.”
• “NG-Rx can also assist with weight loss, and can improve your mood when you are feeling a little down.”
• “I have had paralysis of the left side of my face for many years. I began using your NG-Rx on the advice of your friendly customer service staff. I am happy to report that after only ten days of being on your product, I am seeing changes in the amount of facial paralysis.”

NX-Rx (Neural Enhancer)

• “Stimulates nerve cell regeneration and repair in both the central and peripheral nervous system by encouraging the production of nerve growth factor.”
OR-Rx (Osteo Regeneration Hard Tissue Support)
• “This product assists your body with hard tissue repair of teeth and bones; up-regulates calcium and calcium absorption.”
• “Also beneficial for gum infections, soft teeth, broken bones, osteoporosis and osteoarthritis.”
• “OR-RX has the capability to pull bacterial infections from the oral cavity.”

Oxy-Charge

• “Oxy-Charge effectively increases muscle energy on a cellular level, oxygenates the hemoglobin in blood and eliminates carbon monoxide.”
PN-Rx (Pineal Stimulating Peptides)
• “PN-Rx stimulates pineal harmone production, up-regulates melatonin and sleep while down-regulating Prementrual Syndrome (PMS) and pain.”

Ultra-AV

• “A powerful growth hormone stimulant that effectively suppresses production of the hormone somatostatin (which inhibits growth-hormones) and has life extension and anti-aging properties.”
• “A ‘Fountain of Youth’ of sorts, that helps reverse biological aging, assists in regeneration of all tissues, is anabolic and aids in weight loss.”
Ultra Pure Yohimbe
• “Used in the treatment of male impotence.”
• “Promotes the stimulation of testosterone.”

Your firm markets the above-listed products as dietary supplements. However, your products are labeled as transmucosal sprays for sublingual administration. You also recommend that “It is also
beneficial to nebulize many of the Maxam products.”
In addition, your firm markets your products AV-Rx, BSAID, and CF-Rx for topical administration. Because these products are not intended for
ingestion, they are not dietary supplements as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff). Rather, these products are drugs, as defined by section 201(g)(1) of the Act, 21 U.S.C. §
321(g)(1), because they 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, all of the above-listed products are “new drugs” as defined by section 201(P) of the Act, 21 U.S.C. § 321 (p), because they are 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 your above-listed products, without an approved application, violates these provisions of the Act.

Furthermore, your above-listed products are offered for conditions which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners such as, but not limited to, autism, Alzheimer’s disease, heavy metal toxicity, uterine fibroids, mood disorders, impotence, asthma, diabetes, and infections including herpes, HIV (human immunodeficiency virus), and EBV (Epstein-Barr virus). Therefore, adequate directions cannot be written so that laymen can use your products safely for their intended uses. Thus, the labeling of your above-listed products fail 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 above~listed products are not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that their labeling bear adequate directions for use because they lack approved applications. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act, 21 U.S.C. § 331(a).
In addition to the new drugs that you market and sell on your website, www.maxamlabs.com in violation of the Act, you also market and sell the Heavy Metal Screening Test in violation of the Act.

The Heavy Metal Screening 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. The Heavy Metal Screening Test, used to detect heavy metals in human urine, saliva and/or hair, 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 Heavy Metal Screen 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 products. 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 these products identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the products is not the manufacturer, please
include the name of your supplier in addition to the manufacturer. Address your reply to the Food and Drug Administration, 22201 23rd Drive Southeast, Bothell, Washington 98021-4421, Attention: Lisa M. Althar, Compliance Officer.
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 20993-0002.

Sincerely,
/S/
Charles M. Breen
District Director