ANALYSIS OF PROPOSED CONSENT
The Federal Trade Commission has accepted an agreement to a proposed consent order from the American College for Advancement in Medicine ("ACAM" or the "proposed respondent"). ACAM is an incorporated non-profit professional association comprised principally of physicians. The Commission has alleged that ACAM promotes EDTA chelation therapy to the public as an effective treatment for atherosclerosis, i.e., blocked arteries. Chelation therapy consists of the intravenous injection into the body of a chemical substance (ethylene diamine tetraacetic acid, ("EDTA")), which, after bonding with metals and minerals in the bloodstream, is expelled through the bodys excretory functions. ACAM promotes this service to consumers through print materials and a Web site.
The proposed consent order has been placed on the public record for sixty (60) days for reception of comments by interested persons. Comments received during this period will become part of the public record. After sixty (60) days, the Commission will again review the agreement and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
The Commission has alleged that proposed respondent has made false and unsubstantiated claims in its advertising materials that are likely to mislead consumers concerning (1) the effectiveness of EDTA chelation therapy to treat atherosclerosis; and (2) the existence of scientific proof of the effectiveness of EDTA chelation therapy.
The proposed consent order addresses the alleged misrepresentations cited in the accompanying complaint by prohibiting proposed respondent from representing in any future advertising for chelation therapy that EDTA chelation therapy is effective to treat atherosclerosis unless the representation is supported by competent and reliable scientific evidence (Part IA). In addition, the proposed order requires that proposed respondent have 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 (Part I.B).
The proposed consent order also prohibits proposed respondent from misrepresenting in any future advertising for chelation therapy, the existence, contents, validity, results, conclusions or interpretations of any test, study, or research (Part II). Part III of the order allows proposed respondent to make representations permitted in labeling by the U.S. Food and Drug Administration.
The proposed consent order also requires that ACAM send a letter to its membership notifying them of the existence of the FTC order and advising them that any member who makes unsubstantiated advertising claims for chelation therapy could be subject to an enforcement action (Part IV). Other provisions in the consent order are customary record keeping, reporting and notification requirements as well as a "sunsetting" clause prescribing that the order automatically expires 20 years from either the date that the order becomes effective or the date of the last enforcement action.
The complaint and consent agreement in this matter address issues raised by certain statements that respondent made in its promotional brochures and other materials that were distributed to the public. The Commissions action should not be construed to regulate how doctors use or prescribe drugs in the course of treating their patients or other choice of therapy issues.
The purpose of this analysis is to facilitate public comment on the proposed order, and is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.