The Federal Trade Commission has again charged a company with falsely advertising that a non-surgical eye care treatment is a safe and effective way to correct vision. The company, Eye Care Associates, and its owner, Sami El Hage, O.D., are the primary sources for an eye care service called "Controlled Kerato-Reformation" orthokeratology ("CKR"). They have agreed to settle the charges. Eye Care Associates markets CKR as a safe and effective non-surgical alternative to laser PRK (photorefractive keratectomy) and RK (radial keratotomy) that corrects certain vision impairments by reshaping the cornea, thereby eliminating the need for eyeglasses and contact lenses. According to the FTC, El Hage's claims are false and unsubstantiated. The settlement with the FTC would prohibit El Hage from making any false claims and would require reliable scientific evidence for any safety, success or efficacy claims. The investigation, which was conducted with the Attorney General of the state of Texas, resulted in a settlement similar to one previously announced against J. Mason Hurt, O.D., a Tennessee eye doctor who was charged by the Commission with deceptive advertising for his eye care treatment.
"Once again, the FTC is sending the message that no one should be allowed to lure consumers into undertaking eye treatments that don't deliver as promised," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "Working with the Texas Attorney General, consumers will be assured of the reliability and accuracy of information about these products."
CKR, a form of orthokeratology, uses a series of contact lenses purportedly to reshape the cornea gradually to correct nearsightedness, farsightedness, and astigmatism. Four academic studies published in the late 1970s and early 1980s examined questions of whether contact lenses could be used to reshape the cornea and lessen or eliminate the need for corrective eyewear. These studies found only a very small decrease in nearsightedness that would not eliminate the need for eyewear for most patients. Further, the reduction is only temporary because the cornea tends to regain its pre-treatment shape when lens wear is discontinued.
According to the FTC, El Hage has aggressively promoted CKR through Texas print media, including daily newspapers, fitness magazines distributed free in health clubs, health food stores, book stores, and concert programs for cultural organizations such as the Houston Ballet and Symphony. Since 1994, El Hage also has conducted "symposia" to teach and promote CKR to optometrists.
The FTC's complaint charges that El Hage made false and unsubstantiated claims that CKR is a proven, safe, and effective means of correcting vision in children and adults. The Commission specified as false claims that:
The complaint also alleges that El Hage expressly or by implication 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 ortho-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 or improving nearsightedness, farsightedness, and astigmatism; (6) CKR ortho-k has helped thousands of people achieve normal vision; and (7) CKR ortho-k provides commercial pilots and other career professionals with stable 20/20 vision thereby enabling them to meet occupational requirements for unaided vision.
The settlement would prohibit El Hage from claiming that CKR or any similar procedure corrects nearsightedness and astigmatism; that people can permanently correct their vision without glasses or contact lenses if they wear CKR devices occasionally or at night; and that the academic studies prove that CKR is safe and effective in correcting vision problems. In addition, the FTC would require El Hage to have "competent and reliable scientific evidence" before making any claims that CKR or a similar procedure can stabilize vision after a few weeks or months of treatment, prevent or reverse nearsightedness in children, and enable pilots and other career professionals to meet occupational vision requirements. El Hage must have similar support for claims about the number of people whom the service has helped to achieve normal vision, claims regarding the safety of the procedure compared to contact lenswear, and claims about the effectiveness of the service compared to surgical methods to correct nearsightedness, farsightedness, or astigmatism.
Any testimonial about the expected results of CKR would have to be true for the general public and supported by scientific evidence, unless El Hage clearly disclosed what the typical experience would be or that consumers should not expect to achieve the same result as the endorser. Any misrepresentation of study results also would be prohibited by the settlement.
El Hage also could not send to any eye care provider any material containing any representations prohibited by the settlement order. He would be required to send to each optometrist or eye care provider who has attended one of his seminars a notice informing them of the settlement and requesting that any materials that violate the settlement not be used. El Hage also would have to terminate any right he had granted to an optometrist to market and/or perform CKR ortho-k if any ad or promotion restricted by the settlement is disseminated by that optometrist.
Finally, the order contains various record keeping requirements that would assist the FTC in monitoring compliance.
The Commission vote to accept the proposed consent agreement for public comment was 4-0 with Commissioner Mary L. Azcuenaga not participating.
An analysis of the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 60 days, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaint, proposed consent agreement and an analysis of the agreement to assist the public in commenting will be available on the Internet at the FTC's World Wide Web site at: http://www.ftc.gov or by calling 202-326-3627. FTC documents also are available from the FTC's Consumer Response Center, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 1-866-653-4261. TTY for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC's NewsPhone recording at 202-326-2710.
(FTC File No. 962-3211)