The American College for Advancement in Medicine (ACAM) has agreed to settle Federal Trade Commission charges that it made unsubstantiated and false advertising claims that non-surgical, EDTA "chelation therapy" is effective in treating atherosclerosis, and that the effectiveness of the therapy has been proven by scientific studies. The proposed settlement would prohibit ACAM from representing, in advertising, that chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to support the representation. In addition, ACAM would be prohibited from making any representation about the efficacy or comparative efficacy of chelation therapy for any disease of the human circulatory system unless supported by competent and reliable scientific evidence.
ACAM, based in Laguna Hills, California, is an association comprised principally of physicians who administer traditional and complementary/alternative medical therapies including chelation therapy. ACAM promotes chelation therapy in brochures and promotional materials and by maintaining a Web page on the Internet. Chelation therapy involves the intravenous injection of a prescription drug, ethylene diamine tetra acetic acid (EDTA), which is approved by the Food and Drug Administration for the limited use of ridding the human body of excess heavy metals.
According to the FTC's complaint detailing the charges, ACAM's advertisements and promotional materials for chelation therapy contained such statements as:
- Chelation therapy is a safe, effective, and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery;
- Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms; and
- Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy.
Through the use of such statements, the FTC alleged, ACAM has represented that EDTA chelation therapy is an effective treatment for atherosclerosis, and that ACAM possessed and relied upon a reasonable basis when making the representations.
The FTC charged that the representations are false and misleading because ACAM did not possess and rely upon a reasonable basis to substantiate the claims.
The proposed settlement, announced today for a public comment period, would prohibit ACAM from representing that EDTA chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to substantiate the representations. In addition, the proposed settlement would require ACAM to possess competent and reliable scientific evidence to support any claims about the effectiveness or comparative effectiveness of chelation therapy for any disease of the human circulatory system.
The proposed settlement would also prohibit ACAM from misrepresenting the existence, validity, results, or contents of any test, study, or research in connection with the advertising or promotion of chelation therapy.
The settlement addresses issues raised by claims ACAM made in brochures and other materials distributed to the public. It does not attempt to regulate how doctors use or prescribe drugs in the course of treating their patients or other choice of therapy issues.
The settlement would permit ACAM to make representations permitted in labeling by the FDA.
The Commission vote to accept the proposed settlement and place it on the public record for comment was 4-0. An announcement regarding the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 60 days, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaint, the proposed settlement and an analysis of the settlement to aid in public comment, are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 202-382-4357; TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
(FTC File No.: 962 3147)
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