The Federal Trade Commission staff has received numerous inquiries concerning the promotion and advertising of radial keratotomy (RK) and photorefractive keratectomy (PRK) using the excimer laser systems recently approved by the U.S. Food and Drug Administration (FDA). The FDA and FTC staff issued a joint communique on PRK promotion and advertising on May 7, 1996. The FTC staff takes this opportunity to provide further guidance to eye care providers concerning the requirements of Section 5 of the Federal Trade Commission Act that may apply to the marketing of these, and other, refractive surgical procedures.

Requirements for Advertising Under the Federal Trade Commission Act

The FTC enforces the Federal Trade Commission Act (FTC Act), which among other things prohibits deceptive or unfair practices in or affecting commerce. 15 U.S.C. §§ 45, 52-57. An advertisement is deceptive under Section 5 of the FTC Act, and therefore unlawful, if it contains a representation or omission of fact that is likely to mislead consumers acting reasonably under the circumstances, and that representation or omission is material, that is, likely to affect a consumer’s choice or use of a product or service. It is important to note that advertisers are responsible for claims that are reasonably implied from their advertisements, as well as claims that are expressly stated.

In addition, under the FTC Act, advertisers must have substantiation for all objective claims about a product or service before the claims are disseminated. In the context of claims about the safety, efficacy, success or other benefits of RK or PRK, substantiation will usually require competent and reliable scientific evidence(1) sufficient to support the claim that is made.(2)

Finally, under the FTC Act, deception can occur through omission of information when that information is necessary to prevent an affirmative representation from being misleading, or simply by remaining silent, if doing so constitutes an implied but false representation. Not all omissions are deceptive, even if providing the information would benefit consumers. An omission is considered deceptive only if the absence of the information causes the advertisement to convey an inaccurate impression about a material fact.

Under FTC law, therefore, advertisements, promotional brochures, informational tapes, seminars and other forms of marketing of RK or PRK to consumers should not contain express or implied claims that are false or unsubstantiated, or omissions of material information. In particular, claims that convey an inaccurate impression about the safety, efficacy, success or other benefits of PRK would raise deception concerns. For example, an unqualified claim for PRK that patients can “throw away their eyeglasses” would be suspect because the FDA has approved the excimer laser only for the treatment of mild to moderate nearsightedness and not to treat other refractive vision deficiencies. Likewise, the same claim made for RK would also be questionable because published, multi-center studies indicate that RK does not eliminate the need for corrective lenses for all refractive vision deficiencies. Even a more limited claim, suggesting only that patients who are nearsighted, with no other refractive vision deficiencies, can “throw away their eyeglasses” may also be deceptive, without further qualification, if, after surgery, a significant number of patients require eyeglasses for best vision, for reading, or under particular circumstances, such as for night driving.

Similarly, claims regarding success rates, long-term stability or predictability of outcome would also need to be substantiated by competent and reliable scientific evidence. It is important to keep in mind that the fact that the FDA has approved the excimer laser for use in PRK does not by itself necessarily provide adequate substantiation for all specific claims about the success of the procedure.

Finally, representations made about the safety or efficacy of RK or PRK, may, in certain circumstances, require disclosures of material information about health risks or limitations associated with the surgery to prevent deception. For example, an advertisement containing express or implied representations that the surgery is safe may also need to contain information about any significant risks associated with the surgery, and, for PRK, with the particular laser in use.

Questions about this letter may be directed to the FTC’s Service Industry Practices, Bureau of Consumer Protection staff at (202) 326-3319 (Walter Gross) or (202) 326-3291 (Matt Daynard) or the FTC’s Boston Regional Office staff at (617) 424-5960 (Paul Block or Colleen Lynch).

(1)“Competent and reliable scientific evidence” means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted by others in the profession to yield accurate and reliable results.

(2)The substantiation must also be examined in the context of the entire body of evidence, particularly if it produces results that are contrary to that body of evidence. Further guidance on the deception and substantiation standards are set forth in the Commission’s Policy Statement on Deception (Cliffdale Associates, Inc., 103 F.T.C. 100, 176 (1984), reprinting as Appendix letter dated Oct. 14, 1983, from the Commission to The Honorable John D. Dingell, Chairman, Committee on Energy and Commerce, U.S. House of Representatives) and its Policy Statement on Advertising Substantiation (48 Fed. Reg. 10,471 (1984) reprinted in Thompson Medical Co., 104 F.T.C. 648, 839 (1984), aff’d, 791 F.2d 189 (D.C. Cir.1986), cert. denied, 479 U.S. 1086 (1987).

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