[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Notices]
[Pages 69291-69292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33282]
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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
[[Page 69292]]
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