Department of Health and Human Services' logo 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



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 at 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:

Your website also contains disease claims in the form of personal testimonials from Dr. Garry Gordon, including:

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

District Director

This page was posted on October 16, 2010.

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