Inspections, Compliance, Enforcement, and Criminal Investigations
Artery Health Institute LLC 10/12/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Ave.
Jamaica, NY 11433
October 12, 2010
WARNING LETTER NYK-2011-02
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 at www.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
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.
Ronald M. Pace