Direct-to-Consumer Advertising of Genetic Tests

Sarah BothaDivision 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