[Federal Register Volume 63, Number 37 (Wednesday, February 25, 1998)]
[Notices]
[Pages 9547-9549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4753]
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FEDERAL TRADE COMMISSION
[File No. 962-3211]
Eye Research Associates, Inc., et al.; 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 April 27, 1998.
ADDRESSES: Comments should be directed to: FTC/Office of the Secretary,
Room 159, 6th St. and Pa. Ave., NW., Washington, D.C. 20580.
FOR FURTHER INFORMATION CONTACT:
Judy Shepherd, FTC, Dallas Regional Office, 1999 Bryan St., Suite 2150,
Dallas, TX 75201. (214) 979-9383. Matt Daynard, FTC/H-200, Washington,
D.C. 20580. (202) 326-3291.
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 February 19, 1998), on the World Wide Web, at ``http://
www.ftc.gov/os/actions/htm.'' A paper copy can be obtained from the FTC
Public Reference Room, Room H-130, Sixth Street and 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, subject to final
approval, an agreement to a proposed Consent Order (``proposed order'')
from Eye Research Associates, Inc. d/b/a Eye Care Associates, ICKRS, d/
b/a/ International Controlled Kerato Reformation Society, and Sami G.
El Hage, O.D., the sole owner and President of the corporations.
The proposed consent order has been placed on the public record for
sixty (60) days for the 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.
This matter concerns print advertisements and videotapes provided
directly to consumers, and to optometrists for distribution under their
own name to consumers, for proposed respondents' ``CKR'') (``Controlled
Kerato Reformation'') orthokeratology service (``CKR ortho-k''). CKR
ortho-k is an eye care service involving the use of a series of contact
lenses purportedly to reshape the cornea gradually for the treatment of
myopia, or nearsightedness (difficulty seeing at a distance),
hyperopia, or farsightedness (difficulty seeing up close), and
astigmatism (blurred vision).
The Commission's complaint charges that the proposed respondents
engaged in deceptive advertising in violation of Sections 5 and 12 of
the FTC Act by making false and unsubstantiated claims that: (1) CKR
ortho-k corrects nearsightedness and astigmatism thereby permanently
eliminating the need for all corrective eyewear, including eyeglasses
and contact lenses for nearsightedness and astigmatism; and (2) all or
most people can achieve normal vision without eyeglasses or contact
lenses on a permanent basis if they wear CKR ortho-k devices
occasionally or at night.
The complaint further alleges that proposed respondents made false
claims that: (1) Four named University studies prove that CKR ortho-k
is safe and effective in correcting, controlling, or improving
nearsightedness, farsightedness and astigmatism; and (2) consumer
testimonials for respondents' CKR ortho-k services reflect the typical
or ordinary experience of members of the public who receive those
services, which experience is that CKR ortho-k patients typcially
achieve 20/20 vision and no longer need corrective eyewear.
The complaint further alleges that proposed respondents made
unsubstantiated claims that: (1) A significant number of people can
achieve normal vision without eyeglasses or contact lenses on a
permanent basis if they wear CKR ortho-k devices occasionally or at
night; (2) all or most people will experience stabilized vision after
only a few weeks or months of CKR otho-k treatments; (3) CKR ortho-k
prevents and reverses deteriorating nearsightedness in children; (4)
CKR ortho-k is as safe as contact lens wear; (5) CKR ortho-k is as
effective as refractive surgical methods in correcting, controlling, or
improving nearsightedness, farsightedness, and astigmatism; (6) CKR
ortho-k has helped thousands of people achieve normal vision; and (7)
CKR ortho-k provides commerical pilots and other career professionals
with stable 20/20 vision thereby enabling them to meet occupational
requirements for unaided vision.
The proposed order contains provisions designed to remedy the
violations charged and to prevent proposed respondents from engaging in
similar acts in the future.
Paragraph I of the proposed order prohibits proposed respondents
from claiming that CKR ortho-k, or any substantially similar service
(defined as any ophthalmic service or procedure using contact lenses or
similar devices to modify the shape of the cornea and reduce or
eliminate nearsightedness, farsightedness, and astigmatism): (1)
Corrects nearsightedness and astigmatism thereby permanently
eliminating the need for all corrective eyewear, including eyeglasses
and contact lenses for those conditions; and (2) all or most people can
achieve normal vision without eyeglasses or contact lenses on a
permanent basis if they wear devices used with CKR ortho-k or any
substantially similar service occasionally or at night. Paragraph I
further prohibits proposed respondents from representing that four
named University studies prove that CKR ortho-k or any substantially
similar service is safe and effective in correcting, controlling, or
improving nearsightedness, farsightedness, and astigmatism.
