Eye Research Associates, Inc., et al.; Analysis to Aid Public Comment

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,

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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