American College for Advancement in Medicine; Analysis to Aid Public Comment

FEDERAL TRADE COMMISSION

[File No. 9623147]

American College for Advancement in Medicine; Analysis to Aid

Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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SUMMARY: The consent agreement in this matter settles alleged

violations of federal law prohibiting unfair or deceptive acts or

practices or unfair methods of competition. The attached Analysis to

Aid Public Comment describes both the allegations in the draft

complaint that accompanies the consent agreement and the terms of the

consent order--embodied in the consent agreement--that would settle

these allegations.

DATES: Comments must be received on or before February 16, 1999.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,

Room 159, 600 Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Dean Graybill, FTC/H-200, Washington, D.C. 20580. (202) 326-3284 or

Richard Cleland, FTC/H-200, Washington, D.C. 20580. (202) 326-3088.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal

Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46 and Section 2.34 of

the Commission's Rules of Practice (16 CFR 2.34), notice is hereby

given that the above-captioned consent agreement containing a consent

order to cease and desist, having been filed with and accepted, subject

to final approval, by the Commission, has been placed on the public

record for a period of sixty (60) days. The following Analysis to Aid

Public Comment describes the terms of the consent agreement, and the

allegations in the complaint. An electronic copy of the full text of

the consent agreement package can be obtained from the FTC Home Page

(for December 8, 1998), on the World Wide Web, at ``http://www.ftc.gov/

os/actions97.htm.'' A paper copy can be obtained from the FTC Public

Reference Room, Room H-130, 600 Pennsylvania Avenue, NW., Washington,

D.C. 20580, either in person or by calling (202) 326-3627. Public

comment is invited. Such comments or views will be considered by the

Commission and will be available for inspection and copying at its

principal office in accordance with Section 4.9(b)(6)(ii) of the

Commission's Rules of Practice (16 CFR 4.9(b)(6)(ii).

Analysis of Proposed Consent Order To Aid Public Comment

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

body's 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

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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 I.A). 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

Commission's 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.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98-33282 Filed 12-15-98; 8:45 am]

BILLING CODE 6750-01-M