Paragraph II of the proposed order prohibits proposed respondents
from making any representation for CKR ortho-k, or any substantially
similar service, about: (1) The number of people who can achieve normal
vision without eyeglasses or contact lenses on a permanent basis if
they wear devices used with such service occasionally or at night; (2)
the number of people will experience stabilized vision after only a few
weeks or months of treatments under such service; (3) the ability of
such service to prevent or reverse deteriorating nearsightedness in
children; (4) the comparative safety of such service and contact lens
wear; (5) the comparative effectiveness of such service and refractive
surgical methods in eliminating nearsightedness,
[[Page 9549]]
farsightedness, or any form a astigmatism; (6) the number of people
whom such service has helped achieve normal vision; and (7) the ability
of such service to provide pilots and other career professionals with
stable visual acuity sufficient to meet occupational vision
requirements, unless, at the time the representation is made, proposed
respondents possess and rely upon competent and reliable scientific
evidence that substantiates the representation.
Paragraph III of the proposed order prohibits proposed respondents
from misrepresenting the existence, contents, validity, results,
conclusions, or interpretations of any test, study, survey, or report.
Paragraph IV of the proposed order prohibits proposed respondents
from representing that the experience represented by any user
testimonial or endorsement of any service, procedure, or product
represents the typical or ordinary experience of members of the public
who use the service, procedure, or product, unless the representation
is true, and competent and reliable scientific evidence substantiates
that claim, or respondents clearly and prominently disclose either: (1)
What the generally expected results would be for program participants;
or (2) the limited applicability of the endorser's experience to what
consumers may generally expect to achieve, that is, that consumers
should not expect to achieve similar results.
Paragraph V of the proposed order prohibits proposed respondents
from making any representation about the relative or absolute efficacy,
performance, or benefits of any ophthalmic service, procedure, or
product purporting to treat, mitigate, or cure nearsightedness,
farsightedness, or astigmatism, unless the representation is true and,
at the time the representation is made, proposed respondents possess
and rely upon competent and reliable scientific evidence that
substantiates the representation.
Paragraph VI of the proposed order requires that proposed
respondents: (1) Not disseminate to any optometrist or eye care
provider any material containing any representations prohibited by the
order; (2) send a required notice to each optometrist or eye care
provider who has attended one of proposed respondents' seminars since
January 1, 1994 requesting that the optometrist cease using any
materials previously received from proposed respondents that contain
any claims violative of the order, informing the optometrist of this
settlement, and attaching a copy of this proposed complaint and order;
(3) in the event that proposed respondents receive any information that
subsequent to receipt of the required notice any optometrist or eye
care provider with whom the proposed respondents have an agreement to
market and/or perform CKR services is using or disseminating any
advertisement or promotional material that contains any representation
prohibited by the order, immediately notify the optometrist or eye care
provider that proposed respondents will terminate the optometrist or
eye care provider's right to market and/or perform CKR ortho-k if he or
she continues to use such advertisements or promotional materials; (4)
terminate any such optometrist or eye care provider about whom proposed
respondents receive any information that such person has continued to
use advertisements or promotional materials that contain any
representation prohibited by the order after receipt of the required
notice; and (5) for a period of three (3) years following service of
the order, send the required notice to each optometrist or eye care
provider who attends proposed respondents' seminars who has not
previously received the notice; the notices shall be sent no later than
the earliest of: (1) The execution of a sales or training agreement or
contract between proposed respondents and the prospective optometrist
or eye care provider; or (2) the receipt and deposit of payment from a
prospective optometrist or eye care provider of any consideration in
connection with the sale of any service or rights associated with CKR
ortho-k. The mailing shall not include any other documents.
Paragraph VII of the proposed order contains record keeping
requirements for materials that substantiate, qualify, or contradict
covered claims and requires the proposed respondents to keep and
maintain all advertisements and promotional materials containing any
representation covered by the proposed order. In addition, Paragraph
VIII requires distribution of a copy of the consent decree to current
and future officers and agents. Further, Paragraph IX provides for
Commission notification upon a change in the corporate respondents.
Paragraph X requires proposed respondent Sami G. El Hage, O.D. to
notify the Commission when he discontinues his current business or
employment and of his affiliation with any new business or employment.
The proposed order, in paragraph XI, also requires the filing of a
compliance report.
Finally, Paragraph XII of the proposed order provides for the
termination of the order after twenty years under certain
circumstances.
The purpose of this analysis is to facilitate public comment on the
proposed order, and it is not intended to constitute an official
interpretation of the agreement and proposed order, or to modify in any
way their terms.
Donald S. Clark,
Secretary.
[FR Doc. 98-4753 Filed 2-24-98; 8:45 am]
BILLING CODE 6750-01-M
