[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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[[Page 9548]]

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