Direct-to-Consumer Advertising of Genetic Tests Sarah Botha Division of Advertising Practices Federal Trade Commission The opinions expressed are my own and not necessarily those of the FTC

DTC Advertising of Genetic Tests and the FTC FTC’s jurisdiction over DTC advertising of genetic tests FTC’s method for evaluating promotional claims for health-related products Tools the FTC uses to prevent consumer deception FTC’s role with respect to genetic testing

FTC Legal Framework and Approach to Regulation Primarily a law enforcement agency No pre-market approval process No regulatory distinction between product categories No regulatory distinction between health/disease/structure function claims

Advertising and the FTC “The dissemination or the causing to be disseminated of any false advertisement . . . shall be an unfair or deceptive act or practice . . . under section 5 [of the FTC Act, 15 U.S.C. § 45].” 15 U.S.C. § 52(b)

Health Products and the FTC “It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement . . . by any means . . . for the purpose of inducing . . . directly or indirectly, the purchase . . . of food, drugs, devices, services, or cosmetics.” 15 U.S.C. § 52(a)

Advertiser’s Responsibilities An advertiser is responsible for all objective claims – express and implied – that are conveyed to reasonable consumers “[A]n otherwise false advertisement is not rendered acceptable merely because one possible interpretation of it is not untrue.” (In re National Commission on Egg Nutrition et al., 1976) Ads must be truthful and not misleading An ad may be literally truthful and yet still be deceptive to consumers An ad may be deceptive by omission

Advertiser’s Responsibilities All objective claims must be substantiated at the time they are made Any disclaimer that is necessary to prevent an ad from being deceptive must be “clear and conspicuous” and must effectively convey the correct net impression to consumers

Substantiation Must have a reasonable basis for any objective claim At least the level claimed in the ad Depends on a variety of factors, including nature of the claim - “soft, radiant skin” vs. “proven protection against skin cancer”

Substantiation for Scientific Claims Health- or safety-related claims must be substantiated with competent and reliable scientific evidence at the time that the claims are made.

Not all clinical studies are the same – the best studies: Test the relevant clinical endpoints Are tested on a representative human population Test the finished product itself, not individual ingredients Test the same dosages and delivery method Are double-blinded, randomized, and placebo-controlled Are statistically significant and have clinically meaningful results Are published in peer-reviewed journals

Clinical studies must be examined in context Can’t evaluate studies in isolation Consider all relevant evidence Reconcile inconsistent/conflicting results Claim may need to be qualified Don’t make claim if weight of evidence contradicts

What Are Our Priorities? Products that claim to treat or cure serious diseases Products that potentially pose significant safety concerns to consumers Products that are deceptively marketed to or for children and adolescents Claims with the potential to cause widespread or severe consumer injury Referrals from the NAD and other self-regulatory programs

FTC Tools for Combating Deception Monitoring of DTC advertising claims for genetic testing and enforcement actions where appropriate Consumer education July 2006: FTC-FDA-CDC joint consumer fact sheet titled, “At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription”

FTC Participation on SACGHS Serve as an Ex Officio member on the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS)

WWW.FTC.GOV Sarah Botha sbotha@ftc.gov 202-326-2036