[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45650-45652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22902]


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FEDERAL TRADE COMMISSION

[File No. 962-3279]


Mid-South PCM Group, P.C.; Eye and Vision Clinic, P.C.; 
International Computerized Orthokeratology Society, Inc.; J. Mason 
Hurt, O.D.; 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 October 27, 1997.

ADDRESSES: Comments should be directed to: FTC/Office of the Secretary, 
Room 159, 6th St. and Pa. Ave., NW., Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:
Christa Vecchi, Federal Trade Commission, H-200, 6th St. and Pa. Ave., 
NW., Washington, DC 20580. (202) 326-3166. Matthew Daynard, Federal 
Trade Commission, H-200, 6th St. and Pa. Ave., NW., Washington, DC 
20580. (202) 326-3291.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C.

[[Page 45651]]

46, and Sec. 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 accompanying complaint. 
An electronic copy of the full text of the consent agreement package 
can be obtained from the Commission Actions section of the FTC Home 
Page (for August 21, 1997), 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, DC 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 Sec. 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 Mid-South PCM Group, P.C., Eye and Vision Clinic, P.C., the 
International Computerized Orthokeratology Society, Inc., and J. Mason 
Hurt, 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, broadcast and Internet advertisement 
provided directly to consumers, and to optometrists for distribution 
under their own name to consumers, for proposed respondents' ``Precise 
Corneal Molding'' orthokeratology (``PCM ortho-k'') service. PCM 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) PCM 
ortho-k provides a cure for any refractive vision deficiency thereby 
permanently eliminating the need for all corrective eyewear, including 
eyeglasses and contact lenses; and (2) all people can achieve normal 
vision without eyeglasses or contact lenses on a permanent basis if 
they wear PCM ortho-k devices occasionally or at night.
    The complaint further alleges that proposed respondents made false 
claims that: (1) PCM ortho-k has been approved by the Federal Aviation 
Administration and all branches of the United States military for use 
in correcting refractive vision deficiencies; (2) four named University 
studies prove that PCM ortho-k is safe and effective in correcting 
nearsightedness, farsightedness, and astigmatism; and (3) consumer 
testimonials for respondents' PCM ortho-k services reflect the typical 
or ordinary experience of members of the public who receive those 
services, which experience is that PCM ortho-k patients typically 
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 PCM ortho-k devices occasionally or at 
night; (2) all or most people will experience stabilized vision after 
only a few weeks or months of PCM ortho-k treatments; (3) PCM ortho-k 
prevents and reverses deteriorating nearsightedness in children; (4) 
PCM ortho-k is safer than contact lenswear; (5) PCM ortho-k is more 
effective than refractive surgical methods in eliminating 
nearsightedness, farsightedness, and all forms of astigmatism; and (6) 
PCM ortho-k has helped thousands of people achieve normal 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 PCM 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 refractive vision deficiencies): (1) Provides a cure for any 
refractive vision deficiency thereby permanently eliminating the need 
for all corrective eyewear, including eyeglasses and contact lenses: 
and (2) has been approved by the Federal Aviation Administration and 
all branches of the United States military for use in correcting 
refractive vision deficiencies. Paragraph I further prohibits proposed 
respondents from representing that: (1) All people can achieve normal 
vision without eyeglasses or contact lenses on a permanent basis if 
they wear devices used with PCM ortho-k or any substantially similar 
service occasionally or at night; and (2) four named University studies 
prove that PCM ortho-k or any substantially similar service is safe and 
effective in correcting nearsightedness, farsightedness, and 
astigmatism.
    Paragraph II of the proposed order prohibits proposed respondents 
from making any representation for PCM 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 who 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 
lenswear; (5) the comparative effectiveness of such service and 
refractive surgical methods in eliminating nearsightedness, 
farshghtedness, or any form of astigmatism; and (6) the number of 
people whom such service has helped achieve normal vision, 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 respondents from 
misrepresenting the existence, contents, validity, results, 
conclusions, or interpretations of any test, study, or research.
    Paragraph IV of the proposed order prohibits proposed respondents 
from representing that any service, procedure, or product is endorsed 
or approved by any governmental or professional organization or 
association, or complies with or meets standards or guidelines for such 
services, procedures, or products established by any such organization 
or association, unless such is the case.
    Paragraph V of the proposed order prohibits respondents from 
representing that the experience represented by any user testimonial or 
endorsement of any

[[Page 45652]]

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 VI of the proposed order prohibits respondents from 
making any representation about the relative or absolute efficacy, 
performance, benefits, safety, or success of any ophthalmic service, 
procedure, or product purporting to treat, mitigate, or cure any 
refractive vision deficiency, 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 VII 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 with whom proposed respondents have done business 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 compliant 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 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 PCM ortho-k if he or she 
continues to use such advertisements or promotional materials; (4) 
terminate any 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 with whom proposed respondents do business after the date of 
service of the order 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 PCM ortho-k. The mailing shall 
not include any other documents.
    Paragraph VIII 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 IX 
requires distribution of a copy of the consent decree to current and 
future officers and agents. Further, Paragraph X provides for 
Commission notification upon a change in the corporate respondents. 
Paragraph XI requires proposed respondent J. Mason Hurt, 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 XII, also requires the filing of a 
compliance report.
    Finally, Paragraph XIII 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. 97-22902 Filed 8-27-97; 8:45 am]
BILLING CODE 6750-01-M