http://www.ftc.gov/bcp/guides/eyecare2.shtm
Marketing of Refractive Eye Care Surgery:
Guidance for Eye Care Providers
The Federal Trade Commission (FTC) has prepared this guidance on marketing
Lasik and alternative laser refractive procedures, known as "surface
ablation techniques," for eye care providers. It explains the requirements
of Section 5 of the FTC Act that apply to the promotion of these
procedures.
The FDA has approved excimer laser systems for Lasik and surface ablation
techniques, and millions of people have undergone these procedures in
search
of better vision.
Requirements for Advertising Under the FTC Act
The FTC enforces Section 5 of the Federal Trade Commission Act (FTC Act),
which prohibits deceptive or unfair practices in or affecting commerce,
and
Section 12 of the FTC Act, which prohibits the dissemination of any false
advertisement to induce the purchase of any food, drug, device, or
service.
An ad is deceptive under Section 5 of the FTC Act if it has a statement -
or
omits information - that:
a.. is likely to mislead consumers acting reasonably under the
cir***stances; and
b.. is "material" - that is, im****tant to a consumer's decision to buy
or
use the product.
An ad or business practice is unfair if:
a.. it causes or is likely to cause substantial consumer injury that a
consumer could not reasonably avoid; and
b.. the injury is not outweighed by any benefit the practice provides to
consumers or competition.
The FTC looks at an ad from the point of view of the "reasonable consumer"
-
the typical person looking at the ad. Rather than focusing on certain
words
or phrases, the FTC looks at an ad's entire context - words, phrases, and
pictures - to determine what it conveys to consumers.
Both "express" and "implied" claims are im****tant to the FTC. An express
claim is one that is made literally in the ad. For example, a claim that
"more of our [ABC Lasik Center] patients achieve 20/20 vision than those
of
our competitors" is an express claim that ABC's patients achieve better
results. An implied claim is made indirectly or by inference. For example,
the representation made by a patient in a testimonial that "the procedure
was easy" implies that there are no complications or side effects for most
of ABC Lasik Center's patients. Under the law, advertisers must have proof
to back up any claim that consumers reasonably take from an ad.
The FTC also looks at what the ad does not say - that is, if omitting
information leaves consumers with a misimpression about the product or
service. For example, a representation that ABC Lasik Center "provides a
free consultation" may mislead consumers if it doesn't say that a
non-refundable deposit is required before their candidacy for the surgery
is
determined by a healthcare professional, if that is the case.
Whether a claim would be "material" - that is, im****tant to a consumer's
decision to buy or use the product or service also is a key factor for the
FTC. Examples of material claims are representations about a product or
service's performance, features, safety, price, or effectiveness.
Finally, a company must have a "reasonable basis" for its claims before it
runs an ad. A "reasonable basis" means objective evidence that sup****ts
the
claim. The kind of evidence depends on the claim. At a minimum, an
advertiser must have the level of evidence that it says it has. For
example,
the statement, "clinical studies show that the laser used by Dr. X results
in 20/20 vision 85 percent of the time," must be sup****ted by clinical
studies to that effect for Dr. X's patients. If the ad isn't specific, the
FTC looks at several factors to determine what level of proof is
necessary,
including what experts in the field think is needed to sup****t the claim.
In
most cases, ads that make health or safety claims must be sup****ted by
"competent and reliable scientific evidence," which means tests, studies,
or
other scientific evidence that has been evaluated by qualified people. In
addition, any tests or studies must be conducted using methods that
experts
in the field accept as accurate. Statements from satisfied customers are
not
sufficient to sup****t a health or safety claim or any other claim that
requires objective evaluation.
Under FTC law, ads, promotional brochures, informational tapes, seminars
and
other forms of marketing of Lasik or any other refractive surgery to
consumers should not have express or implied claims that are false or
unsubstantiated, or that omit material information. In particular, claims
that convey an inaccurate impression about the safety, efficacy, success
or
other benefits of any form of refractive surgery would raise concerns
about
deception. For example, a claim for Lasik or surface ablation procedures
suggesting that patients who are nearsighted, with no other refractive
vision deficiencies, can "throw away their eyegl*****" may be deceptive
without further qualification, if, after surgery, a significant number of
patients require eyegl***** for best vision, for reading, or under
particular cir***stances, such as for night driving.
Claims about success rates, long-term stability, or predictability of
outcome must be substantiated by competent and reliable scientific
evidence.
Keep in mind that FDA approval of the excimer laser for use in Lasik is
not,
by itself, adequate substantiation for all specific claims about the
success
of the procedure.
In addition, representations about the safety or efficacy of Lasik or any
other refractive surgery sometimes may require disclosures of key
information about health risks or limitations associated with the surgery
to
prevent charges of deception. An advertisement with express or implied
representations that the procedure is "safe," or "clinically proven to be
safe," for example, also should tell consumers that, like any surgery,
Lasik, or other advertised refractive surgery, has risks and potential
complications, and that they will be discussed during a surgical
consultation prior to the procedure.
For further guidance on FTC requirements for advertising, see the FTC
Policy
Statement on Deception at www.ftc.gov/bcp/policystmt/ad-decept.htm and the
FTC Policy Statement on Unfairness at
www.ftc.gov/bcp/policystmt/ad-unfair.htm.
For more information contact Matt Daynard in the FTC's Division of
Advertising Practices, Bureau of Consumer Protection, at mdaynard@[EMAIL PROTECTED]
(202) 326-3291.
October 2008
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